C.T.M. MOBILITY SCOOTER, MODEL HS-120 by C.T.M. HOMECARE PRODUCT, INC.

The C.T.M. Mobility Scooter HS-120 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 provided text describes a 510(k) submission for a mobility scooter and does not contain information about acceptance criteria or a study proving its performance in the context of medical device AI or diagnostic tools. The document is for a physical device (a mobility scooter) and explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, I cannot generate the requested table and study details.

The document focuses on:

Device Identification: C.T.M. Mobility Scooter HS-120.
Substantial Equivalence: Comparison to a legally marketed predicate device (C.T.M. Mobility Scooter HS-320).
Device Description and Intended Use: An indoor/outdoor electric scooter for disabled or elderly persons.
Testing Conducted: Mention of tests listed in a "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995." However, specific results or acceptance criteria for these tests are not detailed in the provided text.
Lack of Performance/Clinical Data: Crucially, it states that comparative performance testing and clinical evaluations were not submitted.

To answer your request, I would need a document that describes the acceptance criteria for a specific performance metric (e.g., sensitivity, specificity, accuracy for a diagnostic device) and details a study designed to demonstrate that the device meets those criteria.

Summary

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MAY 2 0 2003

KO31272

510(k) SUMMARY

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

Date summary prepared:

April 14, 2003

Device name:

Proprietary name: Common or usual name: Classification name:

C.T.M. Mobility Scooter HS-120 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-320 submitted by Warepalmy Enterprise LLC (USA) and cleared for marketing under 510(k) *K012791.

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-120 and the HS-320 are very similar. Both are electric scooters that are battery operated and have automatic braking systems. Batteries and battery chargers are provided with each scooter. Use parameters are very similar, varving only slightly with selected parameters, such as the travel range and the grade the scooter can climb.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2003

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: K031272

Trade/Device Name: C.T.M. Mobility Scooter HS-120 Regulation Number: 21 CFR 850.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 21, 2003 Received: April 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 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.

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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 vours.

sincerely yours,

Mark A. McMillan

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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C.T.M. Mobility Scooter HS-120 510(k) Notification Page 3

Indications for Use Statement

510(k) Number (if known):

Device name: C.T.M. Mobility Scooter HS-120

Indications for Use:

The C.T.M. Mobility Scooter HS-120 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use √

Mark N Milken

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K03127

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).