(36 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The COMFORT SCOOTER, LY-EW408 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair 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 the submission of a 510(k) premarket notification for a medical device, the COMFORT SCOOTER, LY-EW408. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with specific acceptance criteria and detailed performance metrics as one might find for an AI/ML medical device.
Therefore, many of the requested elements for acceptance criteria and study design are not applicable to this type of regulatory submission. The goal here is to show the new device is as safe and effective as a legally marketed one, not to quantify its performance against pre-defined accuracy thresholds using a clinical study involving experts and ground truth.
Here's an attempt to address your request based on the provided text, highlighting what is (and isn't) present:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The "acceptance criteria" in this context refer to the demonstration of substantial equivalence to a predicate device (COMFORT SCOOTER LY-EW415 (K063032)). The criteria are broad comparisons of features, safety, and functionality rather than specific statistical performance thresholds.
| Acceptance Criteria Category (Implied by Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use | Met: The device is intended for medical purposes to provide mobility to persons restricted to a seated position, which is the same as the predicate. |
| Technological Characteristics (Overall Dimensions & Appearance) | Met (with minor differences): Overall dimensions and visual appearance are similar. The new device has smaller dimensions, which is presented as an improvement (can fit into most ordinary car trunks, more convenient for moving and turning). This difference is not presented as a compromise in safety or effectiveness. |
| Technological Characteristics (Electronic Systems) | Met: Electronic systems (controller, batteries, recharger) are from the same suppliers and are UL certificated, ensuring safety and performance equivalent to the predicate. |
| Technological Characteristics (Materials) | Met: Back upholstery is made of the same material and passed the resistance ignition test by SGS, ensuring material safety is equivalent to the predicate. |
| Technological Characteristics (Mechanical Design) | Met: Suspension of cross brace, footplates, incline degree (12°), armrest type, and warranty are all the same, ensuring mechanical stability and user experience are equivalent to the predicate. |
| Performance (Safety & Functions) | Met: "The safety and performance functions of two systems are assured and validated." (This is a general statement rather than specific metrics, relying on the equivalence of components and design.) |
| Performance (Maximum Speed) | Met (with minor differences): 1.0 mph difference in maximum speed. This difference is deemed not significant because the throttle allows continuous adjustment, and operators can set adequate speeds for indoor/outdoor use. This difference is not considered to impact overall performance or safety negatively. |
| Performance (Battery Charger) | Met (with minor differences): Battery charger types are "almost the same," with a difference in output electric current (4A for new, 5A for predicate). This difference relates to charging period or battery capacity, not safety aspects, and is therefore considered substantially equivalent. The chargers are UL certificated as part of the overall electronic system. |
| Compliance with Standards | Met: Performance testing included EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (for Electrically Powered Wheelchairs, controller, and their chargers). These standards demonstrate compliance with recognized safety and performance requirements for such devices. |
Regarding the other desired information points:
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Sample size used for the test set and the data provenance:
- N/A. This submission is for a physical medical device (Electric Scooter) and does not involve an AI/ML algorithm or a "test set" of data in the manner implied by the question. Performance testing involved compliance with engineering standards (e.g., EMC, wheelchair standards) on the device itself, not on a dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No "ground truth" establishment by experts on a test set of data is described. Device performance testing is against established engineering and safety standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set or adjudication method as described is applicable here.
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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:
- N/A. This is a physical mobility device, not an AI-assisted diagnostic or clinical decision support tool. No human reader studies are described.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. The "ground truth" for this device's performance is adherence to recognized engineering standards for safety and functionality, and verification of components' certifications (e.g., UL, SGS).
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The sample size for the training set:
- N/A. This is a hardware device, not an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established:
- N/A. Not applicable for this type of device.
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COMFORT ORTHOPEDIC CO., LTD.
www.comfort.com.tw No. 120, Nan Shiang Tsuen, Shoei Shang Shiang, Chia-yi, Taiwan, R. O. C. 608 TEL : 886-5-2892093 2 FAX : 886-5-2890070
OCT 3 2007
દ દ 510(k) SUMMARY "
Submitter's Name: COMFORT ORTHOPEDIC CO., LTD.
NO. 120, NAN SHIANG TSUEN, SHOEI SHANG SHIANG, CHIA-YI, 608. TAIWAN, ROC
Date summary prepared:
Device Name:
September 20, 2007
Proprietary Name: Common or Usual Name: Classification Name:
COMFORT SCOOTER, LY-EW408 Electric 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 COMFORT SCOOTER, LY-EW408 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair 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, controller, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison: COMFORT SCOOTER LY-EW415 (K063032)
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Summary for substantial equivalence comparison:
The overall dimensions and visional appearance are similar, and the dimensions for the new device are smaller than that of the predicate device. The device of the smaller dimensions can be fitted into most of the ordinary car trunk. Thus the new device may be fitted into smaller car trunk. It certainly the new device has more convenient during moving and turning.
The electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, and recharge. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Moreover, the suspension of cross brace, footplates, incline degree 12°, armrest type, and warranty are all the same. The safety and performance functions of two systems are assured and validated. They are substantially equivalent.
The maximum speed is 1.0 mph difference for the two devices. The throttle tiller can continuously adjust the speeds. The operators can set the adequate speed according to their feeling and need, i.e., outdoor or indoor, and the maximum speed differences do not mean any performance differences. They are substantially equivalent.
The battery chargers types are almost the same; only for the output electric current is 4A for the new device and 5A for the predicate device. The current differences lead to the charging period differences or arise from the different battery capacity, not related with safety aspect.
Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and only minor differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Comfort Orthopedic Co., LTD. % ROC Chinese European Industrial Research Society Dr. Jen, Ke-Min No. 58 Fu-Chiun Street Hsin-Chu City, Taiwan, ROC
Re: K072712
Trade/Device Name: Comfort Scooter, LY-EW 408 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: September 20, 2007 Received: September 25, 2007
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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. Jen, 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 vour 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 the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain 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 M. Melkers
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 ): K
Device Name: COMFORT ELECTRIC SCOOTER, LY-EW408
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)
Mark A. Mulkerin
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Page of l
510(k) Number
F1
§ 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).