The intended use of the Liberator™ is to provide mobility for those persons limited to a seated position, which are capable of operating a simple hand control.

The Liberator™ may be operated on internal DC batteries, which can be recharged by using a wall- charger and supplemented by using the detachable solar assisted battery maintaining device (Solar Companion).

Device Description

The Liberator™ powered wheelchair is a six wheeled battery powered wheelchair. It has a controller system, which is used to operate the Liberator™ powered wheelchair. The one-piece base of the wheelchair is made of welded steel construction. The main frame also consists of a battery floor pan. The center drive wheels are mounted on the drive shafts of separate motor/gear assemblies, one on the left side of the wheelchair, the other on the right side of the wheelchair. The seat comes with ergonomic contoured comfort cushions, recliner, tilt-up adjustable arm rests, and patient can dial in their seating Position, can adjust the setting for air fan control, joy stick adjustments and table adjustments and settings. The Liberator™ powered wheelchair requires 2 NF22 batteries, has an on board charger, the Solar Companion, with solar panel and an assisted battery maintaining device (Solar Companion).

The Liberator™ powered wheelchair has a maximum load capacity of 300 lbs.

The Liberator™ can travel at ranges of 15-20 miles with maximum speed of 4.09 miles per hour on flat terrain under ideal conditions (RESNA testing). In order to achieve the maximum extended range of 20 miles the Solar Companion has the ability to maintain the batteries based on the intensity, angle, and availability of sunlight.

The Liberator™ has an air ride suspension system seat, cushion ventilation system (fan) for the seat and lumbar cushion with laser ported holes in fabric.

The Solar Companion is an onboard battery maintaining device that comes with the Liberator™. It has the ability to maintain the batteries based on availability sunlight intensity and angle. The solar panel assembly is affixed to the Liberator™ and the height can be adjusted to allow the user excellent visibility

AI/ML Overview

Acceptance Criteria and Device Performance for Liberator Powered Wheelchair with Solar Companion

Based on the provided FDA 510(k) summary, the device is a powered wheelchair with a solar-assisted battery maintaining device. The study used to demonstrate substantial equivalence relies primarily on non-clinical testing according to RESNA standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the device, but rather lists the RESNA test methods used and the conclusions drawn regarding performance. The "acceptance criteria" are implied to be the successful demonstration of compliance with these RESNA standards and the comparison of performance characteristics to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	Demonstrated through successful completion of various RESNA tests. Any differences in technological characteristics from the predicate device (e.g., Solar Companion, air-ride suspension) do not raise new questions of safety and effectiveness, as confirmed by RESNA testing.
Static Stability	Complies with RESNA WC-1 Volume 1, Section 1.
Dynamic Stability	Complies with RESNA WC-2 Volume 2, Section 2 (for electrically powered wheelchairs).
Brake Effectiveness	Complies with RESNA WC-2 Volume 2, Section 3.
Energy Consumption & Theoretical Range	Theoretical range of 15-20 miles based on RESNA WC-2 Volume 2, Section 4. This compares favorably to the predicate device's advertised 15-mile range. The Solar Companion assists in maintaining battery charge to achieve the extended range.
Dimensions, Mass, & Maneuvering Space	Complies with RESNA WC-1 Volume 1, Section 5. Differences in wheelchair weight and overall height due to the Solar Companion were tested and found not to impact performance.
Maximum Speed	4.09 miles per hour on flat terrain under ideal conditions (RESNA testing). Complies with RESNA WC-2 Volume 2, Section 6.
Seating & Wheel Dimensions	Complies with RESNA WC-1 Volume 1, Section 7.
Static, Impact & Fatigue Strengths	Complies with RESNA WC-2 Volume 1, Section 8.
Climatic Tests	Complies with RESNA WC-2 Volume 2, Section 9 (for electrically powered wheelchairs).
Obstacle-Climbing Ability	Complies with RESNA WC-2 Volume 2, Section 10 (for electrically powered wheelchairs).
Power and Control Systems	Complies with RESNA WC-2 Volume 2, Section 14. EMC testing was specifically performed for the Solar Companion to establish its safety.
Electromagnetic Compatibility (EMC)	Complies with RESNA WC-2 Volume 2, Section 21 and ISO 7176-21:2009 for the Solar Companion.
Load Capacity	Maximum load capacity of 300 lbs, identical to the predicate device.
Intended Use	"To provide mobility for those persons limited to a seated position, which are capable of operating a simple hand control." This is the same as the predicate device (Golden Spyder). The device may be operated on internal DC batteries, recharged by a wall-charger, and supplemented by the detachable solar assisted battery maintaining device (Solar Companion). The intended use of the Solar Companion features is also similar to the predicate device, AEU-14CF Expedition Dental System, in prolonging battery life using a solar panel.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for the individual tests (e.g., number of wheelchairs tested for each RESNA standard). The testing is described as occurring on "the Liberator™ powered wheelchair." It is implied that typical prototypes or production samples of the device were used for the non-clinical testing.
Data Provenance: The data provenance is from non-clinical testing performed by or for the manufacturer (Solar Mobility LLC) and reported within the 510(k) submission. It is prospective in the sense that these tests were conducted to demonstrate compliance for this specific device. There is no mention of country of origin for the data beyond the US for the submitting company.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the evaluation relies on established international and national standards (RESNA and ISO) for medical device performance (specifically for wheelchairs), not on expert consensus for "ground truth" as would be the case for diagnostic AI. The "ground truth" is defined by the objective measurement and performance requirements specified in these standards.

4. Adjudication Method for the Test Set

This is not applicable. The testing involves objective measurements against predefined acceptance criteria from RESNA and ISO standards. There is no mention or need for a subjective adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI systems in diagnostic tasks, especially how they impact human reader accuracy or efficiency. The Liberator Powered Wheelchair is a physical medical device, not a diagnostic AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical powered wheelchair, not an algorithm or AI system. The "standalone performance" refers to the device itself performing according to its specifications as determined by the RESNA tests.

7. The Type of Ground Truth Used

The "ground truth" used for this device is based on established objective performance standards outlined in RESNA (Rehabilitation Engineering and Assistive Technology Society of North America) and ISO (International Organization for Standardization) guidelines for wheelchairs. These standards dictate acceptable performance characteristics (e.g., stability, speed, braking effectiveness, energy consumption) for safe and effective operation. There is no pathology, expert consensus (in the diagnostic sense), or outcomes data used as "ground truth" in this context.

8. The Sample Size for the Training Set

This is not applicable. The Liberator Powered Wheelchair is a physical device and not an AI or machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this device.

Summary

{0}------------------------------------------------

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 stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 9, 2016

Solar Mobility LLC % E.J Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K153636

Trade/Device Name: Liberator Powered Wheelchair with Solar Companion Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 9, 2016 Received: August 9, 2016

Dear E.J Smith:

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

{1}------------------------------------------------

Page 2 - E.J Smith

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 the quality systems (QS) 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

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153636

Device Name

Liberator Powered Wheelchair with Solar Companion

Indications for Use (Describe)

The intended use of the Liberator™ is to provide mobility for those persons limited to a seated position, which are capable of operating a simple hand control.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Sponsor:

Company Name:	Solar Mobility LLC
Address:	1426 East 3rd Avenue Suite B110Kennewick, WA 99336
Telephone:	509.851.3611
Contact Person:	Kurt Schneider
Summary Preparation Date:	August 28, 2016
Device Name
Trade Name:	Liberator Powered Wheelchair with Solar Companion
Common Usual Name:	Powered Wheelchair
Classification Name:	Powered Wheelchair
Product Code(s):	ITI
Regulation Number:	21 CFR 890.3860
Device Class:	Class II
Panel:	Office of Device Evaluation (ODE) Division of Neurological and PhysicalMedicine Devices

Predicate Device:

Manufacturer	Brand Name	510(k) Number
Golden Technologies, Inc.	Golden Spyder	K041341
Aspetic International	AFU-14CF Expedition DentalSystem	K050201

Device Description:

{4}------------------------------------------------

Position, can adjust the setting for air fan control, joy stick adjustments and table adjustments and settings. The Liberator™ powered wheelchair requires 2 NF22 batteries, has an on board charger, the Solar Companion, with solar panel and an assisted battery maintaining device (Solar Companion).

The Liberator™ powered wheelchair has a maximum load capacity of 300 lbs.

The Liberator™ has an air ride suspension system seat, cushion ventilation system (fan) for the seat and lumbar cushion with laser ported holes in fabric.

Indications for Use

The intended use of the Liberator™ is to provide mobility for those persons limited to a seated position, which are capable of operating a simple hand control.

The Liberator™ may be operated on internal DC batteries, which can be recharged by using a wallcharger and supplemented by using the detachable solar assisted battery maintaining device (Solar Companion).

Technological Characteristics Discussion

The Liberator™ powered wheelchair and the predicate have identical frame material, overall length and width, maximum speed, turning radius, controller, battery type, AC-Wall Charger, suspension system, drive wheels, casters, footplate adjustable heights, armrest type, seat size depth, and wheel locks.

The Liberator™ powered wheelchair has similar seat size widths and heights, back adjustment angle, armrest heights, and upholstery material.

The Liberator™ powered wheelchair has a battery maintaining device (Solar Companion) which is not offered on the predicate device. The Solar Companion safety was established by conducting EMC testing and effectiveness was determined through RESNA testing.

The Liberator™ Powered Wheelchair incorporates a seat cushion which allows the user to have an air ride suspension system which reduces the amount of jarring, friction and shear factor associated with a normal wheelchair seat and allows for a smoother ride for the patient. The predicate device offers a standard wheelchair cushion. The differences between the two seat cushions raises no new safety issues. This conclusion was reached after the Liberator™ powered wheelchair passed the required RESNA tests.

The Liberator™ powered wheelchair and the predicate have a maximum load capacity of 300 lbs.

{5}------------------------------------------------

The Liberator™ powered wheelchair has a range per charge of approximately 15-20 miles based on RENSA Testing Section 4 Determination of Energy Consumption Theoretical Range. The predicate device advertises a theoretical range of 15 miles. The RESNA testing for the Liberator™ supports a theoretical range of 15-20 miles per charge.

The Liberator™ Powered Wheelchair and predicate have a wheelchair weight and overall height difference due to the fact the Liberator Powered Wheelchair has the Solar Companion onboard battery maintaining device and Solar Companion frame attached to the wheelchair. RESNA testing was conducted with the Solar Companion accessory attached to the wheelchair to ensure the Solar Companion accessory did not have any unintended impact on the performance of the wheelchair. RESNA testing supports the safe use of the Liberator™ with the Solar Companion.

The indications for use for the AEU-14CF Expedition Emergency Field Dental Unit differ from the Liberator™ Powered Wheelchair in their intended use. However, both offer the user the capability of prolonging the life of the batteries (while in use) using a solar panel as a source of energy for onboard battery maintenance. Both the subject device and the predicate offer a detachable solar panel.

Non-Clinical Testing

o RESNA WC-1 Volume Requirements and Test Methods for Wheelchairs (including Scooters) Section 1 Determination of static stability
. RESNA WC-2 Volume 2American National Standard for Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs
. RESNA WC-2 Volume 3 Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakes
. RESNA WC-2 Volume 2 Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance
RESNA WC-1 Volume 1 Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space
. RESNA WC-2 Volume 2 Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed,
RESNA WC-1 Volume 1 Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions
. RESNA WC-2 Volume 1 Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths
RESNA WC-2 Volume 2 Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs
. RESNA WC-2 Volume 2 Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
RESNA WC-1 Volume 1 Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies

{6}------------------------------------------------

. RESNA WC-1 Volume 1 Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces
RESNA WC-2 Volume 2 Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and control systems for electrically powered wheelchairs, Requirements and test methods
RESNA WC-1 Volume 1 Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling
o RESNA WC-1 Volume 1 Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts - Requirements and test methods
. RESNA WC-2 Volume 2 Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters
. RESNA WC-1 Volume 1 Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up procedures
RESNA WC-1 Volume 1 Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary
. ISO 7176-21: 2009 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Motorized Scooters: Solar Companion onboard battery maintaining device

Clinical Testing

No clinical studies were conducted.

Conclusion

The Liberator™ powered wheelchair has the same intended use and similar technological characteristics as the Golden Spyder. Non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety and effectiveness. Thus, the Liberator™ powered wheelchair device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).