(19 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The A&I Scooter SC-402 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the stecring column. The device can be disassembled for transport and is provided with an onboard battery charger.
This submission is for a motorized scooter, not an AI/ML powered device. Therefore, many of the requested categories for describing an AI study are not applicable. I will extract the relevant information from the provided text regarding the scooter's performance and testing.
Device: A&I Scooter, SC-402
The regulatory submission describes the A&I Scooter, SC-402, as an indoor/outdoor battery-operated powered scooter with four wheels and a seat. It is controlled by hand controls on the steering column, can be disassembled for transport, and includes an onboard battery charger.
The study presented here is a 510(k) submission for substantial equivalence to a predicate device, focusing on safety and functional similarities rather than a performance study with acceptance criteria in the typical sense for an AI/ML device. The "performance testing" referenced is related to electrical and mechanical safety standards rather than clinical efficacy or accuracy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a 510(k) for substantial equivalence of a medical device, specifically a motorized scooter), "acceptance criteria" and "device performance" are framed in terms of compliance with safety standards and similarity to a predicate device, rather than specific numerical efficacy metrics.
| Acceptance Criteria (Implied from comparison and testing) | Reported Device Performance |
|---|---|
| Intended Use: Device provides mobility to persons restricted to a seated position. | Met. "The device is intended for medical purposes to provide mobility to persons restricted to a seated position." (Same as predicate device) |
| Compliance with Safety Standards: EMC, Electrical Scooter standards. | Met. "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995. IEC61000-3-3: 1995 (Electrically Powered Scooters, controller, and their chargers requirements and test methods)" "Electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries, recharge, and the electronic controllers. Thus the same safety level for the two devices is assured." |
| Maximum Speed: Below 6 mph limit. | Met. "The maximum speed is 5.6 mph for the new device and 6.0 mph for the predicate device that are also under the 6 miles maximum speed limited." |
| Material Safety (Back Upholstery): Resistance ignition test. | Met. "back upholstery is the same material, and also passed the resistance ignition test by SGS." |
| Technological Characteristics: Similar electronic systems, battery, charger, controller. | Met. "Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries, recharge, and the electronic controllers." |
| Overall Dimensions/Weight: Differences are not safety-critical. | Met. "The major differences existing of the two Powered Scooters are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety aspect." |
2. Sample size used for the test set and the data provenance
This section is not applicable as this is a medical device approval for a physical product (electric scooter) based on substantial equivalence to a predicate device and compliance with safety standards, not an AI/ML software device requiring a test set of data. The "testing" involves physical product testing against specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. Ground truth, in the context of expert consensus, is typically used for AI/ML diagnostic or prognostic devices. For this physical product, regulatory bodies (e.g., UL, SGS) or internal engineering teams would verify compliance with standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically employed in clinical studies or for establishing ground truth in AI/ML performance evaluations.
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
This section is not applicable. MRMC studies are designed for evaluating diagnostic AI systems, not physical medical devices like a scooter.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a physical device, an electric scooter, with no AI algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is implied by the established engineering and electrical safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, UL certification, SGS resistance ignition test). Compliance with these standards serves as the "ground truth" for the device's safety and foundational functionality. Substantial equivalence to a legally marketed predicate device (WU's 3-Wheeled Neo Scooter, WT-L4Jr (K032617)) also forms a key part of the "ground truth" for regulatory approval.
8. The sample size for the training set
This section is not applicable. The device is a physical product and does not involve AI/ML requiring a training set.
9. How the ground truth for the training set was established
This section is not applicable due to the absence of an AI/ML component and training set.
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WELL SUCCESS BIOTECH. INC
6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan, R.O.C. FAX : 886-3-5357669 TEL:886-3-5357667 E-mail:j5357667@yahoo.com.tw
MAY 2 5 2004
510(k) SUMMARY " 66
Submitter's Name: WELL SUCCESS Biotech. Inc.
6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan, R.O.C.
Date summary prepared:
Device Name:
Proprictary Name:
Common or Usual Name: Classification Name:
May 2, 2004
A&I Scooter, SC-402 ( Trade name: A&I, A&E, J&C ) Electrical Scooter Motorized 4-Wheeled Vehicle, Class II, 21 CFR 890.3800
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The A&I Scooter SC-402 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the stecring column. The device can be disassembled for transport and is provided with an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995. IEC61000-3-3: 1995 (Electrically Powered Scooters, controller, and their chargers requirements and test methods)
Legally marketed device for substantial equivalence comparison: WU's 3-Wheeled Neo Scooter, WT-L4Jr (K032617)
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Summary for substantial equivalence comparison:
The intended uses, the size of tires, back upholstery, and warranty period between the new device SC-402 and the predicate device WT-L4JR are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries, recharge, and the electronic controllers. Thus the same safety level for the two devices is assured. The major differences existing of the two Powered Scooters are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
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WELL SUCCESS BIOTECH 6F, No.70, Zi You Road, Hsinchu City, 300, Tai TEL:886-3-5357667 FAX : 886-3-53576 E-mail:j5357667@yahoo.com.tw
C.2 COMPARISON SUMMARY
( We place the related information for the predicate device in the following pages. including the 510k information on the FDA website and the comparison and summary table. )
The intended uses, the size of tires, back upholstery, and warranty period between the new device SC-402 and the predicate device WT-L4JR are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries, recharge, and the electronic controllers. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured.
The maximum speed is 5.6 mph for the new device and 6.0 mph for the predicate device that are also under the 6 miles maximum speed limited. Those speeds can be continuous adjusted by the throttle tiller. The operators can set the adequate speed according to their feeling and need, and the maximum speed differences do not mean any performance differences. They are substantially cquivalent.
The major difference existing for the two devices are the overall dimension, the size of tires, and the weight are differences between the two devices. So the sizes and visual appearance among them have differences, and there is no safety level difference.
Based on the above the information and the analysis, we know that the subject device and the predicute devices have the same intended use, the same technological aspects and only minor dimensions or data differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 25 2004
Well Success Biotech, Inc. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K041193
Trade/Device Name: A & I Scooter, SC - 402 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: May 2, 2004 Received: May 6, 2004
Dear Dr. Jen:
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, de nees that have been 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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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.
Sincerely yours,
Mark A. Milburn
Celia 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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Page 1 of 1
510 (K) NUMBER ( IF KNOW ): _ TBA DEVICE NAME: A&LScooter, SC-402
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use
AND/OR
()ver-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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 K041193
§ 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).