(182 days)
Not Found
No
The description mentions a "micro-processor-controlled" console and a temperature sensor, but there is no mention of AI, ML, or any algorithms that learn or adapt based on data. The performance studies focus on thermal output and safety, not on the performance of any AI/ML component.
Yes
The device's intended use is to elevate tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increased local circulation, which are therapeutic effects. The performance studies also explicitly state that the system "meets the requirements for a therapeutic treatment."
No
The device is described as providing therapeutic treatment by elevating tissue temperature for conditions like pain relief and increased circulation, not for diagnosing medical conditions.
No
The device description explicitly states it is comprised of a console housing power supply, electronics, and user interface, and a handpiece, indicating significant hardware components beyond just software. Performance studies also detail testing of hardware aspects like thermal output, electrical safety, and biocompatibility of the handpiece.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "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." This describes a therapeutic treatment applied directly to the patient's body.
- Device Description: The device utilizes "monopolar RF energy for the purpose of elevating tissue temperature." This is a physical therapy modality.
- Anatomical Site: The device is applied to external anatomical sites like the forearm, thigh, and abdomen.
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
This device operates in vivo (on the living body) for therapeutic purposes, not in vitro (outside the body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PBX
Device Description
The Thermal RF System is a Class II Medical Device that utilizes monopolar RF energy for the purpose of elevating tissue temperature for selected medical conditions. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It then has a handpiece that is attached to the console, and through the user interface can be selected for administering the treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forearm, thigh, abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
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.
1
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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. |
| 125 Fleming Dr | |
| Cambridge, Ontario, Canada N1T 2B8 | |
| Contact Person: | Mr. Gregory Berzak |
| Director of Regulatory Affairs and Quality Compliance | |
| Contact Information: | 519-620-3900- phone |
| 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 |
| accessories; Massager, Vacuum, Radio Frequency Induced Heat | |
| Product Code: | PBX - Massager, Vacuum, Radio Frequency Induced Heat |
| Legally Marketed | |
| 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 |
| monopolar RF energy for the purpose of elevating tissue | |
| temperature for selected medical conditions. The system is | |
| comprised of a micro-processor-controlled and user-friendly | |
| console that houses the power supply, the electronics and the | |
| user interface. It then has a handpiece that is attached to the | |
| console, and through the user interface can be selected for | |
| administering the treatment. | |
| 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. |
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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 | ||
| elevating tissue | |||
| temperature for selected | |||
| medical conditions such as | |||
| temporary relief of pain, | |||
| muscle spasms, and | |||
| increase in local circulation | 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 | Same | ||
| Technical | |||
| 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.