(20 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The KING I Powered Scooter, CTL-11 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.
This document describes the regulatory submission for the KING I Powered Scooter, CTL-11, where substantial equivalence to a predicate device (WU'S 3-WHEELED NEO SCOOTER WT-T3D) is claimed rather than presenting a performance study with defined acceptance criteria and device performance metrics. Therefore, many of the requested elements are not applicable in this context.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission claiming substantial equivalence, explicit performance acceptance criteria and reported device performance metrics in the way one would see for a novel device or a clinical trial are not presented. Instead, the submission focuses on demonstrating that the new device has "the same safety level" and similar characteristics to the legally marketed predicate device.
The "Performance Testing" section lists standards it meets, which could be interpreted as implicit acceptance criteria for safety and electrical compatibility:
| Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|
| EMC Report ANSI / RESNA WC/Vol.2-1998 | Met |
| CISPR 11: 1990 | Met |
| EN61000-4-2: 1995 | Met |
| IEC61000-4-3: 1995 | Met |
The narrative also states: "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. Thus the same safety level for the two devices is assured."
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 submission does not describe a clinical study with a test set of data. The performance testing refers to engineering and safety standards applied to the device itself.
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. This is not a study involving expert assessment or ground truth establishment in a medical imaging or diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set requiring adjudication is described.
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 an electric scooter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This refers to an electric scooter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. Ground truth, in the context of device performance, typically refers to a gold standard for a diagnostic task. For this device, the "ground truth" for safety and performance is adherence to established engineering and safety standards (e.g., ANSI/RESNA, CISPR, IEC) and certifications (UL, SGS).
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image shows a logo with a cartoon bird on the left and the word "KINGI" in bold letters. Above the word "KINGI" is the date "OCT 17 2005". The cartoon bird is facing left and has a small drop of water coming off of its wing. The word "KINGI" is underlined.
K 052673
#65 Chyau-Shiaw St., Pei-Tun District. Taichung, Taiwan, R.O.C. Tel: 04 2244 5815 Fax: 04 2244 0700
દ ૯ 510(k) SUMMARY "
Submitter's Name: KING I Tech Corporation
No. 65, Chyau-Shiaw Street, Pei-Tun Area, Taichung City, 408, Taiwan
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
September 22, 2005
KING I Powered Scooter, CTL-11 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 KING I Powered Scooter, CTL-11 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front The movement of the scooter is controlled by the rider who uses hand basket. 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 3-WHEELED NEO SCOOTER WT-T3D (K032488)
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Image /page/1/Picture/0 description: The image shows a cartoon bird next to the word "KINGI". The bird is drawn in black and white and has a large beak and small eyes. The word "KINGI" is written in bold, black letters, with a line underneath it. The image is simple and likely used as a logo or branding element.
Summary for substantial equivalence comparison:
The intended uses, weight limit, and back upholstery between the new device CTL-11 and the predicate device WT-T3D are all the same. Especially 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. Thus the same safety level for the two devices is assured.
The major difference existing for the predicate device is more agile and easy to fold for storage or transportation and the new device is for general use. The new device needs drive bigger turning radius. 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 Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.
OCT 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
King I Tech Corporation c/o Ke-Min Jen, Ph.D. ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, Taiwan, ROC China
Re: K052673
Trade/Device Name: KING I POWERED SCOOTER CTL-11 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: September 22, 2005 Received: September 27, 2005
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 docs 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 - Ke-Min Jen, Ph.D.
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/cdrh/industry/support/index.html
Sincerely yours,
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Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a cartoon bird next to the word "KING I". The bird is drawn in black and white and has a large beak and round eyes. The word "KING I" is written in bold, black letters. The letter "I" is underlined.
#65 Chyau-Shiaw St., Pei-Tun District. Taichung, Taiwan, R.O.C. Tel: 04 2244 5815 Fax: 04 2244 0700
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Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: KING I, POWERED SCOOTER CTL-11
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | V |
|---|---|
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED) (Division Signo Off)RH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices Page 1 of 1 510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).