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Electronic Code of Federal Regulations

e-CFR data is current as of November 14, 2019

Title 21Chapter ISubchapter HPart 868 → Subpart F


Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES


Subpart F—Therapeutic Devices


Contents
§868.5090   Emergency airway needle.
§868.5100   Nasopharyngeal airway.
§868.5105   External negative pressure airway aid.
§868.5110   Oropharyngeal airway.
§868.5115   Device to relieve acute upper airway obstruction.
§868.5120   Anesthesia conduction catheter.
§868.5130   Anesthesia conduction filter.
§868.5140   Anesthesia conduction kit.
§868.5150   Anesthesia conduction needle.
§868.5160   Gas machine for anesthesia or analgesia.
§868.5165   Nitric oxide administration apparatus.
§868.5170   Laryngotracheal topical anesthesia applicator.
§868.5180   Rocking bed.
§868.5220   Blow bottle.
§868.5240   Anesthesia breathing circuit.
§868.5250   Breathing circuit circulator.
§868.5260   Breathing circuit bacterial filter.
§868.5270   Breathing system heater.
§868.5273   Positive airway pressure delivery system.
§868.5280   Breathing tube support.
§868.5300   Carbon dioxide absorbent.
§868.5310   Carbon dioxide absorber.
§868.5320   Reservoir bag.
§868.5330   Breathing gas mixer.
§868.5340   Nasal oxygen cannula.
§868.5350   Nasal oxygen catheter.
§868.5365   Posture chair for cardiac or pulmonary treatment.
§868.5375   Heat and moisture condenser (artificial nose).
§868.5400   Electroanesthesia apparatus.
§868.5420   Ether hook.
§868.5430   Gas-scavenging apparatus.
§868.5440   Portable oxygen generator.
§868.5450   Respiratory gas humidifier.
§868.5454   High flow humidified oxygen delivery device.
§868.5460   Therapeutic humidifier for home use.
§868.5470   Hyperbaric chamber.
§868.5530   Flexible laryngoscope.
§868.5540   Rigid laryngoscope.
§868.5550   Anesthetic gas mask.
§868.5560   Gas mask head strap.
§868.5570   Nonrebreathing mask.
§868.5580   Oxygen mask.
§868.5590   Scavenging mask.
§868.5600   Venturi mask.
§868.5620   Breathing mouthpiece.
§868.5630   Nebulizer.
§868.5640   Medicinal nonventilatory nebulizer (atomizer).
§868.5650   Esophageal obturator.
§868.5655   Portable liquid oxygen unit.
§868.5665   Powered percussor.
§868.5675   Rebreathing device.
§868.5690   Incentive spirometer.
§868.5700   Nonpowered oxygen tent.
§868.5710   Electrically powered oxygen tent.
§868.5720   Bronchial tube.
§868.5730   Tracheal tube.
§868.5740   Tracheal/bronchial differential ventilation tube.
§868.5750   Inflatable tracheal tube cuff.
§868.5760   Cuff spreader.
§868.5770   Tracheal tube fixation device.
§868.5780   Tube introduction forceps.
§868.5790   Tracheal tube stylet.
§868.5795   Tracheal tube cleaning brush.
§868.5800   Tracheostomy tube and tube cuff.
§868.5810   Airway connector.
§868.5820   Dental protector.
§868.5830   Autotransfusion apparatus.
§868.5860   Pressure tubing and accessories.
§868.5870   Nonrebreathing valve.
§868.5880   Anesthetic vaporizer.
§868.5895   Continuous ventilator.
§868.5905   Noncontinuous ventilator (IPPB).
§868.5915   Manual emergency ventilator.
§868.5925   Powered emergency ventilator.
§868.5935   External negative pressure ventilator.
§868.5955   Intermittent mandatory ventilation attachment.
§868.5965   Positive end expiratory pressure breathing attachment.
§868.5975   Ventilator tubing.
§868.5995   Tee drain (water trap).

§868.5090   Emergency airway needle.

(a) Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.

(b) Classification. Class II (performance standards).

§868.5100   Nasopharyngeal airway.

(a) Identification. A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001]

§868.5105   External negative pressure airway aid.

(a) Identification. An external negative pressure airway aid is a prescription device that applies negative pressure to a patient's neck to aid in providing a patent airway during procedures requiring anesthesia.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must document any adverse events observed during clinical use, including impaired blood flow, and demonstrate that the device performs as intended under anticipated conditions.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated patient positions, does not fail during use, and does not lose negative pressure capability. The following testing should be performed:

(i) Ability of the device to maintain a seal during various patient positions;

(ii) Device leakage testing to demonstrate the device maintains vacuum;

(iii) Drop testing to ensure the device does not incur functional damage after dropping the device; and

(iv) Functional testing after high and low storage temperature.

(3) All patient contacting components must be demonstrated to be biocompatible.

(4) Labeling must include:

(i) A summary of clinical testing results, including any adverse events and evidence that effectiveness has been achieved.

(ii) Technical specifications of the device, including collar sizes, maximum duration of use, operating temperature, and storage temperature range.

(iii) Technical specifications of the vacuum source, including maximum vacuum level and operational vacuum level.

(iv) Instructions for use that includes how to place the device, determination of size, verification of suction, reference to training materials, and information on troubleshooting the device if it does not attach properly.

(v) A warning to screen patients for carotid artery disease due to the probable risk of the device to dislodge arterial plaques in the carotid artery.

(vi) A warning to exclude patients with anatomical abnormalities.

(vii) A warning not to use the device during medical procedures involving medications that contain propofol.

[82 FR 60867, Dec. 26, 2017]

§868.5110   Oropharyngeal airway.

(a) Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001]

§868.5115   Device to relieve acute upper airway obstruction.

(a) Identification. The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction.

(b) Classification. Class II (special controls) (“Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices”). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to §868.9.

[65 FR 39099, June 23, 2000; 65 FR 47669, Aug. 3, 2000]

§868.5120   Anesthesia conduction catheter.

(a) Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

(b) Classification. Class II (performance standards).

§868.5130   Anesthesia conduction filter.

(a) Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.

(b) Classification. Class II (performance standards).

§868.5140   Anesthesia conduction kit.

(a) Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

(b) Classification. Class II (performance standards).

§868.5150   Anesthesia conduction needle.

(a) Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

(b) Classification. Class II (performance standards).

§868.5160   Gas machine for anesthesia or analgesia.

(a) Gas machine for anesthesia—(1) Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.

(2) Classification. Class II (performance standards).

(b) Gas machine for analgesia—(1) Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

(2) Classification. Class II (performance standards).

§868.5165   Nitric oxide administration apparatus.

(a) Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.

(b) Classification. Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”

[65 FR 11465, Mar. 3, 2000]

§868.5170   Laryngotracheal topical anesthesia applicator.

(a) Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.

(b) Classification. Class II (performance standards).

§868.5180   Rocking bed.

(a) Identification. A rocking bed is a device intended for temporary use to help patient ventilation (breathing) by repeatedly tilting the patient, thereby using the weight of the abdominal contents to move the diaphragm.

(b) Classification. Class II (performance standards).

§868.5220   Blow bottle.

(a) Identification. A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a patient. The patient blows into the device to move a column of water from one bottle to another.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, 2001]

§868.5240   Anesthesia breathing circuit.

(a) Identification. An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001]

§868.5250   Breathing circuit circulator.

(a) Identification. A breathing circuit circulator is a turbine device that is attached to a closed breathing circuit and that is intended to circulate anesthetic gases continuously by maintaining the unidirectional valves in an open position and reducing mechanical dead space and resistance in the breathing circuit.

(b) Classification. Class II (performance standards).

§868.5260   Breathing circuit bacterial filter.

(a) Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.

(b) Classification. Class II (performance standards).

§868.5270   Breathing system heater.

(a) Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

(b) Classification. Class II (performance standards).

§868.5273   Positive airway pressure delivery system.

(a) Identification. A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:

(i) Waveform testing must simulate breathing conditions and evaluate pressure and airflow response over a range and combination of high and low breath rates and tidal volumes.

(ii) Use life testing must demonstrate adequate device performance over the labeled use life of the device.

(iii) Device integrity testing must demonstrate that the device can withstand typical forces expected during use.

(iv) Carbon dioxide rebreathing testing must be performed.

(v) System flow rate, maximum expiratory pressure, inhalation pressure, and intra-mask static pressure testing must be performed.

(vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures.

(vii) Maximum limited pressure testing of the flow generator in single fault condition must be performed.

(viii) Maximum output temperature testing of delivered gas, if humidified, must be performed.

(3) Performance data must validate reprocessing instructions for any reusable components of the device.

(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Labeling must include the following:

(i) Therapy pressure range;

(ii) Use life and replacement schedule for all components;

(iii) Cleaning instructions; and

(iv) Instructions for assembly and connection of device components.

[83 FR 52966, Oct. 19, 2018]

§868.5280   Breathing tube support.

(a) Identification. A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s).

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, 2001]

§868.5300   Carbon dioxide absorbent.

(a) Identification. A carbon dioxide absorbent is a device intended for medical purposes that consists of an absorbent material (e.g., soda lime) that is intended to remove carbon dioxide from the gases in the breathing circuit.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001]

§868.5310   Carbon dioxide absorber.

(a) Identification. A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001]

§868.5320   Reservoir bag.

(a) Identification. A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001]

§868.5330   Breathing gas mixer.

(a) Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

(b) Classification. Class II (performance standards).

§868.5340   Nasal oxygen cannula.

(a) Identification. A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38794, July 25, 2001]

§868.5350   Nasal oxygen catheter.

(a) Identification. A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38794, July 25, 2001]

§868.5365   Posture chair for cardiac or pulmonary treatment.

(a) Identification. A posture chair for cardiac or pulmonary treatment is a device intended to assist in the rehabilitation and mobilization of patients with chronic heart or lung disease.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, 2001]

§868.5375   Heat and moisture condenser (artificial nose).

(a) Identification. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5400   Electroanesthesia apparatus.

(a) Identification. An electroanesthesia apparatus is a device used for the induction and maintenance of anesthesia during surgical procedures by means of an alternating or pulsed electric current that is passed through electrodes fixed to a patient's head.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any electroanesthesia apparatus that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an electroanesthesia apparatus that was in commercial distribution before May 28, 1976. Any other electroanesthesia apparatus shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 61 FR 50706, Sept. 27, 1996]

§868.5420   Ether hook.

(a) Identification. An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001]

§868.5430   Gas-scavenging apparatus.

(a) Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.

(b) Classification. Class II (performance standards).

§868.5440   Portable oxygen generator.

(a) Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

(b) Classification. Class II (performance standards).

§868.5450   Respiratory gas humidifier.

(a) Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

(b) Classification. Class II (performance standards).

§868.5454   High flow humidified oxygen delivery device.

(a) Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:

(i) Alarm testing must be performed;

(ii) Continuous use thermal stability testing must be performed;

(iii) Humidity output testing must be performed; and

(iv) Blender performance testing must evaluate fraction of inspired oxygen (FiO2) blending accuracy.

(3) Performance data must validate cleaning instructions for any reusable components of the device.

(4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Labeling must include:

(i) A description of available FiO2 ranges for different flowrates and inlet gas pressures;

(ii) Instructions for applicable flowrates for all intended populations;

(iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry;

(iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and

(v) A description of all alarms and their functions.

[83 FR 54007, Oct. 26, 2018]

§868.5460   Therapeutic humidifier for home use.

(a) Identification. A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes the vapor during normal respiration.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5470   Hyperbaric chamber.

(a) Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§878.5650).

(b) Classification. Class II (performance standards).

§868.5530   Flexible laryngoscope.

(a) Identification. A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5540   Rigid laryngoscope.

(a) Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9

[47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5550   Anesthetic gas mask.

(a) Identification. An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5560   Gas mask head strap.

(a) Identification. A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 41107, Sept. 17, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001]

§868.5570   Nonrebreathing mask.

(a) Identification. A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5580   Oxygen mask.

(a) Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5590   Scavenging mask.

(a) Identification. A scavenging mask is a device positioned over a patient's nose to deliver anesthetic or analgesic gases to the upper airway and to remove excess and exhaled gas. It is usually used during dentistry.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5600   Venturi mask.

(a) Identification. A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5620   Breathing mouthpiece.

(a) Identification. A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

§868.5630   Nebulizer.

(a) Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

(b) Classification. Class II (performance standards).

§868.5640   Medicinal nonventilatory nebulizer (atomizer).

(a) Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

§868.5650   Esophageal obturator.

(a) Identification. An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask.

(b) Classification. Class II (performance standards).

§868.5655   Portable liquid oxygen unit.

(a) Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.

(b) Classification. Class II (performance standards).

§868.5665   Powered percussor.

(a) Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.

(b) Classification. Class II (performance standards).

§868.5675   Rebreathing device.

(a) Identification. A rebreathing device is a device that enables a patient to rebreathe exhaled gases. It may be used in conjunction with pulmonary function testing or for increasing minute ventilation.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

§868.5690   Incentive spirometer.

(a) Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.

(b) Classification. Class II (performance standards).

§868.5700   Nonpowered oxygen tent.

(a) Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

§868.5710   Electrically powered oxygen tent.

(a) Identification. An electrically powered oxygen tent is a device that encloses a patient's head and, by means of an electrically powered unit, administers breathing oxygen and controls the temperature and humidity of the breathing gases. This generic type device includes the pediatric aerosol tent.

(b) Classification. Class II (performance standards).

§868.5720   Bronchial tube.

(a) Identification. A bronchial tube is a device used to differentially intubate a patient's bronchus (one of the two main branches of the trachea leading directly to the lung) in order to isolate a portion of lung distal to the tube.

(b) Classification. Class II (performance standards).

§868.5730   Tracheal tube.

(a) Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

(b) Classification. Class II (performance standards).

§868.5740   Tracheal/bronchial differential ventilation tube.

(a) Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.

(b) Classification. Class II (performance standards).

§868.5750   Inflatable tracheal tube cuff.

(a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.

(b) Classification. Class II (performance standards).

§868.5760   Cuff spreader.

(a) Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001]

§868.5770   Tracheal tube fixation device.

(a) Identification. A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5780   Tube introduction forceps.

(a) Identification. Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5790   Tracheal tube stylet.

(a) Identification. A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5795   Tracheal tube cleaning brush.

(a) Identification. A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[51 FR 40388, Nov. 6, 1986, as amended at 66 FR 38795, July 25, 2001]

§868.5800   Tracheostomy tube and tube cuff.

(a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

(b) Classification. Class II.

[51 FR 40389, Nov. 6, 1986]

§868.5810   Airway connector.

(a) Identification. An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5820   Dental protector.

(a) Identification. A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

§868.5830   Autotransfusion apparatus.

(a) Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

(b) Classification. Class II (performance standards).

§868.5860   Pressure tubing and accessories.

(a) Identification. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

§868.5870   Nonrebreathing valve.

(a) Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

(b) Classification. Class II (performance standards).

§868.5880   Anesthetic vaporizer.

(a) Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

(b) Classification. Class II (performance standards).

§868.5895   Continuous ventilator.

(a) Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

(b) Classification. Class II (performance standards).

§868.5905   Noncontinuous ventilator (IPPB).

(a) Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

(b) Classification. Class II (performance standards).

§868.5915   Manual emergency ventilator.

(a) Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

(b) Classification. Class II (performance standards).

§868.5925   Powered emergency ventilator.

(a) Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

(b) Classification. Class II (performance standards).

§868.5935   External negative pressure ventilator.

(a) Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.

(b) Classification. Class II (performance standards).

§868.5955   Intermittent mandatory ventilation attachment.

(a) Identification. An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.

(b) Classification. Class II (performance standards).

§868.5965   Positive end expiratory pressure breathing attachment.

(a) Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

(b) Classification. Class II (performance standards).

§868.5975   Ventilator tubing.

(a) Identification. Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

§868.5995   Tee drain (water trap).

(a) Identification. A tee drain (water trap) is a device intended to trap and drain water that collects in ventilator tubing during respiratory therapy, thereby preventing an increase in breathing resistance.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

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