(196 days)
To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
The ViaTherm BOOST Diathermy System is a single-patient reusable device 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.
The ViaTherm BOOST Diathermy System is a shortwave diathermy device intended to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
Here's an analysis of the acceptance criteria and supporting study information:
1. Acceptance Criteria and Device Performance
The primary performance criterion for the ViaTherm BOOST Diathermy System, as implied by comparison to its predicate device (Selicor D100), is its ability to raise tissue temperature.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (ViaTherm BOOST) |
|---|---|
| Achieves 4°C temperature rise at 20 minutes | Achieves 4°C temperature rise at 25 minutes |
| Operating Frequency: 13.56 MHz | Operating Frequency: 13.56 MHz |
| RF Power: 8 to 40 watts | RF Power: 5 watts |
| Duty Cycle: Continuous Wave | Duty Cycle: Continuous Wave |
| Impedance: 50 Ohms nominal | Impedance: 50 Ohms nominal |
| Load Standing Wave Ratio: 1.6:1 max | Load Standing Wave Ratio: 3.0:1 max |
| Designed to meet IEC 60601-1 | Designed to meet IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11 |
| Coil design: Two helical coils | Coil design: Two flat spiral coils |
Note on Acceptance Criteria: The document describes the ViaTherm BOOST Diathermy System as "as safe and effective as the predicate device" and that "Performance data demonstrate that the BOOST Diathermy System is as safe and effective as predicate device." While a specific, quantitative acceptance criterion (e.g., minimum 4°C rise within a certain time frame) is not explicitly stated as such for the new device, the comparison to the predicate's thermal performance (4°C rise at 20 minutes) strongly implies that demonstrating a similar or acceptable thermal performance was a key criterion for the new device (achieving 4°C rise at 25 minutes). Other criteria relate to specifications and safety standards compliance.
2. Sample Size and Data Provenance
- Sample Size for Test Set:
- Phantom Test: Not specified as a number of samples, but "temperature testing was performed in a muscle/bone phantom". This refers to a simulated tissue environment, not human subjects.
- Clinical Test: Nine healthy subjects.
- Data Provenance: Not explicitly stated, but the clinical test involved "healthy subjects" and was performed by the submitting company (ViaTherm Therapeutics, LLC) to support market clearance in the US, suggesting the study was likely conducted domestically (US) and prospectively for the purpose of this submission. The document explicitly mentions "clinical test in nine healthy subjects was performed and the temperatures of tissue at the surface, 1cm and 2cm were measured."
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This device is not an AI/imaging device requiring expert interpretation of results for ground truth. It's a therapeutic device with performance measured by physical parameters (temperature rise). Therefore, this section is not applicable. The "ground truth" for its performance is objective temperature measurements.
4. Adjudication Method (Test Set)
Not applicable as the "test set" involves objective temperature measurements in a phantom and healthy volunteers, not subjective human assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This device is a therapeutic diathermy system, not an imaging or diagnostic device that would typically undergo an MRMC study for comparative effectiveness of human readers with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was conducted.
- Phantom Study: "Temperature testing was performed in a muscle/bone phantom to assess the temperature rise in simulated tissue."
- Clinical Study: "A clinical test in nine healthy subjects was performed and the temperatures of tissue at the surface, 1cm and 2cm were measured."
These tests directly measure the device's ability to generate heat in simulated and live tissue, without human intervention in the device's core function.
7. Type of Ground Truth Used
- Objective Measurements: For the phantom study and the clinical study, the ground truth was objective temperature measurements at specific depths (surface, 1cm, 2cm) within the simulated tissue and healthy human tissue.
8. Sample Size for Training Set
This device is not an AI/machine learning device that requires a "training set" in the conventional sense. Its function is based on physical principles of radiofrequency heating. Therefore, this section is not applicable.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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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 CFRReference | ProductCode | Class | Generic Device Name | ClassificationDescription |
|---|---|---|---|---|
| §890.5290 | IMJ | 2 | Diathermy, Shortwave, For Use InApplying Therapeutic Deep Heat | Shortwave diathermy |
New device The indications for use statement for the new device is shown in the table below.
| K Number | ProductCode | Device Name | Indications for Use |
|---|---|---|---|
| K173300 | IMJ | ViaTherm BOOSTDiathermy System | To generate deep heating within body tissuesfor the treatment of conditions such as relief ofpain and muscle spasms. |
Predicate device The predicate device for the ViaTherm BOOST Diathermy System is shown in the table below.
| K Number | ProductCode | Predicate DeviceName | Indications for Use |
|---|---|---|---|
| K020227 | IMJ | Selicor D100 | To generate deep heating within body tissuesfor the treatment of conditions such as reliefof 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.
Continued on next page
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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.Shortwave Diathermy SystemK020227 | ViaTherm Therapeutics LLCViaTherm BOOST Diathermy System K173300 |
|---|---|---|
| IntendedUse/Indications ForUse | To generate deep heating withinbody tissues for the treatment ofconditions such as relief of pain,muscle spasms, and jointcontractures. | To generate deep heating withinbody tissues for the treatment ofconditions such as relief of pain andmuscle 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)whose medical conditions wouldbe treated, in whole or in part,with therapeutic warmth. Someexamples of these types ofmedical conditions are as follows:pain and swelling in soft tissueinjuries; muscle spasms or paindue to injury or over-training; andrehabilitation of joints from injuryor. | Adults (not to be used on children)whose medical conditions would betreated, in whole or in part, withtherapeutic warmth. Some examplesof these types of medical conditionsare as follows: pain and swelling insoft tissue injuries; muscle spasmsor pain due to injury or over-training. |
| IntendedEnvironment ForUse | Designed for home use by a non-technical operator with or withoutthe immediate supervision of ahealthcare practitioner. | OTC device intended for use bypatients in non-clinicalenvironments, including thehome |
| Design | User-friendly device designed withsafety mechanisms that enable itto be effectively and safelyoperated by a non-technical adultin a non-clinical setting, | User-friendly device designedwith safety mechanisms thatenable it to be effectively andsafely operated by a non-technical adult in non-clinicalenvironments, including thehome setting. |
| Mechanism ofAction | Deep heating of tissue bytherapeutic application ofradio frequency electricalcurrents | Deep heating of tissue bytherapeutic application ofradio frequency electricalcurrents |
| Anatomical Site | Various therapy garment sizes | Multi-use therapy garment for |
| Attribute | Selicor Inc.Shortwave Diathermy SystemK020227 | ViaTherm Therapeutics LLCViaTherm BOOST DiathermySystem K173300 |
| Locations | for target locations: hand,forearm, knee, shoulder, lowerback, thigh, foot, or lower leggarment | target location areas of 5 to 18square inches: Arm (e.g. bicep,wrist, forearm), back, shoulder, leg(e.g. thigh, knee, calf), foot. |
| Treatment time | 30 minutes | 40 -45 minutes |
| Available WarmingControl | Knob to adjust therapy durationand intensity settings | Single setting. Not adjusted bypatient. |
| Thermal performance | Achieves 4°C temperature rise at 20minutes | Achieves 4°C temperature rise at 25minutes |
| Materials | GeneratorFamily of anatomically designedtherapy garments Composed of nylon foammaterial with Spandex innerliner. The outer cover is nylon,Cordura Material, by DuPont | GeneratorTherapy Garment Material Futuro™ by 3M, composedof polyurethane foam,nylon, polyester,polyethylene, and spandex Velcro Extender Strap Charger CordPatient Interface – 100% cotton |
| Charger CordPatient Interface - paper | ||
| Safety Factors | The SeliTherm C 100 requires theoperator to interact with thedevice by pushing a button every20-minutes (after a buzzer goesoff) in order to keep the deviceon. This will eliminate thepossibility of overheating due tothe patient operator fallingasleep. | The device treatment is intendedto be self-administered in thehome. The device is batteryoperated. It contains circuitboards that determine if thegarment is making sufficientcontact with the user, and if so,will output the designatedpower. The treatment time isbased on the life of the battery,preventing the user from overtreating. |
| Biocompatibility | Established | Established |
| TechnicalSpecifications | Selicor Inc.Shortwave Diathermy SystemK020227 | ViaTherm Therapeutics LLCViaTherm BOOST DiathermySystem K173300 |
| Generator Technical Specifications: | ||
| OperatingFrequency | 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 WaveRatio | 1.6:1 max | 3.0:1 max |
| Batteries | Rechargeable lead acid - 12V x 2(24V), 4.5Ah | Ni-MH AA – 1.2V x4 (4.8V), 2000mAh |
| 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 |
| OperatingTemperatures | Operating: 32 to 122 degrees F (0 to50 degrees C) | Operating: 59 to 104 degrees F (15to 40 degrees C) at relativehumidity of 30%-90% (non-condensing) and pressure of 700-1060 hPa. |
| StorageTemperatures | Storage: -4 to 140 F (-20 to 60degrees C) | Storage: 50 to 140 degrees F (10 to60 degrees C) at relative humidityof 15%-90% (noncondensing)and pressure of 700-1060 hPa. |
| Radiation Safety | Established | Established |
| RF Shielding | Yes | Yes |
| Designed to meetElectrical SafetyStandards | IEC 60601-1 | IEC 60601-1IEC 60601-1-2IEC 60606-1-6IEC 60601-1-11 |
| Coil design | Two helical coils embedded in afabric garment | Two flat spiral coils embedded in afabric garment |
| Testing | Testing was performed to the following standards:IEC 60601-1 Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance IEC 60601-2 Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard: Electromagneticdisturbances IEC 60601-1-6 Medical Electrical Equipment - General requirements for basicsafety and essential performance - Usability IEC 60601-1-11 Medical Electrical Equipment - Requirements for medicalelectrical equipment and medical electrical systems used in the homehealthcare environment IEC 62366 Medical Devices – Application of Usability Engineering to MedicalDevices ISO 14971 Medical Devices – Application of Risk Management to MedicalDevices | |
| Temperature testing was performed in a muscle/bone phantom to assess thetemperature rise in simulated tissue. A clinical test in nine healthy subjectswas performed and the temperatures of tissue at the surface, 1cm and 2cmwere measured. | ||
| Conclusion | The BOOST Diathermy System is as safe and effective as the predicate device.The BOOST Diathermy System has the same intended uses and similarindications, technological characteristics, and principles of operation as itspredicate device. The BOOST Diathermy System is indicated for over-the-counter use, however, this modification in the indications for use and thelabelling does not alter the therapeutic effect of the device. Usability testingdemonstrated that the BOOST Diathermy System can be appropriatelyselected and used by the general population. The minor differences indesign, size and shape to improve user interface between the BOOSTDiathermy System and its predicate device raise no new issues of safety oreffectiveness. Performance data demonstrate that the BOOST DiathermySystem is as safe and effective as predicate device. | |
| Based on the technical characteristics and the results of the performancetesting, the BOOST Diathermy System is substantially equivalent to thepredicate 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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§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz 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)
Nonthermal shortwave therapy —(1)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.(2)
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.