(196 days)
Not Found
No
The device description focuses on standard RF diathermy technology and electronic circuitry. There is no mention of AI, ML, or any related concepts in the provided text.
Yes
The device Description explicitly states that it is "designed to be self-administered in the home by a non-technical, adult operator" and that "Diathermy is the controlled production of 'deep heating' beneath the skin in the subcutaneous tissues, deep muscles and joints for therapeutic purposes." Additionally, the Intended Use / Indications for Use section states its purpose is "To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms." These statements clearly indicate its therapeutic intent.
No
The device is intended for therapeutic purposes (generating deep heating for pain relief and muscle spasms), not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components including a power generator, heat applicator garment, battery charging cable, Velcro extender strap, and cotton pad. It also describes the electronic circuitry and RF signal generation, indicating it is a hardware-based device with embedded software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate deep heating within body tissues for therapeutic purposes (relief of pain and muscle spasms). This is a physical therapy/treatment application, not a diagnostic one.
- Device Description: The device description details a system that uses radiofrequency energy to heat tissue. This is a physical mechanism of action, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
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
To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
Product codes (comma separated list FDA assigned to the subject device)
IMJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Multi-use therapy garment for target location areas of 5 to 18 square inches: Arm (e.g. bicep, wrist, forearm), back, shoulder, leg (e.g. thigh, knee, calf), foot.
Indicated Patient Age Range
Adults (not to be used on children) whose medical conditions would be treated, in whole or in part, with therapeutic warmth. Some examples of these types of medical conditions are as follows: pain and swelling in soft tissue injuries; muscle spasms or pain due to injury or over-training.
Intended User / Care Setting
OTC device intended for use by patients in non-clinical environments, including the home.
User-friendly device designed with safety mechanisms that enable it to be effectively and safely operated by a non-technical adult in non-clinical environments, including the home setting.
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)
Temperature testing was performed in a muscle/bone phantom to assess the temperature rise in simulated tissue. A clinical test in nine healthy subjects was performed and the temperatures of tissue at the surface, 1cm and 2cm were measured.
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
§ 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.
0
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
Reference | Product
Code | Class | Generic Device Name | Classification
Description |
|---------------------|-----------------|-------|--------------------------------------------------------------------|-------------------------------|
| §890.5290 | IMJ | 2 | Diathermy, Shortwave, For Use In
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
Code | Device Name | Indications for Use |
|----------|-----------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| K173300 | IMJ | ViaTherm BOOST
Diathermy System | To generate deep heating within body tissues
for the treatment of conditions such as relief of
pain and muscle spasms. |
Predicate device The predicate device for the ViaTherm BOOST Diathermy System is shown in the table below.
| K Number | Product
Code | Predicate Device
Name | Indications for Use |
|----------|-----------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| K020227 | IMJ | Selicor D100 | To generate deep heating within body tissues
for the treatment of conditions such as relief
of pain, muscle spasm, and joint contractures. |
Continued on next page
1
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
2
ViaTherm BOOST Diathermy System, Continued
| Characteristics The table below lists the characteristics for both the new and predicate |
|---|
| devices. |
| Attribute | Selicor Inc.
Shortwave Diathermy System
K020227 | ViaTherm Therapeutics LLC
ViaTherm BOOST Diathermy System K173300 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications For
Use | To generate deep heating within
body tissues for the treatment of
conditions such as relief of pain,
muscle spasms, and joint
contractures. | To generate deep heating within
body tissues for the treatment of
conditions such as relief of pain and
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)
whose medical conditions would
be treated, in whole or in part,
with therapeutic warmth. Some
examples of these types of
medical conditions are as follows:
pain and swelling in soft tissue
injuries; muscle spasms or pain
due to injury or over-training; and
rehabilitation of joints from injury
or. | Adults (not to be used on children)
whose medical conditions would be
treated, in whole or in part, with
therapeutic warmth. Some examples
of these types of medical conditions
are as follows: pain and swelling in
soft tissue injuries; muscle spasms
or pain due to injury or over-
training. |
| Intended
Environment For
Use | Designed for home use by a non-
technical operator with or without
the immediate supervision of a
healthcare practitioner. | OTC device intended for use by
patients in non-clinical
environments, including the
home |
| Design | User-friendly device designed with
safety mechanisms that enable it
to be effectively and safely
operated by a non-technical adult
in a non-clinical setting, | User-friendly device designed
with safety mechanisms that
enable it to be effectively and
safely operated by a non-
technical adult in non-clinical
environments, including the
home setting. |
| Mechanism of
Action | Deep heating of tissue by
therapeutic application of
radio frequency electrical
currents | Deep heating of tissue by
therapeutic application of
radio frequency electrical
currents |
| Anatomical Site | Various therapy garment sizes | Multi-use therapy garment for |
| Attribute | Selicor Inc.
Shortwave Diathermy System
K020227 | ViaTherm Therapeutics LLC
ViaTherm BOOST Diathermy
System K173300 |
| Locations | for target locations: hand,
forearm, knee, shoulder, lower
back, thigh, foot, or lower leg
garment | target location areas of 5 to 18
square inches: Arm (e.g. bicep,
wrist, forearm), back, shoulder, leg
(e.g. thigh, knee, calf), foot. |
| Treatment time | 30 minutes | 40 -45 minutes |
| Available Warming
Control | Knob to adjust therapy duration
and intensity settings | Single setting. Not adjusted by
patient. |
| Thermal performance | Achieves 4°C temperature rise at 20
minutes | Achieves 4°C temperature rise at 25
minutes |
| Materials | Generator
Family of anatomically designed
therapy garments Composed of nylon foam
material with Spandex inner
liner. The outer cover is nylon,
Cordura Material, by DuPont | Generator
Therapy Garment Material Futuro™ by 3M, composed
of polyurethane foam,
nylon, polyester,
polyethylene, and spandex Velcro Extender Strap Charger Cord
Patient Interface – 100% cotton |
| Charger Cord
Patient Interface - paper | | |
| Safety Factors | The SeliTherm C 100 requires the
operator to interact with the
device by pushing a button every
20-minutes (after a buzzer goes
off) in order to keep the device
on. This will eliminate the
possibility of overheating due to
the patient operator falling
asleep. | The device treatment is intended
to be self-administered in the
home. The device is battery
operated. It contains circuit
boards that determine if the
garment is making sufficient
contact with the user, and if so,
will output the designated
power. The treatment time is
based on the life of the battery,
preventing the user from over
treating. |
| Biocompatibility | Established | Established |
| Technical
Specifications | Selicor Inc.
Shortwave Diathermy System
K020227 | ViaTherm Therapeutics LLC
ViaTherm BOOST Diathermy
System K173300 |
| Generator Technical Specifications: | | |
| Operating
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
Ratio | 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), 2000
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
Temperatures | Operating: 32 to 122 degrees F (0 to
50 degrees C) | Operating: 59 to 104 degrees F (15
to 40 degrees C) at relative
humidity of 30%-90% (non-
condensing) and pressure of 700-
1060 hPa. |
| Storage
Temperatures | Storage: -4 to 140 F (-20 to 60
degrees C) | Storage: 50 to 140 degrees F (10 to
60 degrees C) at relative humidity
of 15%-90% (noncondensing)
and pressure of 700-1060 hPa. |
| Radiation Safety | Established | Established |
| RF Shielding | Yes | Yes |
| Designed to meet
Electrical Safety
Standards | IEC 60601-1 | IEC 60601-1
IEC 60601-1-2
IEC 60606-1-6
IEC 60601-1-11 |
| Coil design | Two helical coils embedded in a
fabric garment | Two flat spiral coils embedded in a
fabric garment |
| Testing | Testing was performed to the following standards:
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance IEC 60601-2 Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard: Electromagnetic
disturbances IEC 60601-1-6 Medical Electrical Equipment - General requirements for basic
safety and essential performance - Usability IEC 60601-1-11 Medical Electrical Equipment - Requirements for medical
electrical equipment and medical electrical systems used in the home
healthcare environment IEC 62366 Medical Devices – Application of Usability Engineering to Medical
Devices ISO 14971 Medical Devices – Application of Risk Management to Medical
Devices | |
| | Temperature testing was performed in a muscle/bone phantom to assess the
temperature rise in simulated tissue. A clinical test in nine healthy subjects
was performed and the temperatures of tissue at the surface, 1cm and 2cm
were 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 similar
indications, technological characteristics, and principles of operation as its
predicate device. The BOOST Diathermy System is indicated for over-the-
counter use, however, this modification in the indications for use and the
labelling does not alter the therapeutic effect of the device. Usability testing
demonstrated that the BOOST Diathermy System can be appropriately
selected and used by the general population. The minor differences in
design, size and shape to improve user interface between the BOOST
Diathermy System and its predicate device raise no new issues of safety or
effectiveness. Performance data demonstrate that the BOOST Diathermy
System is as safe and effective as predicate device. | |
| | Based on the technical characteristics and the results of the performance
testing, the BOOST Diathermy System is substantially equivalent to the
predicate device. | |
3
4
Continued on next page
5
ViaTherm BOOST Diathermy System, Continued
6
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
7
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
8
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