(25 days)
The SCOUT BOSS is a motorized, battery powered wheelchair for indoor/outdoor mobility purposes by larger disabled individuals.
Not Found
This is a medical device marketing authorization from the FDA for a powered wheelchair, the "Scout Boss." It is not a study describing a device that uses AI/ML or an algorithm-based diagnostic. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not applicable to this document.
This document is a 510(k) clearance letter, which means the device (a powered wheelchair) was found to be "substantially equivalent" to a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, often through engineering tests and comparisons rather than clinical studies in the context of diagnostic accuracy.
Therefore, I cannot provide the requested information as it is not present in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
DEC 24 2002
Burke, Inc. DuWayne E. Kramer, Jr. President 1800 Merriam Lane Kansas City, Kansas 66106
Re: K023961
Trade/Device Name: Scout Boss Regulation Number: 890.3860 Regulation Name: Wheelchair, powered Regulatory Class: Class.II Product Code: ITI Dated: December 9, 2002 Received: December 9, 2002
Dear Mr. Kramer:
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 is 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
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Page 2 - Mr. Du Wayne E. Kramer, Jr.
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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. 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" (21CFR 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Wley Witte
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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K023961/S1
BURKE INC. RE: SCOUT BOSS 510(k) submission K023961
Indication for Use: The SCOUT BOSS is a motorized, battery powered wheelchair for indoor/outdoor mobility purposes by larger disabled individuals. : 上海
Bu Wayne E. Turner/r
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE)
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Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use ✓
SK 37
§ 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).