(82 days)
The subject device and the predicate device intended use The subject device and the produced individuals.
Not Found
The provided text is a 510(k) premarket notification approval letter from the FDA for a medical device called "Amigo Model 680000 Excite F350".
This document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications for AI/ML device evaluation. It is a regulatory approval for a physical mobility device (presumably a powered wheelchair or scooter). Therefore, I cannot fulfill your request for information related to AI/ML device studies based on this document.
The information sought in your prompt (e.g., sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is typical for the evaluation of AI/ML-driven medical devices. However, this specific document predates the widespread use and regulatory frameworks for such devices and is for a different type of product entirely.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 25 1999
Mr. Dale Confer Product Design Development Manager Amigo Mobility International, Inc. 6693 Dixie Highway Bridgeport, Michigan 48722-0402
Re: K992619 Amigo Model 680000 (Amigo Excite F 350) Trade Name: Requlatory Class: II Product Code: ITI Dated: July 30, 1999 Received: August 4, 1999
Dear Mr. Confer:
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 against 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 requlations 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 Requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements 1 action. concerning your device in the Federal Reqister. 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. Dale Confer
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 requlation (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 ene rogaration " (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. 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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K 992679 510(k) NUMBER (IF KNOWN):
AMIGO MODEL 680000 Excite F350 DEVICE NAME:
INDICATIONS FOR USE:
The subject device and the predicate device intended use The subject device and the produced individuals.
(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) ાર
Over-The-Counter-Use
(Optional Format 1-96)
(Division Sign-Off) Division of General Restorative Dev 510(k) Number
§ 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).