(118 days)
The intended use of the Model SE03 is to provide mobility to adults with the ability to place themselves in a sitting position on the Scooter and have the capacity to operate a simple hand control.
Electric Powered Scooter, Model SE03
{0} This document is a 510(k) premarket notification decision letter from the FDA to Sunpex Technology Company regarding their Electric Powered Scooter, Model SE03. It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
This letter does not contain information about acceptance criteria or specific study results showing device performance. Instead, it is a regulatory document confirming the substantial equivalence determination for market approval. Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
This type of information is typically found in the 510(k) submission document itself, which is a detailed technical submission to the FDA, rather than the final decision letter.
{0}------------------------------------------------
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 eagle with three wing-like shapes, representing health and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2004
Sunpex Technology Company. I.TD. Leonard Frier c/o Met Laboratories, Inc. 914 West Patapsco Avenue Baltimore, Maryland 21230
Re: K033019
Trade/Device Name: Electric Powered Scooter, Model SE03 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-whecled vehicle Regulatory Class: II Product Code: INI Dated: December 26, 2003 Received: December 29. 2003
Dear Mr. Frier:
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 adultcration.
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 IDA's issuance of a substantial equivalence determination docs 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 Acts 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.
{1}------------------------------------------------
Page 2 – Mr. Leonard Frier
This letter will allow you to begin marketing your device as described in your Section 510/km 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
sincerely yours.
Mark N. Millherson
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
{2}------------------------------------------------
Indications for Use Statement
510K number:
Device Name: Model SE03, Electric Power Scooter ·
Indications For Use: The intended use of the Model SE03 is to provide mobility to adults with the ability to place themselves in a sitting position on the Scooter and have the capacity to operate a simple hand control.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number Over-The-Counter Use_ Prescription Use______________________________________________________________________________________________________________________________________________________________ ાર
§ 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).