(41 days)
The Cougar Wheelchair's intended function and use is to provide mobility to persons limited to a sitting position.
The wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front pivoting casters for steering and turning.
This looks like a 510(k) clearance letter from the FDA for a mechanical wheelchair, not a document describing an AI/ML medical device. Therefore, the questions about acceptance criteria, study details, ground truth, and training data are not applicable to this document.
The document states:
- Trade/Device Name: Cougar Wheelchair
- Regulation Number: 21 CFR 890.3850
- Regulation Name: Mechanical wheelchair
- Regulatory Class: I
- Product Code: IOR
This device is a mechanical wheelchair, which falls under Class I (general controls) and does not involve AI or algorithms. The FDA's determination is based on substantial equivalence to legally marketed predicate devices, not on a performance study against specific acceptance criteria in the manner you've described for AI/ML products.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2006
R82 A/S % Snug Seat, Inc. Mr. Kirk MacKenzie President 2801 E. Independence Boulevard Stallings, North Carolina 28105
Re: K061810
Trade/Device Name: Cougar Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: May 25, 2006 Received: June 27, 2006
Dear Mr. MacKenzie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kirk MacKenzie
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally predicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Herbert Werner nos
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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R82
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Cougar Wheelchair
Indications For Use:
The Cougar Wheelchair's intended function and use is to provide mobility to persons limited to a sitting position. The wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front pivoting casters for steering and turning.
Militia
(Signature)
Tobias Moller, Product Administrator
(Typed Name)
9 Juni 2006
(Date)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use (Part 21 CFR 801 Subpart D) | Yes | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | Yes |
|---|---|---|---|---|
| ---------------------------------------------- | ----- | -------- | --------------------------------------------- | ----- |
(Division Sign-Off)
Concurrence of CDRH Division of General, Restorative, Device Evaluation (ODE) and Neurological Devices
| 510(k) Number | K061810 |
|---|---|
| --------------- | --------- |
4-1
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).