(82 days)
To provide mobility to disabled or elderly persons limited to a seated position.
The FX 222-02 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market.
This document is a 510(k) premarket notification for a powered wheelchair, the FX 222-02. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific quantitative acceptance criteria in the manner one would expect for an AI/ML device.
Therefore, most of the requested information regarding acceptance criteria, study details, human reader performance, and ground truth establishment is not applicable to this type of regulatory submission. The product is a physical medical device, not an AI/ML algorithm.
Here's an analysis based on the document provided:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in the context of an AI/ML study. Instead, it states:
"There are minor differences in performance specifications of the powered wheelchairs, 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."
This indicates that the key "acceptance criterion" for this 510(k) submission is that the FX 222-02 powered wheelchair is substantially equivalent to the predicate device, Ruike 3421 (K070501), and that any "minor differences in performance specifications" do not negatively impact safety or effectiveness. Specific quantitative performance metrics are not detailed or compared in this summary.
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 physical medical device (powered wheelchair), not an AI/ML algorithm requiring a test set of data. The submission relies on a comparison to a predicate device and general safety/effectiveness considerations for mechanical devices.
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 a physical medical device. Ground truth as typically defined for AI/ML algorithms (e.g., expert consensus on images or pathology results) is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical medical device.
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 is a physical medical device and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For a physical device like a powered wheelchair, regulatory approval relies on general safety standards, mechanical performance tests (which are not detailed in this summary), and comparison to a legally marketed predicate device. "Ground truth" in the AI/ML context is not relevant.
8. The sample size for the training set
Not applicable. This is a physical medical device.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
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Lanzhou Wanli Aviation Electromechanical Inc.
No.30, Wanli West Village, Anning West Rd., Anning District, Lanzhou City, Gansu Province, China, 730070, TEL/FAX: +0086-931-7612159
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date of summary was prepared: Dec. 27, 2010
Device
Trade name: FX 222-02 powered wheelchair
Common name: Powered wheelchair
Classification name: Powered wheelchair
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3860
Product Code: ITI
Classification: Class II
Predicate devices
Ruike 3421(K070501)/ Shanghai Ruike Sports Goods CO., LTD
Intend use of device
To provide mobility to disabled or elderly persons limited to a seated position.
Device description:
The FX 222-02 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market.
Statement of substantial equivalence
The FX 222-02 powered wheelchair is substantially equivalent to the Ruike 3421(K070501) manufactured by Shanghai Ruike Sports Goods CO., LTD..
There are minor differences in performance specifications of the powered wheelchairs, 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.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Lanzhou Wanli Aviation Electromechanical Inc. concludes that, FX 222-02 powered wheelchair is substantially equivalent to predicate devices as described herein.
MAR 2 8 2011
FDA CDRH DMC
JAN 0 5 2011:
ROOK J.L. H
K-37
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Lanzhou Wanli Aviation Electromechanical, Inc. % IRC USA Junnata Chang 16F-2 (16A), No. 462, Sec 2 Chongde Road, Beitun District Taichung, Taiwan China
MAR 2 8 2011
Re: K110036
Trade/Device Name: FX 222-02 Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 27, 2010 Received: January 05, 2011
Dear Junnata 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Junnata Chang
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Al. B. R.
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: FX 222-02 powered wheelchair
Indications for use:
To provide mobility to disabled or elderly persons limited to a seated position.
Over-The-Counter Use __X Prescription Use _ (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR (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
Signature of
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110036
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(Posted November 13, 2003)
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).