(52 days)
The YJ-011S Manual Wheelchair is to provide mobility to persons limited to a sitting position.
The YJ-011S series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
The provided text describes a 510(k) premarket notification for a reclining wheelchair, which is a Class I device. As such, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than a clinical study or AI/software validation. Therefore, many of the requested elements regarding acceptance criteria for AI performance, clinical study details, expert review, effect size, and training/test set specifics are not applicable or not present in this type of regulatory submission.
Applicable Information from the Submission:
This submission for the Zhenjiang Assure Medical Equipment Co., Ltd. Reclining Wheelchair (K232198) primarily relies on demonstrating compliance with recognized performance standards for mechanical wheelchairs and biocompatibility testing. The "acceptance criteria" are implied by the successful execution and results of these tests, showing the device meets the safety and performance benchmarks established by the standards and is comparable to the predicate device.
1. A table of acceptance criteria and the reported device performance
The submission does not present a formal "acceptance criteria" table with specific quantitative thresholds that would be typical for an AI/software device. Instead, acceptance is demonstrated by compliance with international standards for wheelchairs and biocompatibility. The "reported device performance" is that the device complied with these standards.
| Acceptance Criteria (Implied by Compliance with Standards) | Reported Device Performance |
|---|---|
| Mechanical Performance: | Complied with: |
| ISO 7176-1: Determination of static stability | ISO 7176-1:2014 |
| ISO 7176-3: Determination of effectiveness of brakes | ISO 7176-3:2012 |
| ISO 7176-5: Determination of overall dimensions, mass, and maneuvering space | ISO 7176-5:2008 |
| ISO 7176-7: Measurement of seating and wheel dimensions | ISO 7176-7:1998 |
| ISO 7176-8: Requirements and test methods for static, impact, and fatigue strengths | ISO 7176-8:2014 |
| ISO 7176-11: Test dummies | ISO 7176-11:2012 |
| ISO 7176-13: Determination of coefficient of friction of test surfaces | ISO 7176-13:1989 |
| ISO 7176-15: Requirements for information disclosure, documentation, and labeling | ISO 7176-15:1996 |
| ISO 7176-16: Resistance to ignition of postural support devices | ISO 7176-16:2012 |
| ISO 7176-22: Set-up procedures | ISO 7176-22:2014 |
| Biocompatibility: | Complied with: |
| Cytotoxicity (per ISO 10993-5) | Non-cytotoxic |
| Sensitization (per ISO 10993-10) | Non-sensitizing |
| Irritation (per ISO 10993-23) | Non-irritating |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The evaluations were non-clinical performance and biocompatibility tests of the physical device, not an assessment of software or AI performance on a data set. Therefore, there is no "test set" in the context of data or images, nor data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. There was no test set requiring expert ground truth establishment for this type of medical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There was no test set requiring adjudication in this type of submission.
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 information is not applicable. This device is a mechanical wheelchair, not an AI-assisted diagnostic or interpretative device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a mechanical wheelchair and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable in the context of "ground truth" for AI/software. The "ground truth" for this device's performance is defined by the established criteria and methods within the referenced ISO standards for mechanical wheelchairs and biocompatibility.
8. The sample size for the training set
This information is not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that would require a training set or its associated ground truth establishment.
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September 15, 2023
Zhenjiang Assure Medical Equipment Co., Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave. Shanghai. 200122 China
Re: K232198
Trade/Device Name: Reclining wheelchair (YJ-011S 16"D, YJ-011S 16"DF, YJ-011S 18"D, YJ-011S 18"DF, YJ-011S 20"D, YJ-011S 20"DF)
Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: July 25, 2023 Received: July 25, 2023
Dear Eva Li:
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/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.
Tushar Bansal -S
for Heather Dean, 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
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Indications for Use
510(k) Number (if known) K232198
Device Name
Reclining wheelchair (YJ-011S 16"D, YJ-011S 16"DF, YJ-011S 18"DF, YJ-011S 18"DF, YJ-011S 20"DF)
Indications for Use (Describe)
The YJ-011S 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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1. Submitter
Zhenjiang Assure Medical Equipment Co., Ltd. Address: No.297, Chuqiao Road, Zhenjiang City, Jiangsu Province, China Contact Person: Mei Ying Tel: +86-13852941204 Email: shelly@assuremedical.com.cn
Submission Correspondent Contact: Eva Li Phone: + 86 (215) 881-7802 Email: zxfda@sungoglobal.com Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave, Shanghai, 200122 CHN
Prepared Date: July 18th,2023
2. Device
Name of Device: Reclining wheelchair Common Name: Manual Wheelchair Model(s): YJ-011S 16"D, YJ-011S 16"DF, YJ-011S 18"D, YJ-011S 18"DF, YJ-011S 20"D, YJ-011S 20"DF
Regulatory Information Classification Name: Mechanical Wheelchair Regulatory Class: I Product code: IOR Regulation Number: 890.3850 Review Panel: Physical Medicine
3. Predicate device:
K201461 Ningbo Shenyu Medical Equipment Co.,Ltd. Manual Wheelchair (A011)
4. Device description
The YJ-011S series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels.
The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
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Main Components:
Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, rear wheel, hand rim, crossbar, footplates, brake, leg rest.
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
| Model | YJ-011S 16"D, YJ-011S 16"DF, YJ-011S 18"D, YJ-011S 18"DF, YJ-011S 20"D, YJ-011S 20"DF | |||
|---|---|---|---|---|
| Overall dimension | length 1340mm* high 1258mm*16"width 625mm*18"width 675mm*20"width 725mm | |||
| Folded dimension | width 323mm | |||
| Seat width | 16" | 410mm | Seat plane angle | 3° |
| 18" | 460mm | |||
| 20" | 510mm | |||
| Seat depth | 460mm | Seat height from floor | 525mm | |
| Backrest angle | 7°-83.5° | Backrest height | 500mm | |
| Backrest width | 16" | 410mm | Footrest-to-seat distance | 448mm-555mm |
| 18" | 460mm | |||
| 20" | 510mm | |||
| Footrest clearance | 72mm | Footrest length | 200mm | |
| Armrest-to-seat distance | 228mm | Footrest-leg-angle | 95° | |
| Leg-to-seat-surface angle | 140° | Front-armrest-to-backrest distance | -D: 320mm-F: 475mm | |
| Front-armrest-to-backrest distance | -D: 320mm | Armrest length | -D: 260mm-F: 352mm | |
| -F: 475mm | ||||
| Armrest width | 55mm | Armrest angle | 3°-4° | |
| Distance between armrests | 16" | 427mm | Front location of armrest structure | 320mm |
| 18" | 477mm | |||
| 20" | 527mm | |||
| Hand rim diameter | Φ580mm | Material | Q235 | |
| Horizontal location of axle | 55° | Maximum weight bearing capacity of the device | 350LBS | |
| Weight of the device(net) | 25.5kg | Static stability sideways | 15.25° | |
| diameter of front wheels | Φ195mm | diameter of rear wheels | Φ613mm | |
| Static stability uphill | 15.2° | Static stability downhill | 15.2° | |
| Minimum turning radius | 1170mm |
The specification table is as below:
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510(k) Summary K232198
| Parking brake | |
|---|---|
| Max slope uphill | 8.35° |
| Max slope downhill | 8.15° |
5. Indication for use
The YJ-011S Manual Wheelchair is to provide mobility to persons limited to a sitting position.
6. Comparison of technological characteristics with the predicate device
| Device | Predicate Device | Proposed Device | Results |
|---|---|---|---|
| 510K Number | K201461 | K232198 | -- |
| Manufacturer | Ningbo Shenyu MedicalEquipment Co., Ltd. | Zhenjiang Assure MedicalEquipment Co., Ltd. | -- |
| Proprietary Name | Manual Wheelchair | Reclining wheelchair | -- |
| Classification | I | I | same |
| Indications for use | The A011 Manual wheelchair is toprovide mobility to personslimited to a sitting position. | The YJ-011S reclining wheelchair isto provide mobility to personslimited to a sitting position. | same |
| DesignCharacteristic | Manual Operation, Four-Wheels,Foldable, Cross-Brace, Pull-to-Lock, Armrest, Backrest, Foot rest | Manual Operation, Four-Wheels,Foldable, Cross-Brace, Pull-to-Lock, Armrest, Backrest, Foot rest,skirt guard | Similar*1 |
| Brake control | occupant-operated brake only | occupant-operated brake only | same |
| Operation | For indoor/outdoor use | For indoor/outdoor use | same |
| Environment | For indoor/outdoor use | For indoor/outdoor use | same |
| Control Mode | Mechanical | Mechanical | same |
| Size(unfold) | 1100 (L) *660 (W) * 910mm (H) | 1340 (L)* 1258 (H)*16" 625mm(W)*18" 675mm(W)*20" 725mm(W) | Different*2 |
| Stowagelength/width/height | 810 (L) X 320 (W) X 930mm (H) | 1340 (L)* 1258 (H)*323mm(W) | different*2 |
| Weight (Total) | 16kg(35.2lbs) | 25.5kg | different*2 |
| Weight Capacity | 136Kg(300lbs) | 350LBS | different*2 |
| Seat Width | 480mm | 410-510mm | different*2 |
| Seat height | 540mm | 525mm | different*2 |
| Seat depth | 420mm | 460mm | different*2 |
| Back type | Fixed | Adjustable | Different*3 |
| Tires | Front: 200mmRear:610mm | Front: 195mmRear:613mm | different*2 |
| Armrest | Flip back armrest | fixed | different*3 |
| Foot rest | Optional/ swing away Optional/swing away | Optional/ swing away Optional/swing away | same |
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510(k) Summary
| K232198 | |||
|---|---|---|---|
| Rear Axle Position | Single | Single | Same |
| Frame Construction | Foldable framePush inward from left and rightsides to fold | Foldable framePush inward from left and rightsides to fold | Same |
| Safety Feature | Manual Wheel Lock | Manual Wheel Lock | Same |
| Performance | Comply with:ISO7176-1ISO7176-3ISO7176-5ISO7176-7ISO7176-8ISO7176-11ISO7176-13ISO7176-15ISO7176-16 | Comply with:ISO7176-1ISO7176-3ISO7176-5ISO7176-7ISO7176-8ISO7176-11ISO7176-13ISO7176-15ISO7176-16 | Same |
| Biocompatibility | Comply with:ISO10993-1ISO10993-5ISO10993-10 | Comply with:ISO10993-5ISO10993-10ISO10993-23 | Similar*4 |
Discussion :
| Similar*1: | Compared to the predicate device, the subject device adds two skirt guards which installed to the sides of the seat frame under the arm rests to provide a barrier between the occupant and the wheels. This feature can prevent occupant's clothes from getting caught in the wheels. This feature will not raise any new risk of safety or effectiveness. |
|---|---|
| Different*2: | Compared to the predicate device, the subject device has different value on the unfold size, stowage size, device weight, capacity, seat width, seat height, seat depth, tire size. However, the subject has passed the <ISO 7176-7-1998 Part7: Measurement of seating and wheel dimensions > and <ISO 7176-5-2008 Part 5: Determination of dimensions, mass and maneuvering space>, so the above different will not raise any new risk of safety or effectiveness. |
| Different*3: | Compared to the predicate device, the subject device's back is adjustable, and the arm can't be flipped. These differences will not raise any new risk of safety or effectiveness. |
| Similar*4 | The stimulation test in ISO 10993-23 replaces the stimulation test in ISO 10993-10:2010. It will not raise any new risk of safety or effectiveness. |
7. Summary of Non-Clinic Performance Testing Performance Testing
Non-clinical tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
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ISO 7176-5: 2008 Wheelchairs - Part 5: Determination of overall 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 coefficient of friction of test surfaces
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
Biocompatibility testing was conducted in accordance with the 2020 FDA guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." Testing included:
- · Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- · Irritation (ISO 10993-23:2021)
The testing supports the biocompatibility of the patient-contacting device materials that were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission is as safe and effective as the legally marketed predicate device cleared under K201461.
§ 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).