SimulCare II(TM)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 6, 2016 Xanacare Technologies, LLC % Charles Hart Principal Consultant Hart Consulting LLC 2964 Redhaven Way Littleton, Colorado 80126-5595 Re: K160246 Trade/Device Name: Simulcare IITM Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ, ILY, ISA Dated: August 31, 2016 Received: August 31, 2016 Dear Mr. Hart: 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 device {1}------------------------------------------------ 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. 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) K160246 Device Name SimulCare II™ Indications for Use (Describe) The SimulCare II™ is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic pain. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### 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 | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Date prepared: | 06 Oct 2016 | | | Applicant: | Xanacare Technologies, LLC | | | Contact person: | Thomas C. Siirola<br>Manager & CEO<br>Xanacare Technologies, LLC<br>Denver, Colorado 80237-1857<br>Phone: (720) 554-9262<br>Fax: (720) 554-9264<br>Email: tcsiirola@xanacare.com | | | Trade name: | SimulCare II™ | | | Common name: | Multi-function Therapeutic Device | Class: 2 | | Classification name: | Transcutaneous Electrical Nerve Stimulator for Pain Relief | Product code: GZJ, ILY & ISA | | Predicate devices: | K083202, K081141 | | | Device description:<br>The SimulCare II Multi-function Therapeutic Device is modified from the SimulCare and<br>ComboCare 2000 devices previously cleared under 510(k)s K083202 & K081141 and<br>includes improved interface features, EMI filters, additional audible alarm and battery<br>monitoring circuit drain prevention. | | | | Indications for use:<br>The SimulCare II Multi-function Therapeutic Device is intended for the temporary relief<br>of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily<br>increasing local blood circulation, symptomatic relief and management of chronic<br>intractable pain, and adjunctive relief of post-surgical or post-traumatic pain. | | | | Shipping & Storage:<br>The packaged device will withstand normal shipping and storage environments and<br>labeling shall meet 21CFR 801, EN 1041, and ISO 15223. | | | | Non-clinical tests submitted or relied upon: | Safety & EMC Testing | | | Clinical tests submitted or relied upon: | None | | | Substantial equivalence conclusion: | The SimulCare II Multi-function Therapeutic Device is<br>substantially equivalent to the legally marketed FDA cleared<br>predicate devices, based on intended use, materials, and<br>design. The proposed devices do not introduce new issues<br>of safety or effectiveness | | {4}------------------------------------------------ ### Technological Characteristics Comparison Table The following table shows the significant similarities and no differences between the proposed device (this submission) and the predicate Devices (K083202 & K081141): | Device<br>Description | SimulCare II™ | SimulCare™ | ComboCare 2000™ | Differences | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Xanacare Technologies | Xanacare Technologies | Xanacare Technologies | | | 510(k) Number | (This Submission) | K083202 | K081141 | | | Intended Use | The SimulCare II Multi-<br>function Therapeutic<br>Device is intended for the<br>temporary relief of minor<br>muscle and joint pain,<br>promoting the relaxation of<br>muscle tissue, temporarily<br>increasing local blood<br>circulation, symptomatic<br>relief and management of<br>chronic intractable pain,<br>and adjunctive relief of<br>post-surgical or post-<br>traumatic pain. | The SimulCare Multi-<br>function Therapeutic<br>Device is intended for the<br>temporary relief of minor<br>muscle and joint pain,<br>promoting the relaxation of<br>muscle tissue, temporarily<br>increasing local blood<br>circulation, symptomatic<br>relief and management of<br>chronic intractable pain,<br>and adjunctive relief of<br>post-surgical or post-<br>traumatic pain. | The ComboCare 2000 Multi-<br>function Therapeutic Device<br>is intended for the<br>temporary relief of minor<br>muscle and joint pain,<br>promoting the relaxation of<br>muscle tissue, symptomatic<br>relief and management of<br>chronic intractable pain, and<br>adjunctive relief of post-<br>surgical or post-traumatic<br>pain. | Predicate device<br>ComboCare 2000™<br>K081141 did not state<br>an intended use for<br>temporarily increasing<br>local blood circulation. | {5}------------------------------------------------ | Device<br>Description | SimulCare II™ | SimulCare™ | ComboCare 2000™ | | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Xanacare Technologies | Xanacare Technologies | Xanacare Technologies | Differences | | 510(k)<br>Number | (This Submission) | K083202 | K081141 | | | Design | Portable, lightweight,<br>rechargeable unit consisting<br>of a hand-held controller with<br>digital control of stimulation<br>parameters and an attached<br>flexible pad that produces<br>battery-charged therapy<br>consisting of red light<br>emitting diodes, infrared light<br>emitting diodes, micro<br>current, macro current (E-<br>stim), permanent magnets<br>and vibratory massage. | Portable, lightweight,<br>rechargeable unit<br>consisting of a hand-held<br>controller with analog<br>control of stimulation<br>parameters and an<br>attached flexible pad that<br>produces battery-charged<br>therapy consisting of red<br>light emitting diodes,<br>infrared light emitting<br>diodes, micro current,<br>macro current (E-stim),<br>permanent magnets and<br>vibratory massage. | Portable, lightweight,<br>rechargeable unit<br>consisting of a hand-held<br>controller with analog<br>control of stimulation<br>parameters and an<br>attached flexible pad that<br>produces battery-charged<br>therapy consisting of red<br>light emitting diodes,<br>infrared light emitting<br>diodes, micro current,<br>macro current (E-stim), and<br>vibratory massage. | Predicate devices<br>SimulCare™ K083202<br>and ComboCare<br>2000™ K081141<br>utilized analog control<br>of stimulation<br>parameters, while the<br>proposed SimulCare<br>II™ device utilizes<br>digital control of<br>stimulation parameters. | | Device<br>Description | SimulCare II™ | SimulCare™ | ComboCare 2000™ | | | Manufacturer | Xanacare Technologies | Xanacare Technologies | Xanacare Technologies | Differences | | 510(k)<br>Number | (This Submission) | K083202 | K081141 | | | Material | All patient contacting<br>materials used in the device<br>are identical to those<br>similarly used in other FDA<br>cleared or 510(k) exempt<br>devices, in formulation and<br>processing, and no other<br>chemicals have been added<br>(e.g. plasticizers, fillers, color<br>additives, cleaning agents,<br>mold release agents, etc.). | All patient contacting<br>materials used in the device<br>are identical to those<br>similarly used in other FDA<br>cleared or 510(k) exempt<br>devices, in formulation and<br>processing, and no other<br>chemicals have been added<br>(e.g. plasticizers, fillers, color<br>additives, cleaning agents,<br>mold release agents, etc.). | All patient contacting<br>materials used in the device<br>are identical to those<br>similarly used in other FDA<br>cleared or 510(k) exempt<br>devices, in formulation and<br>processing, and no other<br>chemicals have been added<br>(e.g. plasticizers, fillers, color<br>additives, cleaning agents,<br>mold release agents, etc.). | Predicate devices<br>SimulCare™ K083202<br>and ComboCare<br>2000™ K081141<br>utilized Conductive Gel,<br>while the proposed<br>SimulCare II™ device<br>utilizes Conductive<br>Spray. | | Chemical<br>Composition | Pad cloth material = Nylon<br>Jersey Fabric (latex free)<br>IR LED lens & Red LED<br>lens = Water Clear Epoxy<br>Conductive (TENS)<br>electrode contacts =<br>Chrome plated brass<br>Static Magnetic Discs =<br>Ferrite<br>Conductive Spray = Water<br>Soluble, Clear Green,<br>Odorless, Aqueous Liquid<br>Charged Batteries | Pad cloth material = Nylon<br>Jersey Fabric (latex free)<br>IR LED lens & Red LED<br>lens = Water Clear Epoxy<br>Conductive (TENS)<br>electrode contacts =<br>Chrome plated brass<br>Static Magnetic Discs =<br>Ferrite<br>Conductive Gel = Water<br>Soluble, Clear Green,<br>Odorless, Aqueous Liquid<br>Charged Batteries | Pad cloth material = Nylon<br>Jersey Fabric (latex free)<br>IR LED lens & Red LED<br>lens = Water Clear Epoxy<br>Conductive (TENS)<br>electrode contacts =<br>Chrome plated brass<br>None<br>Conductive Gel = Water<br>Soluble, Clear Green,<br>Odorless, Aqueous Liquid<br>Charged Batteries | | | Energy<br>Source | Charged Batteries | Charged Batteries | Charged Batteries | | | Device Description | SimulCare II™ | SimulCare™ | ComboCare 2000™ | | | 510(k) Number: | (This submission) | K083202 | K081141 | | | Available Features: | 3 Modes | 3 Modes | 3 Modes | | | • Infrared Light | Pulsed infrared light emitting diodes (LED) | Pulsed infrared light emitting diodes (LED) | Pulsed infrared light emitting diodes (LED) | | | • Red Light | Pulsed red light emitting diodes (LED) | Pulsed red light emitting diodes (LED) | Pulsed red light emitting diodes (LED) | | | • Magnetic | Static magnetic field. | Static magnetic field. | None | | | • TENS | Transcutaneous electrical nerve stimulator | Transcutaneous electrical nerve stimulator | Transcutaneous electrical nerve stimulator | | | • Vibrator | Vibratory massage | Vibratory massage | Vibratory massage | | | • Laser | None | None | None | | | Treatment Times: | 10-12 minute treatment sessions, 1 to 3 times a day<br>as necessary. | 10-12 minute treatment sessions, 1 to 3 times a day<br>as necessary. | 10-12 minute treatment sessions, 1 to 3 times a day<br>as necessary. | | | Electrical Power<br>Source: | 4 Rechargeable AA NiMH batteries | 4 Rechargeable AA NiMH batteries | 4 Rechargeable AA NiMH batteries | | | LED Pulse Width | 75 milliseconds, 5-12 Hz | 75 milliseconds, 5-12 Hz | 75 milliseconds, 5-12 Hz | | | IR LED Power | < 45 mW per LED | < 45 mW per LED | < 45 mW per LED | | | IR LED Wavelength | 870 nm | 870 nm | 870 nm | | | No. of IR LEDs | 24 LEDS (regular pad) / 48 LEDs (large pad) | 24 LEDS (regular pad) / 48 LEDs (large pad) | 24 LEDS (regular pad) / 48 LEDs (large pad) | | | Red LED Power | ~ 10,000 mcd (millicandela) per LED | ~ 10,000 mcd (millicandela) per LED | ~ 10,000 mcd (millicandela) per LED | | | Red LED Wavelength | 640 nm | 640 nm | 640 nm | | | No. of RED LEDs | 32 LEDs (regular pad) / 64 LEDs (large pad) | 32 LEDs (regular pad) / 64 LEDs (large pad) | 32 LEDs (regular pad) / 64 LEDs (large pad) | | | Types of Magnets | 4 permanent magnets | 4 permanent magnets | None | | | Magnetic Strength | 300 – 475 Gauss | 300 – 475 Gauss | None | | | Vibrator | Miniature pancake motor(s) | Miniature pancake motor(s) | Miniature pancake motor(s) | | {6}------------------------------------------------ {7}------------------------------------------------ #### 13 Substantial equivalence discussion ## Substantial Equivalence Comparison Table #1 The following table shows the significant similarities and differences between the Xanacare SimulCare II (this submission) and the predicate products, Xanacare SimulCare (K083202) and ComboCare 2000 (K083202: {8}------------------------------------------------ ## Substantial Equivalence Comparison Table #2 The following table shows the significant similarities and differences between the Xanacare SimulCare II (this submission) and the predicate products, Xanacare SimulCare (K083202) and ComboCare 2000 (K083202): | Device<br>Description | SimulCare II™1 | SimulCare™ | ComboCare 2000™ | |----------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | 510(k) Number: | (This submission) | K083202 | K081141 | | Number of Channels | 1 | 1 | 1 | | Maximum Output<br>Current2 | 0-40 mA / 500 Ω load (E-stim mode) | 0-40 mA / 500 Ω load (E-stim mode) | 0-40 mA / 500 Ω load (E-stim mode) | | | 0-14.4 mA / 500 Ω load (microcurrent<br>mode) | 0-14.4 mA / 500 Ω load (microcurrent<br>mode) | 0-14.4 mA / 500 Ω load (microcurrent<br>mode) | | Maximum Output<br>Voltage2 | 0-30 V / 1 KΩ load (E-stim mode) | 0-30 V / 1 KΩ load (E-stim mode) | 0-30 V / 1 KΩ load (E-stim mode) | | | 0-9.3 V / 1 KΩ load (microcurrent<br>mode) | 0-9.3 V / 1 KΩ load (microcurrent<br>mode) | 0-9.3 V / 1 KΩ load (microcurrent<br>mode) | | Pulse Rate /<br>Frequency3 | Fixed at 68 pps/Hz, (E-stim mode) | Fixed at 68 pps/Hz, (E-stim mode) | Fixed at 68 pps/Hz, (E-stim mode) | | | Fixed at 3.5 pps/Hz, (microcurrent<br>mode) | Fixed at 3.5 pps/Hz, (microcurrent<br>mode) | Fixed at 3.5 pps/Hz, (microcurrent<br>mode) | | Tens Pulse Width | 200 microseconds | 200 microseconds | 200 microseconds | | Tens Waveform | Asymmetrical Pulse Train ~68 Hz | Asymmetrical Pulse Train ~68 Hz | Asymmetrical Pulse Train ~68 Hz | | µTENS Pulse Width | 143 milliseconds | 62 milliseconds | 62 milliseconds | | µTENS Waveform | Asymmetrical biphasic square wave<br>changes polarity every 8 cycles for net<br>zero charge (biphasic) | Asymmetrical biphasic square wave<br>changes polarity every 8 cycles for net<br>zero charge (biphasic) | Asymmetrical biphasic square wave<br>changes polarity every 8 cycles for net<br>zero charge (biphasic) | Notes: 1 SimulCare II Multi-function Therapeutic Device operates in either in E-stim or micro-current mode, depending on switch setting. ² The SimulCare II Multi-unction Therapeutic Devices. Therefore there output voltage, current and power are dependent upon the load. 3 Nominal factory settings for the SimulCare II is 72 pps/Hz (E-stim mode) and 8 pps/Hz (micro-current mode). {9}------------------------------------------------ | Device<br>Tracings | SimulCare II™ | SimulCare™ | ComboCare 2000™ | | |--------------------------------------|-----------------------------------------------------|--------------------------------------------------|-------------------------------------------------------|---------------------------------------------------------------------| | Manufacturer | Xanacare Technologies | Xanacare Technologies | Xanacare Technologies | Differences | | 510(k) Number | (This Submission) | K083202 | K081141 | | | TENS@500Ω<br>(E-stim mode) | Image: TENS@500Ω (E-stim mode) SimulCare II™ | Image: TENS@500Ω (E-stim mode) SimulCare™ | Image: TENS@500Ω (E-stim mode) ComboCare 2000™ | Predicate<br>devices<br>SimulCare™<br>K083202 and<br>ComboCare | | TENS@2kΩ<br>(E-stim mode) | Image: TENS@2kΩ (E-stim mode) SimulCare II™ | Image: TENS@2kΩ (E-stim mode) SimulCare™ | Image: TENS@2kΩ (E-stim mode) ComboCare 2000™ | 2000™<br>K081141<br>TENS &<br>μTENS<br>Controller<br>outputs | | TENS@10kΩ<br>(E-stim mode) | Image: TENS@10kΩ (E-stim mode) SimulCare II™ | Image: TENS@10kΩ (E-stim mode) SimulCare™ | Image: TENS@10kΩ (E-stim mode) ComboCare 2000™ | identical and<br>are<br>substantially<br>similar to the<br>proposed | | μTENS@500Ω<br>(microcurrent<br>mode) | Image: μTENS@500Ω (microcurrent mode) SimulCare II™ | Image: μTENS@500Ω (microcurrent mode) SimulCare™ | Image: μTENS@500Ω (microcurrent mode) ComboCare 2000™ | device<br>SimulCare II™ | | μTENS@2kΩ<br>(microcurrent<br>mode) | Image: μTENS@2kΩ (microcurrent mode) SimulCare II™ | Image: μTENS@2kΩ (microcurrent mode) SimulCare™ | Image: μTENS@2kΩ (microcurrent mode) ComboCare 2000™ | | {10}------------------------------------------------ Image /page/10/Figure/3 description: The image contains six graphs organized in a 2x3 grid. The top row of graphs are labeled as 'µTENS@10kΩ (microcurrent mode)', and the bottom row of graphs are labeled as 'TENS Train (E-stim mode)'. The graphs in the top row show a repeating square wave pattern, while the graphs in the bottom row show a series of sharp spikes.