The Dynatron ThermoStim probes are used to provide therapeutic electrical stimulation and thermal therapy treatments. The probes consist of a handle with a treatment head and connections for a lead wire and/or circulating water. The probes act as an electrode for therapeutic electrical current provided by a Dynatron Solaris device, or other similar Dynatronics electrical stimulation devices in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) from circulating water when connected to a Dynatron QUAD7™.

The probes are a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatronics electrical stimulation and OUAD7 devices.

There are two versions of the probe face - a flat head with a surface area of 11.4 cm2 (1.5," diameter) and a domed head with a surface area of 12.3cm-(1.1" diameter).

AI/ML Overview

This document describes the Dynatron ThermoStim Combination Electrical Stimulation and Thermal Therapy probe and its substantial equivalence to predicate devices, rather than a clinical study establishing its performance against acceptance criteria in the manner requested.

However, based on the provided text, I can extract and infer information relevant to your request regarding acceptance criteria and performance, primarily from the "Performance Characteristics" and "Non-clinical Bench Testing" sections.

The device is intended to provide therapeutic electrical stimulation and thermal therapy (hot and cold). The "acceptance criteria" here are implied by the desired therapeutic ranges and the device's ability to deliver these. The study described is a non-clinical bench test comparison.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Non-Clinical Bench Testing)
Electrical Stimulation:
Delivery of various waveforms	Wave forms captured show no differences between ThermoSTIM probe and predicate Ultrasound probe in combo mode.
Compliance with safety standards for electrical stimulation (dielectric strength, EMC)	Probes pass applicable test limits per EN60601-1 (dielectric strength) and EN60601-1-2 (EMC).
Thermal Therapy (Hot):
Target temperature: 110°F	Results showed temperatures consistently between 104°F and 112°F when delivering hot mode with electrical stimulation.
Thermal Therapy (Cold):
Selectable target temperature: 37 - 50°F	(Performance for cold therapy not explicitly detailed in summary, but indicated as a selectable target.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document mentions "two body parts per patient" for the thermal data collection. There is no explicit number of patients or total "test set" samples (e.g., number of probes tested, number of measurements taken for waveforms, or number of patients if clinical). The electrical waveform analysis compares the ThermoSTIM probe to a predicate, implying at least one of each was tested.
Data Provenance: Non-clinical bench testing. No country of origin is specified, but the submission is to the U.S. FDA by a U.S. company. The testing is retrospective in the sense that it evaluates the manufactured device; it is not a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This document describes non-clinical bench testing. Therefore, "ground truth" is established by measurement instruments (e.g., oscilloscopes, thermometers) and engineering standards (EN60601-1, EN60601-1-2). No human experts are explicitly mentioned for establishing a ground truth for the test set beyond the engineering team conducting the tests and interpreting the instrument readings against specified criteria.

4. Adjudication Method for the Test Set

Not applicable as it's non-clinical bench testing involving objective measurements against defined engineering standards and electrical/thermal targets. There is no human subjective assessment or adjudication process described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This document primarily focuses on demonstrating substantial equivalence through non-clinical bench testing, comparing the new device's technical performance characteristics to existing predicate devices and safety standards. There is no mention of human readers or AI assistance in this context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a manual therapy accessory that requires a human practitioner to apply it. It is not an algorithm-only device or an AI system. The "standalone" performance here refers to the device's ability to deliver electrical and thermal energy as designed, which was evaluated in the bench tests.

7. The Type of Ground Truth Used

The ground truth for the non-clinical bench testing was primarily objective physical measurements (electrical waveforms, temperature readings) compared against engineering specifications and regulatory standards (e.g., EN60601-1, EN60601-1-2).

8. The Sample Size for the Training Set

This device is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply. The device's design and manufacturing processes are refined through engineering development and testing.

9. How the Ground Truth for the Training Set Was Established

As above, this is not an AI/ML algorithm, so there is no "training set" or establishment of ground truth for a training set in that context. The device's "training" or development involves iterative design, prototyping, and engineering validation to meet design specifications and regulatory requirements.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Dynatronics. The logo features a stylized "D" shape to the left of the company name, "Dynatronics," which is written in a bold, italicized font. Below the logo, the address "7030 Park Centre Drive - Salt Lake City, Ut 84121" is printed, followed by the phone number "800-874-6251" and fax number "801-568-7711".

KI20835 PAGE I OF 3

AUG 2 0 2012

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

16 August 2012

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

2. PREDICATE DEVICES:

Dynatron Solaris™ series Ultrasound probe in combination mode - K031329 (October 22, 2003)

ArTek Spot® thermal probes - Exempt (hot/cold pack) from ThermoTek, Inc.

3. DESCRIPTION:

The probes are a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatronics electrical stimulation and OUAD7 devices.

There are two versions of the probe face - a flat head with a surface area of 11.4 cm2 (1.5," diameter) and a domed head with a surface area of 12.3cm-(1.1" diameter).

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Image /page/1/Picture/1 description: The image shows the logo for Dynatronics. The logo features a stylized "D" shape to the left of the company name, which is written in a bold, sans-serif font. Below the logo, the address "7030 Park Centre Drive • Salt Lake City, Ut 84121" is printed. The image also includes a phone number, "800-874-6251", and a fax number, "801-568-7711".

4. INDICATIONS FOR USE:

A hand held cutancous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and apply heat and cooling to the skin

The Indications for Use stated herein are consistent with the cleared indications for the predicate device.

5. TECHNICAL ANALYSIS:

The Dynatron ThermoStim probes generate therapeutic benefits as described in allowed claims through the delivery of electrical stimulation and thermal therapy to targeted tissues.

The probes allow 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 therapy (hot or cold). The delivery of hot thermal energy has a target value of 110° Fahrenheit and the cold thermal energy has a selectable target value from 37 - 50° Fahrenheit.

Performance Characteristics

There are two treatment face options with the Dynatron ThermoStim probes. Both utilize the same handle and connections to therapy delivery devices. The treatment faces differ in that one is a 1.1" dome with 12.3 cm² surface area and the second is a 1.5" flat with 11.4 cm surface area. Both probes act as an accessory to provide the following treatment options:

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

Thermal therapy - Hot = 110° Fahrenheit Cold = 37 - 50° Fahrenheit

Non-clinical Bench Testing

Wave forms were captured from a Dynatron Solaris device through the ThermoSTIM probe and the Ultrasound probe in combo mode. Analysis of the wave forms for delivery of electrical stimulation treatments show no differences between the two probes

ThermoSTIM probes were tested for dielectric strength per EN60601-1 and for electromagnetic compatibility per EN60601-1-2. The probes pass the applicable test limits associated with the Solaris electrical stimulation device.

Thermal data was collected using the ThermoSTIM probe in "hot" mode and delivering an electrical stimulation treatment. Treatments were delivered on two body parts per patient and using warm gel and room temperature gel. Results showed temperatures consistently between 104°F and 112°F.

6. SUBSTANTIAL EQUIVALENCE (SE) RATIONALE:

The Dynatron ThermoStim probes share the same basic characteristics, features and intended uses as the predicate probes and, therefore, are substantially equivalent to the Dynatron Combination probe (applicable "K' number listed above) and the exempt ArTek Spot thermal probes.

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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.

800-874-6251 · fax 801-568-77

K | 20835 PAGE 3 OF 3

7. SAFETY AND EFFECTIVENESS SUMMARY:

There are no substantive differences between the product defined in this 510(k) submission and the predicate devices. This 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 CFT 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 ThermoSTIM probes are 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, Operations and R&D DYNATRONICS CORPORATION

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Public Health Service

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

AUG 20 2012

Dynatronics Corporation % Mr. Douglas Sampson Vice President 7030 Park Centre Drive Salt Lake City, Utah 84121

Re: K120835

Trade/Device Name: Dynatron ThermoStim probe Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY, ILO Dated: August 9, 2012 Received: August 10, 2012

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

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Page 2 - Mr. Douglas Sampson

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours

Ron Dett Vsi Lira Dr.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K120835

Dynatron ThermoStim probe Device Name:

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kinneth D. Ingram

(Division Sign-Off) (Division Sign eigh eigh of Surgical, Orthopedic, ා Kestorative Devices

510(k) Number K120835

Page 1 of 1

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).