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.

Device Description

The SimulCare II Multi-function Therapeutic Device is modified from the SimulCare and ComboCare 2000 devices previously cleared under 510(k)s K083202 & K081141 and includes improved interface features, EMI filters, additional audible alarm and battery monitoring circuit drain prevention.
Portable, lightweight, rechargeable unit consisting of a hand-held controller with digital control of stimulation parameters and an attached flexible pad that produces battery-charged therapy consisting of red light emitting diodes, infrared light emitting diodes, micro current, macro current (E-stim), permanent magnets and vibratory massage.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device called SimulCare II™. It asserts substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable to this type of submission.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document describes the SimulCare II™ device and compares it to two predicate devices (SimulCare™ K083202 and ComboCare 2000™ K081141) to establish substantial equivalence. It does not present explicit "acceptance criteria" in the traditional sense of performance targets that the device itself must meet independently through a clinical trial. Instead, the "acceptance" is based on demonstrating that the new device is as safe and effective as existing legally marketed devices for the same intended use. The comparison tables highlight the similarities and differences in technological characteristics and electrical parameters.

Feature	Predicate Device Performance (SimulCare™ K083202 & ComboCare 2000™ K081141)	Proposed Device Performance (SimulCare II™)
Intended Use	Temporary relief of minor muscle and joint pain, relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, adjunctive relief of post-surgical or post-traumatic pain.ComboCare 2000™ did not state an intended use for temporarily increasing local blood circulation.	Temporary relief of minor muscle and joint pain, promoting 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.
Design (Control)	Analog control of stimulation parameters	Digital control of stimulation parameters
Material (Conductive Medium)	Conductive Gel	Conductive Spray
Magnetic Feature (present)	SimulCare™: Yes; ComboCare 2000™: No	Yes
Number of Channels	1	1
Maximum Output Current (E-stim mode)	0-40 mA / 500 Ω load	0-40 mA / 500 Ω load
Maximum Output Current (microcurrent mode)	0-14.4 mA / 500 Ω load	0-14.4 mA / 500 Ω load
Maximum Output Voltage (E-stim mode)	0-30 V / 1 KΩ load	0-30 V / 1 KΩ load
Maximum Output Voltage (microcurrent mode)	0-9.3 V / 1 KΩ load	0-9.3 V / 1 KΩ load
Pulse Rate / Frequency (E-stim mode)	Fixed at 68 pps/Hz	Nominal factory settings: 72 pps/Hz (Fixed at 68 pps/Hz based on comparison table #2)
Pulse Rate / Frequency (microcurrent mode)	Fixed at 3.5 pps/Hz	Nominal factory settings: 8 pps/Hz (Fixed at 3.5 pps/Hz based on comparison table #2)
TENS Pulse Width	200 microseconds	200 microseconds
µTENS Pulse Width	SimulCare™ & ComboCare 2000™: 62 milliseconds	143 milliseconds
Waveforms	Asymmetrical Pulse Train ~68 Hz (TENS); Asymmetrical biphasic square wave (µTENS)	Asymmetrical Pulse Train ~68 Hz (TENS); Asymmetrical biphasic square wave (µTENS)
Other Features (IR/Red LED, Magnets, Vibrator)	Largely similar/identical, with differences in what was included in older predicate models (e.g., ComboCare 2000™ lacked magnets)	Included: Pulsed IR/Red LEDs, static magnetic field, vibratory massage

2. Sample size used for the test set and the data provenance:

Not applicable (N/A). The submission states "Clinical tests submitted or relied upon: None" (page 3). The evaluation is based on a comparison to predicate devices, not on a new clinical study with a test set. Non-clinical tests included "Safety & EMC Testing" (page 3), but details on sample size or data provenance for these engineering tests are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. No test set or ground truth established by experts is mentioned, as no clinical study was conducted for this 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

N/A. No test set or adjudication process is mentioned, as no clinical study was conducted.

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:

N/A. This device is an electrical nerve stimulator, not an AI-powered diagnostic or interpretive device. No MRMC study or AI assistance is relevant here.

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

N/A. This device does not involve an algorithm or AI that would have standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

N/A. No ground truth was established, as no clinical study was conducted. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning their safety and effectiveness (previously established) are considered the "ground truth" for comparison.

8. The sample size for the training set:

N/A. The device is not an AI/machine learning model, so there is no training set.

9. How the ground truth for the training set was established:

N/A. No training set or ground truth for a training set exists for this device.

Summary

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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 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

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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

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Indications for Use

510(k) Number (if known) K160246

Device Name SimulCare II™

Indications for Use (Describe)

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)

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510(k) Summary
Date prepared:	06 Oct 2016
Applicant:	Xanacare Technologies, LLC
Contact person:	Thomas C. SiirolaManager & CEOXanacare Technologies, LLCDenver, Colorado 80237-1857Phone: (720) 554-9262Fax: (720) 554-9264Email: 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:The SimulCare II Multi-function Therapeutic Device is modified from the SimulCare andComboCare 2000 devices previously cleared under 510(k)s K083202 & K081141 andincludes improved interface features, EMI filters, additional audible alarm and batterymonitoring circuit drain prevention.
Indications for use:The SimulCare II Multi-function Therapeutic Device is intended for the temporary reliefof minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarilyincreasing local blood circulation, symptomatic relief and management of chronicintractable pain, and adjunctive relief of post-surgical or post-traumatic pain.
Shipping & Storage:The packaged device will withstand normal shipping and storage environments andlabeling 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 issubstantially equivalent to the legally marketed FDA clearedpredicate devices, based on intended use, materials, anddesign. The proposed devices do not introduce new issuesof safety or effectiveness

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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):

DeviceDescription	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-function TherapeuticDevice is intended for thetemporary relief of minormuscle and joint pain,promoting the relaxation ofmuscle tissue, temporarilyincreasing local bloodcirculation, symptomaticrelief and management ofchronic intractable pain,and adjunctive relief ofpost-surgical or post-traumatic pain.	The SimulCare Multi-function TherapeuticDevice is intended for thetemporary relief of minormuscle and joint pain,promoting the relaxation ofmuscle tissue, temporarilyincreasing local bloodcirculation, symptomaticrelief and management ofchronic intractable pain,and adjunctive relief ofpost-surgical or post-traumatic pain.	The ComboCare 2000 Multi-function Therapeutic Deviceis intended for thetemporary relief of minormuscle and joint pain,promoting the relaxation ofmuscle tissue, symptomaticrelief and management ofchronic intractable pain, andadjunctive relief of post-surgical or post-traumaticpain.	Predicate deviceComboCare 2000™K081141 did not statean intended use fortemporarily increasinglocal blood circulation.

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DeviceDescription	SimulCare II™	SimulCare™	ComboCare 2000™
Manufacturer	Xanacare Technologies	Xanacare Technologies	Xanacare Technologies	Differences
510(k)Number	(This Submission)	K083202	K081141
Design	Portable, lightweight,rechargeable unit consistingof a hand-held controller withdigital control of stimulationparameters and an attachedflexible pad that producesbattery-charged therapyconsisting of red lightemitting diodes, infrared lightemitting diodes, microcurrent, macro current (E-stim), permanent magnetsand vibratory massage.	Portable, lightweight,rechargeable unitconsisting of a hand-heldcontroller with analogcontrol of stimulationparameters and anattached flexible pad thatproduces battery-chargedtherapy consisting of redlight emitting diodes,infrared light emittingdiodes, micro current,macro current (E-stim),permanent magnets andvibratory massage.	Portable, lightweight,rechargeable unitconsisting of a hand-heldcontroller with analogcontrol of stimulationparameters and anattached flexible pad thatproduces battery-chargedtherapy consisting of redlight emitting diodes,infrared light emittingdiodes, micro current,macro current (E-stim), andvibratory massage.	Predicate devicesSimulCare™ K083202and ComboCare2000™ K081141utilized analog controlof stimulationparameters, while theproposed SimulCareII™ device utilizesdigital control ofstimulation parameters.
DeviceDescription	SimulCare II™	SimulCare™	ComboCare 2000™
Manufacturer	Xanacare Technologies	Xanacare Technologies	Xanacare Technologies	Differences
510(k)Number	(This Submission)	K083202	K081141
Material	All patient contactingmaterials used in the deviceare identical to thosesimilarly used in other FDAcleared or 510(k) exemptdevices, in formulation andprocessing, and no otherchemicals have been added(e.g. plasticizers, fillers, coloradditives, cleaning agents,mold release agents, etc.).	All patient contactingmaterials used in the deviceare identical to thosesimilarly used in other FDAcleared or 510(k) exemptdevices, in formulation andprocessing, and no otherchemicals have been added(e.g. plasticizers, fillers, coloradditives, cleaning agents,mold release agents, etc.).	All patient contactingmaterials used in the deviceare identical to thosesimilarly used in other FDAcleared or 510(k) exemptdevices, in formulation andprocessing, and no otherchemicals have been added(e.g. plasticizers, fillers, coloradditives, cleaning agents,mold release agents, etc.).	Predicate devicesSimulCare™ K083202and ComboCare2000™ K081141utilized Conductive Gel,while the proposedSimulCare II™ deviceutilizes ConductiveSpray.
ChemicalComposition	Pad cloth material = NylonJersey Fabric (latex free)IR LED lens & Red LEDlens = Water Clear EpoxyConductive (TENS)electrode contacts =Chrome plated brassStatic Magnetic Discs =FerriteConductive Spray = WaterSoluble, Clear Green,Odorless, Aqueous LiquidCharged Batteries	Pad cloth material = NylonJersey Fabric (latex free)IR LED lens & Red LEDlens = Water Clear EpoxyConductive (TENS)electrode contacts =Chrome plated brassStatic Magnetic Discs =FerriteConductive Gel = WaterSoluble, Clear Green,Odorless, Aqueous LiquidCharged Batteries	Pad cloth material = NylonJersey Fabric (latex free)IR LED lens & Red LEDlens = Water Clear EpoxyConductive (TENS)electrode contacts =Chrome plated brassNoneConductive Gel = WaterSoluble, Clear Green,Odorless, Aqueous LiquidCharged Batteries
EnergySource	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 dayas necessary.	10-12 minute treatment sessions, 1 to 3 times a dayas necessary.	10-12 minute treatment sessions, 1 to 3 times a dayas necessary.
Electrical PowerSource:	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)

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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:

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Substantial Equivalence Comparison Table #2

DeviceDescription	SimulCare II™1	SimulCare™	ComboCare 2000™
510(k) Number:	(This submission)	K083202	K081141
Number of Channels	1	1	1
Maximum OutputCurrent2	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 (microcurrentmode)	0-14.4 mA / 500 Ω load (microcurrentmode)	0-14.4 mA / 500 Ω load (microcurrentmode)
Maximum OutputVoltage2	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 (microcurrentmode)	0-9.3 V / 1 KΩ load (microcurrentmode)	0-9.3 V / 1 KΩ load (microcurrentmode)
Pulse Rate /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, (microcurrentmode)	Fixed at 3.5 pps/Hz, (microcurrentmode)	Fixed at 3.5 pps/Hz, (microcurrentmode)
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 wavechanges polarity every 8 cycles for netzero charge (biphasic)	Asymmetrical biphasic square wavechanges polarity every 8 cycles for netzero charge (biphasic)	Asymmetrical biphasic square wavechanges polarity every 8 cycles for netzero 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).

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DeviceTracings	SimulCare II™	SimulCare™	ComboCare 2000™
Manufacturer	Xanacare Technologies	Xanacare Technologies	Xanacare Technologies	Differences
510(k) Number	(This Submission)	K083202	K081141
TENS@500Ω(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™	PredicatedevicesSimulCare™K083202 andComboCare
TENS@2kΩ(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™K081141TENS &μTENSControlleroutputs
TENS@10kΩ(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 andaresubstantiallysimilar to theproposed
μTENS@500Ω(microcurrentmode)	Image: μTENS@500Ω (microcurrent mode) SimulCare II™	Image: μTENS@500Ω (microcurrent mode) SimulCare™	Image: μTENS@500Ω (microcurrent mode) ComboCare 2000™	deviceSimulCare II™
μTENS@2kΩ(microcurrentmode)	Image: μTENS@2kΩ (microcurrent mode) SimulCare II™	Image: μTENS@2kΩ (microcurrent mode) SimulCare™	Image: μTENS@2kΩ (microcurrent mode) ComboCare 2000™

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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.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).