(48 days)
Indications Huayi K3/K4 lightweight wheelchair is indicated for providing mobility to persons limited to a sitting position.
The Danyang Huayi K3/k4 wheelchair is a lightweight wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel and aluminum frame and nylon upholstery back and seat that meet 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 K3/K4 wheelchair is intended for the use in indoors and outdoors, over smooth surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that free of large obstacles and inclines greater than 9 degrees.
The provided document describes the Danyang Huayi K3/K4 lightweight wheelchair, which is a Class I mechanical wheelchair. The primary method of proving substantial equivalence to a predicate device is through conformance to established standards.
Here's an analysis based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Conformance) | Reported Device Performance |
|---|---|
| ISO 7176-1: Determination of static stability | Met |
| ISO 7176-3: Determination of efficiency of brakes | Met |
| ISO 7176-5: Determination of overall dimension, mass, and turning space | Met |
| ISO 7176-7: Measurement of seating and wheel dimensions | Met |
| ISO 7176-8: Requirements and test methods for static, impact, and fatigue strengths | Met |
| ISO 7176-11: Test dummies | Met |
| ISO 7176-13: Determination of friction of test surface | Met |
| ISO 7176-15: Requirements for information disclosure, documentation, and labeling | Met |
| ISO 7176-16: Resistance to ignition of upholstered parts | Met |
| ISO 10993-5-1999: Test for in vitro Cytotoxicity | Met |
| ASTM D751:89 Section 11 Procedure A: Tensile Strength | Met |
| California Technical Bulletin 117 (Parts A, I, D, II, E, 1): Flame Retardance of Resilient Filling Materials | Met |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size for individual tests conducted to meet each ISO or ASTM standard. It generally states that "The Danyang Huayi K3/K4 wheelchair production meets the following standards" and that the device "raises no safety and efficiency issues or makes any claims that differ from the predicate device cited".
The data provenance is from China, as Danyang Huayi Medical Equipment & Supply Co., LTD is a Chinese company. The nature of the testing is generally prospective, as it would involve testing the manufactured wheelchairs against the specified standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For mechanical device testing against standards, the "ground truth" is typically defined by the standard's specifications and test procedures, rather than expert consensus in the way it might be for a diagnostic image analysis algorithm. The expertise lies in the engineers and technicians performing the standardized tests correctly.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of mechanical testing against established standards, the adjudication method would typically involve direct measurement and comparison with the standard's pass/fail criteria, rather than multi-reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI algorithms where the "reader" is a human interpreting images. For a mechanical wheelchair, the assessment focuses on physical performance against engineering standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a mechanical wheelchair, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used is defined by the specifications and test methods outlined in the various ISO, ASTM, and California Technical Bulletin standards. These standards provide objective, measurable criteria for attributes like static stability, brake efficiency, dimensions, strength, and material properties.
8. The Sample Size for the Training Set
This question is not applicable. The Danyang Huayi K3/K4 wheelchair is a mechanical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a mechanical device.
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JUL - 6.2009
Danyang Huayi Medical Equipment & Supply Co., LTD One Zhenxing Road, Yunyang Economical Development Zone, Danyang, 212300 CHINA Tele: 86511-86900809; Fax: 86511-86900805
856.340.3572
831.300.3572
China Solution Consulting
3119 Brick Lane, Decatur, GA 30033
Mr. Jiuguang (Joe) Song, President
Danyang Huayi Medical Supply &
1 Zhenxing Road, Yunyang Economic
Danvang, Jiangsu Province
Mr. Tommy Tang, Manager
Equipment Co., LTD
Development Zone
CHINA 212300
86.511.86900879
86.511.86900807
May 10, 2009
Model: K3, K4
Mechanical wheelchair
Wheelchair, mechanical
Physical Medicine device
Huayi Lightweight Wheelchair
SECTION 5.0: SUMMARY OF SAFETY AND EFFECTIVENESS
Submission Correspondent
- Address Tele Fax Contact Person Email
Sponsor Information
Address
Contact person
- Tele Fax Email
Date Prepared
Trade Name
Common/Usual Name
Classification Name
Classification Number
Classification Panel
CDRH Code
IOR
890 3850
Regulatory Classification
Class I
5.1: Product Description
The Danyang Huayi K3/k4 wheelchair is a lightweight wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel and aluminum frame and nylon upholstery back and seat that meet 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 K3/K4 wheelchair is intended for the use in indoors and outdoors, over smooth surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that free of large obstacles and inclines greater than 9 degrees.
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Image /page/1/Picture/0 description: The image shows a logo with a stylized symbol on the left and text on the right. The symbol appears to be two curved shapes enclosing a circle. To the right of the symbol, the text "HUAYE" is displayed in a bold, sans-serif font, with smaller Chinese characters beneath it. The overall impression is that of a corporate or brand logo, possibly for a company with both English and Chinese branding.
Danyang Huayi Medical Equipment & Supply Co., LTD One Zhenxing Road, Yunyang Economical Development Zone, Danyang, 212300 CHINA Tele: 86511-86900809; Fax: 86511-86900805
Indication for Use 5.2
The Danyang Huayi K3/K4 wheelchair is indicated for providing mobility to persons limited to a sitting position.
Conformance to Standards 5.3 .
The Danyang Huayi K3/K4 wheelchair production meets the following standards:
- ISO 7176-1 Wheelchair: Determination of static stability .
- ISO 7176-3 Wheelchair: Determination of efficiency of brakes. 0
- ISO 7176-5: Determination of overall dimension, mass and turning o 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.
- ISO 10993-5-1999: Biological Evaluation of Medical Devices Part . 5: Test for in vitro Cytotoxicity.
- ASTM D751:89 Section 11 Procedure A Tensile Strength .
- Section A, Part I and Section D, Part II of California Technical . Bullentin 117 Requirements, Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling Materials Used in Upholstered Furniture.
- PVC leather/Nylon fabric/liner in accordance with: Section E part 1 o of California Technical Bullentin 117 Requirement, Test Procedure and Apparatus for Testing the Flame Retrardance of Resilient Filling Materials Used in Upholstered Furniture.
Predicated Device: American Bantex R07-16/18 Wheelchair 5.4 (K915262)
Substantial Equivalence ર્સ્ડ
The Danyang Huayi K3/K4 lightweight wheelchair and American BantexRo7-16/18 Wheelchair (K915262) are substantially equivalent products in all areas impacting safety and effectiveness.
5.6 Conclusion
The Danyang K3/K4 lightweight wheelchair raises no safety and efficiency issues or makes any claims that differ from the predicate device cited.
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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 eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JUL - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Danyang Huayi Medical Supply & Equipment Company, Limited % Mr. Jiuguang Song Managing Director China Solution Consulting 3119 Brick Lane Decatur, Georgia 30033.
Re: K091482
Trade/Device Name: Danyang Huayi K3/K4 Lightweight Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: I Product Code: IOR Dated: May 17, 2009 Received: May 19, 2009
Dear Mr. Song:
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 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
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Page 2-Mr. Jiuguang Song
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/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson 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): K091482
510(x) ?
Device Name: Danyang Huayi K3/K4 lightweight wheelchair
Indications for Use:
Indications Huayi K3/K4 lightweight wheelchair is indicated for providing mobility to persons limited to a sitting position.
Over-The-Counter Use_ AND/OR Prescription Use: Yes (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
.
(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 Sign-On)
Division of Surgical, Orthopedic, Division of Sweet and Restorative Devices
510(k) Number K09.1482
§ 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).