(76 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Be-Mobile 4-Wheeled Electric Scooter DK S280 is an indoor / outdoor electric 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 steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
This looks like a 510(k) premarket notification for a medical device, which is a regulatory submission to the FDA. It's not a study report designed to "prove" a device meets acceptance criteria in the way a clinical trial or performance study would. Rather, it aims to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested elements about statistical sample sizes, expert adjudication, MRMC studies, and standalone performance metrics are not typically part of a 510(k) submission of this nature. The "performance testing" section refers to engineering standards met by the device, not a human reader or algorithm performance study.
Here's an attempt to answer as much as possible based on the provided text, acknowledging the limitations inherent in a 510(k) submission for an electric scooter:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific 510(k) submission, the "acceptance criteria" are demonstrating compliance with relevant engineering standards and showing substantial equivalence to a predicate device. The performance isn't about diagnostic accuracy or clinical outcomes in the same way as a medical imaging AI, but rather about safety and functionality.
| Acceptance Criterion (Compliance Standard) | Reported Device Performance |
|---|---|
| EMC Report | Complied with CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 |
| Safety and Performance for Electric Wheelchairs/Scooters | Complied with ANSI / RESNA WC/Vol.2-1998 |
| Electrical System Certification | "The electronic systems between two devices are the same and all passed by the UL certificated" |
| Substantial Equivalence (General) | Determined to be substantially equivalent to WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of an "algorithm test set." The testing appears to be on a single device or a small sample to confirm engineering compliance.
- Data Provenance: The device manufacturer, TUNG KENG ENTERPRISE CO., LTD., is located in Taichung County, Taiwan. The specific engineering tests would have been performed by testing bodies or the manufacturer in compliance with the referenced standards. The data is prospective for the device being submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth in this context refers to the successful completion of engineering tests according to established standards. The "experts" would be the engineers and technicians performing and verifying compliance with the specified standards (e.g., ANSI / RESNA WC/Vol.2-1998, EMC standards), but they are not establishing a "ground truth" for a diagnostic outcome.
- Qualifications: As above, these would be qualified engineers and testers knowledgeable in the relevant standards.
4. Adjudication Method for the Test Set
- Not applicable. This is not a study requiring human adjudication for diagnostic outcomes. Compliance with engineering standards is typically determined by measurement against predefined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI for medical image analysis) to assess improvement in human reader performance with AI assistance. An electric scooter does not have human "readers" or "cases" in this sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone performance study as typically understood for an algorithm was not done. The device's "standalone" performance is assessed by its compliance with engineering standards (e.g., EMC, safety, and performance for electric wheelchairs/scooters) without a human operator performing a diagnostic task. The document details these compliance tests rather than algorithm-specific performance metrics.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is compliance with established engineering and safety standards. This is demonstrated through measurement and testing against predefined criteria within the standards (e.g., electrical interference levels, stability, charger performance). It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. This device is an electric scooter, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
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DEC 1 8 2003
KD 33220
Image /page/0/Picture/2 description: The image shows the text "DK CITY" in a bold, sans-serif font. The letters "DK" are larger and more prominent than the word "CITY". There are two angled lines between the "K" and the "C".
TUNG KENG ENTERPRISE CO No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, Taiwan Tel: +886-4-25321000 Fax: +886-4-25325000 E-mail: dkcity@ms21.hinte.net
510(k) SUMMARY " દ્ધ
Submitter's Name: TUNG KENG Enterprise Co., Ltd. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, 427,Taiwan
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
Be-Mobile 4-Wheeled Electric Scooter, DK S280 Electrical Scooter Motor Three-Wheeled Vehicle, Class II,
September 28, 2003
21 CFR 890.3800
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a scated position.
Description of the device:
The Be-Mobile 4-Wheeled Electric Scooter DK S280 is an indoor / outdoor electric 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 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, EN61000-3-2: 1995, IEC61000-3-3: 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-L4 (K013763)
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TUNG KENG ENTERPRISE CO., LTD.
No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, Taiwan Talchung Oounty, Taxaan
Tel: +886-4-25321000 Fax: +886-4-25325000 E-mail: dkcity@ms21.hinte.net
Summary for substantial equivalence comparison:
The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured. The major differences existing of the two 4-wheelled scooters are the different controller, and the new device, DK S280, is more agile and easy to storage or transportation and the predicate device, WT-L4, is for more general use. Besides the overall dimension, the size of tires, and the weight 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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEC 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tung Keng Enterprise Company, LTD. Jen Ke-Min Roc Chinese-European Industrial Research Society No. 58 Fu-Chiun Street Hsin-Chu City, Taiwan China
Re: K033220
Trade/Device Name: Be-Mobile 4-Wheeled Electric Scooter, Model DK S280 Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Codes: INI Dated: September 29, 2003 Received: November 10, 2003
Dear: Mr. Ke-Min:
We have reviewed your Scction 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. Drue. 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 HI (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. Ke-Min
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 (r (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.hunl
Sincerely yours.
D Mark N Millerson
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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5 !0 (K) NUMBER ( IF KNOW ): TBA DEVICE NAME: Be-Mobile 4-Wheeled Electric Scooter, DK $280
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE )
Prescription Use __ OR Over-The-Counter-Use _
( Per 21 CFR 801,109 ) ( Optional Format 1-2-96 )
Asion Sign-07)
Division of General. Pestorative
Neurological Devices
Number K033220
§ 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).