C.T.M. MOBILITY SCOOTER# HS-265 by C.T.M. HOMECARE PRODUCT, INC.

The C.T.M. Mobility Scooter HS-265 is an indoor/outdoor scooter that is battery operated. It has a base with three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column which allow the rider to control the movement of the scooter. It can be disassembled for transport and is provided with an on-board battery charger.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the C.T.M. Mobility Scooter HS-265, focusing on acceptance criteria and study details:

This document describes a mobility scooter, which is a physical device, not an AI/ML device. Therefore, the majority of the questions related to AI/ML device testing (e.g., sample size for test sets, ground truth, experts, MRMC studies, standalone performance, training set) are not applicable to this submission.

The 510(k) summary explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This indicates that the regulatory pathway relied on demonstrating "substantial equivalence" to a predicate device (C.T.M. Mobility Scooter HS-235 cleared under K032918) through technological characteristics and adherence to recognized guidance documents, rather than independent performance studies with acceptance criteria in the typical sense for AI/ML or efficacy studies.

However, I can extract the information that is present and indicate where information is missing or not applicable based on the nature of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance	Comments
Adherence to "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995"	"Tests listed in the Guidance Document... were conducted and the results included in the submission."	The specific performance metrics and their acceptance thresholds from the guidance document are not detailed in this summary. The summary only states that the tests were conducted and the results were submitted to the FDA.
Substantial Equivalence to Predicate Device (C.T.M. Mobility Scooter HS-235, K032918)	The device features of the HS-265 and HS-235 are "very similar." Both are battery operated, have one motor, automatic braking, and can be disassembled. Target population and use parameters are "identical and similar."	This is the primary "acceptance criterion" for a 510(k) pathway, demonstrating that the new device is as safe and effective as a legally marketed predicate.

For the following questions, please note that they are largely not applicable to this type of device submission (a physical mobility scooter) and the regulatory pathway chosen (510(k) based on substantial equivalence to a predicate without new clinical or comparative performance studies beyond adherence to guidance documents).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable (N/A). No specific "test set" in the context of AI/ML or comparative clinical performance was described. The testing mentioned refers to engineering/performance tests as outlined in a guidance document, not data-driven evaluations.

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)

Not Applicable (N/A). Ground truth and expert consensus are irrelevant for device performance testing of a mobility scooter. The "ground truth" for a mobility scooter's safety/performance would be adherence to engineering specifications and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable (N/A). Adjudication methods are used in clinical trials or expert label review for data, which is not described here.

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 (N/A). This is a mobility scooter, not a diagnostic AI/ML device. Therefore, MRMC studies and "human readers" are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable (N/A). This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable (N/A). No ground truth in the context of data labeling or clinical outcomes was used for this type of submission. The "ground truth" for device performance would be physical measurements against engineering specifications and safety standards.

8. The sample size for the training set

Not Applicable (N/A). There is no "training set" as this is a physical product, not an AI/ML model.

9. How the ground truth for the training set was established

Not Applicable (N/A). As there is no training set, this question is not relevant.

Summary

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C.T.M. Mobility Scooter HS-265 510(k) Notification

L070602

510(k) SUMMARY

Submitter's name:	C.T.M. Homecare Product, Inc.13825 Norton Ave., Chino, CA 91710	APR - 2 2007
Contact name and address:	Linda J. Bovard, Bovard Consulting, LLC29611 Simmons Road, Eugene, OR 97405(541) 345-5431
Date summary prepared:	February 28, 2007
Device name:

Proprietary name: Common or usual name: Classification name:

C.T.M. Mobility Scooter HS-265 Electric scooter Motorized three-wheeled vehicle (890.3800). Motorized 3-wheeled vehicle (89 INI).

Legally marketed device for substantial equivalence comparison:

The predicate device for this submission is the C.T.M. Mobility Scooter HS-235 submitted by C.T.M. Homecare Product, Inc. and cleared under 510(k) *K032918.

Description of the device:

Intended use of device:

The C.T.M. Mobility Scooter HS-265 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Technological characteristics:

The device features of the C.T.M. Mobility Scooter HS-265 and the HS-235 are very similar. Both are battery operated, have one motor, and have automatic braking systems. Battery chargers are provided with both scooters, but the HS-265 charger is on-board. Both scooters can be disassembled for transport. The target population is identical and the use parameters are similar.

Testing conducted:

Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a circle of text around it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.T.M. Homecare Product, Inc. % Bovard Consulting, LLC Ms. Linda J. Bovard President 29611 Simmons Road Eugene, Oregon 97405

APR - 2 2007

Re: K070602

Trade/Device Name: C.T.M. Mobility Scooter #HS-265 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: February 28, 2007 Received: March 5, 2007

Dear Ms. Bovard:

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. Linda J. Bovard

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Milbern

Mark N. Melkerson 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: C.T.M. Mobility Scooter HS-265

Indications for Use:

The C.T.M. Mobility Scooter HS-265 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerson

(Division Sign-Off) (Division Sign-on) Restorative, Division of Offical Devices 1070602

510(k) Number

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).