(30 days)
The Danyang Huayi® H035 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
The Danyang Huayi H035 Basic Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and nylon upholstery that meets ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Danyang Huayi H035 wheelchair is intended for use indoors and outdoors, over smooth a surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 9 degrees.
The provided text describes a 510(k) premarket notification for the "Danyang Huayi H035 Basic Wheelchair". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on its performance metrics.
Therefore, the requested information components related to acceptance criteria, detailed study design, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable or available within the provided text.
The document states that the Danyang Huayi H035 Basic Wheelchair conforms to several ISO standards, which represent a form of acceptance criteria for manufacturing and certain performance aspects, but not a clinical study proving its performance against specific clinical outcomes or AI-driven metrics.
Here's a breakdown of the available and unavailable information based on your request:
1. Table of acceptance criteria and the reported device performance:
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Acceptance Criteria (Conformance to Standards): The device production meets the following ISO standards:
- ISO 7176-1: Determination of static stability
- ISO 7176-3: Determination of efficiency of brakes
- ISO 7176-5: Determination of overall dimension, mass and turning space
- ISO 7176-7: Measurement of seating and wheel dimensions
- ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-11: Test dummies
- ISO 7176-13: Determination of friction of test surface
- ISO 7171-15: Requirements for information disclosure, documentation and labeling
- ISO 7171-16: Resistance to ignition of upholstered parts requirements and test methods
- ISO 7176-16: Resistance to ignition of Upholstered parts (mentioned in description)
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Reported Device Performance: The document only states that the "Danyang Huayi H035 Basic Wheelchair production meets the following standards" and that it is "substantially equivalent products in all areas impacting safety and effectiveness" to the predicate device. It does not provide specific performance metrics (e.g., braking distance, turning radius values, stability angles) beyond confirming conformity to the standards.
2. Sample sized used for the test set and the data provenance: Not applicable. This is not a study assessing AI/device performance on a test set but a submission for substantial equivalence based on design and conformance to standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 device is a basic wheelchair, not an AI-driven diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/diagnostic device study. The "ground truth" here is the adherence to design specifications and ISO standards, and the comparison to a legally marketed predicate device (Access Point Medical, AXS-1 Basic Wheelchair (K050280)).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
In summary: The provided 510(k) submission for the Danyang Huayi H035 Basic Wheelchair is a regulatory document focused on demonstrating substantial equivalence to a predicate device and adherence to relevant international standards for manufacturing and basic functionality. It does not contain information about clinical studies, performance metrics against specific acceptance criteria for a diagnostic or AI device, or details about training/test sets as would be relevant for such technologies.
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Image /page/0/Picture/1 description: The image shows a logo with the word "HUAYI" in bold, black letters at the bottom. Above the text is a stylized graphic consisting of two curved shapes that resemble stylized letter "S" shapes facing each other. In the center of these shapes is a white circle with a black outline, creating a sense of depth and visual interest. The logo appears to be for a company or brand named HUAYI.
丹阳市华一医疗器械有限公司
Danyang Huayi Medical Supply & Equipment Co., Ltd.
SECTION 10.0 SUMMARY OF SAFETY AND EFFECTIVENESS
ADMINISTRATIVE INFORMATON 10.1
SPONSOR IDENTIFICATION 10.11
Danvang Huayi Medical Supply & Equipment, Co. LTD No. 1 Zhenxing Road, Yunyang Economical Development Zone Danyang, Jiangsu, CHINA 212300 Contact Person: Mr. Tomy Tang e-mail: tomy8034@gmail.com Telephone: 011- (86511) 8690-0809 Fax: 011-(86511)8690-0805
FED | 5 2011
10.12 ESTABLISHMENT REGISTRATION NUMBER: Pending
OFFICIAL CONTACT PERSON 10.13
Norman F. Estrin, Ph.D. President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD 20854 estrin@yourFDAconsultant.com Tel: (301) 279 -2899 Fax: (301) 294-0126
10.14 DATE OF PREPARATION OF THIS SUMMARY: January 6, 2008
10.15 PROPRIETARY (TRADE) NAME:
Danyang HUAYI H035 Basic Wheelchair
- 10.16 COMMON NAME: Wheelchair
- 10.17 CLASSIFICATION N AME: Wheelchair, Mechanical
- 10.18 REGULATION NUMBERS: 21 CFR 890.3850
- 10.19 PROPOSED REGULATORY CLASS: Class 1
- DEVICE PRODUCT CODES: 89 IOR 10.20
- 10.21 MEDICAL SPECIALTIES: Physical Medicine
DESCRIPTION OF DEVICE 10.3
The Danyang Huayi H035 Basic Wheelchair is a wheelchair that pr
00214
地址:丹阳市云阳经济开发区振兴路1号
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mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and nylon upholstery that meets ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Danyang Huayi H035 wheelchair is intended for use indoors and outdoors, over smooth a surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 9 degrees.
10.4 INDI CATIONS FOR USE
The Danyang Huayi H035 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
10.5 CONFOR MANCE TO STANDARDS
The Danyang Huayi H035 Basic Wheelchair production meets the following standards:
- . ISO 7176-1 Wheelchair: Determination of static stability
- ISO 7176-3 Wheelchair: Determination of efficiency of brakes. .
- ISO 7176-5: Determination of overall dimension, mass and turning . space.
- ISO 7176-7: Measurement of seating and wheel dimensions. ●
- ISO 7176-8 Wheelchair: Requirements and test methods for static, . impact and fatigue strengths.
- ISO 7176-11 Wheelchair: Test dummies .
- ISO 7176-13: Determination of friction of test surface. ●
- ISO 7171-15 Wheelchair: Requirements for information disclosure, . documentation and labeling.
ISO 7171-16 Wheelchair: Resistance to ignition of upholstered parts requirements and test methods.
10.6 PREDIC ATE DEVICE
Access Point Medical, AXS-1 Basic Wheelchair (K050280)
10.7 SUBSTANTIAL E QUIVALENCE
The Danyang Huayi H035 Wheelchair and Access Point Medical AXS-1 Basic wheelchair (K080280) are substantially equivalent products in all areas impacting safety and effectiveness.
10.8 CONCLUSION
The Danyang Huayi H035 Basic wheelchair raises no safety/efficiency issues or makes any claims that differ from the predicate device cited.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 15 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Danvang Huayi Medical Supply & Equipment, Co., LTD. % Estrin Consulting Group, Inc. Mr. Norman F. Estrin, Ph.D., President 9109 Copenhaver Drive Potomac, MD 20854
Re: K080114
Trade/Device Name: Huayi H035 Basic Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: January 3, 2008 Received: January 17, 2008
Dear Dr. Estrin:
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 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.
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Page 2 - Mr. Norman F. Estrin, Ph.D., President
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
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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Indications for Use 4.0
Indications for Use
510(k) Number (if known):
Device Trade/Proprietary Name: Danyang Huayi H035 Basic Wheelchair Indications for Use:
The Danyang Huayi® H035 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
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)ver-The-Counter Use Prescription Use X IND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Labels | Values |
|---|---|
| Division Sign-Off | Punh |
| 510(k) Number | L080114 |
§ 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).