ViaTherm BOOST
Device Facts
| Record ID | K173300 |
|---|---|
| Device Name | ViaTherm BOOST |
| Applicant | Viatherm Therapeutics, LLC |
| Product Code | IMJ · Physical Medicine |
| Decision Date | May 1, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5290 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
Device Story
Portable shortwave diathermy system for home use by non-technical adult operators. Device consists of power generator, heat applicator garment, battery charger, strap, and cotton pad. Operates by generating 13.56 MHz radiofrequency (RF) signal; delivered to applicator garment containing two flat spiral induction coils. Electromagnetic fields produced by coils induce deep heating in resistant body tissues. Battery-operated; includes internal circuitry to verify garment contact and regulate power output. Treatment duration fixed by battery life to prevent over-treatment. Output is therapeutic deep heat; used for pain and muscle spasm relief. Patient self-administers therapy; no manual intensity adjustments required. Benefits include non-clinical, convenient access to deep heat therapy for musculoskeletal conditions.
Clinical Evidence
Bench testing only. Performance data included temperature testing in muscle/bone phantom to assess tissue temperature rise. No clinical trials performed.
Technological Characteristics
13.56 MHz RF generator; induction coil technology (two flat spirals). Materials: polyurethane foam, nylon, polyester, polyethylene, spandex, cotton. Battery-powered (Ni-MH). Connectivity: standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11.
Indications for Use
Indicated for adults (not children) requiring therapeutic warmth for pain relief, muscle spasms, or soft tissue injuries. Not for use on children.
Regulatory Classification
Identification
A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.
Special Controls
*Classification: Class II (special controls).* The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. (ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment. (iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined: (A) Peak output power; (B) Pulse width; (C) Pulse frequency; (D) Duty cycle; (E) Characteristics of other types of modulation that may be used; (F) Average measured output powered into the RF antenna/applicator; (G) Specific absorption rates in saline gel test load or other appropriate model; (H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and (I) Characterization of the deposited energy density in saline gel test load or other appropriate model. (iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use. (v) Labeling must include the following: (A) Output characteristics of the device; (B) Recommended treatment regimes, including duration of use; and (C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications. (vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
Predicate Devices
- Selicor D100 (K020227)
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Submission Summary (Full Text)
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## 510(k) Summary per 21 CFR §807.92
#### ViaTherm BOOST Diathermy System
Submitter's information Contact: Michael Thomas ViaTherm Therapeutics, LLC 201 Defense Highway, Suite 260 Annapolis, MD 21401
Contact: Sharon Bishop Graematter, Inc. 1324 Clarkson Clayton Ctr #332 Ballwin, MO 63011 Phone: 919-619-8054 Date: 10/13/2017
Classification The classification for the new device is shown in the table below.
| 21 CFR<br>Reference | Product<br>Code | Class | Generic Device Name | Classification<br>Description |
|---------------------|-----------------|-------|--------------------------------------------------------------------|-------------------------------|
| §890.5290 | IMJ | 2 | Diathermy, Shortwave, For Use In<br>Applying Therapeutic Deep Heat | Shortwave diathermy |
New device The indications for use statement for the new device is shown in the table below.
| K Number | Product<br>Code | Device Name | Indications for Use |
|----------|-----------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| K173300 | IMJ | ViaTherm BOOST<br>Diathermy System | To generate deep heating within body tissues<br>for the treatment of conditions such as relief of<br>pain and muscle spasms. |
Predicate device The predicate device for the ViaTherm BOOST Diathermy System is shown in the table below.
| K Number | Product<br>Code | Predicate Device<br>Name | Indications for Use |
|----------|-----------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| K020227 | IMJ | Selicor D100 | To generate deep heating within body tissues<br>for the treatment of conditions such as relief<br>of pain, muscle spasm, and joint contractures. |
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#### ViaTherm BOOST Diathermy System, Continued
The ViaTherm BOOST Diathermy System is a single-patient reusable device Device description designed to be self-administered in the home by a non-technical, adult operator.
> Diathermy is the controlled production of "deep heating" beneath the skin in the subcutaneous tissues, deep muscles and joints for therapeutic purposes. The ViaTherm BOOST Diathermy System is a portable diathermy heat therapy system that uses a shortwave radiofrequency signal to provide diathermic heating of tissue.
The ViaTherm BOOST Diathermy System consists of five (5) components:
- Power generator
- Heat applicator garment
- Battery charging cable
- Velcro extender strap
- Cotton pad
Electronic circuitry in the power generator components generates a radiofrequency (RF) signal at a frequency of 13.56 Megahertz (MHz). The radiofrequency signal is delivered to the heat applicator garment that uses induction coil (magnetic field) technology to produce electromagnetic fields external to the applicator. This energy is converted into heat by electromagnetically resistant body tissues.
The power generator consists of a battery pack, voltage regulators, a power control and analogue sensor module, and an RF generator. A shielded 1/4" cable with 50 Ohms impedance connects the power generator to the heat applicator garment. The electrode consists of two flat spirals incorporated into the applicator garment. The spirals are each tuned to 50 Ohms. The power from the generator is split and sent to the two spirals, one of which is driven 180 degrees out of phase from the other.
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## ViaTherm BOOST Diathermy System, Continued
| Characteristics The table below lists the characteristics for both the new and predicate |
|---------------------------------------------------------------------------------------------|
| devices. |
| Attribute | Selicor Inc.<br>Shortwave Diathermy System<br>K020227 | ViaTherm Therapeutics LLC<br>ViaTherm BOOST Diathermy System K173300 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications For<br>Use | To generate deep heating within<br>body tissues for the treatment of<br>conditions such as relief of pain,<br>muscle spasms, and joint<br>contractures. | To generate deep heating within<br>body tissues for the treatment of<br>conditions such as relief of pain and<br>muscle spasms. |
| Trade/Device Name | SeliTherm D100 | ViaTherm BOOST Diathermy System |
| Regulation Number | 21 CFR 890.5290 | 21 CFR 890.5290 |
| Regulation Name | Shortwave Diathermy Device | Shortwave Diathermy Device |
| Product Code | IMJ | IMJ |
| Target Population | Adults (not to be used on children)<br>whose medical conditions would<br>be treated, in whole or in part,<br>with therapeutic warmth. Some<br>examples of these types of<br>medical conditions are as follows:<br>pain and swelling in soft tissue<br>injuries; muscle spasms or pain<br>due to injury or over-training; and<br>rehabilitation of joints from injury<br>or. | Adults (not to be used on children)<br>whose medical conditions would be<br>treated, in whole or in part, with<br>therapeutic warmth. Some examples<br>of these types of medical conditions<br>are as follows: pain and swelling in<br>soft tissue injuries; muscle spasms<br>or pain due to injury or over-<br>training. |
| Intended<br>Environment For<br>Use | Designed for home use by a non-<br>technical operator with or without<br>the immediate supervision of a<br>healthcare practitioner. | OTC device intended for use by<br>patients in non-clinical<br>environments, including the<br>home |
| Design | User-friendly device designed with<br>safety mechanisms that enable it<br>to be effectively and safely<br>operated by a non-technical adult<br>in a non-clinical setting, | User-friendly device designed<br>with safety mechanisms that<br>enable it to be effectively and<br>safely operated by a non-<br>technical adult in non-clinical<br>environments, including the<br>home setting. |
| Mechanism of<br>Action | Deep heating of tissue by<br>therapeutic application of<br>radio frequency electrical<br>currents | Deep heating of tissue by<br>therapeutic application of<br>radio frequency electrical<br>currents |
| Anatomical Site | Various therapy garment sizes | Multi-use therapy garment for |
| Attribute | Selicor Inc.<br>Shortwave Diathermy System<br>K020227 | ViaTherm Therapeutics LLC<br>ViaTherm BOOST Diathermy<br>System K173300 |
| Locations | for target locations: hand,<br>forearm, knee, shoulder, lower<br>back, thigh, foot, or lower leg<br>garment | target location areas of 5 to 18<br>square inches: Arm (e.g. bicep,<br>wrist, forearm), back, shoulder, leg<br>(e.g. thigh, knee, calf), foot. |
| Treatment time | 30 minutes | 40 -45 minutes |
| Available Warming<br>Control | Knob to adjust therapy duration<br>and intensity settings | Single setting. Not adjusted by<br>patient. |
| Thermal performance | Achieves 4°C temperature rise at 20<br>minutes | Achieves 4°C temperature rise at 25<br>minutes |
| Materials | Generator<br>Family of anatomically designed<br>therapy garments Composed of nylon foam<br>material with Spandex inner<br>liner. The outer cover is nylon,<br>Cordura Material, by DuPont | Generator<br>Therapy Garment Material Futuro™ by 3M, composed<br>of polyurethane foam,<br>nylon, polyester,<br>polyethylene, and spandex Velcro Extender Strap Charger Cord<br>Patient Interface – 100% cotton |
| Charger Cord<br>Patient Interface - paper | | |
| Safety Factors | The SeliTherm C 100 requires the<br>operator to interact with the<br>device by pushing a button every<br>20-minutes (after a buzzer goes<br>off) in order to keep the device<br>on. This will eliminate the<br>possibility of overheating due to<br>the patient operator falling<br>asleep. | The device treatment is intended<br>to be self-administered in the<br>home. The device is battery<br>operated. It contains circuit<br>boards that determine if the<br>garment is making sufficient<br>contact with the user, and if so,<br>will output the designated<br>power. The treatment time is<br>based on the life of the battery,<br>preventing the user from over<br>treating. |
| Biocompatibility | Established | Established |
| Technical<br>Specifications | Selicor Inc.<br>Shortwave Diathermy System<br>K020227 | ViaTherm Therapeutics LLC<br>ViaTherm BOOST Diathermy<br>System K173300 |
| Generator Technical Specifications: | | |
| Operating<br>Frequency | 13.56 MHz | 13.56 MHz |
| RF Power | 8 to 40 watts | 5 watts |
| Duty Cycle | Continuous Wave | Continuous Wave |
| RF Connector | BNC | BNC |
| Impedance | 50 Ohms nominal | 50 Ohms nominal |
| Load Standing Wave<br>Ratio | 1.6:1 max | 3.0:1 max |
| Batteries | Rechargeable lead acid - 12V x 2<br>(24V), 4.5Ah | Ni-MH AA – 1.2V x4 (4.8V), 2000<br>mAh |
| Weight | 9.6 lbs. | Approximately 26 oz. |
| Size | 3.325" x 9.85" x 10.268" | 2.25" x 4.875" x 6.5" |
| Sterility | Non-sterile | Non-sterile |
| Operating<br>Temperatures | Operating: 32 to 122 degrees F (0 to<br>50 degrees C) | Operating: 59 to 104 degrees F (15<br>to 40 degrees C) at relative<br>humidity of 30%-90% (non-<br>condensing) and pressure of 700-<br>1060 hPa. |
| Storage<br>Temperatures | Storage: -4 to 140 F (-20 to 60<br>degrees C) | Storage: 50 to 140 degrees F (10 to<br>60 degrees C) at relative humidity<br>of 15%-90% (noncondensing)<br>and pressure of 700-1060 hPa. |
| Radiation Safety | Established | Established |
| RF Shielding | Yes | Yes |
| Designed to meet<br>Electrical Safety<br>Standards | IEC 60601-1 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60606-1-6<br>IEC 60601-1-11 |
| Coil design | Two helical coils embedded in a<br>fabric garment | Two flat spiral coils embedded in a<br>fabric garment |
| Testing | Testing was performed to the following standards:<br>IEC 60601-1 Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance IEC 60601-2 Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral Standard: Electromagnetic<br>disturbances IEC 60601-1-6 Medical Electrical Equipment - General requirements for basic<br>safety and essential performance - Usability IEC 60601-1-11 Medical Electrical Equipment - Requirements for medical<br>electrical equipment and medical electrical systems used in the home<br>healthcare environment IEC 62366 Medical Devices – Application of Usability Engineering to Medical<br>Devices ISO 14971 Medical Devices – Application of Risk Management to Medical<br>Devices | |
| | Temperature testing was performed in a muscle/bone phantom to assess the<br>temperature rise in simulated tissue. A clinical test in nine healthy subjects<br>was performed and the temperatures of tissue at the surface, 1cm and 2cm<br>were measured. | |
| Conclusion | The BOOST Diathermy System is as safe and effective as the predicate device.<br>The BOOST Diathermy System has the same intended uses and similar<br>indications, technological characteristics, and principles of operation as its<br>predicate device. The BOOST Diathermy System is indicated for over-the-<br>counter use, however, this modification in the indications for use and the<br>labelling does not alter the therapeutic effect of the device. Usability testing<br>demonstrated that the BOOST Diathermy System can be appropriately<br>selected and used by the general population. The minor differences in<br>design, size and shape to improve user interface between the BOOST<br>Diathermy System and its predicate device raise no new issues of safety or<br>effectiveness. Performance data demonstrate that the BOOST Diathermy<br>System is as safe and effective as predicate device. | |
| | Based on the technical characteristics and the results of the performance<br>testing, the BOOST Diathermy System is substantially equivalent to the<br>predicate device. | |
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## ViaTherm BOOST Diathermy System, Continued
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ViaTherm Therapeutics, LLC. % Melissa Walker President and CTO Graematter, Inc. 1324 Clarkson Clayton Center #332 St. Louis, Missouri 63011
Re: K173300
Trade/Device Name: ViaTherm BOOST Diathermy System Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: IMJ Dated: March 20, 2018 Received: March 22, 2018
Dear Ms. Walker:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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