(205 days)
Not Found
No
The device description and performance studies indicate a passive, manual therapy accessory that delivers electrical stimulation and thermal therapy based on controls from a separate, previously cleared device. There is no mention of AI or ML in the description, intended use, or performance data.
Yes
The device is described as providing "therapeutic electrical stimulation and thermal therapy treatments" and is an "electrode for therapeutic electrical current."
No
Explanation: The device is described as a therapeutic tool for applying electrical stimulation and thermal therapy, not for diagnosing medical conditions. It delivers treatment rather than identifying or characterizing a disease or condition.
No
The device description explicitly states it is a "hand held cutaneous electrode" and a "probe" consisting of a "handle with a treatment head and connections". It also mentions "hardware components" and "bench testing" related to physical outputs (waveforms, thermal data). This clearly indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply electrical stimulation and/or heat and cooling to the skin for therapeutic purposes. This is a physical therapy or pain management application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a hand-held probe that delivers electrical current and thermal energy directly to the skin. It's an accessory for a therapeutic device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts directly with the patient's skin for treatment.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GXY, ILO
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-.
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 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.
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.
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
§ 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).
0
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 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-.
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.
1
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.
2
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.
| | Predicate
Dynatron
ThermoStim Probes | Dynatron Peltier
ThermoStim Probe |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Cutaneous electrode with
heating and cooling | Cutaneous electrode with
heating and cooling |
| Target
Populations | 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 |
| Therapy
Delivery | Electrical stimulation and/or
thermal therapy (hot or cold)
through contact with patient's
skin | Electrical stimulation and/or
thermal therapy (hot or cold)
through contact with patient's
skin |
| Electrical
Stimulation | ThermoStim probe acts as a
cutaneous electrode for the
delivery of electrical
stimulation to a patient from a
Solaris device | Peltier ThermoStim probe
acts as a cutaneous electrode
for the delivery of electrical
stimulation to a patient from a
Solaris device |
| Handle Material | Polypropylene plastic | ABS plastic |
| Treatment Face
Material | 6061 Aluminum | 6061 Aluminum |
| Treatment Face
Options | Flat - 1.5" diameter - $11.4cm^2$
Domed - 1.1" diameter - $12.3cm^2$ | Rectangular - 38 $cm^2$ surface |
| Current Density
(gravity
pressure) | Flat - 0.11 W/ $cm^2$
Round -0.20 W/ $cm^2$ | 0.08 W/ $cm^2$ |
| Power Density
(gravity
pressure) | Flat -4.4mA/ $cm^2$
Round -8.3mA/ $cm^2$ | 3.3mA/ $cm^2$ |
Summary 4
.
3
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.
| | Predicate
Dynatron
ThermoStim Probes | Dynatron Peltier
ThermoStim Probe |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermal
Therapy | ThermoStim probe delivers hot
or cold thermal therapy via
water that is heated or cooled
by Peltier thermo-electric
chips in a reservoir and
circulated to the face of the
probe/electrode. | Peltier ThermoStim probe
delivers hot or cold thermal
therapy via a Peltier thermo-
electric chip that is in contact
with the treatment head of the
probe/electrode |
| Thermal Range | Hot: 104-112F
Cold: 36 - 50F | Hot: 90-112F
Cold: 39 - 60F |
| Range of Skin
Temperatures | Hot: 105.5 - 108.30F
Cold: 53.5 - 56.5"F | Hot: 90 - 110.5ºF
Cold: 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
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white.
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.
5
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
6
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
7
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."