(28 days)
The intended use of the device is in providing mobility to persons restricted to a sitting position.
The Stellar Tilt, Manually Operated Wheelchair
The provided document is a 510(k) premarket notification letter from the FDA for "The Stellar Tilt, Manually Operated Wheelchair." It is a regulatory approval letter, not a study report, and therefore does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/device performance study.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications and general controls but does not include any performance metrics or study details in the context of your questions.
Therefore, I cannot extract the requested information from this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 1999
Mr. Phil Mundy President PDG Product Design Group 9165 Shaughnessy Street Vancouver, B.C. Canada V6P 6R9
Re: K990557 The Stellar Tilt, Manually Trade Name: Operated Wheelchair Requlatory Class: I Product Code: IOR Dated: February 5, 1999 February 22, 1999 Received:
Dear Mr. Mundy:
We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Phil Mundy
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witton, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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8.1.1 Statement of Indications for Use
510(K) Number (if known): K990557
Device Name: The Stellar Tilt Manually Operated Wheelchair
Indications for use:
The intended use of the device is in providing mobility to persons restricted to a sitting position.
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Concurrence of CHRH, Office of Device Evaluation (ODE)
eeda
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use $\not$
§ 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).