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Electronic Code of Federal Regulations

e-CFR data is current as of December 10, 2019

Title 21Chapter ISubchapter HPart 868 → Subpart B


Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES


Subpart B—Diagnostic Devices


Contents
§868.1030   Manual algesimeter.
§868.1040   Powered algesimeter.
§868.1075   Argon gas analyzer.
§868.1100   Arterial blood sampling kit.
§868.1120   Indwelling blood oxyhemoglobin concentration analyzer.
§868.1150   Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
§868.1170   Indwelling blood hydrogen ion concentration (pH) analyzer.
§868.1200   Indwelling blood oxygen partial pressure (PO2) analyzer.
§868.1400   Carbon dioxide gas analyzer.
§868.1430   Carbon monoxide gas analyzer.
§868.1500   Enflurane gas analyzer.
§868.1505   Ventilatory electrical impedance tomograph.
§868.1575   Gas collection vessel.
§868.1620   Halothane gas analyzer.
§868.1640   Helium gas analyzer.
§868.1670   Neon gas analyzer.
§868.1690   Nitrogen gas analyzer.
§868.1700   Nitrous oxide gas analyzer.
§868.1720   Oxygen gas analyzer.
§868.1730   Oxygen uptake computer.
§868.1750   Pressure plethysmograph.
§868.1760   Volume plethysmograph.
§868.1780   Inspiratory airway pressure meter.
§868.1800   Rhinoanemometer.
§868.1840   Diagnostic spirometer.
§868.1850   Monitoring spirometer.
§868.1860   Peak-flow meter for spirometry.
§868.1870   Gas volume calibrator.
§868.1880   Pulmonary-function data calculator.
§868.1890   Predictive pulmonary-function value calculator.
§868.1900   Diagnostic pulmonary-function interpretation calculator.
§868.1910   Esophageal stethoscope.
§868.1920   Esophageal stethoscope with electrical conductors.
§868.1930   Stethoscope head.
§868.1965   Switching valve (ploss).
§868.1975   Water vapor analyzer.

§868.1030   Manual algesimeter.

(a) Identification. A manual algesimeter is a mechanical device intended to determine a patient's sensitivity to pain after administration of an anesthetic agent, e.g., by pricking with a sharp point.

(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. The device is also 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.

[54 FR 25048, June 12, 1989, as amended at 66 FR 38793, July 25, 2001]

§868.1040   Powered algesimeter.

(a) Identification. A powered algesimeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after administration of an anesthetic agent.

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

§868.1075   Argon gas analyzer.

(a) Identification. An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity.

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

§868.1100   Arterial blood sampling kit.

(a) Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.

(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 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001]

§868.1120   Indwelling blood oxyhemoglobin concentration analyzer.

(a) Identification. An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status.

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

(c) Date PMA or notice of completion of 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 September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or 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; 52 FR 22577, June 12, 1987; 69 FR 34920, June 23, 2004]

§868.1150   Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.

(a) Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.

(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001]

§868.1170   Indwelling blood hydrogen ion concentration (pH) analyzer.

(a) Identification. An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.

(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001]

§868.1200   Indwelling blood oxygen partial pressure (PO2) analyzer.

(a) Identification. An indwelling blood oxygen partial pressure (PO2) analyzer is a device that consists of a catheter-tip PO2 transducer (e.g., PO2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.

(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001]

§868.1400   Carbon dioxide gas analyzer.

(a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

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

§868.1430   Carbon monoxide gas analyzer.

(a) Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.

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

§868.1500   Enflurane gas analyzer.

(a) Identification. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.

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

§868.1505   Ventilatory electrical impedance tomograph.

(a) Identification. A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient's thorax.

(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) Characterization of device parameters, including signal-to-noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude response, position error, and ringing;

(ii) Real time evaluation of local impedance variation;

(iii) Plethysmogram accuracy testing; and

(iv) Use life testing of reusable components.

(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) Guidance for interpretation of the images generated;

(ii) A warning that the device should be removed before use of a defibrillator, or defibrillator interaction information based on defibrillator performance testing with the device;

(iii) A use life for any reusable components; and

(iv) Instructions for reprocessing any reusable components.

[84 FR 15098, Apr. 15, 2019]

§868.1575   Gas collection vessel.

(a) Identification. A gas collection vessel is a container-like device intended to collect a patient's exhaled gases for subsequent analysis. It does not include a sampling pump.

(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 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001]

§868.1620   Halothane gas analyzer.

(a) Identification. A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.

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

§868.1640   Helium gas analyzer.

(a) Identification. A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.

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

§868.1670   Neon gas analyzer.

(a) Identification. A neon gas analyzer is a device intended to measure the concentration of neon in a gas mixture exhaled by a patient. The device may use techniques such as mass spectrometry or thermal conductivity.

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

§868.1690   Nitrogen gas analyzer.

(a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.

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

§868.1700   Nitrous oxide gas analyzer.

(a) Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.

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

§868.1720   Oxygen gas analyzer.

(a) Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

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

§868.1730   Oxygen uptake computer.

(a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.

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

§868.1750   Pressure plethysmograph.

(a) Identification. A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.

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

§868.1760   Volume plethysmograph.

(a) Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.

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

§868.1780   Inspiratory airway pressure meter.

(a) Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.

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

§868.1800   Rhinoanemometer.

(a) Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.

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

§868.1840   Diagnostic spirometer.

(a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

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

§868.1850   Monitoring spirometer.

(a) Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.

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

§868.1860   Peak-flow meter for spirometry.

(a) Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

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

§868.1870   Gas volume calibrator.

(a) Identification. A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume.

(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 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001]

§868.1880   Pulmonary-function data calculator.

(a) Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.

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

§868.1890   Predictive pulmonary-function value calculator.

(a) Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

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

§868.1900   Diagnostic pulmonary-function interpretation calculator.

(a) Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

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

§868.1910   Esophageal stethoscope.

(a) Identification. An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds.

(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]

§868.1920   Esophageal stethoscope with electrical conductors.

(a) Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.

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

§868.1930   Stethoscope head.

(a) Identification. A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient's heart, breath, and other physiological sounds.

(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 38793, July 25, 2001]

§868.1965   Switching valve (ploss).

(a) Identification. A switching valve (ploss) is a three-way valve located between a stethoscope placed over the heart, a blood pressure cuff, and an earpiece. The valve allows the user to eliminate one sound channel and listen only to a patient's heart or korotkoff (blood pressure) sounds through the other channel.

(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. The device is also 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 38793, July 25, 2001]

§868.1975   Water vapor analyzer.

(a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry.

(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 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001]

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