(57 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.
The subject device, Electric Wheelchair, mainly powered by DC motor, driven by user controlling joystick controller and adjusting speed. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Rear wheels.
The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the loystick can control the wheelchair to travel in any direction, the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electic Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.
The Electric Wheelchair has 7 inch front wheels and 12 inch rear tires.
Max. distance of travel on the fully charged battery is 15 km and Max. speed forward is 6.5 km/h.
When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate to lock the motor, so as to brake.
This is a 510(k) summary for an Electric wheelchair (KR-8807), not an AI/ML powered device. As such, the requested information regarding AI/ML specific acceptance criteria, study methodologies, and ground truth establishment is not applicable to this document. The document describes the device's adherence to various engineering and safety standards for wheelchairs.
However, I can extract and present the information available in the document regarding the device's performance based on the provided engineering standards:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Electric wheelchair (KR-8807) are primarily defined by adherence and successful testing against a comprehensive set of ISO 7176 series standards, as well as ISO 16840-10 and ISO 10993 series for biocompatibility. The reported performance confirms compliance with these standards.
| Acceptance Criteria (Measured by Adherence to Standards) | Reported Device Performance (Compliance Status) |
|---|---|
| ISO 7176-1: 2014: Determination of static stability | Complies |
| ISO 7176-2: 2017: Determination of dynamic stability | Complies |
| ISO 7176-3: 2012: Determination of effectiveness of brakes | Complies |
| ISO 7176-4: 2008: Energy consumption / theoretical distance range | Complies (Max. distance of travel on fully charged battery is 15 km) |
| ISO 7176-5: 2008: Determination of overall dimensions, mass, maneuvering space | Complies |
| ISO 7176-6: 2018: Determination of maximum speed, acceleration | Complies (Max. speed forward is 6.5 km/h) |
| ISO 7176-7: Measurement of seating and wheel dimensions | Complies |
| ISO 7176-8: 2014: Requirements and test methods for static, impact and fatigue strengths | Complies |
| ISO 7176-9: 2009: Climatic tests | Complies |
| ISO 7176-10: 2008: Determination of obstacle-climbing ability | Complies |
| ISO 7176-11: 2012: Test dummies | Complies |
| ISO 7176-13: 1989: Determination of coefficient of friction of test surfaces | Complies |
| ISO 7176-14: 2008: Power and control systems for electrically powered wheelchairs | Complies |
| ISO 7176-15: 1996: Requirements for information disclosure, documentation and labeling | Complies |
| ISO 16840-10: 2021: Resistance to ignition of postural support devices | Complies |
| ISO 7176-19: 2022: Wheelchairs for use as seats in motor vehicles | Complies |
| ISO 7176-21: 2009: Requirements and test methods for electromagnetic compatibility | Complies |
| ISO 7176-25: 2022: Lead-acid batteries and chargers for powered wheelchairs | Complies |
| ISO 10993 series standards: Biocompatibility | Complies (Differences in materials in contact with user do not impact safety/effectiveness) |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of clinical studies for a human-in-the-loop or AI/ML evaluation. The evidence for compliance comes from non-clinical tests performed on the device itself (likely a prototype or production sample) to verify it meets the specifications outlined in the various ISO standards. The data provenance is implied to be from laboratory testing against established engineering standards. There is no information on the country of origin of this testing data beyond the applicant's location in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for this device's performance is established by engineering standards and their associated test methodologies, not by expert consensus in an AI/ML context. The tests are designed to objectively measure physical and electrical properties of the wheelchair against predefined limits or characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert interpretation is involved. For engineering specifications tested against ISO standards, the results are typically quantitative measurements that either meet or fail the specified criteria.
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 question is not applicable. The document describes an electric wheelchair, which is a physical device, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable for the reasons stated above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" is defined by international engineering and safety standards (ISO 7176 series, ISO 16840-10, ISO 10993 series). The device's performance is compared against the requirements and test methods stipulated within these standards.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 12, 2024
Zhejiang Kairui Medical Device Co., Ltd. % Xu Kiwi Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai 200122 China
Re: K242791
Trade/Device Name: Electric wheelchair (KR-8807) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 16, 2024 Received: September 16, 2024
Dear Xu Kiwi:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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Sincerely,
Heather L. Dean -S
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
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Electric wheelchair (KR-8807)
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)
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| 510(k) #: | 510(k) Summary | Prepared on: 2024-11-05 | ||
|---|---|---|---|---|
| ----------- | -- | ---------------- | -- | ------------------------- |
21 CFR 807.92(a)(1)
| Contact Details | |
|---|---|
| Applicant Name | Zhejiang Kairui Medical Device Co., Ltd. |
| Applicant Address | No.85, Dengyun Road, Tangxia Town, Ruian City, Zhejiang Province, China. Ruian China |
| Applicant Contact Telephone | 86-18958911787 |
| Applicant Contact | Mr. Kevin Ni |
| Applicant Contact Email | ncy128@zjkryl.com |
| Correspondent Name | Shanghai SUNGO Management Consulting Co., Ltd. |
| Correspondent Address | 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai Shanghai 200122 China |
| Correspondent Contact Telephone | +86 17863803443 |
| Correspondent Contact | Ms. Xu Kiwi |
| Correspondent Contact Email | weijia.xu@sungoglobal.com |
21 CFR 807.92(a)(2)
| Device Name | |
|---|---|
| Device Trade Name | Electric wheelchair (KR-8807) |
| Common Name | Powered wheelchair |
| Classification Name | Wheelchair, Powered |
| Regulation Number | 890.3860 |
| Product Code(s) | ITI |
21 CFR 807.92(a)(3)
| Legally Marketed Predicate Devices | ||
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K240913 | Electric Wheelchair | ITI |
21 CFR 807.92(a)(4)
Device Description SummaryThe subject device, Electric Wheelchair, mainly powered by DC motor, driven by user controlling joystick controller and adjusting speed. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Rear wheels.
The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the loystick can control the wheelchair to travel in any direction, the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to
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reduce or increase the speed setting. The Electric manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electic Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.
The Electric Wheelchair has 7 inch front wheels and 12 inch rear tires.
Max. distance of travel on the fully charged battery is 15 km and Max. speed forward is 6.5 km/h.
When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate to lock the motor, so as to brake.
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
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.
Technological Comparison
The design and technological characteristics of the Electric Wheelchair is similar to the predicate chosen. There are minor differences between the devices including Maximum safe operational incline degree, Armrest, Seat cushion, Rear wheel size/type, Max speed forward, Max loading weight, Battery, Maximum distance of travel on the fully charged battery, Turning Radius and Maximum obstacle climbing. All of the parameter with differences have been tested according to ISO 7176 series standards and the test records support its safety and effectiveness. There is no deleterious effectiveness due to the minor differences. Additionally, they do not influence the intended use of the device. The proposed Wheelchair is substantially equivalent (SE) to The Power Wheelchair (K240913).
Different materials were used for parts in contact with user. These differences do not impact the safety and effectiveness of the subject device as demonstrated by biocompatibility tests carried out according to ISO 10993 series standards.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
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 7176-1: 2014, Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs
ISO 7176-3: 2012, Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and wheelchairs for determination of theoretical distance range
ISO 7176-5, Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration of Powered Wheelchairs ISO 7176-7, 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 7176-9:2009, Wheelchairs - Part 9: Climatic tests for PoweredWheelchairs
ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.
ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs -Requirements and test methods
ISO 7176-15:1996,Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 16840-10:2021 Wheelchair seating Part 10: Resistance to ignition of postural support devices - Requirements and test method. ISO 7176-19:2022 Wheelchairs Part 19: Wheelchairs for use as seats in motor vehicles
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers
ISO 7176-25:2022 Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs Requirements and test methods
The conclusion drawn from the nonclinical tests device in the 510(K) submission, Electric Wheelchair,
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
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Model KR-8807, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K240913.
§ 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).