(88 days)
Medline Bariatric Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.
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The provided text is a 510(k) clearance letter from the FDA for a physical device, the Medline Bariatric (Shuttle) Wheelchair.
Therefore, the input request asking for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not applicable to this document.
This document describes the regulatory approval process for a mechanical wheelchair, which is evaluated based on substantial equivalence to a predicate device, adherence to general controls (like GMP, labeling), and compliance with relevant regulations (e.g., 21 CFR Part 807, 801, 820). The concept of "acceptance criteria" and various study types (MRMC, standalone, human readers improve with AI) as described in the prompt are specific to the evaluation of AI/ML-driven medical devices, especially those involved in image analysis or diagnostic support, and do not apply to this traditional medical device.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2005
Ms. Lara N. Simmons Corporate Director, Regulatory Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060-4486
Re: K051302
Trade/Device Name: Medline Bariatric (Shuttle) Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 3, 2005 Received: August 4, 2005
Dear Ms. Simmons:
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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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 marketed 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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milliken
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page Page 2 of
510(k) Number (if known): _
Device Name: Medline Bariatric (Shuttle) Wheelchair
Indications for Use:
Medline Bariatric Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use XX
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(PLEASE DO NOT WRITE BLOEW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Milliken
Vision Sign-Off) ivision of General, Restorative Marrolarical Douges
Number K051302
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§ 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).