(15 days)
The intended use of the Pride Mobility Products Corporation Go Go Elite Traveller Plus, Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.
The Go Go Elite Traveller Plus, Four Wheel Scooter is a compact battery-operated scooter having a programmable 45-amp "S" Drive 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 Go Go Elite Traveller Plus, Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers. The Go Go Elite Traveller Plus, Four Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is that it can be disassembled into 4 parts: the rear section, the front section, the battery pack, and the seat. This allows for ease of use when traveling or storing the unit.
The provided text is a 510(k) summary for a medical device (Go Go Elite Traveller Plus, Four Wheel Scooter). This type of document focuses on establishing substantial equivalence to a predicate device based on non-clinical testing and functional comparisons, not on fulfilling detailed acceptance criteria from a comparative effectiveness study of an AI device.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to AI/algorithm performance studies which are not relevant to this submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantified acceptance criteria or reported performance in a table format as would be typical for an AI device study. Instead, it refers to compliance with established standards for wheelchairs and scooters.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Implied by Compliance) |
|---|---|
| Compliance with ANSI/RESNA WC Vol. 1-1998 (Requirements and Test Methods for Wheelchairs) | Device is compliant with this standard. |
| Compliance with ANSI/RESNA WC Vol. 2-1998 (Additional Requirements for Wheelchairs with Electrical Systems) | Device is compliant with this standard. |
| Compliance with ANSI/RESNA WC Vol. 2-1998 Section 21 (Electromagnetic Compatibility) | Device is compliant with this standard. |
| Compliance with IEC 601-1-1 (Medical Electrical Equipment. General Requirements for Safety) | Device is compliant with this standard. |
| Compliance with CAL 117 (Flammability Testing) | Device is compliant with this standard. |
| Substantial equivalence to predicate device (Sunrunner SC-440 (K930953)) in performance, maneuverability, stability, and structure. | The device has the same intended use and similar technological characteristics, and differences do not raise new safety or effectiveness questions. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for a physical medical device, not an AI algorithm. The testing involves compliance with physical standards, not data analysis on a test set.
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. There is no "ground truth" establishment in the context of an AI algorithm from experts described in this document. The assessment is based on engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication for a test set 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 device. No MRMC study was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" in this context is defined by adherence to established engineering, safety, and performance standards for power scooters, rather than a clinical "ground truth" for an AI algorithm.
8. The sample size for the training set
Not applicable. This is not an AI device; there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device; there is no training set or ground truth establishment in that context.
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Image /page/0/Picture/1 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", the words "Mobility Products Corp." are written in a smaller, less bold font. The logo is black and white.
NOV 17 2006
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 Go Go Elite Traveller Plus, 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:
10-18-06
Name of Device and Proprietary Name:
Go Go Elite Traveller Plus, 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 Go Go Elite Traveller Plus, Four Wheel Scooter is substantially equivalent to the Pride Mobility Sunrunner SC-440 (K930953) when comparing comparits. performance, 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 Sunrunner SC-440 (K930953) and the Go Go Elite Traveller Plus, Four Wheel Scooter is in the overall size, front and rear frame construction, and the Control Mechanisms.
$\rightarrow$ mm/s
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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 large, bold, sans-serif font, with a horizontal line running through the middle of the word. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, sans-serif font. The logo is black and white.
Device Description:
The Go Go Elite Traveller Plus, Four Wheel Scooter is a compact battery-operated scooter having a programmable 45-amp "S" Drive 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 Go Go Elite Traveller Plus, Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
The Go Go Elite Traveller Plus, Four Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is that it can be disassembled into 4 parts: the rear section, the front section, the battery pack, and the seat. This allows for ease of use when traveling or storing the unit.
Intended Use:
The intended use of the Pride Mobility Products Corp. Go Go Elite Traveller Plus Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.
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 601-1-1 Medical Electrical Equipment. General Requirements for Safety
CAL 117 - Flammability Testing
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Go Go Elite Traveller Plus, Four Wheel Scooter has the same intended use and similar technological characteristics as the Sunrunner SC-440 (K930953), 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 Go Go Elite Traveller Plus, Four Wheel Scooter is substantially equivalent to the predicate device, has passed all the necessary testing procedures, and is considered to be safe for user operation.
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Public Health Service
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2006
Pride Mobility Products Corporation % Mr. Thomas Schappert 182 Susquehanna Avenue Exeter, Pennsylvania 18643
Re: K063389
Trade/Device Name: Go Go Elite Traveller Plus/Four Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: ITI Dated: October 18, 2006 Received: November 2, 2006
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 10gally marketed predicate device results in a classification for your device and thus, verroits 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 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 063389
Device Name: Go Go Elite Traveller Plus / Four Wheel Scooter
Indications for Use:
The intended use of the Pride Mobility Products Corporation Go Go Elite Traveller Plus, Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.
Prescription Use x AND / OR (Part 21 CFR 801 Subpart D)
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) | |
|---|---|
| -------------------------------------------------------- | -- |
P.K
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number k
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3315
§ 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).