The ZX-1 is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.

Device Description

The ZX-1 Power Add On is a light duty, power add-on device with the purpose of delivering powered mobility to a manual wheelchair. The device easily attaches/detaches to the frame of a manual wheelchair. The engagement between the ZX-1 and the manual wheelchair is accomplished without the need for hardware or other fixed attachment devices. The user remains seated in their manual wheelchair and performs a simple maneuver to attach the ZX-1 to their manual wheelchair. Once securely attached to the ZX-1, the user negotiates the speed and direction of their wheelchair by using a VR2 joystick controller attached to the arm rest of the ZX-1. The device consists primarily of a stainless steel base with drive wheels, a power module with joystick, two drive motors, a connector mechanism, two armrests and an anti-tilt assembly. It functions by connecting to the host manual wheelchair rear camber tube. Once the connection is made, the linear actuator lifts the manual wheelchair rear wheels slightly off the ground and onto the stainless steel base with drive wheels. Power to the drive motors is supplied by use of the joystick which is used to engage wheelchair motion and steer the chair. During use, the ZX-1 offers forward, reverse and 360 degree turning maneuverability. The user is able to adjust the speed setting to meet their needs and level of comfort.

AI/ML Overview

The provided text describes the Spinergy ZX-1 Power Add On, a device designed to provide powered mobility to manual wheelchairs. The document is a 510(k) summary, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Albers E-Fix Conversion Kit - K943789) and adherence to recognized standards. The "acceptance criteria" are not explicitly listed in a separate table as pass/fail thresholds, but are instead derived from the performance specifications of the predicate device and relevant industry standards.

Acceptance Criteria (Inferred from Predicate Device & Standards)	Reported Device Performance (Spinergy ZX-1 Power Add On)
Intended Use/Indications for Use: Provide powered mobility to manual wheelchairs for disabled persons capable of operation.	Met: "The ZX-1 is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs." (Page 3, 4, 8)
Maximum Speed: (Predicate: 3.7 mph)	Met (with minor difference): Maximum speed 3.2 mph. (Page 2). (Discussion indicates minor difference of .5mph is negligible - Page 4)
Maximum Patient Weight Capacity: (Predicate: 250 lbs)	Met: Maximum patient weight capacity is 250 lbs. (Page 2, 4)
Maximum Operation Incline: (Not explicitly stated for predicate)	Met: Maximum operation incline 6 degrees. (Page 2)
Curb Clearance: (Not explicitly stated for predicate)	Met: Highest curb clearance 2 inches (50mm). (Page 2)
Electromagnetic Compatibility (EMC): Adherence to relevant standards.	Met: Tested in accordance with EN55011/A2:2007, IEC 60601-1-2:2007 (Modified) and American National Standard: Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters RESNA WC-2:2009 Standard Section 21. (Page 3)
Leakage Current: Less than 100 Amp maximum value.	Met: Results confirm that leakage current is less than the 100 Amp maximum value specified in the Powered Wheelchair and Scooter 510(k) Guidance Document. (Page 3)
General Performance & Safety: Adherence to RESNA and ISO standards for wheelchairs.	Met: Tested to and meets the requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs -Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs." (Page 3)
Basic Electro-mechanical Drive Technology: (Similar to predicate)	Met: Incorporates basic electro-mechanical drive technology, two drive motors and basic gear reduction, microprocessor-based motor controller, 24 VDC operating voltage. (Page 2, 4)
Power Source: Two 12 VDC batteries.	Met: Powered by two 12VDC batteries. (Page 2, 4)
Joystick Control: Engage motion and steer the chair.	Met: Joystick control to engage motion and steer the chair. (Page 2, 4)
Free Wheel Mode: Allows manual movement when attached.	Met: Free Wheel Mode which disables the drive motors and allows the device to be attendant propelled when the power-conversion device is attached. (Page 4)
Braking Mechanism: Effective and safe braking.	Met: Electromagnetic braking system and disk park brake. (Page 5, discussed as similar in function to predicate's two braking systems)
Battery Level Indicator:	Met: Battery level indicator. (Page 4). The ZX-1 battery indicator flashes red when the batteries are near depletion. (Page 5)

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

The document does not specify a "sample size" in the context of user testing or a clinical trial for the ZX-1 Power Add On. The testing described is non-clinical performance testing of the device itself and its components against established engineering standards. Therefore, there's no "test set" of individuals or patient data. The provenance of the data is from Spinergy's own internal testing in accordance with recognized international and national standards.

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

Not applicable. This was non-clinical engineering and electrical safety testing against established standards, not a study requiring expert clinical assessment for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The testing described is objective measurement against defined technical standards, not a subjective assessment requiring adjudication.

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 medical device (power add-on for wheelchairs), not an AI diagnostic or assistance tool for human interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a mechanical/electrical device used by a human operator, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance claims of the ZX-1 Power Add On are the requirements and test methods specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991), ISO Standard ISO 7176: 1993(E), IEC 60601-1 Standard for Medical Equipment, and EN55011/A2:2007, IEC 60601-1-2:2007, and RESNA WC-2:2009 Standard Section 21. These are objective, internationally recognized standards for wheelchair safety and performance.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. There is no training set for this type of device.

Summary

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K 123769

MAY 1 0 2013

Image /page/0/Picture/2 description: The image shows the logo for Spinergy. The logo consists of the word "SPINERGY" in a bold, stylized font, with a swoosh-like graphic to the left of the word. Below the word "SPINERGY" is the tagline "Faster by Design!" in a smaller font.

"510(K) SUMMARY" AS REQUIRED BY SECTION 807.92(c) Modified May 1, 2013

510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared.

SM Power, LLC, an affiliate of Spinergy, Inc. 1914 Palomar Oak Way Carlsbad, CA. 92008 · Phone: (760) 496-2121 Fax: (760) 496-2153

Contact Person:

Edward A. Kroll President, Spectre Solutions, Inc. and Representative Consultant for Spinergy, Inc. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9801 Fax: (440) 546-9124

Date Prepared: February 10, 2013

Name of Device

. Trade Name: ZX-1 Power Add On
Common Name: Manual Wheelchair Power Add On �
Classification Name: Wheelchair, Powered (21 CFR 890.3860) Product Code: ITI .

Predicate Device

Albers E-Fix Conversion Kit (K943789)

Page 1 of 6

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Device Description:

The engagement between the ZX-1 and the manual wheelchair is accomplished without the need for hardware or other fixed attachment devices.

The user remains seated in their manual wheelchair and performs a simple maneuver to attach the ZX-1 to their manual wheelchair. Once securely attached to the ZX-1, the user negotiates the speed and direction of their wheelchair by using a VR2 joystick controller attached to the arm rest of the ZX-1.

Device Function

The device consists primarily of a stainless steel base with drive wheels, a power module with joystick, two drive motors, a connector mechanism, two armrests and an anti-tilt assembly. It functions by connecting to the host manual wheelchair rear camber tube. Once the connection is made, the linear actuator lifts the manual wheelchair rear wheels slightly off the ground and onto the stainless steel base with drive wheels.

Power to the drive motors is supplied by use of the joystick which is used to engage wheelchair motion and steer the chair. During use, the ZX-1 offers forward, reverse and 360 degree turning maneuverability. The user is able to adjust the speed setting to meet their needs and level of comfort.

Scientific Concepts .

The ZX-1 incorporates basic electro-mechanical drive technology. It is powered by two 12VDC, permanent magnet motor/gearboxes with brakes. The motors are controlled using a joystick/controller combination that is specifically designed for use with powered wheelchairs and scooters.

Significant Physical and Performance Characteristics

Design:

. Maximum speed 3.2mph.
. May be used both indoors and outdoors
· Maximum operation incline 6 degrees
Highest curb clearance 2 inches (50mm). .
Maximum patient weight capacity is 250 lbs. .

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Materials:

Stainless Steel Base o
o Rubber Drive Wheels
Carbon Fiber Plastic Cover o

Physical Properties: .

The ZX-1 can be used with any manual wheelchair with the following characteristics.

Rigid frame with a horizontal, round camber tube O
Camber tube must be mounted level with wheelchair rear wheel axles o
No obstructions under camber tube o
24", 25" or 26" wheelchair rear wheels o
o 15"-20" rear seat width (14" can be used with some configurations)
Minimum of 6" between camber tube and front caster wheels or footplate o

Intended Use/Indications for Use

The ZX-1 is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.

Predicate Device Comparison

The ZX-1 Power Add On is substantially equivalent to the Albers Technologies, Inc. "E-Fix", Power Wheelchair Conversion Kit (E-Fix). This device was granted marketing clearance by FDA on November 8. 1994. under 510(k) Accession Number K943789.

Both of these products are electrically powered, motor driven devices with the intended function and use of providing powered mobility to manual wheelchairs. They are constructed from the same basic materials, incorporate the same operational principles and both use two, 12 VDC batteries as their power source. Additionally, both devices include a joystick operated motor controller to engage system motion and steer the wheelchair. See Tables 1 and 2 below for similarities and differences.

Performance Data: (Non-clinical Testing)

The ZX-1 Power Add On has been tested to and meets the requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs -Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs."

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Additionally, Spinergy has conducted Leakage Current Testing in accordance with the IEC 60601-1 Standard for Medical Equipment. Results confirm that leakage current is less than the 100 Amp maximum value specified in the Powered Wheelchair and Scooter 510(k) Guidance Document.

Finally, Spinergy has conducted EMC Testing in accordance with EN55011/A2:2007, IEC 60601-1-2:2007 (Modified) and American National Standard: Requirements and

Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters RESNA WC-2:2009 Standard Section 21:

Conclusion:

The Spinergy ZX-1 Power Add On is substantially equivalent to and is as safe and effective as its predicate device. They have the same indications for use, are constructed from the same basic materials and both incorporate the same operational principles.

Results of performance tests conducted on the ZX-1 clearly demonstrate that the device is safe and effective for its intended use.

Page 4 of 6

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TABLE 1

: .

	SIMILARITIES
Indications for Use
Spinergy ZX-1 Power Add On	Alber Technologies E-Fix (K943789)
The Zx-1 is intended to provide enhanced mobility todisabled persons who are capable of operating apowered and manual wheelchair, by providingpowered mobility to manual wheelchairs	The E-Fix is intended to aid disabled individuals by increasing their mobility
General Similarities:
Spinergy ZX-1 Power Add On	Alber Technologies E-Fix (K943789)
The ZX-1 is basically a kit intended to be attached toan existing manual wheelchair	Same
Major components of the ZX-1 are wheels, frame,motors, motor controller, joystick, rechargeablebatteries	Same
Free Wheel Mode which disables the drive motorsand allows the device to be attendant propelled whenthe power-conversion device is attached	Same
The ZX-1 kit may be removed altogether and the hostwheelchair restored to its status as a manualwheelchair	Same
The ZX-1 may be used both indoors and outdoors	Same
Power wheelchair operation is carried out by the userand not by an attendant.	Same
Technology:
Spinergy ZX-1 Power Add On	Alber Technologies E-Fix (K943789)
Basic electro-mechanical drive technology consistingof two drive motors and basic gear reduction	Same
Motors are controlled using a microprocessor basedmotor controller	Same
The microprocessor automatically controls the speedof acceleration and deceleration	Same
Power source is two 12 VDC batteries	Same
Joystick control to engage motion and steer the chair	Same
Features/Specifications:
Spinergy ZX-1 Power Add On	Alber Technologies E-Fix (K943789)
Weight limitation of 250 pounds	Same
Maximum speed of 3.2 mph	Maximum speed of 3.7 mph (Minor difference of .5mph is negligible)
Operating voltage is 24 VDC	Same
Hand-operated hom	Same
Battery level indicator	Same

Page 5 of 6

. . . . .

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TABLE 2

11 11:10 PM 11 11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DIFFERENCES
Description:	Spinergy ZX-1Power Add On	Alber Technologies E-Fix (K943789)	Discussion
Wheelconfiguration	4 wheels: I rear anti-tip. I front lift wheel.2 (10") central drivewheels	2 main drive wheels	Both devices utilize centrally located drive wheels andmaintain usage of the host wheelchair's front casters.Therefore, they are substantially equivalent in thisrespect.
Mechanism toattach/detach towheelchair	Mechanized clampattaches/detaches tomanual wheelchairframe	Manuallyattached/detach E-Fixwheels and standardrear wheels.	The ZX-1 attach/detach process is motorized while theE-Fix wheels are attached/detached manually. This doesnot affect safety as the ZX-I does not operate unless theconnection has been made and confirmed via the devicesoftware.
Brakemechanism	Electromagneticbraking system anddisk park brake.	Electronic enginebraking system, springloaded drum brakes andthe original wheelchairbrake.	While the E-Fix claims to have 3 braking systems it isrelying on the host wheelchair hand brake as one ofthem. Therefore, there are only two brakes in the deviceitself and they are similar to the ZX-1. The engine brakefunctions in the same manner as the ZX-1electromagnetic brake in that both go into effectwhenever the joystick control is returned to its neutral,central position. The E-fix drum brake functions in thesame manner as the ZX-1 disk park brake in that bothbrakes become engaged once the wheelchair comes to astop.
Theoreticaldriving range	5.0 mi.	Up to 12 milesdepending on theweight of the person.Typical range is 15.5miles.	The E-Fix will travel further between charges. This hasno effect on safety or effectiveness as battery depletionis still possible for both devices. The ZX-1 batteryindicator flashes red when the batteries are neardepletion. If the batteries fail, the ZX-1 may be placed infree wheel mode and can be moved. If the E-Fixbatteries fail it can be reset to manual mode and can bemoved. Therefore, they are equivalent in this respect.
Battery Mount	Self-contained battery	Docking battery pack	ZX-1 battery is permanently mounted to the ZX-1frame. E-Fix is contained in a battery pack which mountsto the rear of the host wheelchair. This does notdeleteriously affect safety. With the E-Fix the user ismore likely to be exposed to the battery than with theZX-1.
HostWheelchairRequirements	Used only with a rigidframe manualwheelchair. Cannot beused with a foldingframe manualwheelchair	Adapts to both a rigidframe and foldingframe manualwheelchair	This has no effect on safety or effectiveness. It onlylimits the type of wheelchair with which the ZX-1 can beused. The ZX-1 labeling clearly states that it cannot beused with a folding frame manual wheelchair.
Free WheelOperation	Attendant propelled.only	Can be both userpropelled and attendantpropelled.	This has no effect on safety or effectiveness. Free wheelmode is intended to permit the device to be movedmanually, if needed. Should the user for some reason beunable to operate the chair in power mode, it is likelyhe/she would not be able to self-propel the wheelchairand would require attendant assistance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

May 10,2013

Public Health Service

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

Spinergy, Inc. C/O Spectre Solutions, Inc. ATTN: Edward A. Kroll 5905 Fawn Lane Cleveland, Ohio 44141

Re: K123769

Trade/Device Name: ZX-1 Power Add On Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 19, 2013 Received: March 22, 2013

Dear Mr. Kroll:

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. Isting 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 device-related 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.

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Page 2 - Mr. Edward A. Kroll

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting 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): K123769

Device Name : ZX-1 Power Add On

Indications for Use:

The ZX-1 is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.

Prescription Use X (Part 21 CFR 801 Subpart D)

. AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

K123769 510(k) Number

Page 1 of 1

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).