(136 days)
The Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The Manual Wheelchair is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the wheelchair by rotating two handrims protruding from rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device can be folded for transport. The device can be operated indoor or outdoor on dry, smooth surfaces composed of concrete, blacktop or asphalt under normal driving conditions. The subject manual wheelchair is a mechanical wheelchair with four wheels, including two front casters and two rear wheels, a frame made of carbon steel, a seat and a backrest made of oxford fabric, which is soft and water-resistant, two handles, armrests, handrims, foot pedals, legrest strap and seat belt. The subject manual wheelchair has a physical dimension of 1085mm × 700mm ×935mm (length × width × height). The device has a weight capacity of 100 kilograms, and its total mass is 17.3kg. The color is black.
This document describes the premarket notification (510(k)) for a Manual Wheelchair (Model: SYIV100-RLD-G01) seeking clearance from the U.S. Food and Drug Administration (FDA).
It's important to note that this is a Class I medical device (Mechanical Wheelchair, Product Code: IOR), which are generally considered low risk and do not require extensive clinical trials or complex AI performance criteria as seen with higher-class devices. The primary method for proving substantial equivalence for such devices is often through non-clinical performance testing and comparison to an existing predicate device.
Therefore, many of the typical "AI device" specific questions (like MRMC studies, training set details, or expert consensus for ground truth) are not applicable to this specific submission, as the device is not an AI-powered diagnostic or therapeutic tool. The "acceptance criteria" here refer to the device meeting established performance standards for manual wheelchairs, rather than AI performance metrics.
Here is the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this manual wheelchair, the acceptance criteria are based on compliance with recognized performance and safety standards, and demonstrating that the proposed device performs "as well as" a legally marketed predicate device. The document does not present a formal "table of acceptance criteria and reported device performance" as one might see for an AI algorithm with metrics like sensitivity/specificity. Instead, it demonstrates compliance through adherence to ISO standards and a comparative analysis.
Acceptance Criteria (Implicit: Compliance with Standards and Predicate Equivalence)
| Criteria Category | Specific Standards/Tests | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ISO 7176-1: Determination of static stability | Complies with ISO 7176-1 (Static stability: longitudinal forward tilt ≥ 10°, longitudinal backward tilt ≥ 10°, flank tilt ≥ 15°) |
| ISO 7176-3: Determination of effectiveness of brakes | Complies with ISO 7176-3 (Hill-holding performance: ≥8°) | |
| ISO 7176-5: Determination of overall dimensions, mass and manoeuvring space | Complies with ISO 7176-5 (Overall dimensions, weight, min. turning radius, min. reversing width as specified: Length: 1085mm, Width: 700mm, Height: 935mm, Weight: 17.3kg, Min. Turning Radius: ≤850mm, Min. Reversing Width: ≤1500mm, Sliding offset: ≤350mm) | |
| ISO 7176-7: Measurement of seating and wheel dimensions | Complies with ISO 7176-7 (Seat width: 420mm, Seat depth: 410mm, Seat height from floor: 505mm, Backrest height: 405mm, etc. as specified) | |
| ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths | Complies with ISO 7176-8 (Load capacity: 100kg) | |
| ISO 7176-11: Test dummies | Complies with ISO 7176-11 (Used for relevant tests) | |
| ISO 7176-13: Determination of coefficient of friction of test surfaces | Complies with ISO 7176-13 (Used for relevant tests) | |
| ISO 7176-15: Requirements for information disclosure, documentation and labeling | Complies with ISO 7176-15 | |
| ISO 7176-16: Resistance to ignition of postural support devices | Complies with ISO 7176-16 | |
| ISO 7676-22: Set-up procedures | Complies with ISO 7176-22 | |
| Biocompatibility | ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Complies with ISO 10993-1 |
| ISO 10993-5: Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | Complies with ISO 10993-5 (for PP material) | |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Complies with ISO 10993-10 (for handrim and PP armrest material) | |
| Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements (Table 3) |
| Substantial Equivalence | Device performs "as well as" legally marketed predicate device (K180852) despite minor differences in dimensions or material choices. | All differences analyzed and demonstrated not to affect safety or effectiveness, with performance confirmed through compliance with relevant ISO standards. Conclusion: "as safe, as effective, and performs as well as the legally marketed predicate device." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in terms of number of patients or images, because this is a physical medical device. The "test set" here refers to the physical units of the manual wheelchair subjected to various engineering and biocompatibility tests. Typically, a small number of units (e.g., 1-3) are tested to demonstrate compliance with standards for Class I devices like this.
- Data Provenance: The tests are non-clinical (laboratory and engineering tests) conducted on the manufactured device. The geographic origin of the testing is not specified, but the manufacturer is based in China. The data would be considered prospective in the sense that the tests were performed specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to this type of device submission. There is no "ground truth" established by human experts in the context of diagnostic or AI performance for a manual wheelchair. The "ground truth" for this device's performance is objective measurements against established engineering and biocompatibility standards.
4. Adjudication method for the test set
- This is not applicable. No adjudication method (like 2+1, 3+1 consensus) is relevant for non-clinical engineering and biocompatibility testing of a physical product like a manual wheelchair.
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. This is not an AI device or an imaging device requiring human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is based on objective measurements and results from standardized non-clinical engineering tests (ISO 7176 series) and biocompatibility tests (ISO 10993 series). For example, a wheelchair either passes the static stability test at a certain angle or it doesn't; this is a measured outcome against a defined specification, not an expert opinion.
8. The sample size for the training set
- This is not applicable. This device is a physical product and does not involve AI/machine learning models that require training sets.
9. How the ground truth for the training set was established
- This is not applicable. As it's not an AI device, there is no training set or associated ground truth establishment process.
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July 21, 2022
Hebei Ruilangde Medical Equipment Technology Group Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K220671
Trade/Device Name: Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: May 25, 2022 Received: May 25, 2022
Dear Ivy Wang:
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.
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 medical devices and radiation-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,
for Heather Dean, Ph.D 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
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Indications for Use
510(k) Number (if known) K220671
Device Name Manual Wheelchair (Model: SYIV100-RLD-G01)
Indications for Use (Describe)
The Manual Wheelchair is intended for medical purposes 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)
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510(K) Summary
(As requirement by 21 CFR 807.92)
Date prepared: 21st, February, 2022
A. Applicant:
Name: Hebei Ruilangde Medical Equipment Technology Group Co., Ltd Address: Zhongkuang S. Rd., High-tech Development Zone, Jing County, Hengshui, Hebei, China Contact: Liu Zhihao Title: General Manager Tel: +86-13475165790 Email: hebeiruilangde(@163.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name: Manual Wheelchair (Model: SYIV100-RLD-G01) Common Name: Manual Wheelchair Model: SYIV100-RLD-G01
Regulatory Information Classification Name: Wheelchair, Mechanical Classification: Class I Product code: IOR Regulation Number: 21 CFR 890.3850 Review Panel: Physical Medicine
C. Predicate device: K180852 Manual Wheelchair JIANGYIN NEWRISE MEDICAL EQUIPMENT CO., LTD.
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D. Device Description:
The Manual Wheelchair is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the wheelchair by rotating two handrims protruding from rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device can be folded for transport. The device can be operated indoor or outdoor on dry, smooth surfaces composed of concrete, blacktop or asphalt under normal driving conditions.
The subject manual wheelchair is a mechanical wheelchair with four wheels, including two front casters and two rear wheels, a frame made of carbon steel, a seat and a backrest made of oxford fabric, which is soft and water-resistant, two handles, armrests, handrims, foot pedals, legrest strap and seat belt. The subject manual wheelchair has a physical dimension of 1085mm × 700mm ×935mm (length × width × height). The device has a weight capacity of 100 kilograms, and its total mass is 17.3kg. The color is black.
| Main components | Main materials |
|---|---|
| Frame | Carbon steel |
| Back upholstery | Oxford fabric |
| Seat upholstery | Oxford fabric |
| Handle | PVC |
| Armrest | Polypropylene |
| Front casters | Polypropylene |
| Rear wheels | PU and aluminium alloy |
| Handrim | Polypropylene |
| Foot pedal | Polypropylene |
| Legrest strap | Leather |
| Seat belt | Nylon |
| Brake | PVC |
| Main Components and materials: | ||
|---|---|---|
The specification of the device is as below:
| Main dimensions and structural parameters | |||
|---|---|---|---|
| Overall dimension | 1085mm × 700mm ×935mm (length × width × height) | ||
| Folded dimension | 900mm×300mm×750mm (length × width × height) | ||
| Seat width | 420mm | Horizontal angle of seat | 14.4° |
| Seat depth | 410mm | Backrest angle | 22.3° |
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| Seat height from floor | 505mm | Angle of the legrest against the seat surface | 108.5° |
|---|---|---|---|
| Distance between armrests | 450mm | Distance from footrest to seat | 425mm |
| Backrest height | 405mm | Front position of armrest structure | 370mm |
| Footrest height from floor | 145mm | Diameter of armrest circle on rear wheels | 525mm |
| Horizontal position of shaft | 20mm | ||
| Load capacity | 100kg (220lb) | ||
| Specification of front wheels | Φ195mm | ||
| Specification of rear wheels | Φ598mm | ||
| Main technical performance | |||
| Static stability | longitudinal forward tilt ≥ 10°, longitudinal backward tilt ≥ 10°, flank tilt ≥ 15° | ||
| Hill-holding performance | ≥8° | ||
| Sliding offset | ≤350mm | ||
| Minimum turning radius | ≤850mm | ||
| Minimum reversing width | ≤1500mm |
E. Indications for Use:
The Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
F. Comparison of Technological Characteristics with the Predicate Device
Table 1 General Comparison of Proposed and Predicate Devices
| Items | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K220671 | K180852 | - |
| Manufacturer | Hebei Ruilangde Medical EquipmentTechnology Group Co., Ltd | JIANGYIN NEWRISE MEDICALEQUIPMENT CO., LTD. | - |
| Product Name | Manual Wheelchair | Manual Wheelchair | Same |
| Product Code | IOR | IOR | Same |
| RegulationNumber | 21 CFR 890.3850 | 21 CFR 890.3850 | Same |
| Indications foruse | The device is intended for medical purposesto provide mobility to persons restricted to asitting position. | The device is intended for medicalpurposes to provide mobility to personsrestricted to a sitting position. | Same |
| DesignCharacteristic | Manual Operation, Four-Wheels, Foldable,Cross-Brace, Pull-to-Lock, Armrest, | Manual Operation, Four-Wheels,Foldable, Cross-Brace, Pull-to-Lock, | Same |
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| Backrest, Foot pedal | Armrest, Backrest, Footpad | ||
|---|---|---|---|
| OperationEnvironment | For indoor/outdoor use | For indoor/outdoor use | Same |
Table 2 Performance Comparison of Proposed and Predicate Devices
| Items | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Overall Dimensions | Length: 1085mmWidth: 700mmHeight: 935mm | Length: 1030mmWidth: 640 mmHeight: 930 mm | Analysis |
| Rear Wheel | Size: 598 mmTire Type: PU Solid MaterialRim Diameter/Material: 525 mm/Polypropylene | Size: 610mmTire Type: PU Solid MaterialRim Diameter/Material: 534 mm/Steel Composite | Analysis |
| Wheel Lock | Pull-to-Lock | Pull-to-Lock | Same |
| Ground Clearance | 150mm | 150mm | Same |
| Min. TurningDiameter | 1600mm | 1700mm | Analysis |
| Armrest | Armrest material: PolypropyleneHeight-Adjustable: No | Arm pad: PaddedHeight-Adjustable: No | Analysis |
| Seat Dimensions | Depth: 410mmHeight: 505mmWidth: 420mm | Depth: 460 mmHeight: 420 mmWidth: 410 mm | Analysis |
| Casters | Size: 195 mmTire Type: Polypropylene | Size: 200mmTire Type: PVC Solid Material | Analysis |
| Weight ofwheelchair | 17.3kg | 18kg | Analysis |
| Weight Capacity | 100kg | 100kg | Same |
| Folding mechanism | Push inward from left and right sides tofold | Push inward from left and right sidesto fold | Same |
| Stowagelength/width/height | 900mm/300mm/750mm | Not Publicly Available | Analysis |
Difference Analysis:
a. Overall dimensions and seat dimensions: the proposed device has minor difference with the predicate device, which will only affect the appearance of the device but not affect the safety and effectiveness of the subject manual wheelchair. The subject manual wheelchair has already been tested for performance according to ISO 7176-1/-3/-5/-7/-8/-11/-13/-16/-22 and complies with the standards. Therefore, the subject manual wheelchair is as safe, effective and performs as well as the legally marketed predicate device.
b. Rear Wheel : the size, tire material and rim diameter of the proposed device are similar with the predicate device. The handrim material of the proposed device is different with the predicate device. The handrim of the proposed device has been tested for biocompatibility according to ISO 10993-10 and
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complies with the requirements. Therefore, the subject manual wheelchair is as safe, effective and performs as well as the legally marketed predicate device.
c. Min. Turning Diameter, the proposed device has smaller min. turning diameter than predicate device, which meet the design specification and has better flexibility than predicate device. The subject manual wheelchair has already been tested for performance and complies with the standards. Therefore, the subject manual wheelchair is as safe, effective and performs as well as the legally marketed predicate device.
d. Armrest: the armrest of the proposed device is solid PP material while the armrest of the predicate device is padded. The PP material has been tested for biocompatibility according to ISO 10993-10 and it was proven to be safe. Therefore, the subject manual wheelchair is as safe, effective and performs as well as the legally marketed predicate device.
e. Casters: the proposed device has minor difference with the predicate device, which will only affect the appearance of the device but not affect the safety and effectiveness of the subject manual wheelchair. The material of casters is different with the predicate device. The PP material has been tested for biocompatibility according to ISO 10993-5 and ISO 10993-10 and it was proven to be safe. Therefore, the subject manual wheelchair is as safe, effective and performs as well as the legally marketed predicate device.
f. Weight of wheelchair, the proposed device has minor difference with predicate device, this different is caused by different framework design, but it could not affect the safety and effectiveness of proposed device. The subject manual wheelchair has already been tested for performance and complies with the standards. Therefore, the subject manual wheelchair is as safe, effective and performs as well as the legally marketed predicate device.
g. Although the stowage length, stowage width and stowage height of the predicate device are not available, the folding mechanism of the proposed device and the predicate device is same. In light of the slight difference of overall dimension between the proposed device and the predicate device, and the same folding way of the two devices, the difference of the stowage length/width/height between the devices can be considered as minor, which will not affect the safety and effectiveness of proposed device. Therefore, the subject manual wheelchair is as safe, effective and performs as well as the legally marketed predicate device.
| Item | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Performance Test | Comply with ISO7176-1/-3/-5/-7/-8/-11/-13/-15/-16/-22 | Comply with ISO7176-1/-3/-5/-7/-8/-11/-13/-15/-16/-22 | Same |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Same |
| Labelandlabeling | Conforms to FDA RegulatoryRequirements | Conforms to FDA RegulatoryRequirements | Same |
Table 3 Safety Comparison of Proposed and Predicate Devices
G. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
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Non-clinical Test
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
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 vitro cytotoxicity >
-
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
- A ISO 7176-5: 2008 Wheelchairs - Part 5: Determination of overall 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 coefficient of friction of test surfaces
-
ISO 7176-15: 1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- A ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices
-
ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
Substantial Equivalence discussion:
The proposed device is substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Manual Wheelchair is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K180852.
§ 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).