(15 days)
The intended use of the Golden Liteway is to provide mobility to persons limited to a seated position that are capable of operating an electric scooter.
The intended use of the Golden Liteway is to provide a lightweight scooter that offers mobility to persons limited to a seated position who are capable of operating a simple hand control.
The Golden Liteway is a three wheeled battery powered scooter. It has a 45-amp controller, which is used to operate the Golden Liteway. The one-piece base of the scooter is made of welded steel construction. The drive unit is separable from the floor pan and includes spaced apart, differentially connected rear wheels (2) and an electric motor with a gear housing. It comes standard with a removable fold down seat, which is connected, to the drive unit frame via a pedestal and seat post concentrating the users' weight near the rear wheels to aid in traction. All seating meets California Bulletin 117 fire standards. The Golden Liteway comes standard with a compact removable 24-volt battery pack with auto contact and lock and an off board charger. The Golden Liteway has an operating range of 7.5 miles on a full charge at Maximum weight of 300 lbs. The frame can be separated from the rear wheel assembly for stowage and transportation. It has intelligent electronic regenerative braking and a disc parking brake. The weight capacity is 300-lbs and it has a maximum speed of 4-mph.
The Golden Liteway is a three-wheeled battery-powered scooter intended to provide mobility to persons limited to a seated position who are capable of operating an electric scooter. The submission is a 510(k) premarket notification, and therefore, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the document addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) summary demonstrating substantial equivalence to a predicate device (the Buzzaround, K041025) and not a de novo clearance or PMA submission for a novel device, the "acceptance criteria" are primarily established by conformity to relevant industry standards and comparison to the predicate. The performance reported focuses on meeting these standards and having similar characteristics to the predicate.
| Acceptance Criterion (Standard/Characteristic) | Reported Device Performance (Golden Liteway) |
|---|---|
| ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass and Turning Space | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| EN 12184 With Reference to: EN 55022(B) Emissions IEC 61000-4-3 Immunity IEC 61000-4-2 ESD | All EMC tests performed and compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| ISO 7176-2 (ANSI/RESNA WC/Vol. 2-1998 Section 2) Dynamic Stability Testing | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| ISO 7176-1 Static stability testing | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| ISO 7176-4 Energy Consumption of Electric Wheelchairs and Scooters for determination of theoretical distance range | Operating range of 7.5 miles on a full charge at maximum weight of 300 lbs. |
| ISO 7176-6 Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Maximum speed of 4-mph |
| ISO 7176-10 Determination of obstacle climbing ability of electric wheelchairs | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| ISO 7176-9 2001 Climatic Tests for wheelchair | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| ISO 7176-8 (1998) Requirements and test methods for static, impact and fatigue strengths | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| TB117 Flammability test (1) SEC. A Part I Flame Retardance Test | All seating meets California Bulletin 117 fire standards. |
| Predicate Device Equivalence (Buzzaround, K041025) | Controlled by paddle type potentiometer, onboard batteries/charger, equivalent safety features, same intended use, similar technological characteristics. |
| Weight Capacity | 300-lbs |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a "test set" in the context of clinical trials or AI/algorithm performance. The non-clinical tests refer to standardized testing of mechanical and electrical components, not typically involving distinct "test sets" of patient data or users.
- Data Provenance: Not applicable in the context of this 510(k) for a mobility scooter, as it relies on engineering and performance standards rather than clinical data sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This submission concerns a physical medical device (scooter) and relies on engineering standards and technical specifications rather than expert interpretation of medical images or data.
4. Adjudication Method for the Test Set:
- Not applicable. As noted above, this involves technical standards and physical product testing, not subjective expert adjudication.
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-enabled device requiring MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used:
- The "ground truth" for this device is based on established engineering and safety standards (e.g., ISO, ANSI/RESNA, EN, California Bulletin 117). Compliance with these standards serves as the benchmark for acceptable performance. The performance characteristics of the predicate device also serve as a "ground truth" for demonstrating substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/algorithm device.
Summary of the Study and Substantial Equivalence:
The study proving the device meets its acceptance criteria is a series of non-clinical engineering tests (as listed in Section {1} and {2}) and a comparison to a predicate device. The Golden Liteway demonstrates its substantial equivalence to the predicate device, the Buzzaround (K041025), by:
- Having the same intended use: providing mobility to persons limited to a seated position capable of operating an electric scooter.
- Possessing similar technological characteristics: both are controlled by a paddle-type potentiometer, have onboard batteries and chargers, and equivalent safety features.
- Successfully undergoing a battery of non-clinical tests (e.g., stability, energy consumption, speed, flammability, EMC) according to recognized international and national standards (ANSI/RESNA, EN, ISO, TB117). The successful completion of these tests implicitly demonstrates compliance with the safety and performance requirements of these standards.
The conclusion is that the differences in technological characteristics of the Golden Liteway compared to the Buzzaround do not raise any new questions of safety or effectiveness, thus establishing substantial equivalence. No clinical trials were performed or deemed necessary for this type of device.
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510 (K) Summary Golden Technologies, Inc. 510 (K) Premarket Notification Golden Liteway
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Golden Technologies, Inc. 401 Bridge Street Old Forge, Pa. 18518 Phone: (800) 624-6374 Facsimile: (570) 451-7494 Contact Person: Gene Kulon Official Correspondent Date Prepared: September 25, 2006
NOV - 2 2006
Name of Device and Name / Address of Sponsor:
Golden Liteway
Golden Technologies, Inc. 401 Bridge Street Old Forge, Pa. 18518 Phone: (800) 624-6374 Facsimile: (570) 451-7494
Common or Usual Name: 3-Wheeled scooter
Classification Name: Motorized Three-Wheel Vehicle
Comparison to Predicate Devices:
The product, which is substantially equivalent to the Golden Liteway, is the Buzzaround, (K041025). They are both controlled by the use of a paddle type potentiometer, with onboard batteries and battery charger. All safety features are equivalent.
DEVICE DESCRIPTION:
The Golden Liteway is a three wheeled battery powered scooter. It has a 45-amp controller, which is used to operate the Golden Liteway. The one-piece base of the scooter is made of welded steel construction. The drive unit is separable from the floor pan and includes spaced apart, differentially connected rear wheels (2) and an electric motor with a gear housing. It comes standard with a removable
{1}------------------------------------------------
fold down seat, which is connected, to the drive unit frame via a pedestal and seat post concentrating the users' weight near the rear wheels to aid in traction.
All seating meets California Bulletin 117 fire standards. The Golden Liteway comes standard with a compact removable 24-volt battery pack with auto contact and lock and an off board charger. The Golden Liteway has an operating range of 7.5 miles on a full charge at Maximum weight of 300 lbs. The frame can be separated from the rear wheel assembly for stowage and transportation. It has intelligent electronic regenerative braking and a disc parking brake. The weight capacity is 300-lbs and it has a maximum speed of 4-mph.
Intended Use:
The intended use of the Golden Liteway is to provide mobility to persons limited to a seated position that are capable of operating an electric scooter.
Discussion of non-clinical tests performed for determinations of substantial equivalence are as follows:
ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass and Turning Space
EN 12184 With Reference to: EN 55022(B) Emissions IEC 61000-4-3 Immunity IEC 61000-4-2 ESD All EMC tests performed.
ISO 7176-2 (ANSI/RESNA WC/Vol. 2-1998 Section 2) Dynamic Stability Testing ISO 7176-1 Static stability testing.
ISO 7176-4 Energy Consumption of Electric Wheelchairs and Scooters for determination of theoretical distance range.
ISO 7176-6 Determination of maximum speed, acceleration and deceleration of electric wheelchairs.
ISO 7176-10 Determination of obstacle climbing ability of electric wheelchairs. ISO 7176-9 2001 Climatic Tests for wheelchair.
ISO 7176-8 (1998) Requirements and test methods for static, impact and fatigue strengths.
TB117 Flammability test (1) SEC. A Part I Flame Retardance Test.
{2}------------------------------------------------
Discussion of Clinical Tests Performed: N/A
Conclusions:
The Golden Liteway has the same intended use and similar technological characteristics as the Buzzaround. 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 Golden Liteway device is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Golden Technologies, Inc. % Mr. Gene R. Kulon Official Correspondent 401 Bridge Street Old Forge, Pennsylvania 18518
Re: K063162
Trade/Device Name: Golden Liteway, Vehicle, Motorized 3-Wheeled Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 15, 2006 Received: October 18, 2006
Dear Mr. Kulon:
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.
NOV - 2 2006
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. Gene R. Kulon
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
.
Carl N. Weller
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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510(k) Number (if known): K-06316 2
Device Name: Golden Liteway, Vehicle, Motorized 3-Wheeled
Indications for Use:
The intended use of the Golden Liteway is to provide a lightweight scooter that offers mobility to persons limited to a seated position who are capable of operating a simple hand control.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801Subpart 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-Orr Division of General, Restorative and Neurological Devices
510(k) I
§ 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).