DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) by DYNATRONICS CORP.

The Dynatron Solaris Series of products, including Solaris 709, 708, 706, and 705, provide electrical stimulation, ultrasound and/or combination electrical stimulation and ultrasound, as well as infrared therapy.

Electrical Muscle stimulation therapy for: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion
Transcutaneous electrical nerve stimulation and Interferential Current Therapy for: Symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.
Ultrasound therapy for: Applying therapeutic deep heat within body tissues for the treatment of selected medical conditions such as: Relief of pain Muscle spasms Joint contractures
Infrared therapy to provide topical heating for: Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis

Device Description

The Dynatron® Solaris™ Series (Model numbers 709, 708, 706, and 705) provide electrical stimulation, ultrasound, and/or electrical stimulation and ultrasound, as well as optional infrared therapy. Components: System console, containing software and control electronics with alpha-numeric displays Ultrasound transducer, infrared probe, and multi-probe for administering electrotherapy Accessories such as patient cables, electrodes, transducer gel and elastic straps.

AI/ML Overview

The Dynatron® Solaris™ Series (models 709, 708, 706, and 705) are therapeutic devices offering electrical stimulation, ultrasound, and/or infrared therapy. The document K031329 confirms their safety and effectiveness through substantial equivalence to predicate devices, following the FDA's 510(k) premarket notification process.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" in the typical sense (e.g., a specific sensitivity or specificity threshold for a diagnostic device). Instead, the acceptance criteria are implicitly met through demonstrating Substantial Equivalence (SE) to legally marketed predicate devices. The "reported device performance" is the confirmation of this substantial equivalence.

Criterion	Acceptance Standard	Reported Device Performance (as per K031339 Summary)
Safety and Effectiveness	Substantial equivalence to predicate devices	"The Solaris family of electrical stimulation, ultrasound, and/or combination products, and accessories, are safe and effective, when used as indicated in specific applications under a clinician's supervision/therapy program."
Basic Characteristics & Features	Same or similar to predicate devices	"The Dynatron Solaris 709, 708, 706, and 705, offer electrical stimulation, ultrasonic therapy and/or a combination of the two, and share the same or similar basic characteristics and the same general intended use in physical medicine... as the predicate devices."
General Intended Use/Indications	Same as predicate devices	"The Intended Use/Indications For Use stated herein are consistent with the cleared indications for the predicate devices." (Page 2) and "share the same general intended use in physical medicine..." (Page 2)
Performance Standards Compliance	Conformance to applicable CFR sections	"The Dynatron Solaris Series of devices conform to the applicable requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General) and 1050 (Performance Standards for Sonic, Infrasonic, and Ultrasonic Radiation-Emitting Products)." (Page 1)
Quality Management System	Developed under a mature Quality Management System	"They were developed and documented under Dynatronics' mature Quality Management System, under the Quality System Regulation, 21 CFR Part 820, under design/change control, and is verified/validated to applicable standards/guidance documents." (Page 2)

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

The document does not describe a "test set" in the context of a prospective clinical study with a defined sample size. The substantial equivalence determination is based on a comparison to existing predicate devices.

Sample Size for Test Set: Not applicable or not explicitly stated as a separate test set with specific patient data. The "sample" is effectively the design, specifications, and performance characteristics of the new devices being compared to existing, cleared devices.
Data Provenance: Not applicable in the sense of patient data. The "data" pertains to the technical specifications, intended uses, and safety/performance characteristics of the devices themselves, derived from their design documentation, manufacturing processes, and compliance with performance standards. This is not retrospective or prospective patient data from a clinical trial.

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

This information is not applicable as the document does not describe a study involving human experts establishing "ground truth" on a test set of patient cases. The "ground truth" for predicate devices is established by their prior clearance through the FDA and their safe and effective use in the market.

4. Adjudication Method for the Test Set

This information is not applicable as there is no specific "test set" and no "ground truth" arbitration process described for a diagnostic or AI performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done and is not described in the document. This type of study is typically performed to evaluate the impact of an AI diagnostic tool on human reader performance, which is not the subject of this 510(k) submission.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

A standalone performance study was not done and is not described. The devices in question are physical therapeutic devices (electrical stimulators, ultrasound, infrared) and not AI algorithms or diagnostic software that would undergo standalone performance testing.

7. Type of Ground Truth Used

The "ground truth" in this context is established by the prior FDA clearance of the predicate devices. The new devices (Dynatron Solaris Series) are deemed safe and effective because they are substantially equivalent to devices already recognized as safe and effective by regulatory bodies. It's not based on pathology, outcomes data, or expert consensus on new patient data for the new devices, but rather on the established performance and regulatory status of the predicate devices.

8. Sample Size for the Training Set

This information is not applicable. The devices are not AI or machine learning models that require a "training set."

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

This information is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K031329'. The characters are written in a dark ink on a white background.

OCT 2 2 2003

SUMMARY OF SAFETY AND EFFECTIVENESS

DYNATRONICS CORPORATION SUBMITTED BY: 7030 Park Centre Drive Salt Lake City UT 84121 Phone: (800) 874-6251; (801) 568-7000; Fax: (801) 568-7711

1. DEVICE NAME (Trade/common, and classification): Dynatron® Solaris™ Series (model numbers 709, 708, 706, and 705); Therapeutic Ultrasound, Interferential Current Therapy, Electrical Muscle Stimulator, Electrotherapy, Non-Invasive Electrical Nerve Stimulator, Ultrasound and Muscle Stimulator (and Accessories), and Infrared therapy.

Classification:	Class II
Regulation Nos .:	882.5890, 890.5300, 890.5850, 890.5860 and 890.5500
Product Codes:	GZJ, IMI, IPF, IMG, LIH and ILY

2. PREDICATE DEVICES:

Solaris 709 Previously Dynatron 950, cleared under K950349 (Sep 13, 1995); Solaris 708 - Previously Dynatron 850, cleared under K941461 (Sep 01, 1995); Solaris 706 - Previously Dynatron 650, cleared under K950348 (Sep 13, 1995); Solaris 705 - Previously Dynatron 550, cleared under K941577 (Sep 01, 1995); Solaris D880 Infrared Probe -- SE to MedX 1000 Series, cleared under K020017 (July 12, 2002)
PERFORMANCE STANDARDS: The Dynatron Solaris Series of devices conform to 3. the applicable requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General) and 1050 (Performance Standards for Sonic, Infrasonic, and Ultrasonic Radiation-Emitting Products).
1. DESCRIPTION: The Dynatron® Solaris™ Series (Model numbers 709, 708, 706, and 705) provide electrical stimulation, ultrasound, and/or electrical stimulation and ultrasound, as well as optional infrared therapy.

Components:

System console, containing software and control electronics with alpha-numeric displays

Ultrasound transducer, infrared probe, and multi-probe for administering electrotherapy

Accessories such as patient cables, electrodes, transducer gel and elastic straps.

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1. INTENDED USE/INDICATIONS FOR USE: The Dynatron Solaris Series of products, including Solaris 709, 708, 706, and 705, provide electrical stimulation, ultrasound and/or combination electrical stimulation and ultrasound, as well as infrared therapy.
- 1. Electrical Muscle stimulation therapy for: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion
- 1. Transcutaneous electrical nerve stimulation and Interferential Current Therapy for:

Symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.

1. Ultrasound therapy for:
  Applying therapeutic deep heat within body tissues for the treatment of selected medical conditions such as:
Relief of pain Muscle spasms Joint contractures
1. Infrared therapy to provide topical heating for:

Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles

Muscle spasms

Minor pain and stiffness associated with arthritis

The Intended Use/Indications For Use stated herein are consistent with the cleared indications for the predicate devices.

1. SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: The Dynatron Solaris 709, 708, 706, and 705, offer electrical stimulation, ultrasonic therapy and/or a combination of the two, and share the same or similar basic characteristics and the same general intended use in physical medicine, general and plastic surgery and neurology as the predicate devices. Therefore, the proposed Dynatron Solaris products are substantially equivalent to the Dynatron 950, 850, 650 and 550. The infrared therapy probe provides topical heating for treatment of selected medical conditions and shares the same or similar basic characteristics, features and intended use as the predicate and, therefore, is substantially equivalent to the MedX 1000 Series infrared probe (applicable 'K' numbers listed above).

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1. SAFETY AND EFFECTIVENESS: There are no substantive differences between the products defined in this 510(k) submission and the predicate devices. They are similar to the technologies that are currently used in other similar medical devices. They were developed and documented under Dynatronics' mature Quality Management System, under the Quality System Regulation, 21 CFR Part 820, under design/change control, and is verified/validated to applicable standards/guidance documents. The Solaris family of electrical stimulation, ultrasound, and/or combination products, and accessories, are safe and effective, when used as indicated in specific applications under a clinician's supervision/therapy program.
  Signed: Ronald J. Hatch

Ronald J. Hatch, VP Operations/RA
DYNATRONICS CORPORATION

Dated: April 24, 2003

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

Ronald J. Hatch VP Operations/Regulatory Affairs Dynatronics, Corp. 7030 Park centre Dr. Salt Lake City, Utah 84121

Re: K031329

Trade/Device Name: Solaris Models 708 and 709 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI

Trade/Device Name: Solaris Models 705, 706, 708 and 709 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF

Trade/Device Name: Solaris Models 705, 706, 708 and 709 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator v Regulatory Class: Class II Product Code: GZJ

Trade/Device Name: Solaris Models 705, 706, 708 and 709 Regulation Number: 21 CFR 882.5890 Regulation Name: Interferential Current Therapy Regulatory Class: Class II Product Code: LIH

Trade/Device Name: D880 Infrared Probe for use with Solaris Models 705, 706, 708 and 709 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Heat Lamp Regulatory Class: Class II Product Code: ILY

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Page 2 - Mr. Ronald J. Hatch

Dated: August 29, 2003 Received: September 4, 2003

Dear Mr. Hatch:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll

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Page 3 – Mr. Ronald J. Hatch

free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K031329

Device Name: Dynatron® Solaris™ Series

Indications for Use:

Hi Volt, Russian, and Biphasic modes of stimulation are all forms of electrical muscle stimulation therapy available with the Solaris 709, 708, 706 & 705 and indicated for:

Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion

The Direct Current mode of stimulation is also a form of electrical muscle stimulation therapy available with the Solaris 709, 708, 706 & 705 and indicated for:

Relaxation of muscle spasms

IFC, Premodulated, Microcurrent and Diadynamic modes of stimulation are all forms of transcutaneous electrical nerve stimulation (TENS) or Interferential Current Therapy (IFC) available with the Solaris 709, 708, 706 & 705 and indicated for:

Symptomatic relief of chronic intractable pain and/or management of post traumatic or post-surgical pain

for Mark A. Milliner

[continued]

Division Sign-Off.
Division of General Restorative
and Neurological Devices

510(k) Number K031329

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Ultrasound therapy is available with the Solaris 709 & 708 and indicated for:

Applying therapeutic deep heat within body tissues for the treatment of selected medical conditions such as:

Relief of pain , Muscle spasms Joint contractures

Infrared therapy is available as an optional accessory (D880) probe with the Solaris 709, 708, 706 & 705 and indicated to provide topical heating for:

Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis

for Mark N. Millerson

vision Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031329

Regulation Number and Section

§ 890.5300 Ultrasonic diathermy.

(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.