(118 days)
The intended use of the Rumba SR (P4R), is to provide mobility to adults weighing up to 300 Pounds and the ability to place themselves in a seated position on the chair and have the capacity to operate a standard joy stick hand control.
Not Found
This is a letter about the FDA's decision regarding a 510(k) premarket notification for a powered wheelchair. This type of document, particularly older ones, typically does not contain detailed information about acceptance criteria or specific studies in the way you've outlined for AI/ML devices. The focus here is on substantial equivalence to a predicate device.
Therefore, I cannot provide the information requested in your prompt based on the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone performance studies.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
This document is a regulatory approval letter for a medical device (a powered wheelchair) based on its substantial equivalence to previously marketed predicate devices, not a study report for an AI/ML device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IMC-Heartway, LLC % Mr. Michael Chen President 6140 Mid Metro Drive, Suite 6 Fort Myers, Florida 33912
FEB 2 7 2007
Re: K063307
:
Trade/Device Name: Model-Rumba SR (P4R) Electric Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 19, 2007 Received: February 21, 2007
Dear Mr. Chen:
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 (sec 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. Michael Chen
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) 276-0120 . 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,
Mark N. Melkerson
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510K number: K063307
Device Name: Model - Rumba SR (P4R) Electric Powered Wheelchair
Indications For Use: The intended use of the Rumba SR (P4R), is to provide mobility to adults weighing up to 300 Pounds and the ability to place themselves in a seated position on the chair and have the capacity to operate a standard joy stick hand control.
rescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, O Device Evaluation (ODE) (Division S Division of General, Restauri . and 1999 1998 8 11 510(k) Nun
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).