(2 days)
The intended use of the Medline Strider MIDI 3 scooter is to provide mobility to 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.
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This is a 510(k) clearance letter for the Medline Strider MIDI 3, a motorized three-wheeled vehicle. This type of clearance indicates substantial equivalence to a predicate device, rather than a de novo clinical study with specific acceptance criteria and performance metrics described in detail. Therefore, much of the requested information regarding acceptance criteria and a detailed study for performance cannot be extracted from this document, as it is not a clinical study report.
However, I can infer some aspects based on the nature of a 510(k) submission for a device of this type.
Here's an attempt to answer your questions based on the provided text and general 510(k) processes for similar devices:
1. A table of acceptance criteria and the reported device performance
Based on this document, specific quantitative acceptance criteria and reported device performance metrics (e.g., speed, range, turning radius, stability during specific maneuvers) are not provided. For a motorized three-wheeled vehicle like this, acceptance criteria would typically relate to:
- Safety Standards Compliance: Adherence to national or international safety standards for motorized mobility devices (e.g., ISO, ANSI/RESNA standards for wheelchairs and scooters). This would cover aspects like braking performance, stability (static and dynamic), electromagnetic compatibility (EMC), controller functionality, and charging system safety.
- Performance Specifications: Meeting advertised or specified performance characteristics such as:
- Maximum speed
- Range per charge
- Weight capacity
- Ability to climb inclines
- Turning radius
- Overall dimensions
- Durability and Reliability: Demonstrating that the device can withstand expected use over its intended lifespan, typically through accelerated life testing.
- Substantial Equivalence: The primary acceptance criterion for a 510(k) is demonstrating that the device is as safe and effective as a legally marketed predicate device. This often involves comparing design features, materials, operating principles, and intended use.
Since this is a clearance letter, it confirms that the FDA reviewed the applicant's submission and found it substantially equivalent. The specific data demonstrating this equivalence is in the original 510(k) submission, not in this clearance letter.
| Acceptance Criteria (Inferred for this type of device) | Reported Device Performance (Not explicitly stated in this document) |
|---|---|
| Adherence to relevant safety standards (e.g., ISO, ANSI/RESNA) | Implied to meet standards for clearance |
| Equivalent performance to predicate device (speed, range, stability) | Implied to be equivalent for clearance |
| Mechanical safety, braking effectiveness, stability | Implied to meet safety requirements |
| Electromagnetic compatibility | Implied to meet safety requirements |
| Durability and reliability | Implied to be adequate for intended use |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the clearance letter. Clinical studies with test sets and data provenance are typically not explicitly required for 510(k) submissions unless the device presents novel technology or significant differences from a predicate that raise new questions of safety or effectiveness. For a motorized scooter, performance testing often involves engineering bench tests, simulated use, and potentially limited user trials, rather than large-scale clinical trials. The number of units tested would likely be small (e.g., 1-5 units per test).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to a 510(k) submission for a motorized scooter. "Ground truth" established by experts is typically a concept used in diagnostic or AI-driven medical devices where a human expert establishes the correct diagnosis or finding against which the device's performance is measured. For a physical device like this, compliance with engineering standards and performance specifications are the primary assessments, usually conducted by engineers and technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical trials involving subjective assessments or interpretation (e.g., radiology reads, pathology diagnoses) to resolve discrepancies between multiple readers. This is not relevant for the type of testing performed for a motorized scooter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. MRMC studies are specific to diagnostic devices, particularly those involving image interpretation or AI assistance, where the performance of human readers with and without AI is compared. This is entirely outside the scope of a motorized three-wheeled vehicle.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. "Standalone" performance testing is also typically associated with AI algorithms or diagnostic devices. For a motorized scooter, performance is inherent to the physical device and its components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As explained in point 3, the concept of "ground truth" as relevant to diagnostic or AI devices does not apply here. The "truth" for a mobility device is its adherence to specified physical and functional performance parameters and safety standards.
8. The sample size for the training set
Not applicable. "Training set" refers to data used to train machine learning models. This device does not appear to involve machine learning in a way that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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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.
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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
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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
§ 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).