ZX-I POWER ADD ON

{0}------------------------------------------------ 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 {1}------------------------------------------------ # 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. #### 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. . {2}------------------------------------------------ #### 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." {3}------------------------------------------------ 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 {4}------------------------------------------------ TABLE 1 1. 1. 1. 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 to<br>disabled persons who are capable of operating a<br>powered and manual wheelchair, by providing<br>powered 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 to<br>an existing manual wheelchair | Same | | | Major components of the ZX-1 are wheels, frame,<br>motors, motor controller, joystick, rechargeable<br>batteries | Same | | | Free Wheel Mode which disables the drive motors<br>and allows the device to be attendant propelled when<br>the power-conversion device is attached | Same | | | The ZX-1 kit may be removed altogether and the host<br>wheelchair restored to its status as a manual<br>wheelchair | Same | | | The ZX-1 may be used both indoors and outdoors | Same | | | Power wheelchair operation is carried out by the user<br>and not by an attendant. | Same | | | Technology: | | | | Spinergy ZX-1 Power Add On | Alber Technologies E-Fix (K943789) | | | Basic electro-mechanical drive technology consisting<br>of two drive motors and basic gear reduction | Same | | | Motors are controlled using a microprocessor based<br>motor controller | Same | | | The microprocessor automatically controls the speed<br>of 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 . . . . . . . {5}------------------------------------------------ TABLE 2 . : 11 11:10 PM 11 11 : . : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : | DIFFERENCES | | | | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description: | Spinergy ZX-1<br>Power Add On | Alber Technologies E-<br>Fix (K943789) | Discussion | | Wheel<br>configuration | 4 wheels: I rear anti-<br>tip. I front lift wheel.<br>2 (10") central drive<br>wheels | 2 main drive wheels | Both devices utilize centrally located drive wheels and<br>maintain usage of the host wheelchair's front casters.<br>Therefore, they are substantially equivalent in this<br>respect. | | Mechanism to<br>attach/detach to<br>wheelchair | Mechanized clamp<br>attaches/detaches to<br>manual wheelchair<br>frame | Manually<br>attached/detach E-Fix<br>wheels and standard<br>rear wheels. | The ZX-1 attach/detach process is motorized while the<br>E-Fix wheels are attached/detached manually. This does<br>not affect safety as the ZX-I does not operate unless the<br>connection has been made and confirmed via the device<br>software. | | Brake<br>mechanism | Electromagnetic<br>braking system and<br>disk park brake. | Electronic engine<br>braking system, spring<br>loaded drum brakes and<br>the original wheelchair<br>brake. | While the E-Fix claims to have 3 braking systems it is<br>relying on the host wheelchair hand brake as one of<br>them. Therefore, there are only two brakes in the device<br>itself and they are similar to the ZX-1. The engine brake<br>functions in the same manner as the ZX-1<br>electromagnetic brake in that both go into effect<br>whenever the joystick control is returned to its neutral,<br>central position. The E-fix drum brake functions in the<br>same manner as the ZX-1 disk park brake in that both<br>brakes become engaged once the wheelchair comes to a<br>stop. | | Theoretical<br>driving range | 5.0 mi. | Up to 12 miles<br>depending on the<br>weight of the person.<br>Typical range is 15.5<br>miles. | The E-Fix will travel further between charges. This has<br>no effect on safety or effectiveness as battery depletion<br>is still possible for both devices. The ZX-1 battery<br>indicator flashes red when the batteries are near<br>depletion. If the batteries fail, the ZX-1 may be placed in<br>free wheel mode and can be moved. If the E-Fix<br>batteries fail it can be reset to manual mode and can be<br>moved. Therefore, they are equivalent in this respect. | | Battery Mount | Self-contained battery | Docking battery pack | ZX-1 battery is permanently mounted to the ZX-1<br>frame. E-Fix is contained in a battery pack which mounts<br>to the rear of the host wheelchair. This does not<br>deleteriously affect safety. With the E-Fix the user is<br>more likely to be exposed to the battery than with the<br>ZX-1. | | Host<br>Wheelchair<br>Requirements | Used only with a rigid<br>frame manual<br>wheelchair. Cannot be<br>used with a folding<br>frame manual<br>wheelchair | Adapts to both a rigid<br>frame and folding<br>frame manual<br>wheelchair | This has no effect on safety or effectiveness. It only<br>limits the type of wheelchair with which the ZX-1 can be<br>used. The ZX-1 labeling clearly states that it cannot be<br>used with a folding frame manual wheelchair. | | Free Wheel<br>Operation | Attendant propelled.<br>only | Can be both user<br>propelled and attendant<br>propelled. | This has no effect on safety or effectiveness. Free wheel<br>mode is intended to permit the device to be moved<br>manually, if needed. Should the user for some reason be<br>unable to operate the chair in power mode, it is likely<br>he/she would not be able to self-propel the wheelchair<br>and would require attendant assistance. | : {6}------------------------------------------------ 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. {7}------------------------------------------------ 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 {8}------------------------------------------------ #### 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