(119 days)
Not Found.
Mechanical Wheelchair "CHUMP", "KRYPTO"
This document is a 510(k) premarket notification letter from the FDA regarding a mechanical wheelchair. It explicitly states that the device is "substantially equivalent" to legally marketed predicate devices and is classified as Class I.
The information provided does not describe an acceptance criteria and study for a device that uses AI or machine learning. It pertains to a physical product (a wheelchair) and its fire retardancy testing, which is a physical property test, not an AI performance study.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC study, or standalone performance) because this document does not contain any information related to AI or machine learning performance.
The only relevant "acceptance criteria" mentioned is the "Fire retardant test accomplished at Swedish Handicapped Institute to I.S.O. 7176 under umbrella of ISO 9000/9001" and "All fabric is in accordance to California specification 117." However, these are not AI-specific performance metrics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
MAY - 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Victor R. Box Quality Assurance Colours 'N Motion, Inc. 1591 South Sinclair Street Anaheim, CA 92806
Re: K030017
Trade/Device Name: Mechanical Wheelchair "CHUMP", "KRYPTO" Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: April 21, 2003 Received: April 22, 2003
Dear Mr. Box:
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. Victor R. Box
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), 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 vours.
Mark A. Milliman
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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K030017 510(k) Number (if known):
Mechanical Wheelchair "CHUMP", "KRYPTO" Device Name:
Fire Retardant:
Fire retardant test accomplished at Swedish Handicapped Institute to I.S.O. 7176 under umbrella of ISO 9000/9001. Documentation is available on request. Note: Colours N Motion, Inc. uses the same identical fabric on all wheelchair models.
All fabric is in accordance to California specification 117
Victor R. Bay
4-21-03
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evalua
Mark N Mikkelsen
Division Sign Off
Di ision of General, Restorative and Neurological Devices
510(k) Number K030017
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).