Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of February 23, 2021

Title 21Chapter ISubchapter HPart 882Subpart F → §882.5600


Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices


§882.5600   Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.

(a) Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.

(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:

(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.

(ii) Mechanical testing to evaluate the radial forces exerted by the device.

(iii) Non-clinical testing to verify the dimensions of the device.

(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.

(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.

(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.

(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.

(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.

(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.

(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.

(6) The labeling must include:

(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.

(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.

(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.

(iv) A shelf life.

[81 FR 94253, Dec. 23, 2016]

Need assistance?