(3 days)
The intended use of the Medline Strider MIDI 4 scooter is to provide mobility to persons that have difficulty walking for short periods of time. It is intended to be used by persons who are mentally capable of assessing and reacting to any driving situation. The Medline Strider MIDI 4 scooter is constructed for use both indoors and outdoors. It is for use indoors, on pavements, sidewalks, pedestrian zones and areas free from motor traffic. It must not be driven on public roads with the exception of crossing or when no pavements are available.
Medline Strider MIDI 4 scooter
This document is a 510(k) clearance letter from the FDA for a medical device called the "Medline Strider MIDI 4". This device is a motorized three-wheeled vehicle (scooter) and is classified as a Class II device.
The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for devices that employ AI or rely on performance metrics like sensitivity, specificity, or AUC.
Instead, this document is a regulatory clearance based on the device being "substantially equivalent" to a legally marketed predicate device. This means the FDA has determined that the new device is as safe and effective as a similar device already on the market, usually without requiring new clinical performance studies that define and test against specific numerical acceptance criteria.
Therefore, I cannot fulfill your request for the detailed breakdown of acceptance criteria and study information because it is not present in the provided document. The 510(k) process for this type of device (a mobility scooter) typically focuses on engineering specifications, safety features, and comparison to an existing similar product rather than the kind of AI/algorithm performance metrics you've asked for.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
OCT 8 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Margaret Stephens Regulatory Specialist Medline Industries Inc. One Medline Place Mundelein, Illinois 60060
Re: K042764
Trade/Device Name: Medline Strider MIDI 4 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 1, 2004 Received: October 5, 2004
Dear Ms. Stephens:
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 (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.
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Page 2 - Ms. Margaret Stephens
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 (240) 276-0120. 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 N. Millerson
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
510(k) Number (if known): _
Device Name: Medline Strider MIDI 4
Indications for Use:
The intended use of the Medline Strider MIDI 4 scooter is to provide mobility to The intended use of the Medific Strider Hiber For probotions of time. It is intended to persons that have difficulty walking to: profession with the mentally capable of assessing and reacting to any driving situation.
The Medline Strider MIDI 4 scooter is constructed for use both indoors and outdoors.
The from The Meditie Strider MIDT 4 soocts: is oolks, pedestrian zones and areas free from of If is for use indoors, bil pavellent, sidewares, possession
motor traific. It must not be driven on public roads with the exception of crossing or when no pavements are available.
X __ AND/OR Over-The-Counter Use Prescription Use_ (21 CFR 807 Subpart C) (Part 21 C.FR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliman
Division of General, Restorative, and Neurological Devices
510(k) Number K042764
§ 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).