(211 days)
The subject device and the predicate device intended use, e is personal transportation for walking impaired individuals.
AMIGO MODEL 590000 (Joystick)
The provided text is a 510(k) clearance letter from the FDA for a medical device (Amigo Model 590000, a joystick-controlled personal transportation device for walking-impaired individuals). It is not a study report or clinical trial document. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, ground truth establishment, or any details about a study proving the device meets acceptance criteria for an AI/ML product.
The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the clearance is based on a comparison to existing predicate devices, not on a new study demonstrating performance against specific acceptance criteria in the way you've outlined for an AI/ML product.
Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8 1999
Mr. Dale Confer Product Design Development Manager Amigo Mobility International, Inc. 6693 Dixie Highway Bridgeport, Michigan 48722-0402
Re: K983987 Amigo Model 590000 Trade Name: Regulatory Class: II Product Code: INI April 23, 1999 Dated: April 26, 1999 Received:
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ 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. 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 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. Witten, Ph.D., M.D.
Director
Division of General and
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) NUMBER (IF KNOWN): K
3A1-1
1.95% 11.2% 26.0% 3.0% 1.0% 1.0% 1.0% 1.0% 1.0% 1.4%
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AMIGO MODEL 590000 (Joystick) DEVICE NAME:
INDICATIONS FOR USE:
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.
The subject device and the predicate device intended use, e is personal transportation for walking impaired individuals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
510(k) Number
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).