(52 days)
The YJ-010B Manual Wheelchair is to provide mobility to persons limited to a sitting position.
The YJ-010B 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 footplates 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 document is a 510(k) premarket notification for a Bariatric Heavy Duty Wheelchair. It does not describe an AI medical device or a study involving AI assistance or human readers. Therefore, I cannot extract information related to acceptance criteria and study proving a device meets those criteria for an AI-powered device, as the document pertains to a mechanical wheelchair.
The document discusses:
- Acceptance criteria (implicitly): The device (a manual wheelchair) needs to demonstrate substantial equivalence to a predicate device, primarily through non-clinical performance testing and biocompatibility assessments, adhering to various ISO standards.
- Device performance: The document lists various specifications of the proposed wheelchair (e.g., dimensions, weight capacity, stability angles, brake effectiveness) and states that these comply with relevant ISO standards.
- Ground Truth: For a mechanical device like a wheelchair, "ground truth" would relate to its physical properties and performance metrics as measured according to established engineering and safety standards (e.g., ISO 7176 series).
- Sample Size: Not applicable in the context of an AI test set. This refers to physical samples of the wheelchair models being tested.
- Experts/Adjudication/MRMC/Standalone: These concepts are not applicable to the evaluation of a mechanical wheelchair. There is no AI algorithm being evaluated.
- There is no clinical study included in this submission.
To answer your request, here's a blank template for an AI medical device study, illustrating the elements you've asked for, as this document does not contain the necessary information.
Acceptance Criteria and Study for an AI Medical Device
Study Description:
(This section would be filled if the document were about an AI device. As it is not, this remains a template.)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Threshold for Acceptance | Reported Device Performance | Meets Criteria? |
|---|---|---|---|---|
| Clinical Performance | Sensitivity | ≥ 90% | [Reported Sensitivity]% | [Yes/No] |
| Specificity | ≥ 80% | [Reported Specificity]% | [Yes/No] | |
| AUC (ROC) | ≥ 0.85 | [Reported AUC] | [Yes/No] | |
| Technical Performance | Inference Time | ≤ 2 seconds/image | [Reported Time] | [Yes/No] |
| Usability Score | > 70 (SUS) | [Reported SUS Score] | [Yes/No] | |
| Safety | False Positive Rate | As low as reasonably achievable, not impacting patient management negatively | [Reported FPR]% | [Yes/No] |
| False Negative Rate | As low as reasonably achievable, not impacting patient management negatively | [Reported FNR]% | [Yes/No] |
Note: The above table is a placeholder for a hypothetical AI device study and cannot be populated from the provided document, which describes a mechanical wheelchair.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: [Number of cases/patients/images]
- Data Provenance: [e.g., Retrospective or Prospective; Country of origin (e.g., Multi-site from US, Europe, Asia)]
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: [ e.g., 3]
- Qualifications of Experts: [e.g., Board-certified Radiologists with >10 years of experience in [specific domain, e.g., chest imaging, mammography]; Certified Pathologists with >5 years of experience]
4. Adjudication Method for the Test Set
- Adjudication Method: [e.g., 2+1 (two initial readers, third independent reader for discordance); 3+1 (three initial readers, fourth independent reader for discordance if majority not reached); Consensus meeting; None (if single reader ground truth)]
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?
- MRMC Study Conducted?: [Yes/No]
- Effect Size (e.g., improvement in AUC or F-measure for human readers with AI assistance vs. without AI): [e.g., Human readers' AUC improved from X to Y (an absolute increase of Z); F-measure increased by Z%]
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study Conducted?: [Yes/No]
- Key Performance Metrics (if Yes): [e.g., Sensitivity: X%, Specificity: Y%, AUC: Z]
7. The Type of Ground Truth Used
- Type of Ground Truth: [e.g., Expert consensus (radiologist readings); Pathological diagnosis (biopsy/histology); Clinical outcomes data (e.g., hospital discharge codes, follow-up imaging); Longitudinal follow-up data]
8. The Sample Size for the Training Set
- Training Set Sample Size: [Number of cases/patients/images]
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: [e.g., Clinical reports by attending physicians; Single expert review; Automated label extraction; A subset might be expert-reviewed, while the majority are from routine clinical practice.]
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo features a stylized representation of a human figure, while the FDA text is presented in a clear, sans-serif font, with the acronym in a bold, blue color.
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 Shanghai, China
Re: K232199
Trade/Device Name: Bariatric Heavy Duty Wheelchair (YJ-010B 20"DS; YJ-010B 20"DE; YJ-010B 20"DFS; YJ-010B 20"DFE;YJ-010B 20"ADS; YJ-010B 20"ADE; YJ-010B 20"ADFS; YJ-010B 20"ADFE; YJ-010B 22"DS; YJ-010B 22"DE; YJ-010B 22"DFS;YJ-010B 22"DFE; YJ-010B 22"ADS;YJ-010B 22"ADE; YJ-010B 22"ADFS; YJ-010B 22"ADFE; YJ-010B 24"DS; YI-010B 24"DE; YJ-010B 24"DFS; YJ-010B 24"DFE; YJ-010B 24"ADS; YJ-010B 24"ADE; YJ-010B 22"ADFS; YJ-010B 24"ADFE) 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
{1}------------------------------------------------
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 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K232199
Device Name
Bariatric Heavy Duty Wheelchair (YJ-010B 20''DE: YJ-010B 20''DFS: YJ-010B 20''DFE:YJ-010B 20'' ADS: YJ-010B 20'' ADS: YJ-010B 20"ADE: YI-010B 20''ADFS: YI-010B 22''DS: YI-010B 22''DE: YI-010B 22''DFS:YI-010B 22''DFE: YI-010B 22''ADS;YI-010B 22''ADE; YJ-010B 22''ADFS; YJ-010B 22''ADFE; YJ-010B 24''DE; YJ-010B 24''DE; YJ-0
Indications for Use (Describe)
The YJ-010B 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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: Bariatric Heavy Duty Wheelchair Common Name: Manual Wheelchair
Model(s):
| YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B |
|---|---|---|---|---|---|---|---|
| 20"DS | 20"DE | 20"DFS | 20"DFE | 20"ADS | 20"ADE | 20"ADFS | 20"ADFE |
| YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B |
| 22"DS | 22"DE | 22"DFS | 22"DFE | 22"ADS | 22"ADE | 22"ADFS | 22"ADFE |
| YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B | YJ-010B |
| 24"DS | 24"DE | 24"DFS | 24"DFE | 24"ADS | 24"ADE | 24"ADFS | 24"ADFE |
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-010B 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
{4}------------------------------------------------
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 footplates 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.
Main Components:
Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, rear wheel, hand rim, crossbar, leg rest strap, footplate, brake, leg rest (only device model with "-E").
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
| Model | YJ-010B series | |||
|---|---|---|---|---|
| Overall dimension | -E: 1275mm(L)1258mm(H) 20"width 730mm/22"width 780mm/24"width 830mm-S: 1175 mm(L)*1258mm(H) 20"width 730mm/22"width 780mm/ 24"width 830mm | |||
| Folded dimension | Width 310mm | |||
| Seat width | 20" 509mm | Backrest width | 20" 497mm | |
| 22" 559mm | 22" 547mm | |||
| 24" 610mm | 24" 597mm | |||
| Seat depth | 485mm | Seat height from floor | 547mm | |
| Backrest angle | 10° | Backrest height | 420mm | |
| Footplate length | -E: 245 mm-S:370 mm | Footplate-to-seat distance | -E: 448-555mm-S:370-520mm | |
| Footplate clearance | 50mm | Footplate-leg-angle | 95° | |
| Front location of armrest structure | -D: 275mm-F: 432mm | Front-armrest-to-backrest distance | -D: 275mm-F: 432mm | |
| Front-armrest-to-backrest distance | -D: 275mm-F: 432mm | Armrest length | -D: 260mm-F: 352mm | |
| Leg-to-seat-surface angle | 110° | Armrest angle | 25° | |
| Material | Q235 | Armrest-to-seat distance | 245mm | |
| Distance between armrests | 20" 510mm22" 560mm24" 610mm | Seat plane angle | 3° | |
| Hand rim diameter | Φ 570mm | Armrest width | 55mm | |
| Maximum weight bearing | 500LBS |
The specification table is as below:
{5}------------------------------------------------
| capacity of the device | ||||
|---|---|---|---|---|
| Horizontal location of axle | 65° | Weight of the device(net) | 20" | 27.3kg |
| 22" | 27.5kg | |||
| 24" | 27.7kg | |||
| diameter of front wheels | Φ190mm | diameter of rear wheels | Φ613mm | |
| Backpack carrier or permission | N/A | Static stability sideways | 11.75° | |
| Static stability uphill | 12.8° | Static stability downhill | 13.2° | |
| Minimum turning radius | 865mm | |||
| Parking brake | ||||
| Max slope uphill | 7.3° | |||
| Max slope downhill | 7.1° |
5. Indication for use
The YJ-010B Manual Wheelchair is to provide mobility to persons limited to a sitting position.
| Device | Predicate Device | Proposed Device | Results |
|---|---|---|---|
| 510(k) Number | K201461 | K232199 | -- |
| Manufacturer | Ningbo Shenyu Medical EquipmentCo., Ltd. | Zhenjiang Assure MedicalEquipment Co., Ltd. | -- |
| Proprietary Name | Manual Wheelchair | Bariatric Heavy Duty Wheelchair | -- |
| Classification | I | I | same |
| Indications for use | The A011 Manual wheelchair is toprovide mobility to persons limitedto a sitting position. | The YJ-010B Manual 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,side panel | Similar*1 |
| Brake control | occupant-operated brake only | occupant-operated brake only | same |
| OperationEnvironment | For indoor/outdoor use | For indoor/outdoor use | same |
| Control Mode | Mechanical | Mechanical | same |
| Size(unfold) | 1100 (L) *660 (W) * 910mm (H) | -E: 1275mm(L)1258mm(H)20"width 730mm/22"width780mm/24"width 830mm-S: 1175 mm(L)*1258mm(H) | Different*2 |
6. Comparison of technological characteristics with the predicate device
{6}------------------------------------------------
| 20"width 730mm/22"width780mm/ 24"width 830mm | |||
|---|---|---|---|
| Stowagelength/width/height | 810 (L) X 320 (W) X 930mm (H) | E: 1275mm(L)*1258mm(H)*310m(W)S: 1175 mm(L)*1258mm(H)*310mm(W) | different*2 |
| Weight (Total) | 16kg(35.2lbs) | 27.3-27.7Kg | different*2 |
| Weight Capacity | 136Kg(300lbs) | 500LBS | different*2 |
| Seat Width | 480mm | 509-610mm | different*2 |
| Seat height | 540mm | 547mm | different*2 |
| Seat depth | 420mm | 485mm | different*2 |
| Back type | Fixed | Fixed | Same |
| Tires | Front: 200mmRear:610mm | Front: 190mmRear:613mm | different*2 |
| Armrest | Flip back armrest | Armrest height adjustable (-A)/fixed | Similar*3 |
| Foot rest | Optional/ swing away Optional/swing away | with elevating leg rest(-E)with swing-away leg rest(-S) | Similar*3 |
| Rear Axle Position | Single | Single | Same |
| Frame | Foldable frame | Foldable frame | Same |
| Construction | Push inward from left and rightsides to fold | Push 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 |
|---|---|
| are 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. |
{7}------------------------------------------------
| Different*2: | Compared to the predicate device, the subject device has different value on theunfold size, stowage size, device weight, capacity, seat width, seat height, seatdepth, and 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 abovedifferent will not raise any new risk of safety or effectiveness. |
|---|---|
| Similar*3: | Compared to the predicate device, the subject device model with "-E" adds theelevating leg rest. This component provides convenience for orthopedic surgerypatients and the armrest of the subject can't be flipped. The above differences willnot 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
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.
{8}------------------------------------------------
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).