(23 days)
The intended use of the Medline Excel Recliner Wheelchair is to provide mobility to persons limited to a sitting position but unable to sit in an upright position for long periods of time.
Medline Excel Recliner Wheelchair
This document is a 510(k) clearance letter from the FDA for a mechanical wheelchair, not a device that would typically have acceptance criteria and performance studies in the way you've described for an AI/medical imaging product.
The provided text does not contain any information about:
- Acceptance criteria tables or reported device performance for an AI/imaging device.
- Sample sizes for test sets, data provenance, or the number of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets or how ground truth was established for training sets.
This document is solely focused on the FDA's determination of substantial equivalence for a physical product (a wheelchair) to pre-amendment devices, allowing it to be marketed. It refers to general controls and regulatory requirements for medical devices, but not specific performance criteria or studies in the context you've outlined.
Therefore, I cannot provide the requested table and study details based on the input text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Medline Industries, Inc. Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs One Medline Place Mundelein, Illinois 60060-4486
Re: K013761
Trade Name: Medline Excel Recliner Wheelchair Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: I Product Code: IOR Dated: November 9, 2001 Received: November 13, 2001
Dear Ms. Haferkamp:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Ms. Andrea Haferkamp
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to began inding of substantial equivalence of your device to a legally premarket notification: "The Price is 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 and II you desire specific advisor you in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Comphance at (301) 597-1057. The case Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Ourler general mionmation on your 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,
Marls M. Milherson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 2.0 Intended Use
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): Device Name: Medline Excel Recliner Wheelchair
Indications for Use:
The intended use of the Medline Excel Recliner Wheelchair is to provide mobility to persons limited to a sitting position but unable to sit in an upright position for long periods of time.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use - - -
(Optional Format 12-96)
R. Mad. A. Millers
510(k) Number
§ 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).