(455 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.
Manual Wheelchair W54 is a mechanical wheelchair including four wheels, a steel frame and a textilene upholstery that is flame resistant. W54 has a physical dimension of 1160mm × 890mm (depth × width × height) with the seat itself has a dimension of 470mm × 488mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 19.7 kilograms. The color is dark black.
The components include back upholstery, handgrip, back cane, arm pad, armrest, seat upholstery, seat extension, rear wheel, handrim, anti-tipper, wheel lock, crossbrace, frame, footplate, caster, caster housing, front fork.
Main materials: Steel (Frame, crossbrace, back cane, armrest, wheel lock, footrest, front fork), hard plastics (handgrip, rear wheel, handrim, castor, footplate, castor housing), flame resistant fabrics (seat and back upholstery) and flame retardant sponge (seat stuffing), armrest pad, tire of caster and rear wheel (PU), all kinds of pipe plugs and pipe shroud for the frame and steel parts (PP)
The provided text describes the 510(k) premarket notification for a Manual Wheelchair W54. This device is a mechanical wheelchair and, as such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to performance standards and non-clinical testing rather than clinical efficacy studies often associated with AI/software medical devices.
The document does not contain details about an AI/ML-based device. It is a submission for a mechanical wheelchair, therefore, many of the requested bullet points pertinent to AI/ML (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this specific device submission.
However, I can extract the information relevant to the performance of this mechanical device and its acceptance criteria as described in the document.
Acceptance Criteria and Device Performance for Manual Wheelchair W54
The acceptance criteria for the Manual Wheelchair W54 are based on compliance with various ISO standards for wheelchairs. The study proving the device meets these criteria involved non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance:
| Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static stability | Meets ISO 7176-1:2014 (Requirements for static stability angles: uphill/downhill, lateral, forward, rearward as detailed in ISO 7176-5) | Meets ISO 7176-1:2014 |
| Effectiveness of brakes | Meets ISO 7176-3:2012 | Meets ISO 7176-3:2012 |
| Dimensions, mass and manoeuvring space | Meets ISO 7176-5:2008 | Meets ISO 7176-5:2008 |
| Seating and wheel dimensions | Meets ISO 7176-7:1998 | Meets ISO 7176-7:1998 |
| Static, impact, and fatigue strengths | Meets ISO 7176-8:2014 (Requirements for resistance to various forces and stresses) | Meets ISO 7176-8:2014 |
| Information disclosure, documentation and Labeling | Meets ISO 7176-15:1996 | Meets ISO 7176-15:1996 |
| Resistance to ignition | Meets ISO 7176-16:2012 | Meets ISO 7176-16:2012 |
| Test Dummies Standards | ISO 7176-11:2012 (Followed for performance tests) | Followed (implied by meeting other standards) |
| Friction of test surface determination | ISO 7176-13:1989 (Followed for performance tests) | Followed (implied by meeting other standards) |
| Set-up procedures | ISO 7176-22:2014 (Followed for performance tests) | Followed (implied by meeting other standards) |
| Biocompatibility (material contact with intact skin) | Meets ISO 10993-1:2009/C1:2010 (General requirements for biological evaluation) | Meets ISO 10993-1:2009/C1:2010 |
| In Vitro Cytotoxicity Test | Meets ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Performed and met |
| Skin Irritation and Delayed-Type Hypersensitivity | Meets ISO 10993-10:2010 (Tests for irritation and delayed-type hypersensitivity) | Performed and met (Skin Sensitization Test too) |
| Usability | Device meets usability requirements as defined in verification & validation test report. | Meets usability requirements (15 participants) |
2. Sample size used for the test set and the data provenance:
- Quantitative Performance Tests: The document refers to compliance with ISO standards (e.g., ISO 7176 series for mechanical performance). These standards define specific test methods and often involve testing a single or small number of devices to demonstrate conformance. The exact "sample size" of wheelchairs tested for each specific ISO standard is not explicitly stated as a number of units, but rather the statement "Tests were conducted following the recommended procedures outlined in the respective consensus standards" and "results for 'Mechanical Wheelchair W54' met all relevant requirements."
- Usability Study: 15 participants were used for the usability study.
- Data Provenance: Not explicitly stated beyond the manufacturer being Jiangsu Jumao Medical Equipment Co., Ltd. in China. The testing would have been conducted by the manufacturer or a certified testing lab for compliance with international standards. The data is retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to this type of mechanical device testing. "Ground truth" in this context refers to established engineering and performance standards (ISO standards) rather than expert interpretation of medical images or conditions.
4. Adjudication method for the test set:
This concept is not applicable. Mechanical tests according to ISO standards have objective pass/fail criteria or measurements, not subjective evaluations requiring adjudication.
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:
This is not applicable as the device is a manual wheelchair, not an AI/ML-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable for a mechanical wheelchair.
7. The type of ground truth used:
- For mechanical performance: The "ground truth" is defined by the internationally recognized ISO standards (e.g., ISO 7176 series) for wheelchair design, performance, and testing. Compliance with these standards is the "ground truth" for demonstrating safety and effectiveness.
- For biocompatibility: The "ground truth" is defined by ISO 10993 series standards for biological evaluation of medical devices, involving specific lab tests (cytotoxicity, irritation, sensitization).
- For usability: The "ground truth" was established by verification & validation testing records and reported user understanding and operation ability assessed on 15 participants.
8. The sample size for the training set:
This is not applicable as the device is a mechanical wheelchair and does not utilize a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
This is not applicable as the device is a mechanical wheelchair and does not utilize a "training set" in the context of AI/ML.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 3, 2019
Jiangsu Jumao Medical Equipment Co., Ltd. % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, Guangdong, 511660 CN
Re: K180309
Trade/Device Name: Manual Wheelchair W54 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: April 16, 2019 Received: April 16, 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.
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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,
for Carlos Peña. PhD, MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180309
Device Name Manual Wheelchair W54
Indications for Use (Describe)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K180309 - 510(k) Summary
Revised Date of Summary: May 2, 2019 Date of Summary Preparation: August 1, 2018
1. Submitter's Identifications
Submitter's Name: Jiangsu Jumao Medical Equipment Co., Ltd. Address: No.36 Danyan road, Danyang City, Jiangsu, China, 212300 Contact Person: Qian Gao Contact Title: QA Manager Contact E-mail Address: jsjmfda@126.com Telephone: +86 (511) 86197066 Fax: +86 (511) 86197033
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 W54 Model: W54 Classification Panel: Physical Medicine Product Code: IOR Device Classification: Class I
4. The Predicate Devices
Primary Predicate: K170517 Merits Model R106/R136 Rehab Wheelchair Secondary Predicate: K151797 Nuocande Plastic Manual Wheelchair Model NKD L07
5. Device Description
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom
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walking is difficult or impossible due to illness, injury, or disability.
Manual Wheelchair W54 is a mechanical wheelchair including four wheels, a steel frame and a textilene upholstery that is flame resistant. W54 has a physical dimension of 1160mm × 890mm (depth × width × height) with the seat itself has a dimension of 470mm × 488mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 19.7 kilograms. The color is dark black.
The components include back upholstery, handgrip, back cane, arm pad, armrest, seat upholstery, seat extension, rear wheel, handrim, anti-tipper, wheel lock, crossbrace, frame, footplate, caster, caster housing, front fork.
Main materials: Steel (Frame, crossbrace, back cane, armrest, wheel lock, footrest, front fork), hard plastics (handgrip, rear wheel, handrim, castor, footplate, castor housing), flame resistant fabrics (seat and back upholstery) and flame retardant sponge (seat stuffing), armrest pad, tire of caster and rear wheel (PU), all kinds of pipe plugs and pipe shroud for the frame and steel parts (PP)
The specification table is as below:
| Type | W54 |
|---|---|
| Occupant mass group | III |
| Control mode | Mechanical |
| Physical dimension | 1160mm × 610mm × 890mm (depth × width × height) |
| Seat dimension | 470mm × 425mm × 488mm (depth × width × height) |
| Stowage width | 290mm |
| Handgrip height | 870mm |
| Total mass | 19.7kg |
| Weight capacity | 300lb(136kg) |
| Required width of angled corridor | 1000mm |
| Required doorway entry depth | 1270mm |
| Required corridor width for side opening | 1170mm |
| Armrest | Non flip back/Non height adjustable |
| Rear axle | Offset axle, Quick release axle |
| Real wheel | 610mm(24inch) |
| Casters | 190mm(8inch) |
| Wheel Lock | Pull to Lock |
| Color | Black |
SPECIFICATIONS
Note: Physical dimension is the dimension when the device is equipped with the ordinary hanging leg (without leg supports and/or foot supports), and the Overall length with legrest is 1270mm.
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Information disclosure in manufacturer's specification sheets
Manufacturer: Jiangsu Jumao Medical Equipment Co., Ltd.
Address: No.36 Danyan road, Danyang City, Jiangsu, China, 212300
Model: W54
Maximum occupant mass: 300 lbs/136kg
| Disclosure information (ISO) | |||||||
|---|---|---|---|---|---|---|---|
| Standardreference | Min. | Max. | Standardreference | Min. | Max. | ||
| ISO 7176-5 | Overall lengthwith legrest | 1270mm | ISO 7176-7ISO7176-22 | Seat planeangle | 6.2° | ||
| ISO 7176-5 | Overall width | 610mm | ISO 7176-7ISO7176-22 | Effective seatdepth | 470mm | ||
| ISO 7176-5ISO7176-7 | Handgripheight | 870mm | ISO 7176-7ISO7176-22 | Effective seatwidth | 425mm | ||
| ISO 7176-5 | Folded width | 290mm | ISO 7176-7ISO7176-22 | Seat surfaceheight at frontedge | 488mm | ||
| ISO 7176-5 | Net weight | 19.7kg | ISO 7176-7ISO7176-22 | Backrest angle | 11.6° | ||
| ISO 7176-5 | Maximumoccupant mass | 136kg(300 lbs) | ISO 7176-7ISO7176-22 | Backrestheight | 440mm | ||
| ISO 7176-5 | Requiredwidthofangledcorridor | 1000mm | ISO 7176-7ISO7176-22 | Footresttoseat distance | 430mm | 550mm | |
| ISO 7176-5 | Requireddoorway entrydepth | 1270mm | ISO 7176-7ISO7176-22 | Leg to seatsurface angle | 107.2° | ||
| ISO 7176-5 | Requiredcorridor widthforsideopening | 1170mm | ISO 7176-7ISO7176-22 | Armresttoseat distance | 270mm | ||
| ISO 7176-3 | Static stabilitydownhill | 14.6° | ISO 7176-7ISO7176-22 | Front locationof armreststructure | 270mm | ||
| ISO 7176-3 | Static stabilityuphill | 14.6° | 16.5° | ISO 7176-7ISO7176-22 | Distancebetweenarmrest | 430mm | |
| ISO 7176-3 | Static stabilitylateralorientation | 11.6° | 17.5° | ISO 7176-7ISO7176-22 | Footrest length | 55mm | |
| ISO 7176-1 | Static stabilityforward | 16.5° | 16.8° | ISO 7176-7ISO7176-22 | Handrimdiameter | 530mm | |
| ISO 7176-1 | Static stabilityrearward | Over 25° | Over 25° | ISO 7176-7ISO7176-22 | Horizontallocation ofaxle | 20mm | |
| ISO 7176-7ISO7176-22 | Frontwheeldiameter | 190mm | ISO 7176-7ISO7176-22 | Rearwheeldiameter | 600mm |
The wheelchair confirms to the following standards:
a) Requirements and test methods of static, impact and fatigue strengths (ISO 7176-8) Yes M
Yes প্র
b) Requirements for resistance to ignition in accordance with ISO 7176-16
Note:
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About the dimensions: The wheelchair can be equipped with the hanging leg, including the ordinary hanging leg and the orthopaedic hanging leg (for wheelchairs with leg supports and/or foot supports). 1270mm length is the full overall length when being adjusted to the maximum length position which equipped with the orthopaedic hanging leg (overall length with legrest). 1160mm length is the full length of a regular leg-mounted wheelchair.
6. Indication for Use / Intended Use of Device
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.
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7. Summary of Substantial Equivalence
| Proposed Device | Primary predicate device | Secondary predicate device | Comparison | |
|---|---|---|---|---|
| 510k Number | K180309 | K170517 | K151797 | ------ |
| Product Code | IOR | IOR | IOR | Same |
| Proprietary Name | Manual Wheelchair W54 | Merits Model R106/R136 Rehab Wheelchair | Nuocande Plastic Manual Wheelchair Model NKD L07 | |
| Model | W54 | R106, R136 | NKD L07 | ------- |
| Manufacturer | Jiangsu Jumao Medical Equipment Co., Ltd. | Merits Healthcare Industries. (suzhou) Co., LTD. | Ningbo Lecount Medical Technology Co., Ltd. | |
| Indications for Use | The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees. | The Merits Model R106/R136 Rehab Wheelchair is to provide mobility to persons limited to a sitting position. | The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 5 degrees. | SimilarThe basic descriptions for intended use of the three devices are the same.The inclines of the proposed device is bigger than that of the predicate device K151797The difference does not affect the effectiveness and safety. |
| Basic Design | W54 is a mechanical | The Merits Model R106/R136 | Four wheels, a plastic frame | Same |
Table 1 Comparison to Predicate Device
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| wheels, a steel frame and a | wheelchairs.They | is flame resistant. | ||
|---|---|---|---|---|
| textilene upholstery that is | adjustable headrest, adjustable | |||
| flame resistant. | armrests, cozy ergonomics | |||
| seat and multiple axle position. | ||||
| Steel (Frame, crossbrace, back | ||||
| cane, armrest, wheellock. | Similar | |||
| footrest, front fork),hard | The frame material of the | |||
| plastics (handgrip, rear wheel, | proposed device is same as | |||
| handrim,castor, footplate, | that of the predicate device | |||
| housing),castorflame | Steel (wheel rim and caster | K170517. | ||
| resistant fabrics (seat and back | Frame Material: Steel | rim), hard plastics (Frame), | The seat and back upholstery | |
| Materials | upholstery)flame | Seat/BackrestCozyPad: | (armrest) andPUflame | material of the proposed |
| retardantsponge(seat | Ergonomics PU Foam | resistant fabrics (seat) | device is same as that of the | |
| stuffing), armrest pad, tire of | predicate device K151797. | |||
| caster and rear wheel (PU), all | Other difference does not | |||
| kinds of pipe plugs and pipe | affect the effectiveness and | |||
| shroud for the frame and steel | safety. | |||
| parts (PP) | ||||
| Back upholstery, handgrip, | Back upholstery, handgrip, | upholstery, handgrip,Back | ||
| back cane, arm pad, armrest, | back cane, arm pad, armrest, | back cane, arm pad, armrest, | ||
| seat upholstery, seat extension, | seat upholstery, seat extension, | seat upholstery, seat extension, | ||
| Components | handrim,wheel, wheel,rear | rearwheel, wheel,handrim, | wheel, wheel,handrim,rear | Same |
| anti-tipper,wheellock, | anti-tipper,wheellock, | anti-tipper,wheel --lock, | ||
| footrest,crossbrace,frame, | crossbrace,frame,footrest, | frame,footrest,crossbrace, |
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| 1 | Jiangsu Jumao Medical Equipment Co., Ltd. | |||
|---|---|---|---|---|
| --- | ------------------------------------------- | -- | -- | -- |
| Occupant massgroup | footplate, caster, casterhousing, front fork. | footplate, caster, casterhousing, front fork. | footplate, caster, casterhousing, front fork. | |
|---|---|---|---|---|
| Occupant massgroup | III | III | II | SameThe occupant mass group ofthe proposed device is same asthat of the predicate deviceK170517. |
| Control Mode | Mechanical | Mechanical | Mechanical | Same |
| Physical Dimension | 1160mm × 610mm × 890mm(depth × width × height)Note: Physical dimension isthe dimension when the deviceis equipped with the ordinaryhanging leg (without legsupports and/or foot supports),and the Overall length withlegrest is 1270mm. | Model R106: 47.5" (±1") ×28-32" (±1") × 42" (±1")i.e. 1026mm × 711mm ~813mm × 1067mmModel R136: 44.5" (±1") ×26-30" (±1") × 42" (±1")i.e. 1130mm × 660mm ~762mm × 1067mm | 1090mm × 730mm × 850mm(depth × width × height) | SimilarThe three physical dimensionsare different. The differencedoes not affect theeffectiveness and safety. |
| Total Mass | 19.7kg | Model R106: 89 lbs / 40.4kgModel R136: 62 lbs / 28.1kg | 19kg | SimilarThe three total masses aredifferent. The difference doesnot affect the effectiveness andsafety. |
| Weight capacity | 300lb (136kg) | 300 lbs (136kg) | 220 lbs (100kg) | SameThe weight capacity of the |
| proposed device is same asthat of the predicate deviceK170517. | ||||
| Width: 16-20"(406-508mm)Height: Model R106: 19-21"(483-533mm); Model R136: 21"(533mm)Depth: 18-20"(457-508mm) | 411 (depth) x 447 (width) x 365 (height) mm | SimilarThe three seat dimensions aredifferent. The difference doesnot affect the effectiveness andsafety. | ||
| Seat dimension | 470mm × 425mm × 488mm(depth × width × height) | |||
| Height Adjustable (8"~12") | Non flip back/Non height adjustable | SimilarThe armrest stucture of theproposed device is same asthat of the predicate deviceK151797, but differene formK170517. The difference doesnot affect the effectiveness andsafety. | ||
| Armrest | Non flip back/Non height adjustable | |||
| Model R106: MultipleModel R136: Fixed | Offset axle, Quick release axle | SameThe rear axle stucture of theproposed device is same asthat of the predicate deviceK151797 and Model R106 ofK170517. | ||
| Rear Axle | Offset axle, Quick release axle | |||
| 610mm(24") | Model R106: 610mm(24")Model R136: | 585mm (23") | SameThe real wheel diameter of the | |
| Real Wheel | ||||
| 317.5mm(12-1/2") | proposed device is same as | |||
| that of the predicate device | ||||
| K170517. | ||||
| Similar | ||||
| 177.8mm (7") | 190mm (8") | The casters diameter of the | ||
| subject device is same as that | ||||
| Casters | 190mm(8") | of the predicate device | ||
| K151797 and of larger than | ||||
| K170517. The difference does | ||||
| not affect the effectiveness andsafety. | ||||
| Similar | ||||
| Headrest | None | Adjustable | / | The difference does not affectthe effectiveness and safety. |
| Similar | ||||
| Back Recline | 11.6° | 9°~57° | / | The difference does not affectthe effectiveness and safety. |
| Similar | ||||
| Seat Tilt | 6.2° | 4°~34° | / | The difference does not affectthe effectiveness and safety. |
| Elevating Legrest | Standard | Standard | Standard | Same |
| Required width of angled | Model | Similar | ||
| Turning Radius | corridor: 1000mm; Required | R106:30" | / | The difference does not affectthe effectiveness and safety. |
| doorway entry depth: | ||||
| 1270mm; Required corridorwidthforsideopening:1170mm | ModelR136:32" | |||
| Shear Reduction | Aligned Backrest Recline &User Pivot Points | Aligned Backrest Recline &User Pivot Points | Same | |
| Wheel Lock | Pull to Lock | Pull to Lock | Pull to Lock | Same |
| Frame Construction | Foldable Frame | Fixed Frame (Not foldable) | Foldable Frame | Same |
| Color | Black | / | Yellow | ------- |
| Standard | ISO7176-1ISO7176-3ISO7176-5ISO7176-7ISO7176-8ISO7176-11ISO7176-13ISO7176-15ISO7176-16ISO7176-22ISO10993-1ISO10993-5ISO10993-10 | ISO7176-1ISO7176-3ISO7176-5ISO7176-7ISO7176-8ISO7176-11ISO7176-13ISO7176-15ISO7176-16ISO7176-22ISO10993-1ISO10993-5ISO10993-10 | ISO7176-1ISO7176-3ISO7176-5ISO7176-7ISO7176-8ISO7176-11ISO7176-13ISO7176-15ISO7176-16ISO7176-22 | Same |
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Jiangsu Jumao Medical Equipment Co., Ltd.
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Note: the purpose of the secondary predicate device for comparison is to be the in terms of basic design, components, armrests, rear axles, casters, elevating legrest, wheel lock and frame structure, and to provide references in terms of substantial equivalence.
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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 "Mechanical Wheelchair W54" 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 andmanoeuvring space | Meets ISO 7176-5:2008 | Meets ISO 7176-5:2008 |
| Seating and wheel dimensions | Meets ISO 7176-7:1998 | Meets ISO 7176-7:1998 |
| Static, impact, and fatiguestrengths | Meets ISO 7176-8:2014 | Meets ISO 7176-8:2014 |
| Information disclosure,documentation and Labeling | Meets ISO 7176-15:1996 | Meets ISO 7176-15:1996 |
| Resistance to ignition | Meets ISO 7176-16:2012 | Meets ISO 7176-16:2012 |
Table 2: Comparison of Performance Testing
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 W54" 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.
Clinical data is not needed for manual wheelchair cleared by the 510(k) process.
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 W54" in accordance with the requirements of the design control regulations and established quality assurance procedures.
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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 manoeuvring 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 devices
ISO 7176-22:2014 Wheelchairs – Part 22: Set-up procedures
Biocompatibility:
ISO 10993-1:2009/C1:2010 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. Biocompatibility
Type of contact: Skin contact duration category A < 24 hours.
Patient contact: Contact of intact skin of hands, arms, back, neck and thigh with the following materials:
Handgrip: made up of PVC, contacts with intact skin of hands of user and/or caregiver.
Seat upholstery and back upholstery: made up of nylon, contact with intact skin of back, neck and thigh of user
Armrest pad: made up of PU, contacts with intact skin of hands and arms of user.
Handrim: made up of PP, contacts with intact skin of hands and arms of user.
Handgrip included PVC with additives, seat upholstery and back upholstery included nylon with additives, armrest included PU with additives, handrim included PP with additives were tested together respectively. The materials only contact with the user's intact skin within 24 hours, so according to ISO 10993-1:2009, the In Vitro Cytotoxicity Test, Skin Sensitization Test and Skin Irritation Test have been performed.
The Manual Wheelchair W54 uses the same contacting materials as the predicate device and does not raise any new biocompatibility issues.
11. 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.
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Based on the verification & validation testing records provided, we concluded that the Manual Wheelchair, Model W54 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 W54, manufactured by Jiangsu Jumao Medical Equipment 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.
12. Conclusion:
Based on the comparison of the proposed device of W54 is determined to be Substantially Equivalent (SE) to the predicate device of Merits Model R106/R136 Rehab Wheelchair and Nuocande Plastic Manual Wheelchair Model NKD L07, in respect of safety and effectiveness.
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§ 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).