(62 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
whole wheelchair can be folded by one button and it can be easily carried or rolled after folding type:left-right folding). The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.
The wheelchair uses lithium batteries as its power source. The crive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are solid polyurethane tires.
When in use, the operator drives the motor of the rear wheel by operating the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels.
The max loading of the device is 136KG. Only for one person sit.
I am sorry, but the provided text is a 510(k) summary for a "Power wheelchair (N6101)" and does not contain information about acceptance criteria or specific studies relevant to AI/ML device performance. It mainly focuses on demonstrating substantial equivalence to a predicate device through adherence to various ISO standards and non-clinical testing.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on compliance with standards rather than specific performance metrics and their acceptance thresholds.
- Sample size used for the test set and the data provenance: Not applicable as no AI/ML test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document discusses non-clinical tests to demonstrate safety, but these are related to physical and electrical aspects of the wheelchair (e.g., ISO 7176 series for wheelchairs, IEC 60601 for medical electrical equipment), not AI/ML performance. It explicitly states "Clinical test summary is not applicable." and focuses on "technological characteristics, features, materials, mode of operation" and "biocompatibility tests."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 13, 2024
Zhejiang Zhonglei Medical Technology Co.Ltd. % Ariel Xiang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K241686
Trade/Device Name: Power wheelchair (N6101) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 12, 2024 Received: June 12, 2024
Dear Ariel Xiang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Power wheelchair
Indications for Use (Describe)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| 510(k) Summary | |||
|---|---|---|---|
| Prepared on: 2024-08-09 | |||
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Zhejiang Zhonglei Medical Technology Co.Ltd. | ||
| Applicant Address | 1st floor, 2nd floor, No. 66, Dayuan Street, Nanmingshan Street, LianduDistrict, Lishui Zhejiang China | ||
| Applicant Contact Telephone | +86 13958430301 | ||
| Applicant Contact | Mr. Chengwei Ying | ||
| Applicant Contact Email | 594506983@qq.com | ||
| Correspondent Name | Shanghai Sungo Management Consulting Co. Ltd. | ||
| Correspondent Address | 14th Floor, 1500# Century Avenue, Shanghai, Shanghai 200122China | ||
| Correspondent Contact Telephone | +86-21-58817802 | ||
| Correspondent Contact | Ms. Ariel Xiang | ||
| Correspondent Contact Email | shouqiu.xiang@sungoglobal.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Power wheelchair (N6101) | ||
| Common Name | Powered wheelchair | ||
| Classification Name | Wheelchair, Powered | ||
| Regulation Number | 890.3860 | ||
| Product Code(s) | ITI | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K230964 | Power wheelchair | ITI | |
| Device Description Summary | 21 CFR 807.92(a)(4) |
whole wheelchair can be folded by one button and it can be easily carried or rolled after folding type:left-right folding). The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.
The wheelchair uses lithium batteries as its power source. The crive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other
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actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are solid polyurethane tires.
When in use, the operator drives the motor of the rear wheel by operating the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels.
The max loading of the device is 136KG. Only for one person sit.
Intended Use/Indications for Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Indications for Use Comparison
Same.
Technological Comparison
The subject device complied with the requirements of ISO 7176-2:2001, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10: 2021, ISO7176-21:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014, IEC 60601-4-2:2016.
The intended uses for both devices are the same. Mainframes of two devices are folded by way of front and rear close.
The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7 176-14.2008. Software validation is carried out on both control systems and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012.
Turning radius and Maximum obstacle climbing are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the ISO 7176-22001, ISO 7176-10:2008.
The flame retardant test of the seat cushion/backrest of the subject device is conducted according to ISO 16840-10. Therefore, both devices are assured to be under the same safety level.
The all rest different between the subject device can proved the safety or effectiveness by the ISO 7176 series support reports.
Different material used for parts in contact with user, will not impact the safety and effectiveness of the subject device as biocompatibility tests are carried out according to ISO 10993 series.
In conclusion, the technological characteristics, features, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject devices do not raise new issues of safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Clinical test summary is not applicable.
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as well as the legally marketed predicate device K230964.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).