(150 days)
The intended use of the Model SE 01 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.
Model SE 01, Four Wheel Electric Scooter
I am sorry, but based on the provided document, I cannot describe the "acceptance criteria and the study that proves the device meets the acceptance criteria."
The document is a 510(k) clearance letter from the FDA for a "Sunpex Technology Company, LTD. Model SE 01, Four Wheel Electric Scooter." This letter states that the device is "substantially equivalent" to legally marketed predicate devices.
The document does not contain any information about:
- Specific acceptance criteria for device performance.
- Details of any study (test set, ground truth, expert qualifications, adjudication, sample sizes, training set, etc.) that would prove the device meets performance criteria. The 510(k) process is primarily about demonstrating substantial equivalence to a predicate device, not necessarily a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria, especially for a motorized scooter.
Therefore, I cannot fulfill your request for the table or the study details.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 8 2002
Sunpex Technology Company, LTD. c/o Met Laboratories. Inc. Leonard Frier 914 West Patapsco Avenue Baltimore, Maryland 21230
Re: K021925
Trade/Device Name: Sunpex Technologies Model SE 01, Four Wheel Electric Scooter Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: August 12, 2002 Received: August 15, 2002
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 adulteration.
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 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. Leonard Frier
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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Melkerson
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
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Indications for Use Statement
510K number:
Device Name: Model SE 01, Four Wheel Electric Scooter
The intended use of the Model SE 01 is to provide mobility to adults with Indications For Use: 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)
Mark A. Millherson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
OR
Prescription Use______________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use ^
§ 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).