SimulCare II(TM)

• K Number: K160246
• Device Name: SimulCare II(TM)
• Manufacturer: XANACARE TECHNOLOGIES, LLC
• Date Cleared: 2016-10-06 ( 248 days)
• Product Code: GZJ ILY ISA
• Regulation Number: 882.5890

Intended Use

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.

Predicate Devices

K083202, K081141

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on physical modalities (light, current, magnets, vibration) and improved interface features, with no mention of AI or ML.

Therapeutic

Yes

The device is explicitly described as a "Multi-function Therapeutic Device" and its intended uses are for the "temporary relief of minor muscle and joint pain," "promoting the relaxation of muscle tissue," "increasing local blood circulation," and "symptomatic relief and management of chronic intractable pain," all of which are therapeutic applications.

Diagnostic

No

The device description and intended use indicate that the SimulCare II is a therapeutic device for pain relief and muscle relaxation, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Portable, lightweight, rechargeable unit consisting of a hand-held controller... 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." This clearly indicates the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use describes the device's application for temporary relief of pain, muscle relaxation, increased blood circulation, and pain management. These are all therapeutic applications applied directly to the body.
• Device Description: The device description details a portable unit with a hand-held controller and a flexible pad that delivers various physical therapies (light, current, magnets, massage). This is a physical therapy device, not a device used to examine specimens from the human body.
• Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on samples, or providing diagnostic information based on laboratory analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SimulCare II™ does not fit this description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GZJ, ILY, ISA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests submitted or relied upon: Safety & EMC Testing
Clinical tests submitted or relied upon: None

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K083202, K081141

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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

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 [phone] or [phone] 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 [phone] or [phone] 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)

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)
☑ 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. Siirola
Manager & CEO
Xanacare Technologies, LLC
Denver, Colorado 80237-1857
Phone: [phone]
Fax: [phone]
Email: [e-mail]
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 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.
Indications for use:
The SimulCare II Multi-function Therapeutic Device 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.
Shipping & Storage:
The packaged device will withstand normal shipping and storage environments and
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
substantially equivalent to the legally marketed FDA cleared
predicate devices, based on intended use, materials, and
design. The proposed devices do not introduce new issues
of 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):

| Device

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-
function Therapeutic
Device 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.	The SimulCare Multi-
function Therapeutic
Device 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.	The ComboCare 2000 Multi-
function Therapeutic Device
is intended for the
temporary relief of minor
muscle and joint pain,
promoting the relaxation of
muscle tissue, symptomatic
relief and management of
chronic intractable pain, and
adjunctive relief of post-
surgical or post-traumatic
pain.	Predicate device
ComboCare 2000™
K081141 did not state
an intended use for
temporarily increasing
local blood circulation.

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| Device

Description	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 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.	Portable, lightweight,
rechargeable unit
consisting of a hand-held
controller with analog
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.	Portable, lightweight,
rechargeable unit
consisting of a hand-held
controller with analog
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), and
vibratory massage.	Predicate devices
SimulCare™ K083202
and ComboCare
2000™ K081141
utilized analog control
of stimulation
parameters, while the
proposed SimulCare
II™ device utilizes
digital control of
stimulation parameters.
Device
Description	SimulCare II™	SimulCare™	ComboCare 2000™
Manufacturer	Xanacare Technologies	Xanacare Technologies	Xanacare Technologies	Differences
510(k)
Number	(This Submission)	K083202	K081141
Material	All patient contacting
materials used in the device
are identical to those
similarly used in other FDA
cleared or 510(k) exempt
devices, in formulation and
processing, and no other
chemicals have been added
(e.g. plasticizers, fillers, color
additives, cleaning agents,
mold release agents, etc.).	All patient contacting
materials used in the device
are identical to those
similarly used in other FDA
cleared or 510(k) exempt
devices, in formulation and
processing, and no other
chemicals have been added
(e.g. plasticizers, fillers, color
additives, cleaning agents,
mold release agents, etc.).	All patient contacting
materials used in the device
are identical to those
similarly used in other FDA
cleared or 510(k) exempt
devices, in formulation and
processing, and no other
chemicals have been added
(e.g. plasticizers, fillers, color
additives, cleaning agents,
mold release agents, etc.).	Predicate devices
SimulCare™ K083202
and ComboCare
2000™ K081141
utilized Conductive Gel,
while the proposed
SimulCare II™ device
utilizes Conductive
Spray.
Chemical
Composition	Pad cloth material = Nylon
Jersey Fabric (latex free)
IR LED lens & Red LED
lens = Water Clear Epoxy
Conductive (TENS)
electrode contacts =
Chrome plated brass
Static Magnetic Discs =
Ferrite
Conductive Spray = Water
Soluble, Clear Green,
Odorless, Aqueous Liquid
Charged Batteries	Pad cloth material = Nylon
Jersey Fabric (latex free)
IR LED lens & Red LED
lens = Water Clear Epoxy
Conductive (TENS)
electrode contacts =
Chrome plated brass
Static Magnetic Discs =
Ferrite
Conductive Gel = Water
Soluble, Clear Green,
Odorless, Aqueous Liquid
Charged Batteries	Pad cloth material = Nylon
Jersey Fabric (latex free)
IR LED lens & Red LED
lens = Water Clear Epoxy
Conductive (TENS)
electrode contacts =
Chrome plated brass
None
Conductive Gel = Water
Soluble, Clear Green,
Odorless, Aqueous Liquid
Charged Batteries
Energy
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
as necessary.	10-12 minute treatment sessions, 1 to 3 times a day
as necessary.	10-12 minute treatment sessions, 1 to 3 times a day
as necessary.
Electrical Power
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