The intended use of the Mega Motion Inc., Travel Pal Powered Scooter, is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.

Device Description

The Travel Pal is a compact battery-operated Three Wheel power Scooter featuring rear anti-tip wheels, a standard digital controller, and a foldable tiller. The Travel Pal is designed for, but not limited to Mega Motion, Inc. providers / retailers and their consumers. As a motorized Scooter, the Travel Pal offers economical mobility, and is equipped with; electronic regenerative disc brakes, off-board battery charger, and removable batteries. Accessories include a front basket. The Travel Pal is designed with ultimate safety, stability, performance, and portability in mind. The product also has a lightweight, foldable seat, which is removable and allows for ease of portability when traveling or storing the unit.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Travel Pal 3-Wheel Scooter. This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a clinical study involving human patients. Therefore, many of the requested categories related to clinical study design (e.g., sample size for test set, number of experts, adjudication, MRMC study, standalone performance, ground truth for training set) are not applicable in this context.

Here's the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Testing Standard)	Reported Device Performance
ANSI/RESNA WC/93 Maximum Overall Dimensions	Compliant
ANSI/RESNA WC/01 Determination of Static Stability	Compliant
ANSI/RESNA WC/02 Determination of Dynamic Stability	Compliant
ANSI/RESNA WC/03 Effectiveness of Brakes	Compliant
ANSI/RESNA WC/04 Determination of Energy Consumption - Theoretical Range	Compliant
ANSI/RESNA WC/05 Overall Dimensions, Mass & Turning Space	Compliant
ANSI/RESNA WC/08 Test methods for Static, Impact and Fatigue Strengths	Compliant
ANSI/RESNA WC/09 Climatic Tests	Compliant
ANSI/RESNA WC/10 Obstacle Climbing	Compliant
ANSI/RESNA WC/15 Documentation and Labeling	Compliant
ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility	Compliant
CAL 117 - Flammability Testing	Compliant

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable. The testing described is non-clinical, involving the device itself against engineering standards, not a set of patient data.
Data provenance: Not applicable. The testing is device-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth, in the context of clinical studies, refers to disease presence/absence or other clinical outcomes. For non-clinical engineering tests, the "ground truth" is defined by the technical specifications of the ANSI/RESNA and CAL standards.

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

Not applicable. This pertains to human reader agreement in clinical studies.

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. This is not an AI-powered diagnostic device, and no MRMC study was performed.

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

Not applicable. This is not an AI algorithm. The device itself underwent performance testing in a standalone fashion against established engineering standards.

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

For the non-clinical testing, the "ground truth" is the compliance with the specified engineering and safety standards (ANSI/RESNA WC series and CAL 117). These are objective, measurable criteria.

8. The sample size for the training set:

Not applicable. There is no AI component or training set involved.

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

Not applicable. There is no AI component or training set involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The Travel Pal 3-Wheel Scooter's acceptance criteria are defined by compliance with a comprehensive set of non-clinical engineering and safety standards. The study proving the device meets these criteria was a series of non-clinical tests performed against the following established standards:

ANSI/RESNA WC/93: Maximum Overall Dimensions
ANSI/RESNA WC/01: Determination of Static Stability
ANSI/RESNA WC/02: Determination of Dynamic Stability
ANSI/RESNA WC/03: Effectiveness of Brakes
ANSI/RESNA WC/04: Determination of Energy Consumption - Theoretical Range
ANSI/RESNA WC/05: Overall Dimensions, Mass & Turning Space
ANSI/RESNA WC/08: Test methods for Static, Impact and Fatigue Strengths
ANSI/RESNA WC/09: Climatic Tests
ANSI/RESNA WC/10: Obstacle Climbing
ANSI/RESNA WC/15: Documentation and Labeling
ANSI/RESNA WC Vol. 2-1998 Section 21: Requirements and Test Methods for Electromagnetic Compatibility
CAL 117: Flammability Testing

The submission states that the Travel Pal "has passed all the necessary testing procedures" and that "Compliance to applicable Testing Standards is as follows: [list of standards]". This indicates that the device's performance was measured against the objective metrics and thresholds established by each of these standards, and in each case, it met the required criteria. The purpose of this testing was to demonstrate substantial equivalence to a predicate device (Mega3, MM-333, K982145) by showing that any differences in technological characteristics do not raise new questions of safety or effectiveness.

Summary

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Travel Pal 510(k) Summary

Submitter's Name & Address:

Mega Motion, Inc. 957 Wood Street Old Forge, Pa. 18518 Phone: (888) 415-1200 Facsimile: (888) 415-1210

Mark Calomino Official Correspondent

Date Prepared:

Contact Person:

Name of Device and Proprietary Name:

Common or Usual Name:

Classification Name:

03-02-06

Travel Pal (MM-111B) / Mega Motion

3-Wheel Power Scooter

Vehicle, Motorized 3-Wheeled

Product Code:

INI

Device Description:

As a motorized Scooter, the Travel Pal offers economical mobility, and is equipped with; electronic regenerative disc brakes, off-board battery charger, and removable batteries. Accessories include a front basket.

The Travel Pal is designed with ultimate safety, stability, performance, and portability in mind. The product also has a lightweight, foldable seat, which is removable and allows for ease of portability when traveling or storing the unit.

Comparison to Predicate Devices:

The Travel Pal is substantially equivalent to Mega Motion, Inc. Mega3, MM-333 (K982145) when comparing configuration, maneuverability, stability, and structure. The performance characteristics and the position of the drive mechanisms are similar to achieve the same intended use function that enables

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Image /page/1/Picture/0 description: The image shows the logo for Mega Motion, Inc. The text "Mega Motion, Inc." is in a stylized font with a 3D effect. Below the logo is the tagline "Products for Better Living" in a simpler, sans-serif font.

the user to maintain optimum stability without hindering performance. Both utilize rear drive and rear anti-tip wheels. The key functional change between the Mega3 and the Travel Pal is the Travel Pal's frame is one piece, and batteries are accessible by shroud removal.

Intended Use:

The intended use of the Mega Motion, Inc, Travel Pal Powered Scooter is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.

Non-Clinical Testing:

Compliance to applicable Testing Standards is as follows: ANSI/RESNA WC/93 Maximum Overall Dimensions ANSI/RESNA WC/01 Determination of Static Stability ANSI/RESNA WC/02 Determination of Dynamic Stability ANSI/RESNA WC/03 Effectiveness of Brakes ANSI/RESNA WC/04 Determination of Energy Consumption - Theoretical Range ANSI/RESNA WC/05 Overall Dimensions, Mass & Turning Space ANSI/RESNA WC/08 Test methods for Static, Impact and Fatigue Strengths ANSI/RESNA WC/09 Climatic Tests ANSI/RESNA WC/10 Obstacle Climbing ANSI/RESNA WC/15 Documentation and Labeling ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility. CAL 117 - Flammability Testing

Discussion of Clinical Testing Performed:

N/A

Conclusions:

The Travel Pal has the same intended use and similar technological characteristics as the Mega3 (K982145), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Travel Pal is substantially equivalent to the predicate device (Mega 3 MM333). The Travel Pal has passed all the necessary testing procedures and is considered to be safe for user operation.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2006

Mega Motion, Inc. c/o Mr. Mark Calomino 957 Wood Street Old Forge, Pennsylvania 18518

Re: K060697

Trade/Device Name: Travel Pal - 3 Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: March 6, 2006 Received: March 16, 2006

Dear Mr. Calomino:

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 - Mr. Mark Calomino

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 N. Melkerson

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): K

Device Name: Travel Pal - 3 Wheel Scooter

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OMDI

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

510(k) Number_ko60697

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).