(63 days)
The intended use of the Model M 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 WHILL Model M is an indoor/outdoor battery-operated 4 wheel drive powered wheelchair. It is powered by two 12 VDC 50Ah batteries and controlled by the R-net 120 amp motor controller. As with all commerciallyavailable powered wheelchairs, the user sits in the wheelchair seat and uses controls positioned on the arms to turn the chair on, control the speed, and direct the movement. The directional controller can be mounted on the left or right arm. When the user activates the directional controller the brakes are released and the motors rotate to move the device in the desired direction. When the user releases the directional controller the device is brought to a controlled stop. The chair frame is a welded nut and steel construction and includes two rear wheels with drive units (motor, gear and brake) connected by belts to the front all directional wheels. Adjustments can be made to the two arm supports, foot support, and seat height and depth to position the user correctly in the device. The device supports a maximum weight of 220 lb, and has an approximate driving range of 12 miles. The device can be operated on carpet, tile, wood, vinyl, concrete, blacktop, dirt, gravel, grass, and wet (<1" standing water) surfaces.
This document is a 510(k) Premarket Notification for the WHILL Model M Powered Wheelchair. It describes the device, its intended use, and compares it to a predicate device (Permobil F3 Corpus) to demonstrate substantial equivalence, primarily through technical specifications and adherence to relevant standards.
Here's an analysis of the acceptance criteria and study information provided, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the sense of specific numerical thresholds that are then met by the device's performance data. Instead, the "acceptance criteria" are implied by the adherence to various national and international standards for powered wheelchairs. The "reported device performance" is the successful completion of testing against these standards.
| Acceptance Criteria (Implied by Standard Adherence) | Reported Device Performance (Successful Completion of Testing) |
|---|---|
| Static Stability defined by ANSI/RESNA WC-1:2009 Section 1 | Performance testing conducted and compliant |
| Dynamic Stability defined by ANSI/RESNA WC-2:2009 Section 2 | Performance testing conducted and compliant |
| Effectiveness of Brakes defined by ANSI/RESNA WC-2:2009 Section 3 | Performance testing conducted and compliant |
| Energy Consumption for Theoretical Distance defined by ANSI/RESNA WC-2:2009 Section 4 | Performance testing conducted and compliant |
| Maneuvering Space defined by ANSI/RESNA WC-1:2009 Section 5 | Performance testing conducted and compliant |
| Maximum Speed, Acceleration, Deceleration defined by ANSI/RESNA WC-2:2009 Section 6 | Performance testing conducted and compliant |
| Seating and Wheel Dimensions defined by ANSI/RESNA WC-1:2009 Section 7 | Performance testing conducted and compliant |
| Static, Impact, Fatigue Strengths defined by ANSI/RESNA WC-1:2009 Section 8 | Performance testing conducted and compliant |
| Climatic Tests defined by ANSI/RESNA WC-2:2009 Section 9 | Performance testing conducted and compliant |
| Obstacle Climbing defined by ANSI/RESNA WC-2:2009 Section 10 | Performance testing conducted and compliant |
| Test Dummies defined by ANSI/RESNA WC-1:2009 Section 11 | Performance testing conducted and compliant |
| Coefficient of Friction of Test Surfaces defined by ANSI/RESNA WC-1:2009 Section 13 | Performance testing conducted and compliant |
| Power and Control Systems for Electrically Powered Wheelchairs defined by ANSI/RESNA WC-2:2009 Section 14 | Performance testing conducted and compliant |
| Information Disclosure, Documentation, Labeling defined by ANSI/RESNA WC-1:2009 Section 15 | Performance testing conducted and compliant |
| Resistance to Ignition of Upholstered Parts defined by ANSI/RESNA WC-1:2009 Section 16 (tests to ISO 8191-1 and ISO 8191-2) | Performance testing conducted and compliant |
| Wheelchairs used as seats in motor vehicles defined by ANSI/RESNA WC-4:2012 Section 19 | Performance testing conducted and compliant |
| Electromagnetic Compatibility defined by ANSI/RESNA WC-2:2009 Section 21 | Performance testing conducted and compliant |
| Performance Testing of Shipping Containers and Systems defined by ASTM D4169 | Performance testing conducted and compliant |
| Resistance to ignition of postural support devices defined by ISO 7176-16:2012 | Performance testing conducted and compliant |
| Assessment of ignitability of upholstered furniture (smouldering cigarette) defined by ISO 8191-1:1987 | Performance testing conducted and compliant |
| Assessment of ignitability of upholstered furniture (match-flame equivalent) defined by ISO 8191-2:1988 | Performance testing conducted and compliant |
| Tests for Flammability of Plastic Materials defined by UL 94 | Performance testing conducted and compliant |
| Biological evaluation of medical devices (risk management) defined by ISO 10993-1 | Performance testing conducted and compliant |
| Biological evaluation of medical devices (in vitro cytotoxicity) defined by ISO 10993-5 | Performance testing conducted and compliant |
| Biological evaluation of medical devices (irritation and skin sensitization) defined by ISO 10993-10 | Performance testing conducted and compliant |
| Power and control systems for electrically powered wheelchairs (R-Net Power Module) defined by ISO 7176-14:2008 | Performance testing conducted and compliant |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes performance testing of the device, not a clinical study on human subjects with a "test set" of patient data. Therefore, the concept of sample size for a test set and data provenance (country of origin, retrospective/prospective) related to patient data is not applicable in this context. The "test set" would refer to the physical WHILL Model M device itself being subjected to various engineering and safety tests as defined by the standards listed. The provenance of the device testing would be from WHILL, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the type of device and study described. This document pertains to the regulatory clearance of a physical medical device (powered wheelchair) based on engineering performance and safety standards, not an AI or diagnostic device that requires expert-established ground truth from medical images or clinical data. The "ground truth" for these tests are the objective performance criteria set by the ISO, ANSI/RESNA, ASTM, and UL standards.
4. Adjudication Method for the Test Set
This question is not applicable. The performance testing of a physical device against engineering standards typically involves objective measurements and adherence to specified test protocols, not subjective adjudication methods like those used for expert consensus in clinical data analysis. The "adjudication" is implicitly the objective pass/fail determination based on the standard's criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The WHILL Model M is a powered wheelchair; it is not an AI diagnostic or assistance system that would involve human readers or affect their performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The WHILL Model M is a physical powered wheelchair, not an algorithm. Its performance is inherent to its design and functional capabilities, not an algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for this regulatory submission is adherence to established international and national engineering, safety, and performance standards for powered wheelchairs. These standards (e.g., ANSI/RESNA WC-1, WC-2, WC-4; ISO 7176, ISO 8191, ISO 10993; ASTM D4169; UL 94) define objective metrics, test methodologies, and acceptable performance limits. The "ground truth" is the successful demonstration that the device's physical and functional attributes meet these predefined requirements.
8. The Sample Size for the Training Set
This question is not applicable. The WHILL Model M is a physical medical device, not an AI model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set."
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Whill, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K153543
Trade/Device Name: Whill Model M Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 28, 2016 Received: January 29, 2016
Dear Mark Job:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153543
Device Name WHILL Model M
Indications for Use (Describe)
The intended use of the Model M powered wheelchair is to provide outdoor 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5 510(k) Summary
| Submitter's Name: | WHILL, Inc. |
|---|---|
| Address: | 285 Old County Rd, Suite 6, San Carlos CA |
| Contact Person: | Terese Bogucki |
| Title: | Regulatory Consultant |
| Telephone Number: | 650-488-7799 |
| Fax Number: | 650-227-2264 |
| Email: | terri@decusbiomedical.com |
| Date Summary Prepared: | August 24, 2015 |
| Device Proprietary Name: | WHILL Model M Powered Wheelchair |
| Model Number: | Model M |
| Common Name: | Powered Wheelchair |
| Regulation Number: | 21 CFR 890.3860 |
| Product Code: | ITI |
| Device Class: | II |
Predicate Device
| Trade Device Name: | F3 Corpus |
|---|---|
| Manufacturer: | Permobil AB |
| Address: | Per Uddens Vag 20 Timra, SE 86123 VasternorrlandSweden |
| Regulation Number: | 21 CFR 890.3860 |
| Regulation Name: | Wheelchair, Powered |
| Regulatory Class: | Class II |
| Product Code: | ITI |
| 510(k) Number: | 143180 |
| 510(k) Clearance Date: | March 27, 2015 |
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5.1 Description of the Device
The WHILL Model M is an indoor/outdoor battery-operated 4 wheel drive powered wheelchair. It is powered by two 12 VDC 50Ah batteries and controlled by the R-net 120 amp motor controller. As with all commerciallyavailable powered wheelchairs, the user sits in the wheelchair seat and uses controls positioned on the arms to turn the chair on, control the speed, and direct the movement. The directional controller can be mounted on the left or right arm. When the user activates the directional controller the brakes are released and the motors rotate to move the device in the desired direction. When the user releases the directional controller the device is brought to a controlled stop.
The chair frame is a welded nut and steel construction and includes two rear wheels with drive units (motor, gear and brake) connected by belts to the front all directional wheels. Adjustments can be made to the two arm supports, foot support, and seat height and depth to position the user correctly in the device. The device supports a maximum weight of 220 lb, and has an approximate driving range of 12 miles. The device can be operated on carpet, tile, wood, vinyl, concrete, blacktop, dirt, gravel, grass, and wet (<1" standing water) surfaces.
5.2 Indications for Use
The intended use of the Model M powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
5.3 Summary of Technological Characteristics Comparison
Table 5-1 shows the similarities and differences between the two products. The key difference is that the subject device has the front all-directional wheel and the device controls on two arms instead of one. While these characteristics are different, the testing demonstrates that they do not raise new questions of safety or effectiveness.
| Item | Predicate | Subject Device |
|---|---|---|
| General | ||
| Manufacturer | Permobil AB | WHILL, Inc. |
| Model | F3 Corpus | Model M |
| 510(k) Number | K143180 | unknown |
Table 5-1 Summary of Technological Characteristics Comparison
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| Item | Predicate | Subject Device | ||
|---|---|---|---|---|
| Intended Use | To provide indoor and outdoormobility to persons restrictedto a sitting position that arecapable of operating a poweredwheelchair. | Same | ||
| Indications forUse | The intended use of the F3powered wheelchair is toprovide indoor and outdoormobility to persons limited to aseating position that arecapable of operating a poweredwheelchair. | The intended use of the ModelM powered wheelchair is toprovide outdoor and indoormobility to persons limited toa seated position that arecapable of operating apowered wheelchair. | ||
| Rx/OTCDesignation | Rx or OTC | Rx | ||
| Physical Characteristics | ||||
| Device Width | 24" | 23.6" | ||
| Device Length | Drive base only:40" with anti-tippers36" without anti-tippers | 37"- 42" (depending on footplate setting) | ||
| Weight (includingbatteries) | 386 lb with Group 34 batteries405 1b with Group 24 batteries | 240 lb | ||
| DeviceConstruction | Steel | Welded nut and steel | ||
| Batteries (2) | 12VDC 60Ah (Group M34) or12VDC 73Ah (Group M24) | 12V 50Ah | ||
| Operating Characteristics | ||||
| Maximum WeightCapacity | 300 lb (136 kg) | 220lb (100kg) | ||
| Maximum Speed | 6 mph5 mph (without anti-tippers) | 5.5 mph | ||
| Turning Radius | 26.5" | 28" | ||
| Obstacle ClimbingHeight | 3" | 3" | ||
| Drive System | Front wheel drive | 4 Wheel Drive | ||
| Dynamic Stability(incline) | 6 degrees | 10 degrees | ||
| Item | Predicate | Subject Device | ||
| Driving Range(full batterycharge) | 13 miles | 12 miles | ||
| Battery ChargingTime | 8 hours | ~8 hours to 80% | ||
| Design Features | ||||
| Power Controller | R-net 120 amp controller | R-net 120 amp controller | ||
| Speed Settings | 5 (maximum) | 3 | ||
| Front Wheel Type | Pneumatic or foam-filled | All directional wheel | ||
| Rear Wheel Type | Solid polyurethane | Pneumatic or solid | ||
| Anti-tip Wheels | Front anti-tip wheels (optional) | Rear anti-tip wheels | ||
| Pressure reliefhandles | None | Yes | ||
| Seat slide | No | Yes | ||
| Tail lamps (2) | ReflectorsLights (optional) | Red LED lights (always on) | ||
| Chair Tilt/Recline/ Leg Lift/Seat Elevator | Yes | No | ||
| Tie Downs | Yes | Yes (optional) | ||
| Non-Clinical Performance Testing | ||||
| WheelPerformanceTesting | Detailed performance testingconducted to ISO 7176standard | Detailed performance testingconducted to RESNA WC-1,WC-2 and WC-4 standards | ||
| Flammability | Padded parts: EN 1021-1, EN1021-2 and ISO 7176-16Plastic parts: UL94 | Upholstered parts: ISO 8191-1 and ISO 8191-2 and covers:ISO 7176-16Plastic parts: UL94 |
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Performance Data 5.4
In addition to design verification and validation testing WHILL conducted performance testing to demonstrate the subject device is in compliance with the following test standards:
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- ANSI/RESNA WC-1:2009 Section 1: Determination of Static ● Stability
- ANSI/RESNA WC-2:2009 Section 2: Determination of Dynamic ● Stability
- ANSI/RESNA WC-2:2009 Section 3: Determination of Effectiveness . of Brakes
- ANSI/RESNA WC-2:2009 Section 4: Determination of Static . Stability Determination of Dynamic Stability Determination of Effectiveness of Brakes Energy Consumption for Determination of Theoretical Distance
- ANSI/RESNA WC-1:2009 Section 5: Maneuvering Space ● Determination of Dimensions, Mass and Maneuvering Space
- ANSI/RESNA WC-2:2009 Section 6: Determination of Maximum . Speed, Acceleration and Deceleration
- ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of . Seating and Wheel Dimensions
- ANSI/RESNA WC-1:2009 Section 8: Requirements and Test . Methods for Static, Impact and Fatigue Strengths
- ANSI/RESNA WC-2:2009 Section 9: Climatic Tests ●
- ANSI/RESNA WC-2:2009 Section 10: Determination of Obstacle ● Climbing
- . ANSI/RESNA WC-1:2009 Section 11: Test Dummies
- ANSI/RESNA WC-1:2009 Section 13: Determination Of Coefficient . Of Friction Of Test Surfaces
- ANSI/RESNA WC-2:2009 Section 14: Power And Control Systems . For Electrically Powered Wheelchairs - Requirements And Test Methods
- ANSI/RESNA WC-1:2009 Section 15: Requirements for Information . Disclosure, Documentation and Labeling
- ANSI/RESNA WC-1:2009 Section 16: Resistance to ignition of . upholstered parts - Requirements and test methods (tests to ISO 8191-1 and ISO 8191-2)
- ANSI/RESNA WC-4:2012 Section 19: Wheelchairs used as seats in . motor vehicles
- ANSI/RESNA WC-2:2009 Section 21: Requirements and Test . Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters
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- ASTM D4169, Standard Practice for Performance Testing of ● Shipping Containers and Systems
- ISO 7176-16: 2012 Wheelchairs -- Part 16: Resistance to ignition of ● postural support devices
- . ISO 8191-1: 1987 Furniture -- Assessment of the ignitability of upholstered furniture -- Part 1: Ignition source: smouldering cigarette
- ISO 8191-2: 1988 Furniture -- Assessment of ignitability of . upholstered furniture -- Part 2: Ignition source: match-flame equivalent
- . UL 94 Standard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances
- ISO 10993-1 Biological evaluation of medical devices -- Part 1: . Evaluation and testing within a risk management process
- . ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- ISO 7176-14: 2008 Wheelchairs -- Part 14: Power and control . systems for electrically powered wheelchairs and scooters --Requirements and test methods (for R-Net Power Module)
Based upon the results of this testing, it was determined the Model M performance was substantially equivalent to the predicate device.
ર. ર Substantial Equivalence Conclusion
The July 28, 2014 FDA Guidance entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]'' was used to determine substantial equivalence. The analysis shows that the Intended Use and Indications for Use, principles of operation, and conditions of use are identical, and that differences in technical characteristics do not raise different questions of safety and effectiveness. There are technological differences between the subject and predicate device however, the results of performance testing demonstrate that these differences do not raise any new questions of safety or effectiveness compared to other similar powered wheelchairs currently on the market. Therefore one can conclude that the Model M is substantially equivalent to the predicate Permobil F3 Corpus device.
§ 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).