(12 days)
The intended use of the Buzzaround is to provide mobility to persons limited to a seated position that are capable of operating an electric scooter.
The intended use of the Buzzaround is to provide a lightweight scooter that offers mobility to persons limited to a seated position who are capable of overating a simple hand control.
The Buzzaround is a three wheeled battery powered scooter. It has a 70-amp controller, which is used to operate the Buzzaround. The two-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 scat, which is connected, to the drive unit frame via a pedestal and seat post concentrating the users weight over the rear wheels to aid in traction. All seating meets California Bulletin 117 fire standards. The Buzzaround comes standard with a compact removable 24-volt battery pack and on or off board charger and has an operating range of 10 to 15 miles on a full charge. The front and rear frames can be separated 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 4.5-mph
The provided submission K041025 is for a motorized three-wheeled vehicle (scooter) named Buzzaround. The acceptance criteria and the study performed for this device are focused on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, rather than clinical studies with human readers or AI algorithms.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This device is not an AI/ML powered device, so there is no reported performance in terms of metrics like sensitivity, specificity, or AUC as might be seen for diagnostic algorithms. Instead, the acceptance criteria are met by demonstrating compliance with specific ANSI/RESNA performance standards for scooters.
| Acceptance Criteria (ANSI/RESNA Standard) | Reported Device Performance |
|---|---|
| WC/01 1990: Determination of Static Stability Testing | The device underwent and met the requirements of this standard. This is implied by the statement "Discussion of non-clinical tests performed for determinations of substantial equivalence are as follows:" followed by the list of standards, and the overall conclusion of substantial equivalence. |
| WC/02 1991: Determination of Dynamic Stability Testing | The device underwent and met the requirements of this standard. (Implied) |
| WC/03 1990: Determination of the Effectiveness of Brakes | The device underwent and met the requirements of this standard. (Implied) |
| WC/05 1990: Determination of Overall Dimensions, Mass, and Turning Space | The device underwent and met the requirements of this standard. (Implied) |
| WC/10 1990: Determination of Obstacle Climbing Ability | The device underwent and met the requirements of this standard. (Implied) |
| WC/Vol. 2-1998: Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters | The device underwent and met the requirements of this standard. (Implied) |
| Equivalence in Intended Use | "The Buzzaround has the same intended use..." |
| Equivalence in Technological Characteristics | "...and similar technological characteristics as the Companion 221." |
| No New Questions of Safety or Effectiveness | "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." |
| Weight Capacity | 300 lbs (Stated in device description) |
| Maximum Speed | 4.5 mph (Stated in device description) |
| Seating Fire Standards | Meets California Bulletin 117 fire standards (Stated in device description) |
| Operating Range | 10 to 15 miles on a full charge (Stated in device description) |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not detail a "test set" in the context of clinical data for AI/ML validation. The "testing" referred to comprises non-clinical performance tests conducted on the physical device itself. Therefore, a sample size of human subjects or medical images for a test set is not applicable. The data provenance is from the results of a series of engineering and performance tests on the Buzzaround device according to specified industry standards (ANSI/RESNA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable as the ground truth for this type of device (a mobility scooter) is established through adherence to engineering standards and safety tests, not through expert review of clinical data. The "ground truth" here is the physical performance and safety characteristics of the device when subjected to standardized tests.
4. Adjudication Method for the Test Set
This question is not applicable for the reasons stated above. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human reader performance is being evaluated, either with or without AI assistance. The Buzzaround is a physical mobility device, not a diagnostic tool or AI algorithm.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The Buzzaround is a physical medical device, not a software algorithm, so the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily engineering and performance standards compliance. Specifically, the device's performance was compared against the requirements stipulated in:
- ANSI/RESNA WC/01 1990 Determination of Static Stability Testing
- ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing
- ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes
- ANSI/RESNA WC/05 1990 Determination of Overall Dimensions, Mass, and Turning Space
- ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability
- ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters.
The "ground truth" also includes the design specifications and features of the predicate device (Companion 221, K012258) for comparison of substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. The Buzzaround is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above.
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K041025
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Exhibit 3
MAY = 3 2004
510 (K) Summary Golden Technologies, Inc. 510 (K) Premarket Notification Buzzaround
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: March 18, 2004
Name of Device and Name / Address of Sponsor:
Buzzaround
Golden Technologies, Inc. 401 Bridge Street Old Forge, Pa. 18518 Phone: (800) 624-6374 Facsimile: (570) 451-7494
Common or Usual Name: 3-Wheeled scootcr
Classification Name: Motorized Three-Wheel Vehicle
Comparison to Predicate Devices:
The product, which is substantially equivalent to the Buzzaround, is the Companion 221, (K012258). They are both controlled by the use of a paddle type potentiomctcr, with onboard batteries and battery charger. All safety features are equivalent.
Device Description:
The Buzzaround is a three wheeled battery powered scooter. It has a 70-amp controller, which is used to operate the Buzzaround. The two-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 scat, which is connected, to the drive unit frame via a pedestal and seat post concentrating the users weight over the rear wheels to aid in traction. All
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K041025
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seating meets California Bulletin 117 fire standards. The Buzzaround comes standard with a compact removable 24-volt battery pack and on or off board charger and has an operating range of 10 to 15 miles on a full charge. The front and rear frames can be separated 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 4.5-mph
Intended Use:
The intended use of the Buzzaround 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/01 1990 Determination of Static Stability Testing ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass, and Turning Space ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters.
Discussion of Clinical Tests Performed:
N/A
Conclusions:
The Buzzaround has the same intended use and similar technological characteristics as the Companion 221. 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 Buzzaround device is substantially equivalent to the predicate device.
Discussion of Clinical Tests Performed:
N/A
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Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 3 2004
Gene R. Kulon Golden Technologies, Inc. 401 Bridge Street Old Forge, Pennsylvania 18518
Re: K041025
Trade/Device Name: Buzzaround, Vehicle, Motorized 3-Wheeled Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 15, 2004 Received: April 21, 2004
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, I sting 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 mcan 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 - 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milherson
Cclia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT 2
:
Page _ 1 of
510(k) Number (if known): K-
Device Name: Buzzaround, Vehicle, Motorized 3-Wheeled
Indications for Use:
The intended use of the Buzzaround is to provide a lightweight scooter that offers mobility to persons limited to a seated position who are capable of overating a simple hand control.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
OR
(Optional Format 1-2-96)
Division of General, Restorative, and Neurological Devices
Number K04/025
§ 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).