(8 days)
To provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.
It consists of a rigid, mechanical, steel frame and nylon upholstery back and seat. It has two 24" rear wheels and two 8" front casters for turning and maneuverability.
The provided text describes a 510(k) summary for the HAIDA HD 11 Manual Wheelchair. As a manual wheelchair, the device is subject to mechanical and safety performance testing rather than the kind of AI/algorithm performance studies often associated with diagnostic or image analysis devices. Therefore, many of the requested categories (like sample size for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this type of medical device submission.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance
The device's performance is demonstrated by its compliance with established industry standards for manual wheelchairs.
Applicable sections from the provided text:
"It meets the applicable performance requirements as specified in ANSI/RESNA WC Vol. 1 Sec. 1, Sec.5, Sec.7, Sec.8, Sec.15, Sec.16 and California Bureau of Home Furnishings 117."
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC Vol. 1 Sec. 1 (Requirement for Wheelchairs) | Met |
| ANSI/RESNA WC Vol. 1 Sec. 5 (Dynamic, Static, and Impact) | Met |
| ANSI/RESNA WC Vol. 1 Sec. 7 (Fatigue) | Met |
| ANSI/RESNA WC Vol. 1 Sec. 8 (Strength) | Met |
| ANSI/RESNA WC Vol. 1 Sec. 15 (Flammability) | Met |
| ANSI/RESNA WC Vol. 1 Sec. 16 (Stability) | Met |
| California Bureau of Home Furnishings 117 | Met |
Non-Applicable Categories for this Device Type:
The following categories typically apply to AI/software-based medical devices or diagnostic tools. Since the HAIDA HD 11 Manual Wheelchair is a mechanical device, these concepts are not relevant to its 510(k) submission.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a mechanical device. Performance testing is typically conducted on representative product units, not "data sets."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical devices is defined by compliance with engineering standards, not expert consensus on diagnostic data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not AI-driven or diagnostic.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical devices, ground truth is defined by objective engineering specifications and adherence to recognized performance standards (e.g., ANSI/RESNA).
- The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
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KOY2274
Image /page/0/Picture/1 description: The image shows a logo with a globe-like design at the top. Inside the globe, the letters "HD" are prominently displayed. Below the globe, there are two Chinese characters, which appear to be part of the brand name or company name associated with the logo. The logo has a simple, monochrome design.
Jiangyin East China Medical Technology Co., Ltd.
No.555, Qinfeng Road, Huashi Town, Jiangyin City, Jiangsu, China, 214421 TEL: +86-510-86218310 FAX: +86-510-86218308
510(k) Summary
Device
Trade name: HAIDA HD 11 manual Wheelchair
Common name: Manual Wheelchair
AUG 1 9 2008
Classification name: Mechanical wheelchair
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3850
Product Code: 89IOR
Classification: Class I
Predicate devices
Solara (K012370)/ Invacare Corporation AIDC 8500(K043332)/ Aerospace Industrial Development Corporation (AIDC)
Intend use of device
It is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.
Device description:
: " ···
It consists of a rigid, mechanical, steel frame and nylon upholstery back and seat. It has two 24" rear wheels and two 8" front casters for turning and maneuverability.
Substantial equivalence:
It is substantially equivalent to the legal products in USA. They have the same technological characteristics and intended use of the devices.
There are minor differences in performance specifications of the manual wheelchairs, these differences do not alter the intended use function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness.
Non-Clinical testing
It meets the applicable performance requirements as specified in ANSI/RESNA WC Vol. 1 Sec. 1, Sec.5, Sec.7, Sec.8, Sec.15, Sec.16 and California Bureau of Home Furnishings 117.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jiangyin East China Medical Technology Company., Ltd % Junnata Chang, Ph.D. 14F-2 NO. 1 Lane 25 Zhuangjing Road Banqiao, China (Taiwan) 220
AUG 1 9 2008
K082274 Re: Trade/Device Name: HAIDA HD 11 Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair. Regulatory Class: Class I Product Code: IOR Dated: July 25, 2008 Received: August 11, 2008
Dear Dr. 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, 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 or any Fourtall 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 – Junnata Chang, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological 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: HAIDA HD 11 manual wheelchair
Indications for Use:
To provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
:
(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
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | 1082279 |
(Posted November 13, 2003)
§ 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).