Manual Wheelchair SIVFH2A102

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. May 29, 2019 Jiangsu Horizon Medical Science & Technology Co., Ltd. % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, 511660 CN Re: K190534 Trade/Device Name: Manual Wheelchair SIVFH2A102 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 4, 2019 Received: March 4, 2019 Dear Jinghua Zhou: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Vivek Pinto, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190534 Device Name Manual Wheelchair SIVFH2A102 Indications for Use (Describe) The Manual Wheelchair is to provide mobility to persons restricted to a sitting position. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Section 5 - 510(k) Summary Date of Summary Preparation: February 22, 2019 ### 1. Submitter's Identifications Submitter's Name: Jiangsu Horizon Medical Science & Technology Co., Ltd. Address: No.1 Guanhe Road, Situ Town, Danyang City, Jiangsu Province, China, 212331 Contact Person: Cheng Gong Contact Title: QA Manager Contact E-mail Address: markgong@phoenixmedical.cn Telephone: +86-0511-86808686 Fax: +86-0511-86160891 ### 2. Correspondent's Identifications Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549 ### 3. Name of the Device Device Classification Name: Wheelchair, Mechanical Product Name: Mechanical Wheelchair Trade Name: Manual Wheelchair SIVFH2A102 Model: SIVFH2A102 Classification Panel: Physical Medicine Regulation Number: 21 CFR 890.3850 Product Code: IOR Device Classification: Class I ### 4. The Predicate Devices K181795 AST Model MA012 and MS019 Rehab Wheelchair ### 5. Device Description The Aluminum Manual 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. {4}------------------------------------------------ Main components: Main frame, handle sleeve, back upholstery, seat upholstery, armrest, side panel, rear wheel with handle ring, rear wheel axle, legrest, footplate, front fork, front wheels, cross bar. Main materials: Main frame, cross bar, legrest: Aluminum, silver/blue coating Back upholstery, seat upholstery: Cover is polyester non-woven, inside with flame resistant foam Handle sleeve, handle sleeve, side panel, handle ring, footplate: PVC Tire of rear wheels, front wheels, armrest pad: PU ## 6. Intended Use of Device The Manual Wheelchair is to provide mobility to persons restricted to a sitting position. # 7. Summary of Substantial Equivalence | | Proposed Device | Predicate device | Comparison | | |---------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | 510k Number | K190534 | K181795 | ----- | | | Product Code | IOR | IOR | Same | | | Proprietary Name | Manual Wheelchair<br>SIVFH2A102 | AST Model MA012<br>and MS019 Rehab<br>Wheelchair | ----- | | | Model | SIVFH2A102 | MA012 and MS019 | ----- | | | Manufacturer | Jiangsu Horizon<br>Medical Science &<br>Technology Co., Ltd. | Sichuan AST<br>Medical Equipment<br>Co., Ltd. | ----- | | | Indications for Use | The Manual<br>Wheelchair is to<br>provide mobility to<br>persons restricted to<br>a sitting position. | The AST Model<br>MA012 and MS019<br>Rehab Wheelchairs<br>are to provide<br>mobility to persons<br>limited to a sitting<br>position. | Same | | | Type of Use | Over-the-counter | Over-the-counter | Same | | | Basic Design | The Aluminum<br>Manual Wheelchair<br>is indoor/outdoor<br>wheelchair that has a<br>base with<br>four-wheeled with a | The AST Model<br>MA012 and MS019<br>Rehab Wheelchair<br>are manual<br>wheelchairs.<br>They have adjustable | Similar<br>The structure<br>and materials<br>of main frame<br>of the proposed<br>device and | | | | seat. The device can | armrests, and | predicate | | | | be disassembled for | multiple<br>position. The casters | device are | | | | transport and it is | are 6"/7"/8" PU | same, only | | | | foldable easily. The | wheels with height | individual | | | | device uses a | adjustable forks and | materials are | | | | standard sling type | the rear wheels are | different, such | | | | back and seat. | 20"/22"/24"*1-3/8" | as back | | | | Aluminum frame | polyurethane | upholstery and | | | | with silver/blue | (MA012 and | seat upholstery, | | | | coating and folding | MS019). | etc. | | | | backrest | Aluminum frame | The differences | | | | Flip back armrest | with liquid coated | do not raise | | | | PU pad | and folding backrest | safety and | | | | Detachable and | Flip-up and | effectiveness | | | | elevating footrest | detachable armrest | of the proposed | | | | Front caster PU tires | PU pad | device. | | | | and detachable rear | Detachable footrest | | | | | wheel PU tires | Front casters PU | | | | | Polyester non-woven | tires and quick | | | | | cover of back | release rear wheel | | | | | upholstery and seat | PU tires | | | | | upholstery | Nylon cushion | | | | | Main frame, cross | | | | | | bar, legrest: | AST Model MA012 | Similar | | | | Aluminum, | Rehab Wheelchair: | The Main | | | | silver/blue coating | Aluminum frame | structural | | | | Back upholstery, seat | with liquid coated | materials and | | | | upholstery: Cover is | and folding backrest | wheels | | | | polyester | Flip-up and | materials are | | | | non-woven, inside | detachable armrest | same. | | | Materials | with flame resistant | PU pad | The differences | | | | foam<br>Handle sleeve, | Detachable footrest | do not raise | | | | handle sleeve, side | Front casters PU | safety and | | | | panel, handle ring, | tires and quick | effectiveness | | | | footplate: PVC | release rear wheel | of the proposed | | | | Tire of rear wheels, | PU tires | device. | | | | front wheels, armrest | Nylon cushion | | | | | pad: PU | | | | | | Main frame, handle | AST Model MA012 | Same | | | | sleeve, back | Rehab Wheelchair: | Although the | | | Components | upholstery, seat | Main frame, handle | expressions are | | | | upholstery, armrest | sleeve, back | different, the | | | | pad, armrest, side | upholstery, seat | main | | | | wheel panel, rear | upholstery, armrest | components | | | | | with handle ring, pad, rear wheel axle, legrest, footplate, brake, front fork, front wheels, cross bar. | armrest, side panel, front casters, rear wheel, legrest, footplate, brake, front fork, cross-brace. | are same. | | Control Mode | | Mechanical | Mechanical | Same | | | Length | 1030mm | Model MA012:<br>1173mm(±1mm) | Similar<br>The two physical | | Dimension | Width | 660mm | Model MA012:<br>645mm (±1mm) | dimensions are different. The difference does | | | Height | 930mm | Model MA012:<br>892mm (±1mm) | not affect the effectiveness and safety. | | Net weight | | 30.2 lbs/13.7kg | Model MA012:<br>17.2kg/38lbs | Similar<br>The proposed device is heavier than the predicate device. | | Weight capacity | | 275 lbs/125kg | Model MA012:<br>300lbs/136kg | Similar<br>Weight capacity of the proposed device is less than the predicate device. | | Seat width | | 460mm(18") | Model MA012:<br>16"(406mm)<br>18"(457mm)<br>20"(508mm) | Similar<br>Different seat sizes do not | | Seat height | | 510mm(20") | Model MA012:<br>19.7"(500mm) | raises the safety and | | Seat depth | | 425mm(16.7") | Model MA012:<br>16"-20"<br>(406mm-508mm) | effectiveness of the device. | | Frame type | | foldable | foldable | Same | | Cross-brace configuration | | 18" | 14", 16", 18", 20" or 22" | Same | ### Table 1 Comparison to Predicate Device {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ | Back style | Fixed | Model<br>MS019:<br>Fixed<br>Model<br>MA012:<br>Adjustable | predicate<br>device include<br>with that of<br>proposed<br>device.<br>Same<br>Back style of<br>proposed<br>device is same<br>as predicate<br>device model<br>MS019. | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Anti-tippers | Optional | Optional | Same | | Wheel<br>construction | Quick release | Model<br>MA012:<br>Quick release<br>Model<br>MS019:<br>Fixed | Same<br>Wheel<br>construction of<br>proposed<br>device is same<br>as predicate<br>device model<br>MA012. | | Tires | Front: 8"<br>Rear: 24" | Front: 6",7",8"<br>Rear: 20",22",24" | Same<br>The tires sizes<br>of proposed<br>device<br>are<br>included<br>to<br>those<br>of<br>predicate<br>device. | | Armrest | Flip back armrest | Model<br>MA012:<br>Height<br>Adjustable<br>desk length armrest,<br>Flip back<br>Model<br>MS019:<br>Fixed or adjustable<br>height; desk or full<br>length; removable | Similar<br>The height<br>of<br>armrest<br>of<br>proposed<br>device can not<br>be adjustable. | | Foot rest | Optional/<br>swing<br>away | Optional/<br>swing<br>away | Same | | Rear Axle Position | Single | Multiple | Similar<br>The rear axle<br>of proposed<br>device has only<br>one size. | | Frame<br>Construction | Foldable frame | Foldable frame | Same | | Frame Material | Aluminum | Model MA012:<br>Aluminum<br>Model MS019: Steel | Same<br>The frame<br>material of<br>proposed<br>device is same<br>as predicate<br>device model<br>MA012. | | Safety Feature | Manual Wheel Lock | Manual Wheel Lock | Same | | Standard | ISO7176-1<br>ISO7176-3<br>ISO7176-5<br>ISO7176-7<br>ISO7176-8<br>ISO7176-11<br>ISO7176-13<br>ISO7176-15<br>ISO7176-16<br>ISO7176-22<br>ISO10993-1<br>ISO10993-5<br>ISO10993-10 | ISO7176-1<br>ISO7176-3<br>ISO7176-5<br>ISO7176-7<br>ISO7176-8<br>ISO7176-11<br>ISO7176-13<br>ISO7176-15<br>ISO7176-16<br>ISO7176-22<br>ISO10993-1<br>ISO10993-5<br>ISO10993-10 | Same | {8}------------------------------------------------ ## 8. Substantial Equivalence discussion: Our device and the predicate device are almost identical in terms of all areas described in the above table (Table 1). There are some minor differences with the predicate device don't affect the safety or effectiveness of the subject device. The following table (Table 2) shows similarities and differences of the performance between our device and the predicate device. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for "Manual Wheelchair SIVFH2A102" met all relevant requirements in the test standards, our internal specifications, and are comparable to the predicate device. | Description | Proposed Device | Predicate device | |-------------------------------------------|-----------------------|-----------------------| | Static stability | Meets ISO 7176-1:2014 | Meets ISO 7176-1:2014 | | Effectiveness of brakes | Meets ISO 7176-3:2012 | Meets ISO 7176-3:2012 | | Dimensions, mass and<br>maneuvering space | Meets ISO 7176-5:2008 | Meets ISO 7176-5:2008 | | Seating and wheel<br>dimensions | Meets ISO 7176-7:1998 | Meets ISO 7176-7:1998 | Table 2: Comparison of Performance Testing {9}------------------------------------------------ | Static, impact, and fatigue<br>strengths | Meets ISO 7176-8:2014 | Meets ISO 7176-8:2014 | |----------------------------------------------------------|------------------------|------------------------| | Information disclosure,<br>documentation and<br>Labeling | Meets ISO 7176-15:1996 | Meets ISO 7176-15:1996 | | Resistance to ignition | Meets ISO 7176-16:2012 | Meets ISO 7176-16:2012 | Jiangsu Horizon Medical Science & Technology Co., Ltd. The tests were performed following the general requirements outlined in ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-22:2014. A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Proposed Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses: "Mechanical Wheelchair SIVFH2A102" meets performance requirements per ISO 7176-1:2014, ISO 7176-3: 2012, ISO 7176-5:2008, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-11:2012, 7176-13: 1989, ISO 7176-15: 1996, ISO 7176-16:2012 and ISO 7176-22:2014. It is safe and effective, and its performances meet the requirements of the pre-defined acceptance criteria and intended use. A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence. According to the non-clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. ### 9. Non-Clinical Tests Performed: The following testing was performed on the "Mechanical Wheelchair SIVFH2A102" in accordance with the requirements of the design control regulations and established quality assurance procedures. Safety and performance: ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies ISO 7176-13:1989 Wheelchairs - Part 13: Determination of friction of test surface ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support {10}------------------------------------------------ devices ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures Biocompatibility: ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity # 10. Usability Study: The 15 participants read the User Manual before initial use of the device. They can understand the questions and answer them. The 15 participants can operate the device referring to the User Manual. Based on the verification & validation testing records provided, we concluded that the Manual Wheelchair, Model SIVFH2A102 is considered to meet the usability requirement as defined in the verification & validation test report. These non-clinical tests demonstrate that the labeling for the Manual Wheelchair, Model SIVFH2A102, manufactured by Jiangsu Horizon Medical Science & Technology Co., Ltd. and also distributed by US-Distributors is comprehensive, was well understood by a variety of "patients", and provided sufficient information for safe and proper use of the device. # 11. Conclusion: Based on the comparison of the proposed device of SIVFH2A102 is determined to be Substantially Equivalent (SE) to the predicate device of AST Model MA012 and MS019 Rehab Wheelchair, in respect of safety and effectiveness.