(50 days)
KYMCO ForU EQ40 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.
The KYMCO ForU EQ40 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided 510(k) summary for the KYMCO ForU EQ40 scooter is part of a submission to demonstrate substantial equivalence to predicate devices, not an independent study aimed at proving device performance against specific acceptance criteria in the way a diagnostic AI device might.
Therefore, many of the typical sections requested for an AI device's acceptance criteria and study design are not applicable to this submission. This is a medical device (mobility scooter), and the regulatory pathway focuses on comparing its safety and effectiveness to already legally marketed devices, rather than establishing novel performance metrics.
Here's an analysis based on the information provided, highlighting why certain questions are not directly answerable in this context:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not present in the 510(k) summary as the submission's goal is to demonstrate substantial equivalence to predicate devices, not to meet specific quantitative performance metrics like sensitivity, specificity, or accuracy for a diagnostic device. The "performance" here refers to functional characteristics of a mobility scooter.
| Acceptance Criteria (e.g., Performance Specification) | Reported Device Performance (KYMCO ForU EQ40) |
|---|---|
| Intended Use Equivalence: Provide transportation for disabled or elderly persons limited to a seated position. | Met: Intended use is identical to predicate devices. "KYMCO ForU EQ40 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position." |
| Technological Characteristics Equivalence: Battery-operated, tiller handle, thumb-operated potentiometer throttle control. | Met: Device description aligns with general functionality of predicate devices. "The KYMCO ForU EQ40 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions." |
| Differences in Performance Specifications do not alter intended function or raise new safety/effectiveness questions. | Met: The submission states, "There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." (Specific "minor differences" are not detailed in this summary, but would have been presented to the FDA). |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical medical device (mobility scooter). The "test set" would typically refer to a clinical study or a dataset for evaluating a diagnostic algorithm. For this device, testing would involve engineering and functional performance evaluations for safety and efficacy in line with industry standards, not a "test set" in the context of an AI/diagnostic study. The provenance of data would be from engineering tests and comparisons to predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for a mobility scooter is its functional performance, safety features, and specifications (e.g., speed, range, weight capacity, braking effectiveness), not an expert consensus on interpreting images or patient data. These would be assessed through engineering and physical testing, likely by engineers and quality control personnel, possibly against relevant national or international performance standards.
4. Adjudication method for the test set
Not applicable. This concept is relevant for studies involving human interpretation (e.g., radiologists reviewing images). For a physical device like a scooter, performance and safety are typically evaluated against pre-defined specifications and standards through objective measurements, not by adjudication of subjective interpretations.
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 type of study is specific to diagnostic aids, particularly those involving AI, where human readers (e.g., radiologists) interpret cases with and without algorithmic assistance. The KYMCO ForU EQ40 is a mobility scooter and does not involve human "readers" or AI assistance for diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The KYMCO ForU EQ40 is a non-AI, non-diagnostic physical device. There is no algorithm to be tested in a standalone fashion.
7. The type of ground truth used
For a mobility scooter, the "ground truth" consists of objective performance metrics and safety standards. This would include:
- Engineering Specifications: Measured values like maximum speed, turning radius, battery life/range, weight capacity, climbing ability, brake effectiveness, stability, electromagnetic compatibility (EMC).
- Safety Standards: Compliance with relevant international and national safety standards for powered wheelchairs and scooters (e.g., ISO, ANSI/RESNA, UL).
- Predicate Device Comparison: Data from testing predicate devices or manufacturer specifications for predicate devices to demonstrate equivalence.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model. There is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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JUN 1 0 2008
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KWANG YANG MOTOR CO., LTD.
No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan TEL: +886-7-3822526 FAX: +886-7-3825834
510(k) Summary
Device
Trade name: KYMCO ForU EQ40 scooter
Common name: Electrical scooter
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: 89INI
Classification: Class II
Predicate devices
AVANTICARE SA4022(K051538)/ LERADO CHINA LIMITED ForU EQ30(K072630)/ KWANG YANG MOTOR CO., LTD.
Intend use of device
KYMCO ForU EQ40 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The KYMCO ForU EQ40 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
Substantial equivalence:
The KYMCO ForU EQ40 scooter is substantially equivalent to the AVANTICARE SA4022 (K051538) and ForU EQ30(K072630) manufactured by LERADO CHINA LIMITED and KWANG YANG MOTOR CO., LTD., respectively.
There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, KWANG YANG MOTOR CO., LTD. believes that the KYMCO ForU EQ40 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kwang Yang Motor Company Limited % Junnata Chang 14F-2, No.1 Zhuangjing Road Lane 25 Banqiao, China (Taiwan) 220
JUN 1 0 2008
Re: K081133 Trade/Device Name: KYMCO ForU EQ40 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: May 19, 2008 Received: May 19, 2008
Dear Ms. Chang:
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 - Ms. Junnata Chang
This letter will allow you to begin marketing your device as described in your Section 510(k) promarket notification. The FDA finding of substantial cquivalence 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may oblain 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 W. Milliman
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): K081133
Device Name: KYMCO ForU EQ40
Indications for Use:
To provide mobility to disabled or elderly persons limited to a seated position.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ X (Part 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)
Neil R.P. de forska
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K081133
§ 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).