A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and/or apply heat and cooling to the skin.

Device Description

The Dynatron Peltier ThermoStim probe is used to provide therapeutic electrical stimulation and thermal therapy treatments. The probe consists of a handle with a treatment head and connections to a Dynatron Solaris series controlling console for power and communications with a port for connection to electrical stimulation outputs. The probe acts as an electrode for therapeutic electrical current provided by a Dynatron Solaris device in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) supplied from a thermo-electric chip. The probe is a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatron Solaris series electrical stimulation devices. The probe has a rectangular wedge treatment face of approximately 1¼³ x 2¼" with rounded edges. The maximum surface area that could come in contact with a patient is approximately 38 cm-.

AI/ML Overview

The provided text serves as a 510(k) summary for the Dynatron Peltier ThermoStim device, which is a combination electrical stimulation and thermal therapy probe. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the manner typically found in a clinical trial.

Therefore, the requested information, particularly regarding detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and comparative effectiveness data with human readers, is not present in the provided document. The document primarily describes the device's technical specifications and compares them to a predicate device to establish substantial equivalence for regulatory approval.

However, I can extract the general performance characteristics and the basis for the declaration of substantial equivalence, which can be interpreted as implicitly meeting regulatory acceptance.

Here's what can be inferred from the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative, pass/fail manner. Instead, "acceptance" is implicitly based on demonstrating that the Dynatron Peltier ThermoStim probe performs "equivalently" to the predicate device, Dynatron ThermoStim probe (K120835). The performance characteristics are compared in relation to the predicate's known performance.

Characteristic	Implied Acceptance Criteria (Based on Predicate Equivalence)	Reported Device Performance (Dynatron Peltier ThermoStim Probe)
Indications for Use	Must match the predicate device's Indications for Use.	"A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and/or apply heat and cooling to the skin." (Matches predicate)
Target Populations	Patients with acute or sub-acute pain (Matches predicate).	Patients with acute or sub-acute pain
Thermal Range (Hot)	Within a therapeutic range, comparable to predicate. Predicate: 104-112°F	90-112°F (Falls within and slightly extends the lower end of the predicate's range, still considered therapeutic)
Thermal Range (Cold)	Within a therapeutic range, comparable to predicate. Predicate: 36-50°F	39-60°F (Falls within and slightly extends the upper end of the predicate's range, still considered therapeutic)
Range of Skin Temperatures (Hot)	Within therapeutic range, comparable to predicate. Predicate: 105.5-108.3°F	90-110.5°F (Falls within and slightly extends range of predicate, still considered therapeutic)
Range of Skin Temperatures (Cold)	Within therapeutic range, comparable to predicate. Predicate: 53.5-56.5°F	44-60.5°F (Falls within and slightly extends range of predicate, still considered therapeutic)
Electrical Stimulation Waveforms	Must show "no differences" from the predicate device output.	"Analysis of the wave forms for delivery of electrical stimulation treatments show no differences with the output from the predicate device compared to the subject device."
Current Density (Gravity Pressure)	Must provide a safe current density; generally comparable to predicate. Predicate: Flat - 0.11 W/cm², Round - 0.20 W/cm²	0.08 W/cm² (Lower than predicate, indicating potentially safer or equivalent performance regarding current density)
Power Density (Gravity Pressure)	Must provide a safe power density; generally comparable to predicate. Predicate: Flat - 4.4mA/cm², Round - 8.3mA/cm²	3.3mA/cm² (Lower than predicate, indicating potentially safer or equivalent performance regarding power density)
Safety Standards Compliance	Compliance with EN60601-1 (dielectric strength) and EN60601-1-2 (electromagnetic compatibility) required prior to marketing.	"will be tested for dielectric strength per EN60601-1 and for electromagnetic compatibility per EN60601-1-2. Per the March 2000 F.DA Office of Device Evaluation guidance document 'Use of Standards in Substantial Equivalence Determinations' these tests will be completed prior to marketing the device." (Commitment to meet these standards)
Mechanical Design Considerations	Treatment area large enough for safe current density; patient contact materials identical to predicate.	"Both probes have treatment areas large enough for a safe current density to mitigate risks of patient injury. Patient contact surfaces for both the predicate and subject probe are identical aluminum composition."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Non-clinical Bench Testing" and "Thermal data was collected." However, it does not specify the sample size of devices tested or the number of measurements taken for either the electrical stimulation waveform analysis or the thermal data collection. The data provenance is implied to be from Dynatronics' internal testing ("Non-clinical Bench Testing"), likely in the USA where the company is located. The nature of the testing (bench testing) is prospective for these measurements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The device is purely a physical therapy accessory and likely does not involve diagnostic interpretation by experts for its core function. The "ground truth" for the performance tests (waveform analysis, temperature measurements) would be established by calibrated measurement equipment, not expert opinion.

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

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data and their disagreements need resolution. Since this document describes bench testing of a physical device, such adjudication methods are not relevant.

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

This information is not provided and not applicable. The Dynatron Peltier ThermoStim is a physical therapy device, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are outside the scope of this device.

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

This information is not applicable. The device is a physical therapy probe that inherently requires human-in-the-loop operation by a practitioner. There is no "algorithm only" performance to evaluate in this context.

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

For electrical stimulation waveform analysis: Comparison against expected, known waveforms from the predicate device and the controlling Solaris console. The "ground truth" is the established electrical signal parameters.
For thermal data: Calibrated temperature measurements. The "ground truth" is the actual measured temperature by sensors.
For safety standards: Compliance with international safety standards (EN60601-1, EN60601-1-2). The "ground truth" is adherence to these normative standards.

8. The sample size for the training set

This information is not provided and not applicable. The Dynatron Peltier ThermoStim probe does not utilize machine learning or AI models that require a "training set" of data.

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

This information is not provided and not applicable as there is no training set for this type of medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Dynatronics. The logo features a stylized letter "D" followed by the word "Dynatronics" in a bold, italicized font. Below the logo is the address "7030 Park Centre Drive - Salt Lake City, Ut 84121" and the phone and fax numbers "800-874-6251 - fax 801-568-7711".

K132057

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

11 September 2013

SUBMITTED BY:

DYNATRONICS CORPORTATION 7030 Park Centre Drive Salt Lake City, UTAH 84121 · Phone: (800) 874-6251; (801) 568-7000 Fax: (801) 568-7711

SUBMITTERS NAME:

Douglas Sampson VP, Operations and R&D DYNATRONICS CORPORATION

1. DEVICE NAME:

Trade Name(s): Common Name:

Classification: Regulation Nos: Product Codes:

Dynatron® Peltier ThermoStim™ Combination Electrical Stimulation and Thermal Therapy probe Class II 882.1320. 890.5720 GXY. ILO

2. PREDICATE DEVICE:

Dynatron ThermoStim probe - K120835 (August 20, 2012)

3. DESCRIPTION:

The probe is a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatron Solaris series electrical stimulation devices.

The probe has a rectangular wedge treatment face of approximately 1¼³ x 2¼" with rounded edges. The maximum surface area that could come in contact with a patient is approximately 38 cm-.

4. INDICATIONS FOR USE:

A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and/or apply heat and cooling to the skin.

The Indications for Use stated in this submission match word for word the Indications for Use cleared for the predicate device.

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Image /page/1/Picture/0 description: The image shows the logo for "Dymatronics" in a stylized font. Below the logo is the address "7030 Park Centre Drive • Salt Lake City, Ut 84121". The logo is black and white and the text is in a smaller font than the logo. The logo has a stylized "D" with a swoosh.

· fax 801-568

5. TECHNICAL ANALYSIS:

The Dynatron Peltier ThermoStim probe generates therapeutic benefits as described in allowed claims through the delivery of electrical stimulation and thermal energy to targeted tissues.

The probe allows the practitioner to manually apply various electrical stimulation treatments (limited to modalities available from the FDA cleared Dynatronics Solaris series devices) as well as thermal energy (hot or cold). The delivery of hot thermal energy has a targeted range of 90 - 112° Fahrenheit and the cold thermal energy has a targeted range of 39 - 60° Fahrenheit.

Performance Characteristics

The probe has a treatment face with a rectangular wedge shape and rounded edges. The treatment face is approximately 11/4" x 21/4" and the tip of the wedge is approximately ½' high. The probe acts as an accessory to provide the following clectrotherapy options:

Biphasic, Russian, HiVolt, Interferential Current (IFC), Premodulated (IFC), and Microcurrent

The probe is designed to deliver thermal energy with the following range options.

Hot = 90 -- 1120 Fahrenheit

Cold = 39 - 60° Fahrenheit

Non-clinical Bench Testing

Wave forms of cach electrotherapy output were captured from a Dynatron Solaris device through the Peltier ThermoStim probe and the predicate ThermoStim probe. Analysis of the wave forms for delivery of electrical stimulation treatments show no differences with the output from the predicate device compared to the subject device.

The Peltier ThermoStim probe will be tested for dielectric strength per EN60601-1 and for electromagnetic compatibility per EN60601-1-2. Per the March 2000 F.DA Office of Device Evaluation guidance document "Use of Standards in Substantial Equivalence Determinations" these tests will be completed prior to marketing the device.

Thermal data was collected from the Peltier ThermoSTIM probe in "hot" and "cold" modes. Results showed temperatures consistently falling in the targeted thermal ranges.

Both devices use the Dynatron Solaris controlling console to deliver electrical stimulation through the probes as a cutaneous electrode. The electrotherapy wave form outputs from the predicate and subject are equivalent. Both probes provide heating and cooling in the same thermal ranges. Both probes have treatment areas large enough for a safe current density to mitigate risks of patient injury. Patient contact surfaces for both the predicate and subject probe are identical aluminum composition. From a non-clinical analysis we conclude that the two probes are substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for Dynatronics, with the company name in bold, stylized font. Below the logo is the address "7030 Park Centre Drive • Salt Lake City, Ut 84121". The logo features a stylized "D" shape to the left of the company name. The text is in black and the background is white.

800-874-6251 • fax 801-568-7711

6. SUBSTANTIAL EQUIVALENCE (SE) RATIONALE:

The Dynatron Peltier ThermoStim probe shares the same basic therapeutic characteristics, features and intended uses as the predicate probes.

	PredicateDynatronThermoStim Probes	Dynatron PeltierThermoStim Probe
Intended Use	Cutaneous electrode withheating and cooling	Cutaneous electrode withheating and cooling
TargetPopulations	Patients with acute or sub-acute pain	Patients with acute or sub-acute pain
Dimensions(W x D x L)	1.5" x 1.5" x 11"	2"x3.6"x10"
Weight	125 grams	750 grams
TherapyDelivery	Electrical stimulation and/orthermal therapy (hot or cold)through contact with patient'sskin	Electrical stimulation and/orthermal therapy (hot or cold)through contact with patient'sskin
ElectricalStimulation	ThermoStim probe acts as acutaneous electrode for thedelivery of electricalstimulation to a patient from aSolaris device	Peltier ThermoStim probeacts as a cutaneous electrodefor the delivery of electricalstimulation to a patient from aSolaris device
Handle Material	Polypropylene plastic	ABS plastic
Treatment FaceMaterial	6061 Aluminum	6061 Aluminum
Treatment FaceOptions	Flat - 1.5" diameter - $11.4cm^2$Domed - 1.1" diameter - $12.3cm^2$	Rectangular - 38 $cm^2$ surface
Current Density(gravitypressure)	Flat - 0.11 W/ $cm^2$Round -0.20 W/ $cm^2$	0.08 W/ $cm^2$
Power Density(gravitypressure)	Flat -4.4mA/ $cm^2$Round -8.3mA/ $cm^2$	3.3mA/ $cm^2$

Summary 4

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Image /page/3/Picture/0 description: The image shows the Dynatronics logo with the company name in a stylized font. Below the logo is the company's address, which is 7030 Park Centre Drive, Salt Lake City, UT 84121. The image also includes the company's phone number, 800-874-6251, and fax number, 801-568-7711.

	PredicateDynatronThermoStim Probes	Dynatron PeltierThermoStim Probe
ThermalTherapy	ThermoStim probe delivers hotor cold thermal therapy viawater that is heated or cooledby Peltier thermo-electricchips in a reservoir andcirculated to the face of theprobe/electrode.	Peltier ThermoStim probedelivers hot or cold thermaltherapy via a Peltier thermo-electric chip that is in contactwith the treatment head of theprobe/electrode
Thermal Range	Hot: 104-112FCold: 36 - 50F	Hot: 90-112FCold: 39 - 60F
Range of SkinTemperatures	Hot: 105.5 - 108.30FCold: 53.5 - 56.5"F	Hot: 90 - 110.5ºFCold: 44 - 60.50F

It is our assessment that the Dynatron Peltier ThermoStim probe is substantially equivalent to the predicate Dynatron ThermoStim probes (applicable "K ' number listed above) because both devices are labeled for the same Indications for Use, both deliver equivalent electrotherapy outputs, both deliver equivalent thermal outputs, and both are a hand held cutaneous electrode accessory controlled by a Dynatron Solaris console. The only distinction is the method by which the thermal energy is delivered and the shape of the electrode.

7. SAFETY AND EFFECTIVENESS SUMMARY:

There are no substantive differences between the product defined in this 510(k) submission and the predicate device is similar to the technology that is currently used in other similar medical devices. This device is subject to development and documentation as required in the Quality System Regulation, 21 CFR Part 820, under design/change control. and is subject to verification and validation to applicable standards / guidance documents. The sum of bench test results and design control outcomes allows us to conclude that the Dynatron Peltier ThermoStim probe is as safe and effective in delivering treatments when used as indicated in specific applications under a clinician's supervision / therapy program as the predicate probes.

Signed:

Dated:

Douglas Sampson, VP, Opcrations and R&D DYNATRONICS CORPORATION

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 24, 2014

Dynatronics Corporation Douglas Sampson 7030 Park Centre Drive Salt Lake City, Utah 84121

Re: K132057

Trade/Device Name: Dynatron Peltier ThermoStim Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, ILO Dated: December 21, 2013 Received: December 23, 2013

Dear Mr. Sampson:

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-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. Douglas Sampson

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/ResourcesforYowIndustry/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 Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K132057

Device Name Dynatron Peltier ThermoStim

Indications for Use (Describe)

A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and/or apply heat and cooling to the skin.

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CORH) (Signature)

FORM FDA 3881 (1/14)

PSC friddliching Services (JD) 443-6740 15

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Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).