(124 days)
The XFGW30-107 and XFGW25-203 Powered Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. This product is suitable for disabled people with mobility difficulties and elderly people.
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The XFGW30-107 and XFGW25-203 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.
The provided text is a 510(k) summary for a Powered Wheelchair (K212854). It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence. However, this document does not describe the specific type of study, data, or adjudication methods typically used to prove that an AI/algorithm-based medical device meets acceptance criteria.
The document discusses the regulatory clearance for a physical medical device (a powered wheelchair), not a software or AI-driven diagnostic/therapeutic tool. Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, MRMC studies, training/test sets, and adjudication methods are not applicable to this document.
The "acceptance criteria" discussed in this document relate to the physical and functional performance of the wheelchair as measured against established ISO standards and comparison to a legally marketed predicate device.
To answer your request based on the provided document, I will reinterpret "acceptance criteria" and "study" in the context of a powered wheelchair's regulatory submission.
Reinterpretation for a Powered Wheelchair:
- Acceptance Criteria: These are the performance and safety requirements that the powered wheelchair must meet, often defined by international standards (e.g., ISO 7176 series) and demonstrated through non-clinical testing.
- Study Proving Acceptance: This refers to the non-clinical testing conducted to show compliance with the standards and substantial equivalence to the predicate device.
Here's the information extracted and reinterpreted where appropriate based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by adherence to the listed international standards (ISO 7176 series, IEC standards, EN 12184, ISO 10993 series). The reported device performance is presented in various sections, particularly in the "Performance Comparison" table (Table 2).
| Acceptance Criteria Category (Derived from Standards) | Specific Acceptance Criteria (from text) | Reported Device Performance (Proposed Device) | Predicate Device Performance (for comparison) | Remark (from document) |
|---|---|---|---|---|
| Static Stability | * Forward Static Stability: 30° (ISO 7176-1:2014) | 30° | Not publicly available | Both evaluated to ISO 7176-1:2014; different static stability will not impact safety/effectiveness. |
| * Rearward Static Stability: 17° (ISO 7176-1:2014) | 17° | Not publicly available | ||
| * Sideways Static Stability: 14° (ISO 7176-1:2014) | 14° | Not publicly available | ||
| Maximum Safe Operational Incline | Must comply with relevant standards (e.g., ISO 7176-2:2017 for dynamic stability, implying incline capabilities). | 12 degrees | 8 degrees | Larger safe operational incline is convenient; differences won't impact safety/effectiveness. |
| Braking Effectiveness | * Braking Time: ~2s | ~2s | Not explicitly stated | |
| * Braking Distance: ≤1.5m (ISO 7176-3:2012) | ≤1.5m | 1.5m | Same | |
| Speed | * Max Speed Forward: 1.7m/s (6 km/h) (ISO 7176-6:2018) | 1.7m/s (6 km/h) | 1.5m/s (5.4 km/h) | Evaluated to ISO 7176-6:2018; differences won't impact safety/effectiveness. |
| * Max Speed Backward: 0.7m/s (2.52 km/h) (ISO 7176-6:2018) | 0.7m/s (2.52 km/h) | 0.8m/s (2.88 km/h) | Evaluated to ISO 7176-6:2018; differences won't impact safety/effectiveness. | |
| Obstacle Climbing Ability | Must comply with relevant standards (ISO 7176-10:2008). | 40mm | 50mm | Smaller height won't impact safety/effectiveness; both meet ISO 7176-10:2008. |
| Cruising Range | Must comply with relevant standards (ISO 7176-4:2008 for energy consumption). | 22 km | 20 km | Larger cruising range for the subject device. |
| Maximum Loading | Must comply with relevant standards (e.g., ISO 7176-8:2014 for strengths). | 100 kg (220 lbs) | 125 kg (275 lbs) | Less loading weight means more convenient for transportation. The document implies compliance despite the difference in load capacity. |
| Biocompatibility | Compliant with ISO 10993-1, 10993-5 (Cytotoxicity), 10993-10 (Irritation & Skin Sensitization). | Tests included Cytotoxicity, Sensitization, Intracutaneous Reactivity; complies with ISO 10993-1, FDA Guidance. | Same | Biocompatibility evaluation carried out per ISO 10993-1; no new safety/effectiveness concerns. |
| Electromagnetic Compatibility (EMC) | Compliant with ISO 7176-21:2009 and IEC 60601-1-2:2015. | The device complied with ISO 7176-21:2009 and IEC 60601-1-2:2015. | Complied with relevant standards. | N/A - compliance stated directly. |
| Ignition Resistance | Compliant with ISO 7176-16:2012. | Flame retardant test of seat/back cushion and armrest carried out according to ISO 7176-16. Device complied with ISO 7176-16:2012. | Flame retardant test to ISO 7176-16. | Both devices assured to be under the same safety level. |
| Other General Performance & Safety Standards | Compliance with ISO 7176-5 (Dimensions, mass, maneuvering space), ISO 7176-7 (Seating/wheel dimensions), ISO 7176-8 (Strengths), ISO 7176-9 (Climatic tests), ISO 7176-11 (Test dummies), ISO 7176-13 (Friction), ISO 7176-14 (Power/control systems), ISO 7176-15 (Disclosure/labeling), ISO 7176-22 (Set-up procedures), IEC 62133-2 (Batteries), EN 12184 (Overall requirements). | The device complied with all listed ISO and IEC standards. Non-clinical tests verified that the proposed device met all design specifications. | Complied with relevant standards. | N/A - extensive list of standards complied with to demonstrate safety and effectiveness, and substantial equivalence to predicate. |
2. Sample Size used for the test set and the data provenance
- Sample Size: The document does not specify a "sample size" in the context of a test set for an algorithm, as this is a physical device. For non-clinical performance and safety testing, typically a certain number of units of the device would be tested to demonstrate compliance with standards. The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications..." but doesn't quantify the number of devices or test repetitions.
- Data Provenance: Not applicable in the sense of patient data for AI. The "data" here comes from a physical product's performance and safety testing.
- Country of Origin: The manufacturer is Zhejiang Qianxi Vehicle Co., Ltd. (China). Testing would presumably be conducted by the manufacturer or accredited labs.
- Retrospective or Prospective: Not applicable in the context of an AI study. This is product-specific testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. "Ground truth" in this context is established by objective measurements and standardized test procedures defined in the ISO and IEC standards, not by human experts interpreting data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is for product performance testing against standards, not for human interpretation of data for an AI algorithm.
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
- Not applicable. This device is a powered wheelchair, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the device's performance is established by the specifications and test methods outlined in objective, internationally recognized standards (e.g., ISO 7176 series for wheelchair performance, ISO 10993 for biocompatibility). The measurements obtained from testing the physical device against these standards serve as the "truth."
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" for the device itself in this submission.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for an AI algorithm.
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January 10, 2022
Zhejiang Qianxi Vehicle Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212854
Trade/Device Name: Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 8, 2021 Received: October 13, 2021
Dear Boyle 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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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,
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K212854
Device Name
Powered Wheelchair (Model:XFGW30-107, XFGW25-203)
Indications for Use (Describe)
The XFGW30-107 and XFGW25-203 Powered Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. This product is suitable for disabled people with mobility difficulties and elderly people.
| 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) Summary
K212854
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's information
Name: Zhejiang Qianxi Vehicle Co., Ltd. Address: No.366, Kechuang Road, Yongkang City, Zhejiang Province, China,322000 Tel: 86-579-87153722 Fax: 86-579-87153722 Contact: Ada Zhang Date of Preparation: Dec.20,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Powered Wheelchair Common name: Powered Wheelchair Classification name: Powered Wheelchair Model(s): XFGW30-107,XFGW25-203
3.0 Classification
Production code: ITI Regulation number: 21 CFR 890.3860 Classification: Class II Panel: Physical Medicine
4.0 Predicate device information
Manufacturer: JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. Trade/Device: Y207 Electric Wheelchair 510(k) number: K202482
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5.0 Indication for Use Statement
The XFGW30-107 and XFGW25-203 Powered 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. This product is suitable for disabled people with mobility difficulties and elderly people.
6.0 Device description
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.
The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The XFGW30-107 and XFGW25-203 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.
Folding design: This foldable electric wheelchair has main frame, rear frame, backrest frame, seat frame, front wheel frame and battery frame. Release the locking device of the backrest frame and the rear frame, push the backrest frame downward, drive the seat frame to rotate toward the backrest frame with the rotating mechanism, the two armrest frames rotate towards the direction of the seat frame. At the same time two front wheel frames move to the direction of the seat frame. When the back cushion is in contact with the seat cushion, the folding is completed.
Joystick: This controls the speed and direction of the wheelchairs. Push the joystick in the direction you wish to go. The further you push it, the faster the speed. Releasing the joystick stops the wheelchair and automatically applies the brakes.
Controller: The controller includes a power switch, speed adjustment/driving module Indicator, speed/driving module decreasing button, speed/driving module increasing button, a horn button and a direction joystick. The operation interface controller receives the operation signal and transmits it to the main board of the controller body, and sends a control signal to the electric wheelchair to adjust and operate the electric wheelchair.
Wheel and frame connection method: First, the left and right frames are connected to the motor respectively, and then the motor shaft is connected to the wheel. The motor rotates to drive the wheels to rotate to drive the wheelchair.
Frame design: 1. The frame of this product is aluminum tube. 2. The operation mode of the folding mechanism is to remove the locking device by someone else and
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manually push the backrest frame to complete the folding operation under non-riding state.
The Powered Wheelchair has 8 inch front wheel and 12.5 inch rear tire.
The motor of electric wheelchair is DC24V 180W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/4A.
Max. loading can not be over than 100Kgs.
Max. distance of travel on the fully charged battery is 22km and Max. speed forward is 6km/h.
The braking time is about 2s, and the braking distance is ≤1.5m.
The subject device that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, grass, and bark/woodchips).
The following surfaces are recommended NOT to operate on:
Wet or icy surface Road maintenance hole metal cover Do not use on stairs Do not use escalators. Use the elevator. Too steep incline over 12 degrees. Obstacle climbing ability: 1.57"(40mm)
7.0 Summary of Non-Clinical Testing
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 electrically powered 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 overall dimensions, mass and manoeuvring 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 strengths
ISO 7176-9: 2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs ISO 7176-10 : 2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability
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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 : 2008 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
ISO 7176-16:2012 Wheelchairs -- Part 16: Resistance to ignition of postural support devices
ISO 7176-21 : 2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-22 : 2014 Wheelchairs - Part 22: Set-up procedures
IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests 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 Part 2: Lithium systems EN 12184 :2014 Electrically powered wheelchairs, scooters and their chargers-Requirements and test methods
Biocompatibility of patient-contacting parts
Patient-contacting material are carried out biocompatibility assessment in accordance with ISO 10993-1: 2018, including:
Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Irritation and Skin Sensitization per ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
8.0 Summary of Clinical Testing
No clinical study implemented for the electric wheelchair.
9.0 Technological Characteristic Comparison Table
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| Item | Proposed device | Predicate device | Remark |
|---|---|---|---|
| Product Code | ITI | ITI | Same |
| Regulation No. | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Class | II | II | Same |
| Product name | Powered Wheelchair | Y207 Electric Wheelchair | - |
| 510(k) No. | K212854 | K202482 | - |
| Models | XFGW30-107 XFGW25-203 | Y207 | - |
| Intended Use | The XFGW30-107 and XFGW25-203 Powered 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. This product is suitable for disabled people with mobility difficulties and elderly people. | The Y207 Electric 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. This product is suitable for disabled people with mobility difficulties and elderly people. | Same |
| Use environment | Indoor and outdoor use | Indoor and outdoor use | Same |
| Patient Population | This product is suitable for disabled people with mobility difficulties and elderly people. | This product is suitable for disabled people with mobility difficulties and elderly people. | Same |
| Product structure | Consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. | The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, battery box, controller and charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back upholstery. | Similar |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Number of wheels | 4 | 4 | Same |
| Main frame material | Aluminium alloy | Aluminium alloy | Same |
| Motor | Brushless motor, DC24V* 180W*2pcs | Brushless motor, 24 VDC *200W * 2 pcs | Minor differences in the |
| Battery | DC 24V 12Ah Lithium-ion, 2 pcs | Lithium-ion 20 Ah x 24 VDC | dimensions will not impact the safety and |
| Battery charger | Off-board charger | Off-board charger | effectiveness of the |
| Input: 100-240 VAC | Input: 100-240 VAC | substantial equivalence. | |
| Output: DC 24V, 4A (3A) | Output: DC 24V, 6 Amp |
Table1-General Comparison
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Table2 Performance Comparison
| Item | Proposed Device | Predicate Device | Remark | |
|---|---|---|---|---|
| XFGW30-107 | XFGW25-203 | |||
| Dimensions(mm) | 1100 x 630 x 960 | 1110 x 700 x 980 | Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. | |
| Foldeddimensions(mm) | 750x630x375 | 810 x 700 x 400 | Minor differences in the folded dimensions will not impact the safety and effectiveness of the substantial equivalence. | |
| Weight, w/Battery | 71.65 lbs. /32.5kg | Not publicly available | The difference will not raise any new safety and effectiveness concerns. | |
| Frame design | Foldable/The device consists of a foldable and non-rigid type of power wheelchair base with rear drive and 2 casters in the front and two anti-tippers in the rear. | Foldable/The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, battery box, controller and charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back upholstery. | Same | |
| Foldingmechanism | A foldable seat frames(The backrest could be folded to seat) | Not publicly available | The folding mechanism of the predicate device is not publicly available. No impact on safety and effectiveness. | |
| Frontwheel(inch) | 8(PU solid tire) | 8(PU solid tire) | Same | |
| Rear tire (inch) | 12.5(Pneumatic tire) | 10(PU solid tire) | Larger sizes of front wheels bring steadier pivoting function than predicate device. | |
| CruisingRange(km) | 22 | 20 | There is a larger cruising range for the subject device. | |
| Obstacleclimbing(mm) | 40 | 50 | The smaller height in theobstacle climbing will notimpact the safety andeffectiveness of the subjectdevice. | |
| Static stabilityforward | 30° | Both of the devices areevaluated according to | ||
| Static stabilityrearward | 17° | Not publicly available | standard ISO 7176-1:2014,so the different static stability | |
| Static stabilitysideways | 14° | will not impact the safetyand effectiveness | ||
| Max. loading(kg) | 220lbs(100kg) | 275lbs (125kg) | Less loading weight meansmore convenient for thetransportation | |
| Maximum safeoperationalincline | 12 degrees | 8 degrees | Larger safe operationalincline of subject bring moreconvenient for the useenvironment | |
| Min. Turningradium | 1200mm | 950mm | The difference in the turningradius will bring moreconvenience when it turns.The difference will not raiseany new safety andeffectiveness concerns. | |
| Minimumbrakingdistance | 1.5m | 1.5m | Same | |
| MaxSpeedForwards | 1.7m/s (6 km/h) | 1.5m/s (5.4 km/h) | The devices are evaluatedaccording to standard ISO7176-6:2018, so the differentwill not impact the safetyand effectiveness | |
| Max.SpeedBackward | 0.7m/s (2.52 km/h) | 0.8m/s (2.88 km/h) | The devices are evaluatedaccording to standard ISO7176-6:2018, so the differentwill not impact the safetyand effectiveness | |
| Controller | Shanghai Micon Mechanical &Electrical Co., Ltd.M7084 | PG Drives TechnologyLtd.,newVSI | DifferentAlthough different controlleris used, both the controlsystem, including the joystickcontroller, theelectromagnetic brakes andthe user interface are similar. | |
| The joystick controls thedirections and speed ofmovement, and when thejoystick is released, thepowered wheelchair will slowdown to stop and the brakeswill automatically re-engage.The controller also providesthe battery status displayingand abnormal conditiondisplaying. Both of the controlsystems are evaluatedaccording to standard ISO7176-14:2008 and softwarevalidation requirement andthere are no new safety andeffectiveness concerns dueto the difference. | ||||
| Speed controlmethod | Joystick control method | Joystick control method | Same |
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Table3 Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Materialscontactinguser | Armrest: PU;Backrest/Seat: sandwich mesh fabric(polyester)M7084 controller:Controller Buttons/ joystick: Siliconerubber | Armrest: PU;Backrest/seat: sandwich meshfabric (polyester)newVSi electric wheelchaircontroller:Joystick knob: Santoprene101-80;Joystick Gaiter: Silicone 3032(50%) & 5031 (50%)Enclosure Moulding(s): ABS/PCWonderloy PC-540Keypad: Silicone keypadcoatings TC-2407 & CH-6330 | Biocompatibilityevaluation hasbeen carried outper ISO 10993-1.There are no newsafety andeffectivenessconcerns due to thedifference. |
| Biocompatibility of materialscontactinguser | Comply with ISO 10993-1, FDAGuidance, Tests includedCytotoxicity (ISO 10993-5:2009),Sensitization and IntracutaneousReactivity (ISO 10993-10:2010) | Comply with ISO 10993-1, FDAGuidance, Tests includedCytotoxicity (ISO 10993-5:2009),Sensitization and IntracutaneousReactivity (ISO 10993-10:2010) | Same |
Summary of substantial equivalence discussion:
The Powered Wheelchair model XFGW30-107 and XFGW25-203 complied with the
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requirements of ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2001, 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 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-21:2009, ISO 7176-22:2014, IEC 60601-1-2: 2014, IEC 62133-2:2017, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010.
The intended uses for both devices are the same. Mainframes of two devices are folded by way of front and rear close, and frame materials all meet the Tensile Strength. Yield Load, and Elongation tests. The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14:2008. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012. Maximum obstacle climbing and Maximum safe operational incline 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 requirements of the ISO 7176-2:2001, ISO 7176-10:2008. The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2010. The flame retardant test of the seat cushion/back cushion and armrest of both subject device and predicate device is carried out according to the ISO 7176-16 test. Therefore, both devices are assured to be under the same safety level.
In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device in K202482 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.
§ 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).