(11 days)
The intended use of the Mega Motion, Inc, Travel Pal Four Wheel Scooter is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.
The Travel Pal Four - Wheel Scooter is a battery-operated compact scooter equipped with a digital controller. Features include an adjustable and removable molded plastic seat, a foldable tiller, one-piece solid frame, and an off board charger, designed for ultimate performance, stability and portability. Additional features include electronic regenerative / electromechanical disc brakes, and rear anti-tip wheels designed for ultimate safety.
The device described is the Travel Pal Four-Wheel Scooter (K080288), manufactured by Mega Motion, Inc.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are derived from compliance with various ANSI/RESNA WC standards. The document states that the device has "passed all the necessary testing procedures," implying that it has met the requirements of each standard.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/01 Determination of Static Stability | Passed |
| ANSI/RESNA WC/02 Determination of Dynamic Stability | Passed |
| ANSI/RESNA WC/03 Effectiveness of Brakes | Passed |
| ANSI/RESNA WC/04 Determination of Energy Consumption - Theoretical Range | Passed |
| ANSI/RESNA WC/05 Overall Dimensions, Mass & Turning Space | Passed |
| ANSI/RESNA WC/08 Test methods for Static, Impact and Fatigue Strengths | Passed |
| ANSI/RESNA WC/09 Climatic Tests | Passed |
| ANSI/RESNA WC/10 Obstacle Climbing | Passed |
| ANSI/RESNA WC/14 Power and Controls | Passed |
| ANSI/RESNA WC/15 Documentation and Labeling | Passed |
| ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility | Passed |
| ANSI/RESNA WC/93 Maximum Overall Dimensions | Passed |
| CAL 117 - Flammability Testing | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for the "non-clinical testing" (the testing against the ANSI/RESNA WC standards). These tests are typically performed on a limited number of production or pre-production units. The data provenance is not specified beyond being "non-clinical testing." It's generally assumed such testing is performed in a controlled laboratory environment. It is implicitly "prospective" as it's done specifically to demonstrate compliance for regulatory submission.
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)
The concept of "experts establishing ground truth" as it applies to clinical diagnostics or imaging interpretation (like radiologists) is not relevant for this device. The standards themselves define the "ground truth" or the acceptable performance parameters. The "experts" would be the engineers and technicians performing the tests and verifying compliance with the standard's specifications. Their qualifications are not specified but would typically involve expertise in mechanical engineering, electronics, and product safety testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are used for human expert consensus in interpreting complex data (e.g., medical images). This is not applicable to the non-clinical testing of a mobility scooter. The "adjudication" is inherent in the pass/fail criteria defined by each specific ANSI/RESNA WC standard.
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
No MRMC comparative effectiveness study was done. This type of study (often used for AI-assisted diagnostic tools) is not relevant to a mobility scooter. The study performed focuses on safety and performance characteristics against established engineering standards.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical mobility scooter, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims is defined by the ANSI/RESNA WC standards and CAL 117 Flammability Testing. These are widely accepted industry standards that specify test procedures and acceptable performance limits for wheelchairs and scooters.
8. The sample size for the training set
This question is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows a handwritten string of characters, "K080288". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with the "K" having a distinct shape and the "8" being slightly elongated.
Exhibit 1
Image /page/0/Picture/2 description: The image shows the text "Mega Motion, Inc." in a stylized, three-dimensional font. The text is black and appears to be slightly tilted. The font has a unique design with sharp edges and a textured appearance, giving it a bold and dynamic look.
ducts for Better Livl
Travel Pal 4 Wheel Scooter 510(k) Summary
Submitter's Name & Address:
Name of Device and Proprietary Name:
Contact Person:
Date Prepared:
Mega Motion, Inc. 957 Wood Street Old Forge, Pa. 18518 Phone: (888) 415-1200 Facsimile: (888) 415-1210
Tom Amico Official Correspondent
01-29-08
Travel Pal Four Wheel Scooter / Mega Motion
Four - Wheel Power Scooter
Vehicle, Motorized 3 -Wheeled
INI
Device Description:
Product Code:
Classification Name:
Common or Usual Name:
The Travel Pal Four - Wheel Scooter is a battery-operated compact scooter equipped with a digital controller. Features include an adjustable and removable molded plastic seat, a foldable tiller, one-piece solid frame, and an off board charger, designed for ultimate performance, stability and portability. Additional features include electronic regenerative / electromechanical disc brakes, and rear anti-tip wheels designed for ultimate safety.
The Travel Pal Four Wheel Scooter is to be marketed for, but not limited to Mega Motion, Inc. providers / retailers and their consumers.
Comparison to Predicate Device:
The Travel Pal Four Wheel Scooter is a four-wheel version of the Mega Motion, Travel Pal Three Wheel Scooter (K060697) having similar components to justify substantial equivalence. The additional front wheel increases stability, however, components and performance characteristics are identical to the three wheel model, and achieve the same intended use function.
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Image /page/1/Picture/0 description: The image shows the words "Mega Motion, Inc." in a stylized, three-dimensional font. The text is black and appears to be slightly tilted to the right. The font gives the impression of depth and movement, which aligns with the name "Mega Motion".
Products for Better Living
Intended Use:
The intended use of the Mega Motion, Inc, Travel Pal Four Wheel 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/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/14 Power and Controls ANSI/RESNA WC/15 Documentation and Labeling ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility. ANSI/RESNA WC/93 Maximum Overall Dimensions CAL 117 - Flammability Testing
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Travel Pal Four Wheel Scooter has the same intended use and similar technological characteristics as the Travel Pal Three Wheel Scooter (K060697), 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 Four Wheel Scooter is substantially equivalent to the Travel Pal Three Wheel Scooter predicate device. The Travel Pal Four Wheel Scooter has passed all the necessary testing procedures and is considered to be safe for user operation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.
Public Health Service
FEB 1 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mega Motion, Inc. c/o Mr. Tom Amico 957 Wood Street Old Forge, PA 18518
Re: K080288
Trade/Device Name: Travel Pal - Four Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: January 29, 2008 Received: February 4, 2008
Dear Mr. Amico:
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. Tom Amico
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
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 – Four Wheel { cooter
Indications for Use:
The intended use of the Mega Motion Inc., Travel Pal Four Wheel Scooter, is to provide mobility to persons that have limit id walking capabilities or simply those who wish to ride a scooter for transportation purposes.
| Prescription Use | X | AND / OR | Over-The-Counter Use | X |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Official (Division Sign-Off) Division Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number 11080288
§ 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).