(81 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The KAIYANG Aluminum Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
This looks like a 510(k) summary for a medical device (a wheelchair), not an AI/ML device. Therefore, the requested information about acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable to this document.
The document describes the KAIYANG Aluminum Wheelchair and its intended use. Here's what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC vol. 1 Wheelchair Standards | Meets requirements |
| ISO 7176 Wheelchair Standards | Meets requirements |
| California Technical Bulletin CAL 117 standard for flame retardant | Meets standard |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical non-AI/ML device. Testing refers to product performance testing against standards, not data-driven evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert adjudication are concepts used in AI/ML model evaluation, not for mechanical device testing. The "truth" here is compliance with engineering standards.
4. Adjudication method 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. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
Not applicable in the context of AI/ML. For this mechanical device, the "ground truth" or reference for evaluating performance would be the specifications and test methods defined within the ANSI/RESNA WC vol. 1, ISO 7176, and CAL 117 standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary based on the provided text:
The KAIYANG Aluminum Wheelchair underwent performance testing to demonstrate compliance with established international and state-specific standards for wheelchairs. The manufacturer states that the device "meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." Additionally, the upholstery fabric "meets the California Technical Bulletin CAL 117 standard for flame retardant."
The submission primarily relies on substantial equivalence to a predicate device, the JAN MAO Wheelchair JMC612-FL318EPP & JMC612-FL418EPP (K062218), rather than a clinical study or AI/ML performance evaluation. The comparison highlights similarities in intended use, foldable design, removable armrests, detachable footrests, and flame-retardant back upholstery material. The overall conclusion is that "the new device is substantially equivalent to the predicate device."
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Guangdong Kaiyang Medical Technology Co., Ltd.
Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 52823 B
Tel: +86-757-85502506 Fax:+86-757-85502630 Email:ceirs.jen@msa.hinet.net
OCT 4 2010
510(k) SUMMARY "
Submitter's Name: Guangdong Kaiyang Medical Technology Co., Ltd. Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 528231
Date summary prepared:
June 21, 2010
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
KAIYANG Aluminum Wheelchair Mechanical Wheelchair Mechanical Wheelchair, Class I, 21 CFR 890.3850
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 KAIYANG Aluminum Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Performance Testing:
Wheelchair the applicable performance KAIYANG Aluminum meets requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
JAN MAO Wheelchair JMC612-FL318EPP & JMC612-FL418EPP (K062218 )
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Guangdong Kaiyang Medical Technology Co., Ltd. Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 528231 Tel: +86-757-85502506 Fax:+86-757-85502630 Email:ceirs.jen@msa.hinet.net
Summary for substantial equivalence comparison:
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
From the above comparison table the intended use between the predicate device and new devices are the same. Mainframes of two devices are foldable. There are similar removable desk-length armrest and same swing-away detachable elevating footrest. Besides, back upholstery material is also the same resistance-ignitability fabric and also meets the California Technical standard for flame retardant. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate device.
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Guangdong Kaiyang Medical Technology Co., Ltd. % Dr. Ke-Min Jen Official Correspondent Yanfeng Industrial Area, Dali, Nanhai District Foshan China 528231
OCT 4 2000
Re: K101998
Trade/Device Name: KAIYANG Aluminum Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 17, 2010 Received: August 25, 2010
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. 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.
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
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Page 2 - Dr. Ke-Min Jen
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/CDRHOffices/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,
for
Mark N. Melin
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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Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: _KAIYANG Aluminum Wheelchair
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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
productions and this and world and world be one in the with the with the with the with the with the with the with the with the with the with the with the with the with the wi
Division Sign-Off
(Division Sign. (Division of Surgical, Orthopedic, and Restorative Devices
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number K101998
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).