(2 days)
Not Found
Not Found
No
The summary describes a mobility scooter and contains no mention of AI, ML, or related technologies.
No
Explanation: The description states the device is a scooter for mobility, not for treating any medical condition or alleviating symptoms. It aids in mobility for capable individuals.
No
Explanation: The Medline Strider MIDI 3 scooter is described as a mobility device for transportation, not for diagnosing medical conditions.
No
The device description clearly identifies the device as a "scooter," which is a physical hardware product, not software.
Based on the provided information, the Medline Strider MIDI 3 scooter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing mobility to individuals. This is a physical function, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- No Mention of Diagnostic Technologies: There is no mention of image processing, AI, DNN, or ML, which are sometimes associated with diagnostic devices, although not exclusively.
- No Anatomical Site or Imaging Modality: These are typically relevant for devices that interact with or image the body for diagnostic purposes.
In summary, the Medline Strider MIDI 3 scooter is a mobility aid, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the Medline Strider MIDI 3 scooter is to provide mobility to persons who are unable to walk for prolonged periods of time. They are intended to improve 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
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2004
Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs Medline Industries, Inc Durable Medical Equipment One Medline Place Mundelein, Illinois 60060
Re: K042763
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: October 1, 2004 Received: October 5, 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, 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.
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 (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 yours,
/ Mark A. Mulhearn
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
2
Indications for Use
510(k) Number (if known):_
Device Name: Medline Strider MIDI 3
Indications for Use:
The intended use of the Medline Strider MIDI 3 scooter is to provide mobility to I ne method abo of the May walking for prolonged periods of time. They are intended perone and he 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 indocrs, 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.
X AND/OR Over-The-Counter Use Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 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 N. Mulkerson
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K042763