RF Thermal System
Device Facts
| Record ID | K210129 |
|---|---|
| Device Name | RF Thermal System |
| Applicant | Luvo Medical Technologies, Inc. |
| Product Code | PBX · General, Plastic Surgery |
| Decision Date | Jul 20, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation
Device Story
The RF Thermal System is a prescription-use, microprocessor-controlled console with an attached handpiece that delivers monopolar radiofrequency (RF) energy to human tissue. The device is operated by a clinician to elevate tissue temperature for therapeutic purposes, specifically for pain relief, muscle spasms, and local circulation improvement. The system includes a temperature sensor in the handpiece to monitor and maintain tissue temperature between 40°C and 44°C. The clinician selects treatment parameters via the console interface. By delivering controlled RF energy, the device induces localized heating, which provides therapeutic benefits to the patient. The system is designed for clinical use.
Clinical Evidence
Bench testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and high-frequency surgical equipment safety (IEC 60601-2-2). Biocompatibility was verified per ISO 10993. Mechanical performance testing confirmed output accuracy within ±20%. Human thermal testing (n=9) on the forearm, thigh, and abdomen demonstrated the device's capability to raise tissue temperature to 40°C and maintain it between 40°C–44°C for 10 minutes, confirming therapeutic efficacy.
Technological Characteristics
Monopolar RF generator; 4 MHz frequency; microprocessor-controlled console; handpiece with integrated temperature sensor. Materials comply with ISO 10993-1, 10993-5, 10993-10, and 10993-12. Packaging validated per ASTM D 4169:2016. Electrical safety per AAMI/IEC 60601-1:2005 + AMD 1:2012.
Indications for Use
Indicated for patients requiring elevated tissue temperature for temporary relief of pain, muscle spasms, and increased local circulation.
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Predicate Devices
- TempSure (K200241)
Submission Summary (Full Text)
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Jul1y 20, 2021
LUVO Medical Technologies, Inc. Mr. Gregory Berzak Director of Regulatory Affairs and Quality Compliance 125 Fleming Drive Cambridge, Ontario N1T2B8 Canada
Re: K210129
Trade/Device Name: RF Thermal System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: June 10, 2021 Received: June 22, 2021
Dear Mr. Berzak:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation -emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K210129
Device Name
Thermal RF System
Indications for Use (Describe)
The Thermal RF System is indicated for:
Heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation
Type of Use (Select one or both, as applicable)
| <div> <span style="font-size:12pt"> <span style="font-family:Symbol"> <span> ☑ </span> </span> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:12pt"> <span style="font-family:Symbol"> <span> ☐ </span> </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </div> |
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## 510K Summary RF Thermal System K210129
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Applicant: | LUVO Medical Technologies, Inc. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | LUVO Medical Technologies, Inc.<br>125 Fleming Dr<br>Cambridge, Ontario, Canada N1T 2B8 |
| Contact Person: | Mr. Gregory Berzak<br>Director of Regulatory Affairs and Quality Compliance |
| Contact Information: | 519-620-3900- phone<br>gregoryb@clarionmedical.com |
| Preparation Date: | July 16, 2021 |
| Device Trade Name: | RF Thermal System |
| Common Name: | Radio Frequency generator |
| Regulation Name: | 21 CFR 878.4400, Electrical cutting and coagulation device and<br>accessories; Massager, Vacuum, Radio Frequency Induced Heat |
| Product Code: | PBX - Massager, Vacuum, Radio Frequency Induced Heat |
| Legally Marketed<br>Predicate: | K200241 - Tempsure |
| Regulatory Class: | Class II Prescription Use |
| Description of Thermal RF: | The Thermal RF System is a Class II Medical Device that utilizes<br>monopolar RF energy for the purpose of elevating tissue<br>temperature for selected medical conditions. The system is<br>comprised of a micro-processor-controlled and user-friendly<br>console that houses the power supply, the electronics and the<br>user interface. It then has a handpiece that is attached to the<br>console, and through the user interface can be selected for<br>administering the treatment. |
| Indications for Use | Heating for the purpose of elevating tissue temperature for<br>selected medical conditions such as temporary relief of pain,<br>muscle spasms, and increase in local circulation. |
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### 510K Summary RF Thermal System K210129
Comparison to Predicate Device:
| | Thermal RF | Predicate: TempSure | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | K210129 | K200241 | |
| Indication for Use | Heating for the purpose of<br>elevating tissue<br>temperature for selected<br>medical conditions such as<br>temporary relief of pain,<br>muscle spasms, and<br>increase in local circulation | Heating for the purpose of<br>elevating tissue<br>temperature for selected<br>medical conditions such as<br>temporary relief of pain,<br>muscle spasms, and<br>increase in local circulation | Same |
| Technical<br>Specification | | | |
| Frequency (MHz) | 4 | 4 | Same |
| Operation Type | Monopolar | Monopolar | Same |
| Output Power | Up to 60W | 120-300W | Similar |
| TRF-E Tip | | | |
| Treatment Area | 0.38 cm² | 18mm | Similar |
| TRF-R Tip | | | |
| Treatment Area | 2.54 cm² | 25mm | Similar |
| TRF-S tip | | | |
Performance Data:
The following performance data was provided in support of the substantial equivalence determination:
IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance.
IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
IEC 60601-2-2 Test for Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing Within a Risk Management Process
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### 510K Summary RF Thermal System K210129
Thermal Testing was conducted on nine human subjects. The testing was conducted on three different parts of the body, the forearm, the thigh and the abdomen. Results showed that the Thermal RF system is capable of raising the temperature to 40°C and then maintain the temperate between 40°C – 44°C for 10 minutes, which meets the requirements for a therapeutic treatment.
Performance Test Summary:
The RF Thermal System completed performance testing to ensure safety and efficacy of the device.
Package Validation testing was performed successfully according to ASTM D 4169 : 2016. Assessment to national (National standard AAMI/IEC 60601-1:2005 + AMD 1:2012) and international regulations for Electrical devices was also performed successfully to Electrical Safety (IEC 60601), Electromagnetic compatibility (IEC 60601-1-2) and for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2).
The RF Thermal handpiece TIP comes into contact with the patient' skin was subject to Biocompatibility testing using the following standards to determine compliance: ISO 10993-1, ISO 10993-12, ISO 10993-5 & ISO 10993-10. The Raw material compliance to the Biocompatibility standards demonstrate compliance and that it is safe to contact skin as intended.
Additionally, mechanical performance was done by measuring the output accuracy of the TRF TIP, all results demonstrate accuracy within ±20%. Thermal therapeutic testing was also conducted for the RF Thermal System to show substantial equivalence and safety by showing the correlation between output energy and the corresponding temperature for the intended use. The quantitative data report ensures safety and effectiveness. The RF Thermal handpiece also has a temperature sensor which was tested successfully to demonstrate the device meets design specifications and performance requirements.
#### Conclusion:
The RF Thermal System has the same technology, principle of operation, indications for Use, and similar technical specifications as the predicate device. Performance test results also demonstrated the subject device can perform the same intended use as safely and effectively as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.
