(244 days)
Motorized three-wheeled and four-wheeled battery powered scooters are intended for medical purposes by disabled persons and other non-medical purposes.
Not Found
This is a 510(k) clearance letter for the PaceSaver Espree Scooter, dated July 17, 1997. The document primarily focuses on the regulatory approval of the scooter and explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This type of submission (510(k)) for devices like the PaceSaver Espree Scooter does not typically require the detailed performance studies, acceptance criteria, and ground truth analysis that would be associated with AI/ML-based medical devices or novel technologies. The basis for clearance is demonstrating substantial equivalence to a predicate device, not proving novel clinical effectiveness through extensive studies with acceptance criteria, expert ground truth, or MRMC studies.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not provided within this document because it is not relevant to a 510(k) clearance for this type of device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DuWayne E. Kramer, Jr. President Burke, Inc. 1800 Merriam Lane Kansas City, Kansas 66106
JUL 17 1997
K965123 Re : PaceSaver Espree Scooter Requlatory Class: II Product Code: INI June 11, 1997 Dated: Received: June 16, 1997
Dear Mr. Kramer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - DuWayne E. Kramer, Jr.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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K 965123
INTENDED USE
Motorized three-wheeled and four-wheeled battery powered scooters are intended
ing and also and adjochled persons and other non-medical purposes. Motorized three-wheeled and lour-wheeled batter pon-medical purposes.
for medical purposes by disabled persons and other non-medical purposes.
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Division of General Restorative Devices K985123
510(k) Number
Over-the-Counter Use X
§ 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).