(11 days)
The intended use of the Pride Mobility Products Corporation Victory Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities.
The Victory Three Wheel Scooter is a mid-size battery-operated scooter having a programmable 70-amp Digital Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic reqenerative and electromechanical disc brakes, and rear anti-tip wheels. The Victory Three Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers. The Victory Three Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is a narrow wheelbase (22"), which allows better maneuverability from a mid-sized product.
This document is a 510(k) premarket notification for a medical device, specifically a Victory Three Wheel Scooter. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for a new, AI-driven diagnostic or therapeutic device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not applicable to this document as it is a submission for a durable medical equipment (DME) device, not a diagnostic or AI-enabled device requiring such detailed performance evaluation against clinical endpoints.
The document states:
- "Discussion of Clinical Testing Performed: N/A"
- "The nonclinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
This indicates that clinical testing, in the sense of a performance study with human subjects, was not performed or deemed necessary for this 510(k) submission. Instead, the submission relies on non-clinical testing against established industry standards and comparison to a legally marketed predicate device.
To directly address your request given the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC Vol. 1-1998 Requirements and Test Methods for Wheelchairs (Including Scooters) | Device has passed all testing requirements and is considered safe for user operation. |
| ANSI/RESNA WC Vol. 2-1998 Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems | Device has passed all testing requirements and is considered safe for user operation. |
| ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility. | Device has passed all testing requirements and is considered safe for user operation. |
| IEC 60335-2-29 Safety of Electrical Appliances (Part 2 Battery Chargers) | Device has passed all testing requirements and is considered safe for user operation. |
| IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety | Device has passed all testing requirements and is considered safe for user operation. |
| CAL 117 - Flammability Testing | Device has passed all testing requirements and is considered safe for user operation. |
2. Sample size used for the test set and the data provenance: Not applicable. The document refers to non-clinical testing against standards for the device itself, not a test set of data like in an AI/diagnostic study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is mentioned.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this type of device is compliance with engineering and safety standards, as well as functional equivalence to a predicate device, rather than a clinical ground truth.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.
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K072/65
Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990 www.pridemobility.com
Exhibit 1
510(k) Summary Pride Mobility Products Corporation Victory Three Wheel Scooter
Submitter's Name & Address:
AUG 17 2007
Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 655-2990
Contact Person:
Thomas Schappert Official Correspondent
Date Prepared:
08-03-07
Name of Device and Proprietary Name:
Victory Three Wheel Scooter / Pride Mobility Products Corporation
Common or Usual Name:
Three-Wheel Power Scooter
Classification Name:
Physical Medicine / Motorized Three - Wheeled Vehicle
Product Code:
INI
Comparison to Predicate Devices:
The Victory Three Wheel Scooter is substantially equivalent to the Pride Mobility SC300 (K926295) when comparing components, performance, Legend maneuverability, stability, and structure. The performance characteristics and the position of the electronics and drive mechanisms are similar to achieve the same intended use function that enables the user to maintain optimum stability without hindering performance. The differences between The Legend SC300 (K926295) and the Victory Three Wheel Scooter are in the wheelbase, front and rear frame construction, and the Control Mechanisms.
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Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, stylized font with a horizontal line running through the middle of the letters. Below the word "Pride" is the text "Mobility Products Corp." in a smaller, less bold font. The logo appears to be slightly distressed or textured.
Device Description:
The Victory Three Wheel Scooter is a mid-size battery-operated scooter having a programmable 70-amp Digital Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic reqenerative and electromechanical disc brakes, and rear anti-tip wheels. The Victory Three Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
The Victory Three Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is a narrow wheelbase (22"), which allows better maneuverability from a mid-sized product.
Intended Use:
The intended use of the Pride Mobility Products Corp. Victory Three Wheel Scooter is to provide mobility to persons having limited walking capabilities.
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows:
ANSI/RESNA WC Vol. 1-1998 Requirements and Test Methods for Wheelchairs (Including Scooters)
ANSI/RESNA WC Vol. 2-1998 Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
IEC 60335-2-29 Safety of Electrical Appliances (Part 2 Battery Chargers) IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety CAL 117 - Flammability Testing
Discussion of Clinical Testing Performed: N/A
Conclusions:
The Victory Three Wheel Scooter has the same intended use and similar technological characteristics as the Legend SC300 (K926295), moreover, the nonclinical 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 Victory Three Wheel Scooter is substantially equivalent to the predicate device, has passed all testing requirements, 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 seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized emblem. The emblem is a representation of a human figure, with three lines forming the body and head, and two lines forming the legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pride Mobility Products Corporation % Mr. Thomas Schappert Official Correspondent 182 Susquehanna Avenue Exeter, PA 18643
AUG 1 7 2007
Re: K072165
Trade/Device Name: Victory Three Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: August 3, 2007 Received: August 6, 2007
Dear Mr. Schappert:
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. Thomas Schappert
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 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,
Xanthum
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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Exhibit 3
Indications for Use
510(k) Number (if known): K
Device Name: Victory Three Wheel Scooter SC610
Indications for Use:
The intended use of the Pride Mobility Products Corporation Victory Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities.
| 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)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices
510(k) Number / L072165
Page 1 of 1
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§ 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).