(66 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S 4-WHEELED SCOOTER WT-XL is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided text describes a 510(k) premarket notification for a medical device, the WU'S 4-WHEELED NEO SCOOTER, WT-XL4. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria in the way one might for a novel AI or diagnostic device.
Therefore, many of the requested categories for AI/diagnostic studies are not applicable to this submission. The "study" here is primarily a comparison between the new device and a predicate device based on design specifications and compliance with relevant standards.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device type (a durable medical equipment like a scooter), "acceptance criteria" are generally related to compliance with recognized standards and demonstrating that the new device's performance characteristics are at least as safe and effective as the predicate, especially for its intended use.
| Acceptance Criteria (Inferred from 510(k) summary) | Reported Device Performance (WU'S 4-WHEELED NEO SCOOTER, WT-XL4) |
|---|---|
| Intended Use: Provide mobility to persons restricted to a seated position. | Met: Stated as the intended use, identical to the predicate. No deviation from indications. |
| Safety and Electrical Standards Compliance: (e.g., EMC, electrical safety) | Met: Performance testing conducted against ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, IEC61000-4-3: 1995 standards. Electronic systems (controller, batteries, switching power supplier, excluding recharger) are from the same UL-certified suppliers as the predicate, ensuring "the same safety level." |
| Functional Equivalence: Similar basic operation and components. | Met: Similar batteries, cruising range, back upholstery, armrest types, and warranty period as the predicate. Hand controls for movement. |
| Weight Capacity: Must safely support intended user population. | Met: Designed for patients up to 550 lbs, an increase from the predicate's 300 lbs. This is a differentiating factor, but not a failure to meet a standard; rather, it's an expanded capability. |
| Physical Dimensions/Weight: Appropriate for safe operation and transport. | Met: Overall dimensions, tire size, and weights are different due to the larger weight capacity. These differences are deemed "not safety aspect" and are acceptable for substantial equivalence. |
| Disassembly for Transport: Should be a feature if claimed. | Met: Device can be disassembled for transport. |
| Battery Charging: Proper and safe charging mechanism. | Met: Provided with an onboard battery charger. The recharger supplier differs from the predicate, but this is noted in the context of overall electronic systems being safe. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is not a clinical study involving human subjects or a dataset for AI. The "test set" in this context refers to the physical device itself undergoing engineering and safety testing.
- Data Provenance: Not applicable. The "data" are primarily design specifications, component certifications (UL), and engineering test reports from the manufacturer (WU'S TECH CO., LTD. in Hsin Chu City, China (Taiwan)).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in the context of AI/diagnostic devices typically refers to definitive diagnoses or classifications from medical experts. For a physical device like a scooter, the "ground truth" is defined by compliance with engineering standards and the device's physical performance characteristics as determined by engineering tests.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on a diagnosis. This procedure is irrelevant to the engineering and safety testing of a scooter.
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 device is a mobility scooter, not an AI or diagnostic tool that assists human readers in interpreting medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical, user-operated scooter, not an algorithm.
7. The type of ground truth used
- Engineering Standards and Specifications: The "ground truth" for this submission is established by the relevant engineering and safety standards (e.g., ANSI/RESNA, CISPR, EN, IEC) that the device must comply with, and the functional specifications demonstrated through physical testing and component certifications (e.g., UL certification for electronic components). The predicate device's proven safety and effectiveness also serve as a benchmark.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI training set, this question is irrelevant.
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MAR 1 4 2005
WU'S TECH CO., LTD
NO. 225, YUAN-PIER ST., HSIN CHU CITY, CH TEL: 886-3-5382105 FAX - 886-3-53871 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
46 510(k) SUMMARY "
Submitter's Name: WU'S TECH CO., LTD. NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN)
Date summary prepared: Device Name:
December 30, 2004
Proprietary Name: Common or Usual Name: Classification Name:
WU'S 4-Wheeled Scooter, WT-XL4 Electrical Scooter Motor Three-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 WU'S 4-WHEELED SCOOTER WT-XL is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering 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, EN61000-4-2: 1995, IEC61000-4-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison: WU'S 4-WHEELED NEO SCOOTER WT-LA (K013763)
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NO. 225. YUAN-PIER ST., HSIN CHU CITY, C TEL: 886-3-5382105 FAX: 886-3-5382 Email: wustis@ms45.hinet.net Homepage: www.wustech.com.tw
Summary for substantial equivalence comparison:
The intended uses, similar batteries, cruising range, back upholstery, armrest types, and warranty period between the new device WT-XL4 and the predicate device WT-L4 are all the same. Especially the electronic systems between two devices, except the recharge are the different suppliers, they are the same suppliers and all passed by the UL certificated, for instance the controller, the batteries and recharge and switching power supplier. Thus the same safety level for the two devices is assured.
The major differences existing of the two scooters are the new device WT-XLA is huger for the patients that weight limit are 550 lbs and the predicate device WT-L4 is for general use for the 300 lbs patients. Thus the new device needs bigger the overall dimension, the size of tires, and the weights are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
MAR I = 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Ke Min Jen Official Correspondent Wu's Tech Co., LTD. No. 225, Yuan-Pier St. Hsin Chu City, China (Taiwan)
Re: K050042
Trade/Device Name: Wu's 4- Wheeled Neo Scooter, WT-XL4 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three wheeled vehicle Regulatory Class: II Product Code: INI Dated: February 17, 2005 Received: February 22, 2005
Dear Dr. Ke Min 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, 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 -Dr. Ke Min Jen
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
L. Mark A. Millman
Miriam C. Provost, Ph.D. Acting 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
K 05004 510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________
Device Name: WU'S 4-WHEELED NEO SCOOTER,WT-XL4
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use ___
AND/OR
Over-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 NEEDE!
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, R
and Neurological
Page 1 of _
510(k) Number K050042
§ 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).