C.T.M. MOBILITY SCOOTER, MODEL HS-235 by C.T.M. HOMECARE PRODUCT, INC.

The C.T.M. Mobility Scooter HS-235 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with a lightweight seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

The submitted text describes a 510(k) premarket notification for a medical device, the C.T.M. Mobility Scooter HS-235. However, it explicitly states that "Clinical performance evaluations are not necessary to demonstrate substantial equivalence to the predicate device" and "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

Therefore, based on the provided text, there is no study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/ML medical device. This 510(k) relies on demonstrating substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-120), rather than proving independent performance against acceptance criteria through specific studies.

For the purpose of your request, which implies a study proving performance against acceptance criteria, the provided document does not contain the information requested in points 1-9 because such a study was not conducted or submitted for this 510(k) clearance.

To directly address your points:

A table of acceptance criteria and the reported device performance: Not applicable. No specific acceptance criteria for performance metrics are defined in the document, nor are performance results reported beyond the general statement of "Tests listed in the Guidance Document... were conducted."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No clinical test set described.
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): Not applicable. No ground truth establishment for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication detailed.
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. This is not an AI/ML device, and no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth established or used for performance evaluation.
The sample size for the training set: Not applicable. This is not an AI/ML device, so no training set is described.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device, so no training set or ground truth for it.

Summary based on the provided document:

The C.T.M. Mobility Scooter HS-235 gained 510(k) clearance by demonstrating substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-120). This process primarily involved comparing technological characteristics and intended use, and confirming that non-clinical tests specified in relevant guidance documents were conducted. There was no clinical study or performance evaluation against specific acceptance criteria submitted or required for this clearance.

Summary

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OCT - 6 2003

510(k) SUMMARY

Submitter's Name: C.T.M. Homecare Product, Inc. 1663 Iowa Ave. Riverside, CA 92507 909-788-8168

Date summary prepared:

September 10, 2003

Device name:

Proprietary name: Common or usual name: Classification name:

C.T.M. Mobility Scooter HS-235 Electric scooter. Motorized three-wheeled vehicle, Class II, 21 CFR 890.3800.

Legally marketed device for substantial equivalence comparison:

C.T.M. Mobility Scooter HS-120 submitted by C.T.M. Homecare Product, Inc. and cleared for marketing under 510(k) *K031272.

Description of the device:

Intended use of device:

The device is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Technological characteristics:

The device features and use parameters of the HS-235 and the HS-120 are very similar. They vary only in parameters like dimensions and the size of the motor. Both are electric scooters that are battery operated and have automatic braking systems. Batteries and battery chargers are provided with each scooter.

Testing conducted:

Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission.

Performance testing:

Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).

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C.T.M. Mobility Scooter HS-235 510(k) Notification Page 13

V. Clinical Performance Evaluations

Clinical performance evaluations are not necessary to demonstrate substantial equivalence to the predicate device.

VL. Conclusion

In summary, based on a comparison of regulatory issues, device features, and use parameters, the C.T.M. Mobility Scooter HS-235 is substantially equivalent to the C.T.M. Mobility Scooter HS-120.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with three wavy lines extending from the head, resembling a bird in flight.

Public Health Service

OCT - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.T.M. Homecare Product, Inc. c/o Mr. Robert S. McQuate President R.S. McQuate & Associates, Inc. 3636 E. Columbine Drive Phoenix, AZ 85032

Re: K032918

Trade/Device Name: C.T.M. Mobility Scooter HS-235 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI September 12, 2003 Dated: Received: September 22, 2003

Dear Mr. McQuate:

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 contrôls 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 -- Mr. Robert S. McQuate

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 yours,

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 Statement

510(k) Number (if known): _

Device name: C.T.M. Mobility Scooter HS-235

Indications for Use:

The C.T.M. Mobility Scooter HS-235 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

(Please do not write below this line) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation for

:10(k) Number --

Mark A. Milburn

(Division Sign-Off) Division of General, R Corative and Neurological Devilus 032918

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use ______________

Regulation Number and Section

§ 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).