(116 days)
The Traxx Electric Wheelchair is a battery-operated device that is intended to provide mobility for people with a disability.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device: Traxx Electric Wheelchair. This type of document is an approval for a device to be marketed, based on its substantial equivalence to a predicate device. It does not contain acceptance criteria or study results for device performance in the way you've outlined for an AI/algorithm-based diagnostic device.
The information you're asking for (acceptance criteria, study details, expert involvement, ground truth, training/test set sizes) is typically found in:
- Clinical trial reports
- Performance testing documentation
- User manuals with performance specifications
- Detailed 510(k) summary documents that might include performance data if the device is novel or requires specific performance claims beyond basic safety and function.
For the Traxx Electric Wheelchair, the FDA's clearance is based on its substantial equivalence to existing powered wheelchairs, meaning it performs similarly and has similar safety and effectiveness characteristics. The letter simply states the device's intended use: "to provide mobility for people with a disability."
Therefore, I cannot provide the requested information from the given text because it is not present in this 510(k) clearance letter. This letter primarily confirms regulatory approval rather than detailing performance study specifics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
OCT 2 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Crossroads Distribution Company, L.L.C. c/o Regulatory Insight, Inc. Kevin Walls 13 Red Fox Lane Littleton, Colorado 80127
Re: K022194
Trade/Device Name: Traxx Electric Wheelchair Regulation Number: 890.3860 Regulation Name: Wheelchair, powered Regulatory Class: Class II Product Code: ITI Dated: October 8, 2002 Received: October 9, 2002
Dear Mr. Walls:
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. Iisting 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kevin Walls
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,
L. M. A. Millman
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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510(k) Number (if known):
Device Name: Traxx Electric Wheelchair
Indications for Use: The Traxx Electric Wheelchair is a battery-operated device that is intended to provide mobility for people with a disability.
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 _
Prescription Use × (Per 21 CFR 801.109)
L. Miel. A. Millaire.
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510 Number KC 2.)194
§ 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).