(58 days)
The AVANTICARE SA4021 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The AVANTICARE SA4021 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided text K060068 is a 510(k) summary for a medical device called AVANTICARE SA4021 scooter. It outlines the device description, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with performance evaluations for AI/software-based medical devices.
The document is for a physical medical device (an electric scooter) and the provided information focuses on regulatory classification and substantial equivalence to legally marketed devices based on inherent technical specifications and intended use, rather than performance metrics from a clinical study or benchmark testing.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because the provided text does not contain this information.
Specifically, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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DO CHINA L No.22, Kuang Fu Rd., Chia Tai Industrial Park, Tai Pao City, Chia Yi Hsien, Taiwan TEL: +886-5-2475629 FAX: +886-5-2379672 website:http://www.lerado.com/
510(k) Summary
Device
Trade name: AVANTICARE SA4021 scooter
Common name: Electrical scooter
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: 89INI
Classification: Class II
Predicate devices
Bewell SC 20 (K043326)/Cycling and Health Tech Industry R&D Center/CHC AVANTICARE SA4022(K051538)/ LERADO CHINA LIMITED
Intend use of device
AVANTICARE SA4021 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The AVANTICARE SA4021 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
Substantial equivalence:
The AVANTICARE SA4021 scooter is substantially equivalent to the Bewell SC 20 (K043326) and AVANTICARE SA4022 (K051538) manufactured by Cycling and Health Tech Industry R&D Center/CHC and LERADO CHINA LIMITED.
There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, LERADO CHINA LIMITED believes that the AVANTICARE SA4021 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 8
Lerado China Limited c/o Mr. Jeff Chang 16 F .- 2, No. 462, Section 2 Chongde Road, Beitun District Taichung, China (Taiwan) 40653
Re: K060068
Trade/Device Name: Avanticare SA4021 Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: January 27, 2006 Received: February 10, 2006
Dear Mr. Chang:
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. ITA 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. 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
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Page 2 - Mr. Chang
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. "Misbränding 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.
Hubert Leunens
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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3. Device descriptive information
- 3.1 Statement of indication for use
Statement of Indications for Use
and the contract and the comments of the comments of the comments of
510(k) Number (if known):
Device Name: AVANTICARE SA4021
Indications for Use:
The AVANTICARE SA4021 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Prescription Use ---------Over-The-Counter Use X (Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Herbert Leunard
(Division Sign-Off) Division of General, Restorative and Neurological Devices
10(k) Number K060068
(Posted November 13, 2003)
§ 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).