(19 days)
The intended use of the Pride Mobility Products Corporation Victory Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities.
The Victory Four 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 regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Victory Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
The Victory Four 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.
The provided text describes the regulatory submission for the "Victory Four Wheel Scooter" and primarily focuses on its substantial equivalence to a predicate device, the Pride Mobility SC340 (K930952). The content does not describe a study that involves acceptance criteria, device performance, sample sizes, ground truth from experts, or comparative effectiveness studies in the context of AI/algorithm performance.
Instead, the document details non-clinical testing for compliance with established standards for wheelchairs and scooters. Since the request specifically asks for information related to AI/algorithm performance studies, and this document pertains to a physical medical device (a scooter) and its regulatory approval based on non-clinical testing and predicate device comparison, most of the requested information is not applicable.
Here's a breakdown based on the provided text, highlighting where information is N/A (Not Applicable) or not provided.
Acceptance Criteria and Device Performance (Not Applicable for AI/Algorithm Study)
The document lists compliance with various testing standards for the physical scooter. These are "acceptance criteria" in the sense of regulatory compliance for a physical device, but not in the context of an AI/algorithm performance study.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance / Compliance Status |
|---|---|---|
| Non-Clinical Testing | ANSI/RESNA WC Vol. 1-1998 | Compliant |
| ANSI/RESNA WC Vol. 2-1998 | Compliant | |
| ANSI/RESNA WC Vol. 2-1998 Section 21 (Electromagnetic Compatibility) | Compliant | |
| IEC 60335-2-29 (Battery Chargers) | Compliant | |
| IEC 601-1-1 (Electrical Medical Equipment Safety) | Compliant | |
| CAL 117 (Flammability Testing) | Compliant | |
| Substantial Equivalence | Comparison to Predicate Device (Pride Mobility SC340, K930952) | Considered substantially equivalent based on similar intended use, technological characteristics, components, performance, maneuverability, stability, and structure. Differences (wheelbase, frame construction, control mechanisms) do not raise new safety/effectiveness questions. |
Study Details (Not Applicable for AI/Algorithm Study)
This section is largely N/A as the document explicitly states "N/A" for "Discussion of Clinical Testing Performed" and focuses on non-clinical engineering and design compliance.
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Sample size used for the test set and the data provenance:
- N/A. This device is a physical scooter, not an AI/algorithm. Test sets, in the context of AI, are not relevant here. The "testing" involved physical product performance against engineering standards.
- Data provenance: N/A.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth, in the context of expert review for AI, is not applicable. Regulatory compliance is assessed by adherence to established engineering standards, presumably by qualified engineers/testers.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods for expert consensus on ground truth are not applicable to non-clinical engineering tests.
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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:
- N/A. This is a physical device, not an AI solution designed to "assist human readers."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (in the AI sense). For this device, "ground truth" would be compliance with objective engineering specifications and safety standards (e.g., a specific torque, speed, stability angle, or flammability resistance measured during testing).
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The sample size for the training set:
- N/A. No AI training set is involved.
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How the ground truth for the training set was established:
- N/A. No AI training set is involved.
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Image /page/0/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a stylized font, with a thick black line running horizontally through the middle of the word. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, simpler font. The logo is black and white.
AUG - 1 2007
Image /page/0/Picture/2 description: The image shows the letterhead for Research & Development. The address is 182 Susquehanna Ave, Exeter, PA 18643. The phone number is 570-655-5574, and the fax number is 655-2990. The website is www.pridemobility.com.
Device Description:
The Victory Four 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 regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Victory Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
The Victory Four 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 Four 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 Four Wheel Scooter has the same intended use and similar technological characteristics as the Legend SC340 (K930952), 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. TThus, the Victory Four 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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Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is in a large, bold 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 font. The logo is black and white.
Exhibit 1
510(k) Summary Pride Mobility Products Corporation Victory Four Wheel Scooter
Submitter's Name & Address:
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:
06-29-07
Name of Device and Proprietary Name:
Victory Four Wheel Scooter / Pride Mobility Products Corporation
Common or Usual Name:
Four-Wheel Power Scooter
Classification Name: Physical Medicine / Motorized Three - Wheeled Vehicle
Product Code:
INI
Comparison to Predicate Devices:
The Victory Four Wheel Scooter is substantially equivalent to the Pride Mobility SC340 (K930952) 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 SC340 (K930952) and the Victory Four Wheel Scooter are in the wheelbase, front and rear frame construction, and the Control Mechanisms.
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Image /page/2/Picture/1 description: The image shows the 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. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pride Mobility Products Corporation % Mr. Thomas Schappert 182 Susquehanna Avenue Exeter, PA 18643
AUG - 1 2007
K071949 Re:
Trade/Device Name: Victory Four Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: August 7, 2007 Received: August 12, 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. 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
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Page 2 – Mr. Thomas Schappert
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 n your 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,
Mark N. Mellon
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
00
Enclosure
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Exhibit 3
Indications for Use
510(k) Number (if known): K
Device Name: Victory Four Wheel Scooter
Indications for Use:
The intended use of the Pride Mobility Products Corporation Victory Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities.
| 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K071949 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 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).