The C.T.M. Mobility Scooter HS-890 is an indoor/outdoor electric scooter that is battery operated. It has a base with four wheels with adjustable padded seat, armrests, and headrests. 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 a battery charger.

AI/ML Overview

The provided text describes a 510(k) submission for a mobility scooter, the C.T.M. Mobility Scooter HS-890. While it details the device and its intended use, it explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This means that the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria through performance testing.

The submission focuses instead on demonstrating substantial equivalence to a legally marketed predicate device (Laser 4, K003059) based on similar technological characteristics. It mentions that "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." However, the results of these tests and how they relate to specific acceptance criteria are not provided.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the document.
Sample size used for the test set and the data provenance: Not provided, as comparative performance testing was not submitted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed performance testing for ground truth establishment was not submitted.
Adjudication method for the test set: Not applicable.
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, as this is not an AI device and no clinical effectiveness study was submitted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: Not applicable, as detailed performance testing for ground truth establishment was not submitted.
The sample size for the training set: Not applicable, as this is not an AI device.
How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided document focuses on regulatory compliance through substantial equivalence, not on detailed performance study results against specific acceptance criteria.

Summary

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K030387

MAR 11 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:

January 31, 2003

Device name:

Proprietary name: Common or usual name: Classification name:

C.T.M. Mobility Scooter HS-890 Electric scooter. Motorized three-wheeled vehicle, Class II, 21 CFR 890.3800.

Legally marketed device for substantial equivalence comparison:

Laser 4 submitted by Pride Mobility Products Corp. and cleared for marketing under 510(k) *K003059.

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 C.T.M. Mobility Scooter HS-890 and the Laser 4 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, varying 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 seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of a bird-like figure with three lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 11 2003

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

Re: K030387

Trade Name: C.T.M. Mobility Scooter HS-890 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: February 3, 2003 Received: February 5, 2003

Dear Mr. McQuate:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Mr. Robert 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 A. Melkerson

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-890 510(k) Notification Page 3

Indications for Use Statement

510(k) Number (if known): __K030387

Device name: C.T.M. Mobility Scooter HS-890

Indications for Use:

The C.T.M. Mobility Scooter HS-890 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 (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Mark A. Milkman

Division Fi Division of Sameral. Restorative and Neurological Daries

:10(k) Numoci ___ K030387

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).