(176 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Jiangsu Healthy Way Steel Mechanical 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 resistant to ignition source smouldering cigarette, and match flame equivalent.
The provided text describes a 510(k) summary for a "Jiangsu Healthy Way Steel Mechanical Wheelchair." This document is a premarket notification for a medical device and focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving that the device meets specific acceptance criteria through a clinical study with AI or human readers.
Therefore, the requested information about acceptance criteria, study sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI-assisted image interpretation cannot be extracted from this document, as it is not relevant to a 510(k) submission for a mechanical wheelchair.
The document indicates that the wheelchair meets applicable performance requirements as specified in various ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series standards. However, it does not provide a table of acceptance criteria with reported numerical performance values in the format typically seen for a new technology or AI-driven medical device.
Here's what can be extracted and what cannot:
What can be extracted:
- Device Name: Jiangsu Healthy Way Steel Mechanical Wheelchair
- Intended Use: To provide mobility to persons restricted to a seated position.
- Performance Testing Literature: The document lists several ISO and EN standards that the product meets, such as:
- EN 1021-1 /-2 Assessment of the ignition of upholstered furniture, 2006.
- ISO7176-1 Wheelchairs Part 1: Determination of Static Stability, 1999.
- ISO7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2003.
- And others related to dimensions, strengths, and ignition resistance.
- Predicate Device: KAIYANG Steel Wheelchair (K101999)
- Substantial Equivalence Basis: Similar structure (steel), foldable mainframe, same weight capacity, similar removable armrest and detachable footrest, same flame-retardant upholstery material meeting California Technical standard.
What cannot be extracted (as it's not applicable to this type of device and submission):
- A table of acceptance criteria and the reported device performance: While the document states compliance with standards, it doesn't provide a table of specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) and reported performance metrics for an AI/imaging device.
- Sample sizes used for the test set and the data provenance: Not relevant for a mechanical wheelchair.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not relevant.
- 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 relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not relevant.
- The sample size for the training set: Not relevant.
- How the ground truth for the training set was established: Not relevant.
In summary, the provided document is a 510(k) submission for a mechanical wheelchair, which relies on demonstrating compliance with established performance standards and substantial equivalence to a predicate device, rather than the type of clinical performance study data you'd expect for an AI or imaging diagnostic device.
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Image /page/0/Picture/0 description: The image shows the text "PAGE 1 OF 2" in a handwritten style. The text is in black ink and appears to be part of a document or report. Above the page number, there are some illegible handwritten words.
Image /page/0/Picture/1 description: The image shows a logo for a company. The logo consists of a graphic on the left and text on the right. The graphic appears to be a stylized image of a hand holding a letter Y. The text on the right is in Chinese characters, and it appears to be the name of the company. The text below the Chinese characters is in English, but it is difficult to read.
MAR 2 8 2012
510(k) SUMMARY
K112950
Submitter's Name: Jiangsu Healthy Way Medical Equipment Co., Ltd. Qianjinhe Road, Xinfeng, Danfu District, Zhenjiang, Jiangsu, China, 212141
Date summary prepared:
September 27, 2011
Device Name:
| Proprietary Name: | Jiangsu Healthy Way Steel Mechanical Wheelchair |
|---|---|
| Common or Usual Name: | Mechanical Wheelchair |
| Classification Name: | Mechanical Wheelchair, Class I, |
| Regulation Number: | 21 CFR 890.3850 |
| Product Code: | IOR |
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 Jiangsu Healthy Way Steel Mechanical 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 resistant to ignition source smouldering cigarette, and match flame equivalent.
Literature for Performance Testing:
Jiangsu Healthy Way Steel Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series standards including:
- EN 1021-1 /-2 Assessment of the ignition of upholstered furniture, 2006.
- · ISO7176-1 Wheelchairs Part 1: Determination of Static Stability, 1999.
- ISO7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2003. .
- · ISO7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008.
- · ISO7176-7 Wheelchairs Part 7: Measurement of seating and wheel dimensions, 1998.
- · ISO7176-8 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths, 1998.
- ISO7176-11 Wheelchairs Part 11: Test dummies, 1992. ●
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Image /page/1/Picture/1 description: The image shows a logo with a hand holding a document on the left side. To the right of the logo is Chinese text that translates to "Jiangsu Yaxiwei Medical Equipment Co., Ltd." Below the Chinese text is the English translation of the company name, "JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO., LTD."
- ISO7176-13 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces, 1989.
- · ISO7176-15 Wheelchairs Part 15: Requirements for information disclosure, documentation and labelling, 1996.
- ISO7176-16 Wheelchairs Part 16: Resistance to ignition of upholstered parts --. Requirements and test methods. 1997.
- ISO7176-22 Wheelchairs Part 22:Set-up procedures, 2000.
Legally marketed device for substantial equivalence comparison:
' KAIYANG Steel Wheelchair (K101999)
Summary for substantial equivalence comparison:
From the above comparison table the intended use between the subject device: Jiangsu Healthy Way Steel Mechanical Wheelchair and predicate device: KAIYANG Steel Wheelchair (K101999), are the same structures which are made by similar Steel. Mainframes of two devices are same foldable and same weight capacity. There are similar removable desk-length armrest and same swing-away detachable clevating 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.
Kein Ten
Dr. Jen, Ke-Min Official Correspondent
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The text is in all caps and is written in a sans-serif font. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 8 2012
Jiangsu Healthy Way Medical Equipment Co., Ltd. % ROC Chinese-European Industrial Research Society Dr. Jen Ke-Min No. 58 Fu Chiun Street Hsin Chu City Taiwan, ROC 30067
Re: K112950
Trade/Device Name: Steel Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 14, 2012 Received: March 21, 2012
Dear Dr. Ke-Min:
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 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
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Page 2 - Dr. Jen Ke-Min
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,
Sincerely yours,
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: Steel Mechanical 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 $\sqrt{}$
(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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
Page_
510(k) Number K112950
§ 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).