(41 days)
The device is intended for medical purposes to provide mobility to persons restrict to a seated position.
The ESG 4-WHEEL SCOOTER, ESG-03 is an indoor / outdoor electric scooter tl 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.
The provided text describes a 510(k) premarket notification for the "ESG 4-WHEEL SCOOTER, ESG-03". This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating the device meets specific acceptance criteria through clinical trials or detailed performance metrics.
Therefore, many of the requested sections regarding acceptance criteria, study design, ground truth, and expert evaluation cannot be extracted from this document, as they are not applicable to this type of regulatory submission for a simple mobility device.
However, I can extract information related to the device description and the comparison to the predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance reports in a clinical or analytical study context. Instead, it relies on regulatory standards for performance testing to demonstrate safety and substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (as per document) |
|---|---|
| Electrical Safety & Performance Standards | 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) |
| Electronic Systems Safety | "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." |
| Substantial Equivalence to Predicate Device | The device is deemed substantially equivalent to the predicate device (WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763)) in terms of intended use, electronic systems safety, and overall safety aspects, despite differences in controller, agility, dimensions, tire size, and weight. Overall appearance differences are not considered safety aspects. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a mobility device, not a study involving a test set of data. Performance testing appears to be on a device prototype/model and adherence to standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for a test set is not relevant for this type of device and submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. The device is an electrical scooter and does not involve AI or human "readers".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an electrical scooter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is compliance with established electrical and performance standards for wheelchairs/scooters and demonstrating substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/algorithm-based product.
9. How the ground truth for the training set was established
Not applicable.
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September 28, 2003
NOV 1 2 2003
EMG TECHNOLOGY CO. LTD.
No. 12-1,Lane 267, Sec. 3, Min Sheng Road, Taya Hsiang, Taichung Hsien, 428, Taiwan, ROC Telephone: 886-4-25684040 Fax: 886-4-25684038 E-mail: emg.tech(@msa.hinrt.net
46 510(k) SUMMARY "
Submitter's Name: EMG Technology Co., Ltd.
No. 12-1, Lane 267, Sec. 3, Min Sheng Road, Taya Hsiang, Taichung Hsien, 428, Taiwan, ROC
Date summary prepared:
Device Name:
| Proprietary Name: | ESG 4-WHEEL SCOOTER, ESG-03 |
|---|---|
| Common or Usual Name: | Electrical Scooter |
| Classification Name: | Motor Three-Wheeled Vehicle, Class II21 CFR 890.3800 |
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restrict to a seated position.
Description of the device:
The ESG 4-WHEEL SCOOTER, ESG-03 is an indoor / outdoor electric scooter tl 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)
, s
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EMG TECHNOLOGY CO. LTD.
No. 12-1,Lane 267, Sec. 3, Min Sheng Road, Taya Hsiang, Taichung Hsien, 428, Taiwan, ROC Telephone: 886-4-25684040 Fax: 886-4-25684038 E-mail: emg.tech@msa.hinrt.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, ESG-03, is more agile and easy to storage or transportation and the predicate device. WT-L4, is for 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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a bird or eagle with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2003
EMG Technology Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K033204
Trade/Device Name: ESG 4-Wheeled Scooter, ESG-03 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 8, 2003 Received: October 20, 2003
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. 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 (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. Milliman
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: ESG 4-Wheel Scooter ESG-03_
INDICATIONS FOR USE:
The device is intended for medical parposes 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 )
(Division Sign-Off)
Division of General Restorative
and Neurological Devices
| 510(k) Number | K033204 |
|---|---|
| --------------- | --------- |
ור 1
§ 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).