(139 days)
The power wheelchair 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 power wheelchair, model name: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, is an indoor/outdoor, foldable, battery-operated 2-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion. The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. The power wheelchair, model name: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design. The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
Here's a breakdown of the acceptance criteria and study information for the Power Wheelchair, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Power Wheelchair (models D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) are implicitly defined by compliance with a comprehensive set of ISO standards. The reported device performance is indicated by the statement that the device met all design specifications and passed all tests.
| Attribute Tested | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Static Stability | ISO 7176-1:2014 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Dynamic Stability | ISO 7176-2:2017 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Brake Effectiveness | ISO 7176-3:2012 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Energy consumption/Distance Range | ISO 7176-4:2008 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." (Specific distances: 23km for D36, 20km for other models) |
| Dimensions, Mass, Maneuvering | ISO 7176-5:2008 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." (Specific dimensions listed in Table 2, with minor differences noted but deemed not to affect safety/effectiveness: Length 930-1150mm, Width 530-658mm, etc.) |
| Maximum Speed, Accel., Decel. | ISO 7176-6:2018 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." (Max speed: Up to 6 km/h) |
| Seating/Wheel Dimensions | ISO 7176-7:1998 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Static, Impact, Fatigue Strength | ISO 7176-8:2014 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Climatic Tests | ISO 7176-9:2009 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Obstacle-Climbing Ability | ISO 7176-10:2008 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." (Obstacle climbing: 20mm for some models, 25mm for others, 40mm for D36) |
| Test Dummies | ISO 7176-11:2012 | Test methodologies using standard test dummies were employed. Results implicitly support substantial equivalence. |
| Coefficient of Friction | ISO 7176-13:1989 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Power and Control Systems | ISO 7176-14:2022 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Information Disclosure/Labeling | ISO 7176-15:1996 & FDA Regulatory requirements | Conforms to FDA Regulatory. Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Resistance to Ignition | ISO 16840-10:2021 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Electromagnetic Compatibility (EMC) | ISO 7176-21:2009 & IEC 60601-1-2:2020 & ANSI C63.27:2021 | Met all design specifications; passed all tests. "Extra wireless coexistence testing was conducted and passed." "Subject product is substantially equivalent to the predicate device in performance." |
| Batteries and Chargers | ISO 7176-25:2013 & IEC 62133-2:2017 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." (Battery types and charger specifications detailed in Table 2). |
| Biocompatibility | ISO 10993-1:2018 (including -5, -10, -23) | All user directly contacting materials are compliant. Met all design specifications; passed all tests. "Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021) and irritation (ISO 10993-23: 2021)." |
| Software Validation | Not explicitly referenced, but stated as performed | Performed. "Subject product is substantially equivalent to the predicate device in performance." |
| Risk Analysis | ISO 14971:2019 | Developed in accordance with the standard. |
| Functional Performance (Bluetooth) | FCC 47 CFR 15.247 and RF exposure requirements | The Bluetooth remote control was validated to be effective and does not raise new safety or effectiveness issues. Minor difference in frequency range, but compliance ensured. |
| Cybersecurity | Not explicitly referenced, but stated as validated | Validated to be effective and does not raise new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or images. Instead, the testing refers to physical devices (the specific models D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) and their components. The tests performed are bench tests conducted on these physical devices to verify their performance against engineering standards.
- Data Provenance: Not applicable as the testing involves physical device performance, not data from human subjects. The testing is prospective in the sense that the manufacturer tested their newly designed device models to confirm compliance. The manufacturing location is Anhui, China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a technical performance study of a physical device against engineering standards. Ground truth as typically defined for AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" is defined by the technical specifications and requirements of the referenced ISO standards.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or consensus required for the test results; the tests involve quantifiable measurements (e.g., stability angles, braking distances, electrical properties) that either meet or do not meet the specified criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of device (a power wheelchair). It's typically used for evaluating diagnostic or screening tools where human readers interpret patient data (e.g., radiology images).
6. If a Standalone Study (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence, the entire suite of non-clinical bench testing constitutes a "standalone" evaluation of the device's physical and electrical performance without human operation as a variable beyond what is required to execute the test protocols. The Bluetooth remote control functionality (a form of "algorithm") was also tested in a standalone manner for effectiveness and cybersecurity.
7. The Type of Ground Truth Used
The "ground truth" (or reference standard) for these tests is the quantitative and qualitative requirements set forth in the extensive list of ISO and IEC engineering standards (e.g., ISO 7176 series, IEC 62133-2, IEC 60601-1-2, ANSI C63.27, ISO 14971, ISO 10993 series). These standards define the acceptable performance limits and test methodologies for power wheelchairs.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device where a "training set" of data is used for model development. The development process would involve engineering design and iterative prototyping, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model.
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January 2, 2025
Anhui JBH Medical Apparatus Co., Ltd. % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1 401, Dongfang Building, 1500# Century Ave. Shanghai. 200122 China
Re: K242448
Trade/Device Name: Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 3, 2024 Received: December 3, 2024
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 (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,
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
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)
K242448
Device Name
Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
Indications for Use (Describe)
The power wheelchair 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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510(k) Summary
K242448
SUBMITTER l.
Name: Anhui JBH Medical Apparatus Co., Ltd.
Address: No. 116 Qicang Road, Industrial District, Ming Guang City, Chuzhou, Anhui, China
Name of contact person: Wei Yuanwei
Telephone: +86-0550-8108866
Fax: +86-0550-8106688
Email: outreach@jbhmedical.com
Date prepared: 2024-12-31
II. Device
Device trade name: Power wheelchair
Models: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36
Classification name: Powered wheelchair
Regulation class: 2
Regulation number: 21CFR 890.3860
Panel: Physical Medicine
Product code: ITI
III. Predicate device
Portable Folding Electric Wheelchair (Model: DC01)
Anhui JBH Medical Apparatus Co., Ltd
Reference device
Electric Wheelchair (Model: BBR-LY-01-01)
Shanghai BangBang Robotics Co., Ltd.
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IV. Device description
The power wheelchair, model name: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, is an indoor/outdoor, foldable, battery-operated 2-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The power wheelchair, model name: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.
The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
V. Indication for use
The power wheelchair 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.
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VI. Comparison of technological characteristics with the predicate device
Table 1 General Comparison
| Attribute | Subject device | Predicate device | Reference device | Discussion/Conclusion |
|---|---|---|---|---|
| Manufacturer | Anhui JBH Medical ApparatusCo., Ltd. | Anhui JBH Medical ApparatusCo., Ltd. | Shanghai BangBang RoboticsCo., Ltd. | / |
| Proprietaryname, model | Power WheelchairD03, D05, D06, D09, D11, D16,D22, D23, D26, D36 | power wheelchair, DC01 | Electric Wheelchair(Model: BBR-LY-01-01) | / |
| 510(k) number | TBD | K212092 | K223393 | / |
| Deviceclassificationname | Class II | Class II | Class II | Same |
| Classificationregulations | 21 CFR 890.3860 | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | ITI | Same |
| Indication foruse | The Power wheelchair is a motordriven, indoor and outdoortransportation vehicle with theintended use to provide mobilityto a disabled or elderly personlimited to a seated position. | The wheelchair (Model: DC01) isa motor driven, indoor andoutdoor transportation vehiclewith the intended use to providemobility to a disabled or elderlyperson limited to a seatedposition. | The intended use of theElectric Wheelchair (Model:BBR-LY-01-01) is to provideoutdoor and indoor mobility topersons limited to a seatedposition that are capable ofoperating a poweredwheelchair. | Same |
| Intended user | disabled or elderly personlimited to a seated position | disabled or elderly personlimited to a seated position | disabled or elderly personlimited to a seated position | Same |
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| Use condition | indoor and outdoor use | indoor and outdoor use | indoor and outdoor use | Same |
|---|---|---|---|---|
| Type of use | OTC | OTC | OTC | Same |
Table 2 Basic Parameters Comparison
| Attribute | Subject device | Predicate device | Reference device | Discussion/Conclusion |
|---|---|---|---|---|
| Device length | 930mm – 1150mm | Not publicly available | 1075mm | Minor difference on dimension do not affect safety and effectiveness. |
| Device Width | 530mm – 658mm | Not publicly available | 628mm | |
| Stowage Length | 530mm – 945mm | Not publicly available | 895mm | |
| Stowage width | 280mm – 610mm | Not publicly available | 628mm | All safety and performance have been validated with the maximum rated weight dummy. |
| Stowage height | 740mm -830mm | Not publicly available | 395mm | |
| Ground clearance | 25mm - 120mm | Not publicly available | Not publicly available | Minor difference on ground clearance do not affect effectiveness and safety performance. All safety and performance have been validated with the maximum rated weight dummy. |
| Number of wheels | 4 | 4 | 4 | Same |
| Front wheel size/type | 7" /PU Solid tire | 7" /PU Solid tire | 10 in | larger size of driven wheel will provide better stability |
| Rearwheelsize/type | 8" /PU Solid tire for D03, D05,D06, D22, D2312" /PU Solid tire for D09,D11, D16, D2611.5"/ PU solid tire for D36 | 8" /PU Solid tire | 10 in | and safety performance |
| Functionofwheels | Front wheels: driven wheelssuitable for rotation,acceleration, retrogradeRear wheels: driving wheelsto control the speed anddirection | Front wheels: driven wheelssuitable for rotation,acceleration, retrogradeRear wheels: driving wheels tocontrol the speed and direction | Front wheels: driven wheelssuitable for rotation,acceleration, retrogradeRear wheels: driving wheels tocontrol the speed and direction | Same |
| Frame design | The frame of the wheelchairis type capable of front andrear close. The main part ofthe frame can be folded forsaving space and convenientstorage and transportation. | The frame of the wheelchair istype capable of front and rearclose. The main part of theframe can be folded for savingspace and convenient storageand transportation. | The frame of the wheelchair istype capable of front and rearclose. | Same |
| Foldingmechanism | Manually fold/ expand f | Manually fold/ expand | Automatically fold/expand drove by motor | Same |
| Movementcontrol method | By Joystick control andBluetooth remote controller | By Joystick control | By Joystick control andBluetooth smartphone appcontrol | Same with referencedevice, has one morecontrol method throughBluetooth. |
| Driving system | Direct drive on the rearwheels | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Brake system | Intelligent electromagneticbrake system | Intelligent regenerativeElectromagnetic brake | Electromagnetic | Same |
| Max speedforward | Up to 6 km/h (3.75 mph),continuously adjustable | Up to 6 km/h (3.75 mph),variable | 6km/h | Same |
| Main framematerial | Aluminum alloy | Carbon fiber | Not applicable | Different material used forframe, that suchdifference will not impactthe safety andeffectiveness of thesubject device as theperformance tests areconducted according toISO 7176 series. |
| Armrest cushion | Polyurethane (PU) | Polyurethane (PU) | Not applicable | Same |
| Speed settings | 5 | 5 | 5 | Same |
| Differences | ||||
| Battery | li-ion battery; rechargeable,24 VDC 10Ah/ 6Ah*2 | Li-ion, Rechargeable; 24 VDC20Ah | 1 rechargeable lithium-ionbatteryRatings: 24 V 20Ah | Same rated voltage withdifferent power capacity,both batteries are testedaccording to IEC62133-2,this difference will notaffect the safety andperformance of thesubject device. |
| Maximumdistance of travelon the fullycharged battery | 23 km for model D3620 km for model D03, D05,D06, D09, D11, D16, D22,D23, D26 | 20 km | 20.6 km | Minor difference on traveldistance will not causedifferent performance.This difference will notraise any new safety andeffectiveness concerns. |
| Battery charger | Off-board chargerInput: 100-240Vac, 50/60Hz,1.5AOutput: 24 Vdc, 2A | Off-board chargerInput: 100-240V, 50/60Hz, 1.5AOutput: 24 Vdc, 2A | Input: 100-240VAC50-60Hz 1.9AOutput: 24V 4A | More wide range of inputvoltage in the devicewhich will not cause newsafety and effectivenessconcerns raised. |
| Minimum brakingdistance frommaximum speed | Forward: <1m | Forward:0.5m | 1.2m | Minor difference on brakingdistance will not raise anynew safety andeffectiveness concerns. |
| Max loadingweight | 120kg for models D03, D05,D06, D09, D11, D16, D22,D23, D26150kg for D36 | 120kg | 120kg | Minor difference onloading weight will notcause differentperformance. moreloading weight providemore convenient andstable performance for thetransportation. |
| Maximum safeoperationalincline degree | 8 ° | 8 ° | 6 ° | Same |
| Motor | Brush motor; 24VDC; 250W/;2pcs for D09, D11, D16, D22, D26, D36Brush motor; 24VDC; 180W/;2pcs for D03, D05, D06, D23 | Brushless DC motor; 24 VDC;180 W; 2 pcs | Not applicable | minor difference on motor power will not cause different performance.larger power will provide more driving force, no safety and effectiveness concerns raised. In addition, although brush motor and brushless motor has some difference, while all safety and performance tests are performed, it will not affect the difference on clinical use. |
| Electroniccontroller | Dual Drive Controller forBrushless Motor | Dual Drive Controller forBrushless Motor | Not applicable | Same |
| Remotecontroller | Via Bluetooth | N/A | Via Bluetooth | Same with reference device |
| Wireless RF frequency range | 2.402 GHz to 2.480 GHz | N/A | 2.400GHz ~ 2.4835GHz | Minor difference on the frequency range, however subject device complies with FCC 47 CFR 15.247 and RF exposure requirements, and ISO 7176-12:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs, these differences do not affect safety and effectiveness. |
| Wireless operation range | 10m | N/A | 10m | Same with reference device |
| Turning Radius | D05, D22 – 450mmD03, D06, D09, D26– 750mmD11 - 770mmD16 - 938mmD23 – 675mmD36 - 850mm | 800 mm | 760mm | The minor difference in the turning radius is caused by different size of wheelchair and may cause a little bit inconvenience when it turns in a narrow space while the minor difference will not raise any new safety and effectiveness concerns. |
| Maximumobstacle climbing | 20 mm | |||
| 20 mm for models D05, D06,D2225mm for D03, D09, D11,D16, D23, D2640mm for D36 | 20 mm | 45mm | Minor difference in theobstacle climbing will notimpact the safety andeffectiveness of thesubject device. | |
| seat cushion/back cushion | mesh fabric + sponge | linen cloth filled with PUfoam | Not applicable | different material used forparts in contact with user,which such differenceswill not impact the safetyand effectiveness of thesubject device asbiocompatibility tests arecarried out according toISO 10993 series. |
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Table 3 Safety comparison
| Attribute | Subject device | Predicate device | Reference device | Discussion/Conclusion |
|---|---|---|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO 10993-1 | All user directly contacting materials are compliance with ISO 10993-1 | All user directly contacting materials are compliance with ISO 10993-1 | Same |
| EMC | ISO 7176-21 & IEC60601-1-2ANSI C63.27 | ISO 7176-21 & IEC60601-1-2 | ISO 7176-21 | Extra wireless coexistence testing was conducted and passed. |
| Performance | ISO 7176 seriesBattery safety testing: IEC 62133-2 | ISO 7176 seriesBattery safety testing: IEC 62133-2 | ISO 7176 series | Same |
| Labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | Conforms to FDA Regulatory | Same |
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VII. Summary of substantial equivalence discussion
The proposed device and predicate device are complying to the same ISO standards, ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO 7176-13:1989, ISO 7176-14:2022, ISO 7176-15:1996, ISO 16840-10:2021, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 62133-2:2017, IEC 60601-1-2: 2020, ANSI C63.27:2021, AAMI TIR69:2017, and FDA guidance document for wheelchairs. The proposed device performs in a similar manner to the predicate device. All these tests have corresponding requirements/ control criteria following above mentioned standards. And the test results show that the subject product is substantially equivalent to the predicate device in performance.
The performance testing demonstrates that the subject device is substantially equivalent to the predicate devices regarding Static ability, The Dynamic stability, Brake performance, Theoretical distance range, Dimension and weight, Maximum speed, Dimension of wheel Static, impact and fatigue strengths, Climatic tests, Obstacle-climbing ability, Dummy, friction of test surfaces, Power and control systems, Documentation and labeling, Resistance to iqnition, Electromagnetic Compatibility and Electrical Safety, Batteries and chargers.
The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO10993-10:2010/ ISO 10993-23:2021. Although the standard version updated, test methods for the subject device and the predicate device are same.
The proposed device has additional Bluetooth remote control way to operate the wheelchair which is different with the predicate device, while is substantially equivalent to the reference device. Although the remote-control tool is different, the Bluetooth skill is the same. The cybersecurity has been validated to be effective and do not raise new issues of safety or effectiveness.
The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that the subject device should perform as intended in the specified use conditions.
11
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VIII. Summary of non-clinical testing
>> Performance testing-bench
The following performance data were provided to verify that the subject device met all design
specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971: 2019.
- . Software validation
- . ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- . ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
- . ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- . ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
- ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- 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 strength
- . ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- . 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 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
- ISO 7176-14:2022 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
- . ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
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- . ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method.
- . ISO 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- . ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020.IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- . Wireless coexistence testing in accordance with ANSI C63.27:2021 (American National Standard for Evaluation of Wireless Coexistence) and AAMI TIR69:2017 (Risk management of radio-frequency wireless coexistence for medical devices and systems)
> Biocompatibility of patient-contacting material
Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021) and irritation (ISO 10993-23: 2021). Additionally, the low-biocompatibility-risk materials policy in Attachment G of FDA's 2023 Guidance on "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" was invoked for eligible tissue-contacting materials.
IX. Summary of clinical testing
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device.
X. Conclusions
The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K212092.
§ 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).