(21 days)
The intended use of the WHILL Model F powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The subject device is an update to the existing previously cleared WHILL Model C2 (K213383) (hereafter the "predicate device"). The WHILL Model F is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. It has two arm rests, a seat belt, a foldable backrest, a seat cushion, a foldable frame, two motors, two electromagnetic brakes, an electric motor controller, and a lithium-ion battery with a dedicated off-board battery charger. The wheelchair is powered by a 25.3 V DC 10.6A rechargeable lithium-ion battery charged by an off-board lithium-ion battery charger. The control system, including the directional controller (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. As with all conventional powered wheelchairs, the user sits in the wheelchair seat and uses the control system such as the control pad positioned on either of the two arms to turn the chair on, control the speed, and direct the movement. Adjustments can be made to the arm rests to fit the user's body. The space between the two arms and the height of the arm rests can be adjusted based on the user's seating requirements. Model F contains a new folding feature, not available on the predicate device. The foldable technology is like the legally marketed DYW30A(D09) powered wheelchair (K170787) (hereafter the "reference device"). The subject device can be controlled by the directional controller or remote control by a smartphone app via Bluetooth Low Energy (BLE) wireless communication interface. The smartphone app can also display the battery's status, adjust the speed and acceleration setting and lock the unattended device. The user can lock and unlock the device remotely via the BLE interface using the smartphone app or using a smart key. The device supports a maximum weight of 253.5lb (115 kg), including the weight of the occupant and any carried items. It has a maximum driving range of 12.4 miles (20 km) with a maximum speed limit of up to 3.7mph (6 km/h).
This document is an FDA 510(k) premarket notification for a powered wheelchair, the WHILL Model F. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a novel AI/software medical device.
Therefore, many of the requested elements for AI/software model testing (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document as it describes a hardware medical device (a powered wheelchair) and its comparison to other similar hardware devices, not an AI/software product.
The acceptance criteria provided in the document revolve around the device's compliance with established performance, electrical safety, biocompatibility, and software standards relevant to powered wheelchairs.
Here's the information extracted from the document, acknowledging that most AI/software-specific questions are not relevant:
1. A table of acceptance criteria and the reported device performance
The document provides extensive tables (Table 1, Table 2, Table 3) comparing the WHILL Model F's compliance with various international standards to its predicate devices. Rather than specific numerical performance metrics, the acceptance is based on "Pass" or "Identical to subject device" for compliance with these standards.
| Category | Test Standard (Acceptance Criteria) | Reported Device Performance (WHILL Model F) |
|---|---|---|
| Mechanical Performance | ISO 7176 series (e.g., Static Stability, Dynamic Stability, Braking Effectiveness, Energy Consumption, Dimensions, Speed, Strength, Climatic, Obstacle-Climbing, Test Dummies, Coefficient of Friction, Power & Control Systems, Information Disclosure, Ignition Resistance, EMC) | Passed / Conformed to standards (Identical to predicate/reference device where specified versions align) |
| Biocompatibility | ISO 10993-5:2009 (Tests for In Vitro Cytotoxicity) | Pass (Non-Cytotoxic) |
| ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization) | Pass (Non-Sensitizing, Non-Irritating) | |
| Electrical Safety & EMC | IEC 60601-1-2 Edition 4.0 2014-02 (Medical Electrical Equipment - EMC) | Conformed to standard |
| IEC/EN 61000 series (EMC: harmonic current, voltage changes, ESD, radiated EM, transient/burst, surge, conducted disturbances, magnetic field, voltage dips) | Conformed to standard | |
| EN 61326-2-2:2013, EN 61326-1:2013 (Electrical equipment for measurement, control, lab use) | Conformed to standard | |
| ETSI EN 301 489-1 V2.2.3 (2019-11), ETSI EN 300 328 V2.2.2 (2019-07) (Radio Equipment EMC) | Conformed to standard | |
| FCC 47 CFR 15 Subpart B (Unintentional Radiators) | Complied | |
| IEC 62368-1:2018 (Hazard-based electrical safety for IT/AV products) | Conformed to standard | |
| IEC 62133-2 Edition 1.0 2017-02 (Lithium systems safety) | Conformed to standard | |
| Software | ANSI AAMI IEC 62304:2006/A1:2015 (Software Verification and Validation) | Conducted per requirements |
| Wireless Co-existence | ANSI C63.27-2017 (Evaluation of Wireless Coexistence) | Met all specified |
| Usability | IEC 62366-1:2015 (Application of Usability Engineering) | Validated following standard |
| Battery Transportation Safety | UN 38.3 (Recommendations of the TRANSPORT OF DANGEROUS GOODS, Manual of Test and Criteria, Part III, Lithium metal and lithium-ion batteries) | Complied |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Sample Size: Not specified in the context of statistical testing for a software algorithm. The "test set" here refers to physical units of the device that underwent engineering, performance, and safety testing according to ISO, IEC, FCC, and other relevant standards. These are typically engineering samples rather than large cohorts for clinical data analysis. For usability, it mentions "Performed on 20 Subjects" for the predicate device, and implies the same for the subject device ("Same").
- Data Provenance: Not explicitly stated. The testing was performed to international standards (ISO, IEC, FCC/ETSI), which implies the data was collected in certified testing laboratories. The manufacturer is Whill, Inc. in Japan.
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. This document is for a physical medical device (powered wheelchair), not an AI/software device whose performance relies on interpreting medical images or data. Ground truth for a physical device is established through engineering and performance measurements against established technical standards, not expert medical opinion on a dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a concept used in AI/software medical device studies for establishing expert consensus on ambiguous cases, not for validating engineering performance parameters of a hardware device.
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 is a physical device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a fundamental characteristic of an AI/software device. The WHILL Model F is a powered wheelchair and inherently involves human-in-the-loop operation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and performance is established through compliance with recognized international standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and EMC). These standards define the performance and safety requirements. The tests performed are objective, measurable evaluations against these defined requirements, rather than subjective interpretation by experts.
8. The sample size for the training set
Not applicable. This is not an AI/software device that requires a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2022
Whill, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K221438
Trade/Device Name: WHILL Model F Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 16, 2022 Received: May 17, 2022
Dear Prithul Bom:
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.
{1}------------------------------------------------
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 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.
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
510(k) Number (if known) K221438
Device Name WHILL Model F
Indications for Use (Describe)
The intended use of the WHILL Model F powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
| 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
K221438
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
| SUBMITTER | Whill, Inc. |
|---|---|
| 2-1-11 Higashi-Shinagawa; Harbor Premium Building 2F | |
| Shinagawa-ku, Tokyo 140-0002 Japan | |
| Phone: +819025672984 | |
| Contact Person: Tsuyoshi Iriyama | |
| Date Prepared: April 15, 2022 |
DEVICE II.
| Name of Device: | WHILL Model F |
|---|---|
| Classification Name: | Physical Medicine |
| Regulation: | 21 CFR § 890.3860 |
| Regulatory Class: | Class II |
| Product Classification Code: | ITI |
III. PREDICATE DEVICE Primary Predicate Device
- Manufacturer: Whill, Inc.
- Trade Name: WHILL Model C2 ●
- 510(k): K213383
- Classification Name: Physical Medicine
- Regulation: 21 CFR § 890.3860 ●
- Regulatory Class: Class II ●
- . Product Classification Code: ITI
IV. REFERENCE DEVICE 1
Reference Device 1
- Manufacturer: Nanjing Jin Bai He Medical Apparatus Co. Ltd.
- Trade Name: Powered Wheelchair DYW30A(D09)
- 510(k): K170787 ●
- Classification Name: Physical Medicine
- Regulation: 21 CFR § 890.3860
- Regulatory Class: Class II ●
- Product Classification Code: ITI
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V. DEVICE DESCRIPTION
The subject device is an update to the existing previously cleared WHILL Model C2 (K213383) (hereafter the "predicate device").
The WHILL Model F is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. It has two arm rests, a seat belt, a foldable backrest, a seat cushion, a foldable frame, two motors, two electromagnetic brakes, an electric motor controller, and a lithium-ion battery with a dedicated off-board battery charger. The wheelchair is powered by a 25.3 V DC 10.6A rechargeable lithium-ion battery charged by an off-board lithium-ion battery charger.
The control system, including the directional controller (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.
As with all conventional powered wheelchairs, the user sits in the wheelchair seat and uses the control system such as the control pad positioned on either of the two arms to turn the chair on, control the speed, and direct the movement. Adjustments can be made to the arm rests to fit the user's body. The space between the two arms and the height of the arm rests can be adjusted based on the user's seating requirements.
Model F contains a new folding feature, not available on the predicate device. The foldable technology is like the legally marketed DYW30A(D09) powered wheelchair (K170787) (hereafter the "reference device").
The subject device can be controlled by the directional controller or remote control by a smartphone app via Bluetooth Low Energy (BLE) wireless communication interface. The smartphone app can also display the battery's status, adjust the speed and acceleration setting and lock the unattended device. The user can lock and unlock the device remotely via the BLE interface using the smartphone app or using a smart key.
The device supports a maximum weight of 253.5lb (115 kg), including the weight of the occupant and any carried items. It has a maximum driving range of 12.4 miles (20 km) with a maximum speed limit of up to 3.7mph (6 km/h).
INDICATIONS FOR USE VI.
The intended use of the WHILL Model F powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY PREDICATE VII. DEVICE
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The indications for use, design, and function of the subject device are identical to the primary predicate device WHILL Model C2 (K213383). The following characteristics were compared between the subject device and the predicate devices to demonstrate substantial equivalence:
- о Indications for Use: WHILL Model F has the same indications of use, principles of operation, and mostly identical technical characteristics as the previously cleared primary predicate device, WHILL Model C2 (K213383). Both are indicated for indoor and outdoor mobility to persons limited to a seated position capable of operating a powered wheelchair.
- Materials: The subject device shares identical materials used in surface contacting O components as the primary predicate device. All the subject device's surface-contacting parts are tested to ISO 10993standard.
- Design: The subject device uses the same technology as the primary predicate device. The O key differences are that the subject device can be folded for storage and transportation, uses casters as the front-wheels drive and does not have suspension system on its rear drive wheels. These key features have been evaluated for safety and performance and tested to ISO 7176 standard. The testing demonstrates that the differences do not raise new questions of safety or effectiveness.
- Energy Source: The subject device and the primary predicate share identical batteries. The O Lithium-ion battery used in the subject device has been safety tested to IEC 62133-2 standard.
- Performance Testing: Both the predicate and subject devices were subjected to the same O biocompatibility and performance tests listed below in Section-IX.
VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE REFERENCE DEVICE 1
The subject device can be folded for storage and transportation. Hence Powered Wheelchair-DYW30A(D09) (K170787) manufactured by Nanjing Jin Bai He Medical Apparatus is chosen as the reference device 1 to account for this design feature.
- Indications for Use: WHILL Model F has similar indications of use, principles of operation, o and similar technical characteristics as the reference device 1, Powered Wheelchair DYW30A(D09) (K170787). Although there is a minor difference in the indications of use, the primary indication of both the subject device and the reference device 1 is to assist with mobility to users limited to a seated position who can operate and control the powered wheelchair.
- Materials: The subject device has more surface contacting components tested to ISO 10993 o standard. There is no detail on the surface contacting components and biocompatibility test of the reference device 1 in its 510(k) summary.
- Energy Source: The subject device and the reference device 1 are both powered by a O lithium- ion battery. The lithium-ion battery used in the subject device has been safety tested to IEC62133-2 standard.
- Performance Testing: Both the reference device 1 and subject devices were subjected to O the same performance tests listed below in Section-IX.
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SAFETY AND PERFORMANCE DATA IX.
The following performance data were provided in support of the substantial equivalence determination. (Table 1 Table 2 Table 3 )
Sterilization & Shelf-life Testing:
The device is provided and used non-sterile. There are no parts that can expire, and thus, there is no shelf life.
Non-clinical performance testing:
The subject device, primary predicate, reference device 1 were tested to the ISO 7176 standard. These standards are listed in the FDA document entitled "Guidance Document for the Preparation of Premarket Notification [510k]] Applications for Mechanical and Powered Wheelchairs and Motorized Three-Wheeled Vehicles."
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| Subject DeviceWHILL Model F | Primary Predicate DeviceWHILL Model C2 (K213383) | Reference Device 1Powered Wheelchair |
|---|---|---|
| ISO 7176-1 Third edition 2014-10-01 Wheelchairs -Part 1:Determination of static stability | Identical to subject device | Identical to subject device |
| ISO 7176-2 Third edition 2017-10 Wheelchairs - Part2:Determination of dynamicstability of electrically poweredwheelchairs | Identical to subject device | ISO 7176-2:2001 Wheelchairs - Part 2:Determination ofdynamicstability of electric wheelchairs |
| ISO 7176-3 Third edition 2012-12-15 Wheelchairs -Part 3:Determination of effectiveness of brakes | Identical to subject device | Identical to subject device |
| ISO 7176-4 Third edition 2008-10-01Wheelchairs - Part 4: Energyconsumptionof electric wheelchairs and scooters fordetermination of theoretical distance range | Identical to subject device | Identical to subject device |
| ISO 7176-5 Second edition2008-06-01Wheelchairs - Part 5:Determination of overall dimensions, mass and maneuveringspace | Identical to subject device | Identical to subject device |
| ISO 7176-6 Third edition 2018-06 Wheelchairs - Part 6:Determination of maximum speed, acceleration and decelerationof electric wheelchairs | Identical to subject device | ISO 7176-6:2001 Wheelchairs - Part 6: Determination ofmaximum speed, acceleration and deceleration of electricwheelchairs |
| ISO 7176-8 Second edition 2014-12-15 Wheelchairs - Part 8:Requirements and test methods for static, impact and fatiguestrengths | Identical to subject device | Identical to subject device |
| ISO 7176-9 Third edition 2009-11-15Wheelchairs - Part 9: Climatictests for electric wheelchairs | Identical to subject device | Identical to subject device |
| ISO 7176-10 Second edition 2008-11 01Wheelchairs - Part 10:Determination of obstacle-climbing ability of electrically poweredwheelchairs | Identical to subject device | Identical to subject device |
| ISO 7176-11 Second edition 2012-12-01Wheelchairs - Part 11: Testdummies | Identical to subject device | Identical to subject device |
| Subject Device | Primary Predicate Device | Reference Device |
| WHILL Model F | WHILL Model C2 (K213383) | Powered Wheelchair DYW30A(D09) (K170787) |
| ISO 7176-13: 1989Wheelchairs - Part 13: Determination of Coefficientof Friction of TestSurfaces | Identical to subject device | Identical to subject device |
| ISO 7176-14 Second edition2008-02-15 Wheelchairs - Part 14: Powerand control systems for electrically powered wheelchairs and scooters- Requirements and test methods | Identical to subject device | Identical to subject device |
| ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15:Requirements for information disclosure, documentation and labeling | Identical to subject device | Identical to subject device |
| ISO 7176-16 Wheelchairs -Part 16: Resistance to ignition of posturalsupportdevices- ISO 8191-2:1988Furniture - Assessmentofignitability of upholstered furniture —Part 2: Ignition source:match-flame equivalent | Identical to subject device | Identical to subject device |
| ISO 7176-21 Second edition2009-04-01Wheelchairs - Part 21:Requirements and test methods for electromagnetic compatibility ofelectrically powered wheelchairs and scooters, and battery chargers | Identical to subject device | Identical to subject device |
| ISO 7176-22 Second edition2014-09-01 Wheelchairs - Part 22: Set-upprocedure | Identical to subject device | N/A |
| UN 38.3 Recommendationsof the TRANSPORT OF DANGEROUSGOODS,Manual of Test and Criteria,Part III, Lithium metal and lithium-ionbatteries | Identical to subject device | N/A |
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{9}------------------------------------------------
Biocompatibility Testing
Biocompatibility assessment of patient-contacting components in the subject device was performed in conformance with ISO 10993-1, "biological evaluation of medical devices - part 1: evaluation and testing within a risk management process" as recognized by FDA.
Table 2 Biocompatibility Testing
| Test Standard | Acceptance criteria | Result |
|---|---|---|
| ISO 10993-5:2009, Biological Evaluation ofMedical Devices - Part 5: Tests For In VitroCytotoxicity | Non- Cytotoxic | Pass |
| ISO 10993-10:2010 Biological Evaluation of MedicalDevices - Part 10: Tests for Irritation andSkinSensitization | Non-SensitizingNon-irritating | PassPass |
Electrical Safety and Electromagnetic Compatibility testing
Electrical Safety and Electromagnetic Compatibility testing was performed on a sample of battery and battery chargers in the subject device and found to conform with the following test standards.
| Test Standard | Test description |
|---|---|
| IEC 60601-1-2 Edition 4.0 2014-02 | Medical Electrical Equipment - Part 1-2: General Requirements for BasicSafety and Essential Performance - Collateral Standard: ElectromagneticDisturbances - Requirements and Tests |
| IEC/EN 61000-3-2:2014 | Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmoniccurrent emissions (equipment input current ≤ 16 A per phase) |
| IEC/EN 61000-3-3:2013 | Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltagechanges, voltage fluctuations and flicker in public low-voltage supplysystems, for equipment with rated current ≤16 A per phase and not subjectto conditional connection |
| IEC/EN61000-4-2 Edition 2.0 2008-12 | Electromagnetic compatibility (EMC)- Part 4-2: Testing and measurementtechniques – Electrostatic discharge immunity test |
| IEC/EN61000-4-3 Edition 3.2 2010-04 | Electromagnetic compatibility (EMC)- Part 4-3: Testing and measurementtechniques - Radiated, radiofrequency, electromagnetic field immunity test |
| IEC/EN61000-4-4 Edition 3.0 2012-04 | Electromagnetic compatibility (EMC) Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test (EFT) |
| IEC/EN61000-4-5 Edition 3.1 2017-08 | Electromagnetic compatibility (EMC) Part 4-5: Testing and measurement techniques - Surge immunity test |
| IEC/EN61000-4-6 Edition 4.0 2013-10 | Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields |
| IEC/EN61000-4-8 Edition 2.0 2009-09 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
| IEC/EN61000-4-11 Edition 2.1 2017-05 | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests |
| EN 61326-2-2:2013 | Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. Test configurations, operational conditions and performance criteria for portable test, measuring and monitoring equipment used in low-voltage distribution systems |
| EN 61326-1:2013 | EMC Emissions/Immunity Requirement Changes for Laboratory Equipment |
| ETSI EN 301 489-1 V2.2.3 (2019-11) | Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonized Standard for Electromagnetic Compatibility |
| ETSI EN 300 328 V2.2.2 (2019-07) | Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques |
| FCC 47 CFR 15 Subpart B | Unintentional Radiators |
| IEC 62368-1:2018 | Hazard-based electrical safety standard for IT equipment and Audio-Visual products |
| IEC 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and batteries made from them, for use in portable applications - Part 2: Lithium systems |
Table 3 EMC and Electrical Safety Testing
{10}------------------------------------------------
Software Verification and Validation Testing
Software Verification and Validation Testing was conducted per the requirements of ANSI AAMI IEC 62304:2006/A1:2015.
Level of Concern: The Level of Concern for the subject device software is moderate. This determination is based on answering the questions in the FDA Guidance Document "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
{11}------------------------------------------------
FCC Radio Frequency Testing
The Radiofrequency wireless technology was tested to FCC requirements and found to comply with 47 CFR 15.249.
Wireless Co-existence Testing:
The performance of WHILL Model F was evaluated in an environment with other WHILL Model F devices and with different types of 2.4 GHz wireless devices. The device met all specified in ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence.
Usability Testing
Usability was validated following IEC 62366-1:2015.
Mechanical and acoustic TestingNot Applicable.
Animal Study
Animal performance testing was not required to demonstrate the safety and effectiveness of thedevice.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the device
X. CONCLUSIONS
The July 28, 2014 FDA Guidance entitled "The 510|| Program: Evaluating Substantial Equivalence in Premarket Notfjications [510(k)]" was used to determine substantial equivalence. The WHLL Model F (Subject Device) described herein intended use and the same fundamental technology as the cleared primary predicate device, the WHILL Model C2 (K213383), and the reference device, Powered Wheelchair DY W30A(D09) (K170787), Based on the performance data presented for the subject device and primary predicate device, it can be concluded that the WHLL Model F is as safe and substantially equivalent to both the predicate device and the reference device.
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| Device | Subject DeviceWHILL Model F | Primary Predicate DeviceWHILL Model C2 (K213383) | Reference Device 1Powered WheelchairDYW30A(D09) (K170787) | Remark |
|---|---|---|---|---|
| Manufacturer | Whill, Inc. | Whill, Inc. | Dongguan Prestige SportingGoods Co., Ltd | Same |
| 510K Number | Unknown | K213383 | K170787 | - |
| Common or UsualName | Powered Wheelchair | Powered Wheelchair | Powered Wheelchair | Same |
| Product Code | ITI | ITI | ITI | Same |
| ProductClassification | Class II | Class II | Class II | Same |
| Classification Name | Powered Wheelchair | Powered Wheelchair | Powered Wheelchair | Same |
| Regulation Number | 21 CFR 890.3860 | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| INDICATIONS FOR USE | ||||
| Indications for Use | The intended use of the Model F poweredwheelchair is to provide outdoor and indoormobility to persons limited to a seated positionthat are capable of operating a poweredwheelchair. | The intended use of the Model C2 poweredwheelchair is to provide outdoor and indoormobility to persons limited to a seated positionthat are capable of operating a poweredwheelchair. | The device is a motor-driven, andindoor transportation vehicle withthe intended use to providemobility to a disabled or anelderly person limited to a seatedposition. | -Same as the primarypredicate-Similar to ReferenceDevice. The primaryindication of thesubject and theReference Device is toassist users withmobility |
| Type of Use | Over the Counter (OTC Only) | Over the Counter (OTC Only) | Over the Counter (OTC Only) | Same |
| PHYSICAL CHARACTERISTICS COMPARISON | ||||
| Image: WHILL Model F | Image: WHILL Model C2 | Not available | ||
| Device Construction | Solid aluminium frame | Solid aluminium frame | 6063 Aluminium Alloy | Same as primarypredicate |
| Device weight | 58.9 lbs. | 114 lbs. | Not available | SE-Note 1 |
| Device Length | 36.8" | 38.8" | 37.4" | SE-Note 1 |
| Device Width | 21.8"-23.8" | 21.8" | 22.6" | SE-Note 1 |
| Device Height | 31.6" | 29.3 - 37.2" | 36.2" | SE-Note 1 |
| Number of wheels | 4 | 4 | 4 | same |
| Front WheelDiameter | 7.6" (194 mm) | 10.11" | Not available | SE-Note 2 |
| Rear WheelDiameter | 8.25" | 10.43" | Not available | SE-Note 2 |
| Ground Clearance | 2.4" | 3" | Not available | Similar. The minordifference does notaffect the safety andeffectiveness of thedevice |
| Battery pack | 1 rechargeable lithium-ion batteryRatings: 25.3 V 10.5Ah | 1 rechargeable lithium-ion batteryRatings: 25.3 V 10.5Ah | 2 rechargeable lithium-ion batteryRatings: 24V 6AH | Same as the predicatedevice. |
| Charger | Type: off-boardRated DC output voltage: 28.49V DCRated current output: 2.4A DC | Type: off-boardRated DC output voltage: 28.49V DCRated current output: 2.4A DC | Type: off-boardRated DC output voltage: 24V DCRated current output: 2A DC | Same as the predicatedevice |
| Battery Type | Lithium-ion | Lithium-ion | Lithium-ion | Same |
| Battery weight | 6.0 lbs. | 6.0 lbs. | 17.6 lbs. (8 kg) | Same as the primarypredicate and lighterthan the ReferenceDevice 1 |
| OPERATING CHARACTERISTICS | ||||
| Operatingenvironments | Indoor/outdoor uses | Indoor/outdoor uses | Indoor use | Same as the primarypredicate. The deviceis Designed for indoorand outdoor use.Based on the testing asmentioned in SE-Note1 , SE-Note 2 , thedevice poses no safetyand effectivenessconcerns. |
| Maximum WeightCapacity | 253lb (115 kg) | 300lb (136kg) | 220lb (100 kg) | SE-Note 5 |
| Maximum speed | 3.7 mph | 5 mph | 3.75 mph (6 km/h) | SE-Note 5 |
| forward | ||||
| Braking System | Electromagnetic | Electromagnetic | Electromagnetic | Same |
| Turning Radius | 30.7" | 30" | 32.5" | SE-Note 1 |
| Obstacle ClimbingHeight | 1.4" | 2" | 1.36" (34.5 mm) | SE-Note 1 |
| Drive system | 2 Wheel Drive (Rear wheel drive) | 2 Wheel Drive (Rear wheel drive) | 2 Wheel Drive (Rear wheel drive) | Same |
| Dynamic Stability(incline)/Maximumallowableinclination | 10° | 10° | Not available | Same |
| Driving Range (fullbattery charge) | 12.4 miles | 11 miles | 17.18 miles (27.65 km) | SE-Note 5 |
| On/Off Button | Yes, Power Button on the control pad. | Yes, Power Button on the control pad. | Not available | Same |
| Speed Settings | 4 | 4 | Not available | Same |
| Battery ChargingTime | ~5 hours | ~5 hours | 6~8 hours | Same as the primarypredicate device. TheSubject device chargesfaster than theReference Device 1. |
| DESIGN FEATURES | ||||
| Motor | Manufacturer: NIDECMotor type: brushless DC motorRated output: 150W x 2 PCS | Manufacturer: NIDECMotor type: brushless DC motorRated output: 150W x 2 PCS | Not Applicable | Motor type andRated output issame. Physical size issmaller and lighterthan the predicateddevice.Subjective devicewere conductedsame ISO7176 seriestest and thoseresults show thedifferences do notraise any safetyissues. |
| Motor controller | Manufacturer: WHILL | Manufacturer: WHILL | Not Available | Same enclosure and |
| Model: 21-00011-0 | Model: 21-00011-0 | similar software | ||
| Joystick Location | Left or right arm | Left or right arm | Left or right arm | Same |
| User controlinterface | User controls are housed in a single component-the control pad subassembly. The control pad | User controls are housed in a single component-the control pad subassembly. The control pad | Not Available | Same enclosure andsimilar software. |
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| subassembly may be placed on either the right- orleft-hand side of the device to match the user'spreference.The control pad subassembly contains the inputelements shown below.Image: Control pad subassembly1 Speed select button “-”Decreases the maximum speed.2 Power buttonTurns on/off the device.3 Sound buttonTurns on/off the sound.4 JoystickControls the forward, backward, left, and rightmovements. The degree of joystick inclinationcan also control acceleration and deceleration.5 Speed select button “+”Increases the maximum speed.6 Display | subassembly may be placed on either the right- orleft-hand side of the device to match the user'spreference.The control pad subassembly contains the inputelements shown below.Image: Control pad subassembly1 Speed select button “-”Decreases the maximum speed.2 Power buttonTurns on/off the device.3 Sound buttonTurns on/off the sound.4 JoystickControls the forward, backward, left, and rightmovements. The degree of joystick inclinationcan also control acceleration and deceleration.5 Speed select button “+”Increases the maximum speed.6 Display | |||
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| Arm rest | Height of arm rest can be adjusted in 3 Stages:26.4 inches, 27.2 inches OR 28.0 inchesSpace between arm rests can be adjusted: Wide(18.8 inches) OR Standard (16.9 inches) | Using with tool, Height of armrest are adjustable in4 Stages.Lift type: rotates up and out of the way when thearms are rotated to a vertical position. | Not available | Rotation isimplemented for alightweight design.According to thesubject device, thearmrests can beadjusted without usingadditional tools as withthe predicate device.The arm rest can beeasily and quicklyadjusted during actual |
| use in the subjectdevice. The ISO7176test report shows thedifferences do notraise any safety andperformance issues | ||||
| Seat Cushions | WHILL original | WHILL original | Not available | Similar. Cushion coveris mesh type and itdoes not affect safety,especially anti-flameability andeffectiveness ofdevice. |
| Back Supports | WHILL original | WHILL original | Not available | Similar. Cover is meshtype and it does notaffect safety,especially anti-flameability andeffectiveness ofdevice. |
| PoweredPositioningConfigurations | No | No | Not available | Same |
| Wheelchair TieDowns | None | None | Not available | Same |
| Seat Widths | 17.7" | 16", 18" and 20" | Not available | Similar. Seat width isonly available in onesize. Minor differencesdo not adversely affectthe safety andeffectiveness of thedevice |
| Seat Depths | 15.7" | 16", 18" and 20" | Not available | Similar. Seat depthsare only available inone size Minordifferences do notadversely affect thesafety andeffectiveness of thedevice |
| Back support Height | 15.19" | 13.4 - 18.1" | Not available | Similar. Back supportheight is only availablein one size. Minordifferences do notadversely affect thesafety andeffectiveness of thedevice |
| Front Wheel Type | Caster wheels with solid wheel | Omni-wheel | solid wheel | SE Note 2 |
| Rear Wheel Type | air-filled tires | Standard: Airless tire | solid wheel | SE Note 2 |
| Anti-tip Wheels | Rear anti-tip wheels | Rear anti-tip wheels | Rear anti-tip wheels | Same |
| Pressure reliefhandles | No | No | Not available | Same |
| Seat Slide | No | No | Not available | Same |
| Tail lamps (2) | No LED lightsRear reflector are equipped for safety. | Red LED lights | Not available | The absence of theLED light and lightweight feature in thesubject device will notimpose any additionalrisks and does notraise any safety andeffectiveness. A safetyfeature is considered,the device is equippedwith rear reflectors |
| Foldable | Foldable.Foldable frame | Users can disassemble model C2 without usingtools into four components: Seat, Front Drive Base,Rear Drive Base, and Battery. | Foldable.Two foldable arm restsFoldable frame | SE Note 6 |
| Non-Clinical Performance Testing | ||||
| PerformanceTesting | wheelchair conforms to the ISO 7176 standards | wheelchair conforms to the ISO 7176 standards | wheelchair conforms to the ISO7176 standards | Similar |
| FlammabilityTesting | WHILL-manufactured specialty cushion that testedto ISO 8191-1/8191-2 that is equivalent to ISO7176-16 | WHILL-manufactured specialty cushion that testedto ISO 8191-1/8191-2 that is equivalent to ISO7176-16 | ISO 7176-16, Second edition2012-12-01, Wheelchairs - Part16: Resistance to ignition ofpostural support devices | Similar |
| Biocompatibility | Surface-contacting parts complies with ISO 10993 | Surface-contacting parts tested to ISO 10993 | Not available | The results of thebiocompatibility testsconducted on ModelC2 are applicable to |
| Model F because thesurface contactingparts are the same.Therefore, noadditional testing wasperformed on thesubject device | ||||
| Usability Testing | IEC 62366:2007: Medical Devices – Application ofUsability Engineering to Medical Devices | IEC 62366:2007: Medical Devices – Application ofUsability Engineering to Medical DevicesPerformed on 20 Subjects | Not Available | Same |
| Environmental Conditions | ||||
| OperatingConditions | 5 to 104 degrees F (-15 to 40 degrees C) | 5 to 104 degrees F (-15 to 40 degrees C) | Not available | Same |
| Storage Conditions | 5 to 104 degrees F (-15 to 40 degrees C) | 5 to 104 degrees F (-15 to 40 degrees C) | Not available | Same |
| Radio Frequency Wireless Technology | ||||
| Type of wirelesstechnology | IEEE 802.15.4 (Bluetooth Low Energy) | IEEE 802.15.4 (Bluetooth Low Energy) | Not Applicable | Same |
| FCC compliance | CFR47, Part 15 | CFR47, Part 15 | Not Applicable | Same |
| WirelessCoexistenceCompliance | ANSI C63.27-2017 American National Standard forEvaluation of Wireless Coexistence | ANSI C63.27-2017 American National Standard forEvaluation Of Wireless Coexistence | Not Applicable | Same |
| EMC Compliance | ISO 7176-21:2009 | ISO 7176-21:2009 | ISO 7176-21:2009 | Same |
| Wireless functions | adjust speed, acceleration, turning settings, andlock the device when it is unattended | adjust speed, acceleration, turning settings, andlock the device when it is unattended | Not Applicable | Same |
| Smartphone App | iOS and Android | iOS and Android | Not Applicable | Same |
| Wireless RFfrequency range | 2.402 GHz to 2.480 GH | 2.402 GHz to 2.480 GHz | Not Applicable | Same |
| Wireless RFmaximum outputpower | 6dBm | 6dBm | Not Applicable | Same |
| Wireless operatingrange | 10m | 10m | Not Applicable | Same |
| Smartphone App | IEEE 802.15.4 (Bluetooth Low Energy) | IEEE 802.15.4 (Bluetooth Low Energy) | Not Applicable | Same |
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The following technological characteristics are different from the primary predicate and Reference device 1.
- Note 1: "Device weight," "Device Height "turning radius," "Obstacle Climbing Height" "Ground Clearance" comply with ISO 7176-● 5 Wheelchairs – Part 5: Determination of dimensions, mass, and maneuverings space
- Device weight, length and height: Compared with the predicate device, light weight is one of the main features of subject device. The O ratio of the weight/power for the subject device is 58.9 lbs. / 150 W = 0.39 lbs./W and the predicate device is 114 lbs./150 W= 0.76 lbs, W. The subject device will use one joule energy per second to push 0.39 pounds of wheelchair weight, and the will use one joule energy per second to push of wheelchair weight. That is to say, the subject device consumes less battery power than predicate device. The subject device has passed the testing result, lighter weight itself does not affect the safety and effectiveness of the device. Besides light, the reliability, safety and performance of subject device are complied with EN 12184:2014 Electrically powered wheelchairs, scooters, and chargers.
- Turning radius and Obstacle Climbing Height: there are minor differences in the turning radius and Obstacle Climbing Height. The device o has passed its testing to ISO 7176-5 Wheelchairs – Part 5: Determination of dimensions, mass, and moneuverings space and does not raise any safety and effectiveness concerns
- Note 2: .
- The difference in "wheel diameters" and "wheel type" does not affect the device's safety and the O primary device have passed the same criteria) determined by EN 12184:2014 Electrically powered wheelchairs, scooters, and chargers.
- o Front Wheel The predicate device is equipped with Omni wheels, while the subject device is equipped with caster with solid wheel tires makes the wheelchain lincreases the propulsion efficiency of the wheelchair and can cover long distances. The subject has passed tests determined by EN 12184:2014 Electrically powered wheelchairs, scooters, and the differences does not raise any safety and performance concerns
- Rear Wheel: The subject device has air-filled tires as opposed to the mas airless tires. Pneumatic air-filled tires O are be preferred due to light being a design priority and longer driving range. Air-filled tires are lightweight and shock-absorbing, so they are gentler on the ride. The subject has passed tests determined by EN 12184:2014 Electrically powered wheelchairs, scooters, and chargers and the differences does not raise any safety and performance concerns
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- Note 3: Battery weight ●
- Battery weight: The battery weight is identical to the subject device and lighter than the reference device 1. The battery's light weight O makes the subject device light in weight and easy to transport. The battery is complied with UN38.3. Also, the batteries have passed the testing to IC 62133-2:2017 (Secondary Cells and Batteries containing Alkaline or other Non-Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells, and Batteries made from them, for use in Portable Applications). The battery is able to carry on baggage in airplane. There are no new safety and effectiveness concerns raised for the subject device.
- Note 4 The "Maximum speed forward" is slightly different from the primary with ISO 7176-6 Wheelchairs Part 6: ● Determination of maximum speed, acceleration of electric wheelchairs and has passed the testing. The differences do not raise any safety and effectiveness concerns.
- Note 5 "Energy consumption," "Driving Range," and "Maximum capacity" comply with ISO 7176-4 Wheelchairs Part 4: Energy consumption of ● electric wheelchairs and scooters for determination of there are no new safety and performance concerns raised for the subject device.
- Note 6 "Folding design" Model F's folding and light weight design facilitate easy and compact handling. However, Model C2 is difficult to ● transport down and upstairs, and it requires to disassemble every time during storage and transport. Since Model F can be folded and unfolded without any tools, the lightweight and foldable design of the Model F makes available to be checked in airplane travel.
§ 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).