(353 days)
The A011 Manual Wheelchair is to provide mobility to persons limited to a sitting position.
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 A011 is a mechanical wheelchair including four wheels, a Aluminum alloy frame and a textilene upholstery that is flame resistant. A011 has a physical dimension of 1100mm × 660mm × width × height) with the seat itself has a dimension of 480mm × 430mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 16 kilograms. The color is yellow and black.
This document describes the premarket notification for the Manual Wheelchair, Model A011. The information provided is for a physical medical device (a manual wheelchair) and not a software/AI-based medical device. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and details about training/test sets for an algorithm, are not applicable to this submission.
The acceptance criteria for this device are based on performance standards for manual wheelchairs and comparisons to a predicate device, focusing on physical characteristics and safety.
Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally "Meets [ISO Standard]" or "Comply with [ISO Standard]," implying that the device's performance reached the thresholds defined by these international standards. The reported device performance is explicitly stated as meeting these standards.
| Acceptance Criteria (ISO Standard) | Reported Device Performance |
|---|---|
| Static stability (ISO 7176-1:2014) | Meets ISO 7176-1:2014 |
| Effectiveness of brakes (ISO 7176-3:2012) | Meets ISO 7176-3:2012 |
| Dimensions, mass and maneuvering space (ISO 7176-5:2008) | Meets ISO 7176-5:2008 |
| Seating and wheel dimensions (ISO 7176-7:1998) | Meets ISO 7176-7:1998 |
| Static, impact, and fatigue strengths (ISO 7176-8:2014) | Meets ISO 7176-8:2014 |
| Information disclosure, documentation and labeling (ISO 7176-15:1996) | Meets ISO 7176-15:1996 |
| Resistance to ignition (ISO 7176-16:2012) | Meets ISO 7176-16:2012 |
| Biocompatibility: Cytotoxicity (ISO 10993-5) | Not cytotoxicity effect. |
| Biocompatibility: Irritation (ISO 10993-10) | Not an irritant. |
| Biocompatibility: Sensitization (ISO 10993-10) | Not a sensitizer. |
| Wheel landing performance | All wheels except the lifting wheels must land smoothly |
| Hill-holding performance | >8° |
| Sliding offset | <350mm |
| Minimum turning radius | <850mm |
| Minimum reversing width | <1500mm |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a numerical count of individual wheelchairs tested. For physical devices, testing often involves a small number of units (e.g., a few prototypes or production samples) subjected to stress tests, rather than large "test sets" in the AI/software sense. The document states "Tests were conducted following the recommended procedures outlined in the respective consensus standards." These standards specify the number of units and repetitions needed for testing, but the exact number used by the manufacturer is not disclosed in this summary.
- Data Provenance: The manufacturer is Ningbo Shenyu Medical Equipment Co., Ltd. in China. The testing was "non-clinical" testing, meaning it was performed in a lab environment (not on human subjects). The data is presumably prospective from these tests, as they were conducted to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device, and "ground truth" for its performance is established by objective measurements based on engineering and safety standards (the ISO standards listed), not by expert interpretation of data points or images. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the defined standards.
4. Adjudication method for the test set
- Not Applicable. See point 3. Testing against physical standards does not typically involve an adjudication method in the context of human interpretation of data.
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 is a physical wheelchair, not an AI-assisted diagnostic or therapeutic device. No human-in-the-loop performance or MRMC study was conducted or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical wheelchair, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is defined by adherence to international consensus standards (ISO 7176 series for wheelchairs and ISO 10993 series for biocompatibility). These standards define the acceptable range of physical properties, durability, stability, brake effectiveness, and biological safety. The "outcomes" are whether the device successfully passes these standardized tests, demonstrating compliance.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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May 21, 2021
Ningbo Shenyu Medical Equipment Co., Ltd. % Vivi Shi Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai, Shanghai 200122 China
Re: K201461
Trade/Device Name: Manual Wheelchair, Model A011 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: March 1, 2021 Received: March 5, 2021
Dear Vivi Shi:
We have reviewed vour 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.
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather Dean, PhD Assistant Director. Acute Injurv 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
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Indications for Use
510(k) Number (if known) K201461
Device Name Manual Wheelchair, Model A011
Indications for Use (Describe)
The A011 Manual Wheelchair is to provide mobility to persons limited 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)
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510(K) Summary - K201461
I. Submitter
Ningbo Shenyu Medical Equipment Co.,Ltd.
Address: No.1318 West of Tanjialing Road, Yuyao, Zhejiang, China
Contact Person: Zhou Yuefeng Tel: +86- 574-62517777 Email: sales@shenyumedical.com
Submission Correspondent: Primary contact: Mrs. Vivi Shi Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: wei.shi@sungoglobal.com Secondary contact: Mr. RaymondLuo Room 1309, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda .sungo@gmail.com
II. Device
Name of Device: Manual Wheelchair Common Name: Manual Wheelchair Model(s): A011
Regulatory Information Classification Name: Mechanical Wheelchair Regulatory Class: I Product code: IOR Regulation Number: 890.3850 Review Panel: Physical Medicine
III. Predicate device:
Sichuan AST MedicalEquipment Co., Ltd. AST Model MA012 and MS019 Rehab Wheelchair 510Knumber: K181795
This predicate has not been subject to a design-related recall.
IV. 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 walking is difficult or impossible due to illness, injury, or disability.
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Manual Wheelchair A011 is a mechanical wheelchair including four wheels, a Aluminum alloy frame and a textilene upholstery that is flame resistant. A011 has a physical dimension of 1100mm × 660mm × width × height) with the seat itself has a dimension of 480mm × 430mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 16 kilograms. The color is yellow and black.
Main Components:
Main frame, back upholstery, seat upholstery, handgrip, arm pad, armrest, front wheel, handrim, antitipper, crossbrace, crossbar, side panel, Legrest strap, footplate, Seat belt, brake.
- Main materials:
Frame, crossbrace, crossbar, armrest, brake: Aluminum, yellow/black coating
Handgrip, side panel, handrim, footplate: PVC
Seat and back upholstery: Cover is Nylon fabrics, inside with flame resistant foam
Armrest pad: flame retardant sponge &PU
The device can be operated indoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
The specification table is as below:
| Main dimensions and structural parameters | |||
|---|---|---|---|
| Overall dimension | 1100mm (L) X 660mm (W) X 910mm (H) | ||
| Folded dimension | 810mm (L) X 320mm (W) X 930mm (H) | ||
| Seat width | 475mm | Horizontal angle of seat | 8° |
| Seat depth | 420 mm | Backrest angle | 14° |
| Seat height from floor | 510mm | Angle of the legrest against the seat surface | 65° |
| Distance between armrest and seat | 180 mm | Distance from footrest to seat | 410mm |
| Distance between armrests | 500 mm | Front position of armrest structure | 370mm |
| Backrest height | 370 mm | Diameter of armrest circle on rear wheels | 530mm |
| Footrest height from floor | 145mm | Horizontal position of shaft | 2.5mm |
| Weight of the heaviest part(net weight) | 13.5 Kg | ||
| Load capacity | 136Kg (300LB) | ||
| Specification of front wheels | Ø200mm | ||
| Specification of rear wheels | Ø600 mm | ||
| Main technical performance | |||
| Wheel landing performance | All wheels except the lifting wheels must land smoothly | ||
| Static stability | Vertical forward tilt ≥10°, vertical backward tilt≥10°, and lateral tilt ≥15° | ||
| Hill-holding performance | >8° | ||
| Sliding offset | <350mm | ||
| Minimum turning radius | <850mm | ||
| Minimum reversing width | <1500mm |
V. Indications for use
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The A011 Manual Wheelchair is to provide mobility to persons limited to a sitting position.
| Table 1 General Comparison | |||
|---|---|---|---|
| Device | Proposed Device | Predicate Device | Results |
| 510K Number | NA | K181795 | -- |
| Manufacturer | Ningbo Shenyu Medical EquipmentCo., Ltd. | Sichuan AST Medical EquipmentCo., Ltd. | -- |
| ProprietaryName | Manual Wheelchair | AST Model MA012and MS019 RehabWheelchair | -- |
| Model | A011 | MA012 and MS019 | -- |
| Classification | I | I | Same |
| Indications foruse | The A011 Manual wheelchair is toprovide mobility to persons limitedto a sitting position. | The AST ModelMA012 andMS019 Rehab Wheelchairs are toprovide mobility to persons limitedto a sitting position. | Same |
| Basic Design | The Aluminum Manual Wheelchairis indoor/outdoor wheelchair thathasa base with four-wheeled with a seat.The device can be disassembled fortransport and it is foldable easily. Thedevice uses a standard sling typeback and seat.Aluminum frame with yellow/blackcoating and folding backrestFlip back armrest PU padDetachable and elevating footrestFront caster PU tires and detachablerear wheel PU tires Nylon cushioncover of back upholstery and seatupholstery. | The AST ModelMA012 andMS019Rehab Wheelchairare manualwheelchairs.They have adjustable armrests, andmultiple axle position. The castersare 6"/7"/8" PU wheels with heightadjustable forks and the rear wheelsare 20"/22"/24"* 1-3/8"polyurethane(MA012 and MS019).Aluminum frame with liquid coatedand folding backrest Flip-up anddetachable armrest PU padDetachable footrest Front casters PUtires and quick release rear wheelPU tires Nylon cushion | SimilarThe structureand materialsof main frameof the proposeddevice andpredicate deviceare same, onlyindividualmaterials aredifferent, suchas back upholsteryand seatupholstery,etc.The differencesdo not raisesafety andeffectivenessof the proposeddevice. |
| Material | Frame, crossbrace, crossbar, armrest,brake: Aluminum, yellow/blackcoatingHandgrip, side panel, handrim,footplate: PVCSeat and back upholstery: Cover isNylon fabrics, inside with flame | AST Model MA012 RehabWheelchair: Aluminum framewith liquid coated and foldingbackrest Flip-up and detachablearmrest PU padDetachable footrest Front casters PUtires and quick release rear wheel | SimilarThe MainStructuralmaterials andwheels materialsare same.The differences |
| resistant foamArmrest pad: flame retardant sponge &PU | PU tires Nylon cushion | do not raisesafety andeffectivenessof the proposeddevice. | |
| Components | Main frame, back upholstery, seatupholstery, handgrip, arm pad,armrest, front wheel, rear wheel,handrim, anti-tipper, crossbrace,crossbar, side panel, Legrest strap,footplate, Seat belt, brake | AST Model MA012 RehabWheelchair: Main frame, handlesleeve, back upholstery, seatupholstery, armrest pad, armrest,sidepanel, front casters, rear wheel,legrest, footplate, brake, front fork,crossbrace. | SameAlthough theexpressions aredifferent, themain componentsare same. |
| Control Mode | Mechanical | Mechanical | SE |
| Size(unfold) | 1100mm (L) *660mm (W) * 910mm (H) | 1173mm(L)*645mm(W)*892mm(H) | SimilarThe two physicaldimensions aredifferent. Thedifference doesnot affect theeffectivenessand safety |
| Weight(Total) | 16kg(35.2lbs) | 38lbs | SimilarThe proposeddevice isheavier thanthe predicatedevice. |
| WeightCapacity | 136Kg(300lbs) | Model MA012:300lbs/136kg | Same |
| Seat Width | 480mm | Model MA012:16"(406mm)18"(457mm)20"(508mm) | SimilarDifferent seatsizes do notraise the safetyand effectivenessof the device. |
| Seat height | 540mm | Model MA012:19.7"(500mm) | |
| Seat depth | 420mm | Model MA012:16"-20"(406mm-508mm) | |
| Frame Type | foldable | foldable | SE |
| Cross-braceconfiguration | 18" | 14", 16", 18", 20" or 22" | SE |
| Back Stype | Fixed | Model MS019:Fixed | Same |
| Adjustable | device is sameas predicatedevice modelMS019. | ||
| Anti-tippers | Optional | Optional | Same |
| Wheelconstruction | Quick release | Model MA012:Quick releaseModel MS019:Fixed | SameWheelconstruction ofproposeddevice is sameas predicatedevice modelMA012. |
| Tires | Front: 200mm(8")Rear:610mm(24") | Front: 6",7",8"Rear: 20",22",24" | SE |
| Armrest | Flip back armrest | Model MA012:Height Adjustabledesk length armrest,Flip backModel MS019:Fixed or adjustableheight; desk or fulllength; removable | SimilarThe height ofarmrest ofproposeddevice can notbe adjustable. |
| Foot rest | Optional/swing away Optional/swing away | Optional/swing away Optional/swing away | SE |
| Rear AxlePosition | Single | Multiple | SimilarThe rear axleof proposeddevice has onlyone size. |
| FrameConstruction | Foldable frame | Foldable frame | SE |
| FrameMaterial | Aluminum | Model MA012:AluminumModel MS019: Steel | SEThe framematerialofproposeddevice is sameas predicatedevice modelMA012. |
| Safety Feature | Manual Wheel Lock | Manual Wheel Lock | SE |
| Standard | ISO7176-1ISO7176-3ISO7176-5 | ISO7176-1ISO7176-3ISO7176-5 | SE |
| ISO7176-7 | ISO7176-7 | ||
| ISO7176-8 | ISO7176-8 | ||
| ISO7176-11 | ISO7176-11 | ||
| ISO7176-13 | ISO7176-13 | ||
| ISO7176-15 | ISO7176-15 | ||
| ISO7176-16 | ISO7176-16 | ||
| ISO10993-1 | ISO10993-1 | ||
| ISO10993-5 | ISO10993-5 | ||
| ISO10993-10 | ISO10993-10 |
Comparison of technological characteristics with the predicate device VI.
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VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Test
Non-clinical tests were conducted to verify that the proposed device met all design specificationsas was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-1 :2018 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 VitroCytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin > Sensitization
-
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, Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
-
ISO 7176-7. First Edition 1998-05-15, Wheelchairs - Part 7: Measurement of seating and wheeldimensions
-
ISO 7176-8:2014, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatiguestrengths
-
ISO 7176-11:2012 Test dummies
-
ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of test surfaces
-
ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
-
ISO 7176-16: 2012 Resistance to ignition of postural support devices
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&3) 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 A011" met all relevant requirements in the test standards, our internal specifications, and are comparable to the predicate device.
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| 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 maneuvering 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 | Meets ISO 7176-8:2014 |
| Information disclosure, documentation andlabeling | 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 Performance comparison
Table 3 Biocompatibility Comparison
| Item | Proposed device | Predicate device | Result |
|---|---|---|---|
| Cytotoxicity | Under the conditions of the study, not cytotoxicity effect. | Comply with ISO 10993-5 | Same |
| Irritation | Under the conditions of the study, not an irritant. | Comply with ISO 10993-10 | Same |
| Sensitization | Under the conditions of the study, not a sensitizer. | Comply with ISO 10993-10 | Same |
Difference analysis:
The tests were performed following the general requirements outlined in ISO 7176-11:2012, ISO 7176-13:1989.
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:
Manual wheelchair 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 for a determination of substantialequivalence.
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.
Animal Study
No clinical study is included in this submission.
Clinical Study
No clinical study is included in this submission.
VIII. Conclusion
Based on the comparison of the proposed device of A011 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.
§ 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).