(449 days)
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
The Electrically Powered Wheelchair - Model HP358E is powered by Li-ion battery, driven by DC motor. Users control direction and adjust speed by controller. The main frame of the wheelchair is made of aluminum alloy. It has a seat base with four-wheeled and two with a back cover on the frame. Wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. There are two rear caster wheels in back and anti-tip wheels in front to prevent the power chair from tipping. On the front end of the frame, upon the caster, a foot platform is assembled for foot holding. Two non-adjustable armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base. The backrest can be adjusted by squeezing yellow catches on the back together. A storage compartment located between the seat and foot platform. The joystick can be mounted on the left or right side using the quick release mechanism. The subject device has two 2 inch Anti-tippers, two 8 inch front wheels and two 12 inch rear wheels. The motor is DC24V 250W; the battery is 25.2 V 10.4Ah Li-ion battery; the charger is DC 24V, 2A. Max. loading can not be over than 125Kg, the maximum distance of travel on the fully charged battery is 10km and its maximum speed is 6km/h. The braking time is about 2~3s, and the braking distance is ≤1.0m.
The provided text is a 510(k) Summary for an Electrically Powered Wheelchair (Model HP358E). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device's performance against specific acceptance criteria in the context of AI or advanced diagnostic algorithms. Therefore, much of the requested information regarding AI device evaluation (e.g., sample size for test set, provenance, expert adjudication, MRMC studies, standalone performance, training set details) is not applicable or present in this document.
However, I can extract the relevant "acceptance criteria" (which in this context are performance and safety standards) and the "device performance" as reported for the proposed device, along with other applicable details.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this wheeled device are derived from various ISO and IEC standards that it claims to comply with, and the "reported device performance" are the measured specifications of the HP358E. These are primarily found in the "Non-Clinical Test Summary" and the "Performance Comparison" table.
Acceptance Criteria & Reported Device Performance for Electrically Powered Wheelchair - Model HP358E
| Acceptance Criteria (from Standards/Predicate Device) | Reported Device Performance (Model HP358E) |
|---|---|
| Material/Construction Standards (Implied Compliance) | |
| Main frame material: Aluminum alloy (per ASTM B221 for predicate) | Main frame: Aluminium alloy |
| Performance Standards (ISO & EN) | |
| Static Stability: Conforms to ISO 7176-1:2014 | Static stability forward: 22.4° |
| Static stability rearward: 18.2° | |
| Static stability sideways: 23° | |
| Dynamic Stability: Conforms to ISO 7176-2:2017 | (Not explicitly stated as a single value, but compliance implies meeting the standard's criteria) |
| Effectiveness of Brakes: Conforms to ISO 7176-3:2012 | Minimum braking distance: 1 m (Same as predicate) |
| Energy Consumption & Distance Range: Conforms to ISO 7176-4:2008 | Cruising Range: 10 km (Predicate: 18 km - shorter cruising range noted, but implies compliance with standard) |
| Dimensions, Mass & Maneuvering Space: Conforms to ISO 7176-5:2008 | Dimensions: 960mm635mm880mm (37.8"x25.0"x34.6") |
| Weight, w/ Battery: 59.15 lbs / 27.2 kg | |
| Min. Turning Radius: 57.5" (1460mm) (Larger than predicate 32.5", but compliance implies meeting the standard) | |
| Max Speed, Acceleration & Deceleration: Conforms to ISO 7176-6:2018 | Max Speed: 6 km/h (Same as predicate) |
| Max Speed Forwards: 3.75 mph (6 km/h) (Same as predicate) | |
| Max Speed Backward: 1.80 mph (2.9 km/h) (Predicate: 1.86 mph - noted as different but implies compliance with standard) | |
| Seating & Wheel Dimensions: Conforms to ISO 7176-7:1998 | Front wheel: 8" (PU solid tire) |
| Rear tire: 12" (Pneumatic tire) | |
| Static, Impact & Fatigue Strengths: Conforms to ISO 7176-8:2014 | Max. loading: 275 lbs (125 kg) (Larger than predicate 264 lbs) |
| Climatic Tests: Conforms to ISO 7176-9:2009 | (Implied compliance) |
| Obstacle-climbing ability: Conforms to ISO 7176-10:2008 | Obstacle climbing: 2.36" (60mm) (Larger than predicate 1.36") |
| Maximum obstacle climbing: 2.36" (60mm) (Larger than predicate 1.36") | |
| Test Dummies: Conforms to ISO 7176-11:2012 | (Implied compliance) |
| Coefficient of Friction of Test Surfaces: Conforms to ISO 7176-13:1989 | (Implied compliance) |
| Power & Control Systems: Conforms to ISO 7176-14:2008 | Controller: Shanghai Micon Mechanical&Electrical Co.,Ltd., M7084 (Evaluated per standard and software validation) |
| Information Disclosure, Documentation & Labeling: Conforms to ISO 7176-15:1996 | (Implied compliance, and stated "Comply with FDA Regulatory Requirements" in 'Safety Comparison' table) |
| Resistance to Ignition of Postural Support Device: Conforms to ISO 7176-16:2012 | (Implied compliance, and "flame retardant test of the seat cushion/back cushion and armrest" mentioned in summary discussion) |
| Electromagnetic Compatibility: Conforms to ISO 7176-21:2009 | (Implied compliance) |
| Setup Procedures: Conforms to ISO 7176-22:2014 | (Implied compliance) |
| Electrically powered wheelchairs, scooters and their chargers: EN 12184:2014 | (Implied compliance) |
| Basic Safety and Essential Performance: IEC 60601-1: 2012 | (Implied compliance) |
| Electromagnetic Disturbances: IEC 60601-1-2 Edition 4.0 2014-02 | (Implied compliance) |
| Safety of secondary cells and batteries: IEC 62133:2012 | Battery: Lithium-ion, FH2410 10.4Ah x25.2VDC x1 pc (Implied compliance) |
| Biocompatibility Standards | |
| Biocompatibility: Comply with ISO 10993-1, FDA Guidance | Cytotoxicity (ISO 10993-5:2009) |
| Irritation and Skin Sensitization (ISO 10993-10:2010) (for other patient-contacting materials; Joystick materials refer to predicate K070501) | |
| Software Standards | |
| Software Validation: In accordance with FDA Nov 2005 guidance | Software validation conducted; Moderate level of concern designation |
| General Operational Limits | |
| Maximum safe operational incline: (Predicate 8 degrees) | Maximum safe operational incline: 10 degrees (Larger than predicate) |
2. Sample sized used for the test set and the data provenance:
This document describes the testing of a physical medical device (an electrically powered wheelchair) against engineering and safety standards. The "test set" here refers to the actual device prototypes or samples subjected to the described non-clinical tests. The number of individual devices tested is not specified, but it's standard practice in such non-clinical testing to test a representative sample size to ensure reliability and repeatability according to the testing standards (e.g., ISO and IEC).
- Sample Size: Not explicitly stated for each test, but implied to be a sufficient number of device units to perform the required non-clinical tests according to the cited ISO/IEC standards.
- Data Provenance: The tests are non-clinical engineering and safety performance tests, not clinical data from patients. The document does not specify the location where these tests were performed, but the manufacturer is based in China. The data would be derived from the physical testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for non-clinical performance and safety of a wheelchair is established by the objective measurements against established international engineering and safety standards (ISO, IEC, EN). There are no "experts" establishing a "ground truth" in the way radiologists establish ground truth for an AI diagnostic algorithm; rather, the device's performance is measured and compared against the limits and criteria defined by the standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable for non-clinical engineering and safety tests. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies, particularly for AI device evaluations where human expert consensus is required for labeling data.
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 is not applicable. The device is an electrically powered wheelchair, not an AI-powered diagnostic tool, and therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not an algorithm, so the concept of standalone algorithm performance is irrelevant.
7. The type of ground truth used:
The "ground truth" for the device's performance and safety is derived from established international engineering and safety standards (ISO, IEC, EN). The device's physical and functional attributes were measured and assessed to ensure they comply with the stipulated requirements of these standards. For biocompatibility, the ground truth is established by adherence to ISO 10993 series standards and related FDA guidance, with specific tests like cytotoxicity, irritation, and skin sensitization. For software, the ground truth for its safety and functionality is established through validation against FDA guidance for "Moderate Level of Concern" software.
8. The sample size for the training set:
This is not applicable. The document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this device.
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September 28, 2021
Kunshan Hi-Fortune Health Products Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Rm. 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K201855
Trade/Device Name: Electrically Powered Wheelchair - Model HP358E Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 17, 2021 Received: September 7, 2021
Dear Mr. 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,
Tushar Bansal -S
For Heather Dean, PhD Assistant Director, Acute Injury Device 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
510(k) Number (if known) K201855
Device Name
Electrically powered wheelchair - Model HP358E
Indications for Use (Describe)
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an 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) Summary
(K201855)
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: Kunshan Hi-Fortune Health Products Co.,Ltd. Address: No.625,Juxiang Road, Zhangpu Town, Kunshan City, Jiangsu Province, 200120 China Tel: 86- 512-55195100 Fax: 86- 512-55199300 Contact: Jianjiang Fan Date of Preparation: Sep.23,2021
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: Electrically Powered Wheelchair - Model HP358E Common name: Powered wheelchair Classification name: Wheelchair, Powered Model(s): HP358E
3.0 Classification
Production code: ITI Regulation number: 21 CFR 890.3860 Classification: Class II Panel: Physical Medicine
4.0 Predicate Device &Reference Device Information
Predicate Device:
Manufacturer: Nanjing Jin Bai He Medical Apparatus Co., Ltd.
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Device: Powered Wheelchair, DYW30A(D09) 510(k) number: K170787
Reference Device: K070501, Ruike 3421 powered wheelchair, Shanghai Ruike Sports Goods Co , Ltd.( Reference for biocompatibility of controller / joystick )
5.0 Device Description
The Electrically Powered Wheelchair - Model HP358E is powered by Li-ion battery, driven by DC motor. Users control direction and adjust speed by controller.
The main frame of the wheelchair is made of aluminum alloy which is complied with the standard of ASTM B221, and there is a seat base with four-wheeled and two with a back cover on the frame. Upon the outside of this framework, and to the rear, are assembled two axle plates, wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. There are two rear caster wheels in back and anti-tip wheels in front to prevent the power chair from tipping. On the front end of the frame, upon the caster, a foot platform is assembled for foot holding.Two non-adjustable armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base. The backrest can be adjusted by squeezing yellow catches on the back together. A storage compartment located between the seat and foot platform. The joystick can be mounted on the left or right side using the quick release mechanism.
The subject device has two 2 inch Anti-tippers, two 8 inch front wheels and two12 inch rear wheels.
The motor is DC24V 250W; the battery is 25.2 V 10.4Ah Li-ion battery; the charger is DC 24V, 2A.
Max. loading can not be over than 125Kg, the maximum distance of travel on the fully charged battery is 10km and its maximum speed is 6km/h.
The braking time is about 2~3s, and the braking distance is ≤1.0m
Due to the device design of the body structure the following conditions are recommended NOT to operate in:
- The wheelchair is not intended for use on roads, streets, or highways.
- Do not use on an escalator
- Do not use while lifting weights.
- This device is not safe for use with or around a MRI machine. Do not use in the vicinity of a MRI machine
- Never use the device to negotiate steps or escalators.
- Turning Diameter :1460mm
- Ground Clearance :13mm
- Maximum safe operational incline:10°
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6.0 Indication for Use Statement
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
7.0 Non-Clinical Test Summary
Non-Clinical Performance Testing:
The following non-clinical data were provided in support of the substantial equivalence determination:
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 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 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 device.
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
EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers -Requirements and test methods.
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IEC 60601-1: 2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 62133:2012 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
Biocompatibility of patient-contacting parts:
Statement for Biocompatibility Certification
The materials of the Joystick knob,Joystick Gaiter, Enclosure Mouldings and Keypad of M7084 controller&Joystick of the Electrically Powered Wheelchair, model HP358E, manufactured by Kunshan Hi-Fortune Health Products Co.,Ltd, are identical to the materials of M7084 controller&Joystick of Ruike 3421 powered wheelchair, Shanghai Ruike Sports Goods Co., Ltd., K070501, clearance date February 12, 2007, in formulation, processing, and geometry, and no other chemicals have been added. The patient-contacting materials of the M7084 controller&Joystick of the Electrically Powered Wheelchair, HP358E, has the same nature of tissue contact and contact duration (e.g., surface device category, intact skin contact, less than 24-hour duration) as the Ruike 3421 powered wheelchair.
Other 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.
Software Information:
Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
8.0 Clinical Test Conclusion
Clinical testing was not required for this submission.
9.0 Comparison to Predicate Device
The technological characteristics, features, specifications, materials, mode of
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operation, and intended use of the Electrically Powered Wheelchair - Model HP358E is 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.
| 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 | Electrically PoweredWheelchair - Model HP358E | Powered WheelchairDYW30A(D09) | - |
| 510(k) No. | K201855 | K170787 | - |
| Models | HP358E | DYW30A(D09) | - |
| Intended Use | The device is amotor-driven, and indoortransportation vehicle withthe intended use to providemobility to a disabled or anelderly person limited to aseated position. | The device is a motor-driven,and indoor transportation vehiclewith the intended use to providemobility to a disabled or anelderly person limited to aseated position. | Same |
| Use environment | Indoor use | Indoor use | Same |
| PatientPopulation | The electric wheelchair isintended to provide mobilityto a person with a disabilityor an older adult limited to asitting position | The electric wheelchair isintended to provide mobility to aperson with a disability or anolder adult limited to a sittingposition | Same |
| Product structure | Consists of two foldablearmrests, a backrest, a seatcushion, a foldable frame,two rear driving wheels withhub motor/electromagnetic brakeassemblies, two pivotingcasters, a Li-ion batteries,an off-board batterycharger, a control panel,and an electric motorcontroller. | Two foldable armrests, a seatbelt, a backrest, a seat cushion,a foldable frame, two rear drivingwheels with hub motor/electromagnetic brakeassemblies, two pivotingcasters, two Li-ion batteries, anoff-board battery charger, acontrol panel, and an electricmotor controller. | Similar |
| Driving system | Direct drive on the rearwheels | Direct drive on the rear wheels | Same |
| Number ofwheels | 4 | 4 | Same |
| Main frame | Aluminium alloy | Aluminium alloy | Same |
| material | |||
| Motor | Brushless DC motor250W x 24 VDC x 2 pcs | 24 VDC *250W * 2 pcs | |
| Battery | Lithium-ion, FH241010.4Ah x25.2VDCx1 pc | Lithium-ion, ITP24066 Ah x 24 VDC x 2 pcs | Minor differences in the |
| Battery charger | High Power TechnologyInc.HP0060W(L2)Input: 100-240 VACOutput: DC 24V, 2 Amp | High Power TechnologyInc.HP0060W(L2)Input: 100-240 VACOutput: DC 24V, 2 Amp | dimensions will notimpact the safety andeffectiveness of thesubstantial equivalence. |
Table1- General Device Characteristics Comparison Table
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Table2 Performance Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Dimensions | 960mm635mm880mm(37.8"x25.0"x34.6") | 37.4" x 22.6" x 36.2" | Minor differences in thedimensions will notimpact the safety andeffectiveness of thesubstantial equivalence. |
| Weight, w/Battery | 59.15lbs/27.2kg | 51.8" lbs. / 23.5 kg | The difference willnot raise any new safetyand effectivenessconcerns. |
| Frame design | Foldable/The device consists of a foldableand non-rigid type of powerwheelchair base with rear drive and2 casters in the front and twoanti-tippers in the rear. | Foldable/The device consists of afoldable and non-rigidtype of power wheelchairbase with rear drive and 2casters in the front andtwoanti-tippers in the rear. | Same |
| Foldingmechanism | A foldable seat frames(The backrest could be folded toseat) | A foldable seat frames(The backrest could befolded to seat) | Same |
| Frontwheel(inch) | 8(PU solid tire) | 7(PU solid tire) | Larger sizes of frontwheels bring steadierpivoting function thanpredicate device. |
| Rear tire (inch) | 12(Pneumatic tire) | 12.5(PU solid tire) | Smaller sizes of rear wheels,The difference will not raiseany new safety andeffectiveness concerns. |
| Cruising | 10 | 18 | There is a shorter cruising |
| Range(km) | |||
| Obstacleclimbing(mm) | 2.36"(60mm) | 1.36" (34.5 mm) | The larger height in theobstacle climbing will notimpact the safety andeffectiveness of the subjectdevice. |
| Max. Speed(km/h) | 6 | 6 | Same |
| Static stabilityforward | 22.4° | Both of the devices areevaluated according to | |
| Static stabilityrearward | 18.2° | Not publicly available | standard ISO 7176-1:2014,so the different static stabilitywill not impact the safetyand effectiveness |
| Static stabilitysideways | 23° | will not impact the safetyand effectiveness | |
| Max. loading(kg) | 275lbs(125kg) | 264lbs (120kg) | Larger loading weight meansmore convenient for the user |
| Maximum safeoperationalincline | 10 degrees | 8 degrees | Larger safe operationalincline of subject bring moreconvenient for the useenvironment |
| Min. Turningradium | 57.5"(1460mm) | 32.5" ( 833 mm) | The subject turning radius islarger and may limit wherethe device can be used.The difference will not raiseany new safety andeffectiveness concerns. |
| Maximumobstacleclimbing | 2.36"(60mm) | 1.36" (34.5 mm) | The larger height in theobstacle climbing willnot impact the safetyand effectiveness of thesubject device. |
| Minimumbrakingdistance | 1 m | 1m | Same |
| Max SpeedForwards | 3.75 mph (6 km/h) | 3.75 mph (6 km/h) | Same |
| Max. SpeedBackward | 1.80 mph (2.9 km/h) | 1.86 mph (3.0 km/h) | The devices are evaluatedaccording to standard ISO7176-6:2018, so the differentwill not impact the safetyand effectiveness |
| Controller | Shanghai Micon Mechanical&Electrical | Changzhou Billon | Different |
| Co.,Ltd., M7084. | Electronic ApplianceCo.,Ltd., WS-1 | Although 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 | |
|---|---|---|---|---|
| Main materials | Frame: Aluminium alloy; | Frame: Aluminium alloy; | Biocompatibilityevaluation hasbeen carried outper ISO 10993-1.There are no newsafety andeffectivenessconcerns due to thedifference. | |
| Wheel, Armrest: Leather; | Wheel, Armrest: PU; | |||
| Backrest: Terylene | Backrest: PVC Vinyl | |||
| Materialscontactinguser | Armrest: PU; | Armrest: PU; | ||
| Backrest: Terylene | Seat: PVC Vinyl | |||
| Seat: Terylene | Backrest: PVC Vinyl | |||
| Joystick: ABS | Safety belt: PVC Vinyl | |||
| Joystick: PVC Vinyl | ||||
| 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 | |
| Label and | Conforms to FDA Regulatory | Conforms to FDA Regulatory | Same |
{11}------------------------------------------------
| Labeling | Requirements | Requirements | |
|---|---|---|---|
| Level ofConcern of the | Same | ||
| Moderate | Moderate | ||
| Software |
Summary of substantial equivalence discussion:
The Electrically Powered Wheelchair model HP358E complied with the 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 62133:2012, 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 and raises no new questions of safety or effectiveness. The subject device Electrically Powered Wheelchair - Model HP358E is substantially equivalent to the predicate device in K170787.
§ 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).