(24 days)
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No
The document describes a mobility scooter and does not mention any AI or ML capabilities.
No
The device is a mobility scooter designed to assist individuals with difficulty walking; it does not claim to treat, cure, or prevent any disease or medical condition.
No
The document describes the intended use of the device as providing mobility to persons with walking difficulties, not for diagnosing any medical condition.
No
The device description clearly indicates a physical mobility scooter, which is a hardware device, not software.
Based on the provided information, the Medline Strider MIDI 3 scooter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing mobility to individuals with difficulty walking. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description, Image Processing, AI/ML, Input Imaging Modality, Anatomical Site, Patient Age Range, Intended User/Care Setting, Training/Test Set Descriptions, Performance Studies, Key Metrics, Predicate/Reference Devices: None of these sections mention anything related to analyzing biological samples, diagnosing conditions, or any other activity typically associated with IVDs.
IVDs are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Medline Strider MIDI 3 scooter does not perform any such function.
N/A
Intended Use / Indications for Use
The intended use of the Medline Strider MIDI 3 scooter is to provide mobility to persons that have difficulty walking for prolonged periods of time. They are intended to increase the mobility of persons who are both physically and mentally capable of assessing and reacting to any driving situation.
The Medline Strider MIDI 3 scooter is constructed for use both indoors and outdoors. They are for use indoors, on pavement, sidewalks, pedestrian zones and areas free from motor traffic. They must not be driven on public roads with the exception of crossing or when no pavements are available.
Product codes
INI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2004
Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060-4486
Re: K040097
Trade/Device Name: Medline Strider MIDI 3 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: January 16, 2004 Received: January 20, 2004
Dear Ms. Haferkamp:
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 (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Ms. Andrea Haferkamp
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 McMillan
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K 04:0097
Medline Strider MIDI 3 Device Name:
Indications For Use:
The intended use of the Medline Strider MIDI 3 scooter is to provide mobility to persons that have difficulty walking for prolonged periods of time. They are intended to increase the mobility of persons who are both physically and mentally capable of assessing and reacting to any driving situation.
The Medline Strider MIDI 3 scooter is constructed for use both indoors and outdoors. They are for use indoors, on pavement, sidewalks, pedestrian zones and areas free from motor traffic. They must not be driven on public roads with the exception of crossing or when no pavements are available.
Prescription Use (Parl 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Office of Device Evaluation (ODE)
Mark A. Mulkern
Division of General, Restorative, and Neurological Devices
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510(k) Number K040097