(58 days)
Not Found
No
The device description details a feedback loop based on temperature and impedance measurements to automatically adjust energy delivery. This is a standard control system mechanism, not indicative of AI or ML. There are no mentions of AI, ML, or related concepts in the summary.
Yes
The device is indicated for use in surgical procedures (electrocoagulation and hemostasis) and to create lesions in nervous tissue, which are therapeutic interventions.
No
Explanation: The device is indicated for electrocoagulation and hemostasis, and to create lesions in nervous tissue, which are therapeutic procedures. It does not mention diagnosis.
No
The device description explicitly lists hardware components such as an RF Generator, electrodes, handpieces, foot pedal, and power cord. The performance studies also include testing related to hardware, such as electrical safety and essential performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dermatological and general surgical procedures for electrocoagulation and hemostasis" and "to create lesions in nervous tissue." These are procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a system that delivers radiofrequency energy directly to tissue using electrodes. This is a therapeutic or surgical intervention, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device operates directly on the patient's tissue for therapeutic or surgical purposes.
N/A
Intended Use / Indications for Use
The Thermi Temperature Controlled Radiofrequency (RF) System (generator, electrodes/hanpieces and accessories) are indicated:
- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
- to create lesions in nervous tissue
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Thermi Temperature Controlled Radiofrequency (RF) System consists of a RF generator with integral temperature and impedance feedback, automatically adjusting energy delivery to maintain set temperature and percutaneous and transcutaneous electrodes accessories that deliver the RF to the targeted location on the patient's anatomy when use with Thermi RF generator. It is operating with set temperature range between 35-90° C that allows the physician to control treatment temperature to achieve the desired clinical outcome.
The Thermi RF System consist of:
-
- RF Generator
-
- Percutaneous electrodes
-
- Disposable and re-usable transcutaneous electrodes/handpieces
-
- Foot pedal
-
- Power cord
Thermi RF generator produces an oscillating electric field in the antenna (electrode). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermocouple in the electrode measures this increase in temperature and maintains a feedback loop to ensure a set point temperature in the tissue.
- Power cord
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The Thermi Temperature Controlled Radiofrequency System is similar with regards to indications for use, design, operation principle and technological characteristics to the predicate devices that were cleared in K130689, ThermiRF System (previously named the Symphony RF System), K170116, Thermi Injectable RF Electrode and K171094, Thermi Reusable Non-invasive RF Electrode. Results of bench testing demonstrate Thermi RF Temperature Controlled Radiofrequency System is as safe and effective as the predicate devices.
The Thermi Temperature Controlled Radiofrequency System is similar with regards to indications for use and technological characteristics to the predicate devices that were cleared in K130689, ThermiRF System (previously named the Symphony RF System), K170116, Thermi Injectable RF Electrode and K171094, Thermi Reusable Non-invasive RF Electrode. Results of bench testing demonstrate Thermi RF Temperature Controlled Radiofrequency System works within the device parameters ranges of the legally marketed Thermi RF System with the same indications for use.
All testing performed on the Thermi Temperature Controlled Radiofrequency System derived from the risk assessment in accordance with ISO 14971 which evaluated the safety and effectiveness of the design modification in accordance with Thermi Design & Development procedures. The test methodology and acceptance criteria were developed from within Thermi and from related standards.
A series of bench testing was identified and conducted on the subject Thermi Temperature Controlled Radiofrequency System in accordance with protocols to verify design specifications as follows. Testing inclued:
- Dimensional testing ●
- Functional testing ●
- Performance testing ●
- Design features confirmation ●
- Shelf life testing ●
- Biocompatibility testing ●
- Tensile strength
- Materials confirmation
- Thermal effect on tissue testing including muscle, liver, kidney, and porcine skin ●
- Software functional and performance verification
- Software Validation
- Max Output Energy ●
Electrical safety and essential performance testing was completed on the subject Thermi Temperature Controlled Radiofrequency System in accordance with FDA Guidance "Premarket Notification 510(k) Submission for Electrosurgical Devices for General Surgery. The following electrical safety and essential performance testing was completed:
-
- IEC 60601-1, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performances.
-
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances requirements and test
-
- IEC 60601-1-6, Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
-
- IEC 60601-2-2, Medical Electrical Equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
The results of testing show that the subject Thermi Temperature Controlled Radiofrequency (RF) System, met all performance and functional testing and performed as intended; and did not raise new safety or performance questions.
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, 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.
January 17, 2017
ThermiGen. L.L.C. Ms. Suzanne Cheang Regulatory Affairs Director 3131 West Royal Lane, Suite 100 Irving, Texas 75063
Re: K173582
Trade/Device Name: Thermi Temperature Controlled Radiofrequency (RF) System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 17, 2017 Received: November 20, 2017
Dear Ms. Cheang:
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, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
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, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173582
Device Name
Thermi Temperature Controlled Radiofrequency (RF) System
Indications for Use (Describe)
The Thermi Temperature Controlled Radiofrequency (RF) System (generator, electrodes/hanpieces and accessories) are indicated:
- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
- to create lesions in nervous tissue
| 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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3
SECTION 6: 510(K) SUMMARY
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date is November 15, 2017 [21 CFR 807.92(a)(1)].
General Information
| Trade Name | ThermiX Temperature Controlled Radiofrequency (RF) System |
|---|---|
| Classification Name | 21 CFR §878.4400 Electrosurgical Cutting and Coagulation and |
| Accessories | |
| Regulatory Class | Class II |
| Product Code | GEI |
| Submitter | ThermiGen, L.L.C. |
| 3131 West Royal Lane Suite 100 | |
| Irving, TX 75063 | |
| Contact | Ms. Suzanne Cheang |
| Regulatory Affairs, Director | |
| Phone: (214) 888-0683 | |
| Fax: (214) 279-0101 | |
| Email: scheang@thermi.com |
Predicate Device
| K130689 | ThermiGen Symphony RF System |
|---|---|
| K171094 | Thermi Reusable Non-invasive RF Electrode |
| K170116 | Thermi Injectable RF Electrode |
Indications for Use
The Thermi Temperature Controlled Radiofrequency (RF) System (generator, electrodes/handpieces and accessories) are indicated:
- . for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
- to create lesions in nervous tissue.
Device Description
The Thermi Temperature Controlled Radiofrequency (RF) System consists of a RF generator with integral temperature and impedance feedback, automatically adjusting energy delivery to maintain set temperature and percutaneous and transcutaneous electrodes accessories that deliver the RF to the targeted location on the patient's anatomy when use with Thermi RF generator. It is operating with set temperature range between 35-90° C that allows the physician to control treatment temperature to achieve the desired clinical outcome.
4
The Thermi RF System consist of:
-
- RF Generator
-
- Percutaneous electrodes
-
- Disposable and re-usable transcutaneous electrodes/handpieces
-
- Foot pedal
-
- Power cord
Thermi RF generator produces an oscillating electric field in the antenna (electrode). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermocouple in the electrode measures this increase in temperature and maintains a feedback loop to ensure a set point temperature in the tissue.
Technological Characteristics
The Thermi Temperature Controlled Radiofrequency System is similar with regards to indications for use, design, operation principle and technological characteristics to the predicate devices that were cleared in K130689, ThermiRF System (previously named the Symphony RF System), K170116, Thermi Injectable RF Electrode and K171094, Thermi Reusable Noninvasive RF Electrode. Results of bench testing demonstrate Thermi RF Temperature Controlled Radiofrequency System is as safe and effective as the predicate devices.
Performance Data
The Thermi Temperature Controlled Radiofrequency System is similar with regards to indications for use and technological characteristics to the predicate devices that were cleared in K130689, ThermiRF System (previously named the Symphony RF System), K170116, Thermi Injectable RF Electrode and K171094, Thermi Reusable Non-invasive RF Electrode. Results of bench testing demonstrate Thermi RF Temperature Controlled Radiofrequency System works within the device parameters ranges of the legally marketed Thermi RF System with the same indications for use.
All testing performed on the Thermi Temperature Controlled Radiofrequency System derived from the risk assessment in accordance with ISO 14971 which evaluated the safety and effectiveness of the design modification in accordance with Thermi Design & Development procedures. The test methodology and acceptance criteria were developed from within Thermi and from related standards.
A series of bench testing was identified and conducted on the subject Thermi Temperature Controlled Radiofrequency System in accordance with protocols to verify design specifications as follows. Testing inclued:
- Dimensional testing ●
- Functional testing ●
- Performance testing ●
- Design features confirmation ●
- Shelf life testing ●
5
- Biocompatibility testing ●
- Tensile strength
- Materials confirmation
- Thermal effect on tissue testing including muscle, liver, kidney, and porcine skin ●
- Software functional and performance verification
- Software Validation
- Max Output Energy ●
Electrical safety and essential performance testing was completed on the subject Thermi Temperature Controlled Radiofrequency System in accordance with FDA Guidance "Premarket Notification 510(k) Submission for Electrosurgical Devices for General Surgery. The following electrical safety and essential performance testing was completed:
-
- IEC 60601-1, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performances.
-
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances requirements and test
-
- IEC 60601-1-6, Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
-
- IEC 60601-2-2, Medical Electrical Equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
The results of testing show that the subject Thermi Temperature Controlled Radiofrequency (RF) System, met all performance and functional testing and performed as intended; and did not raise new safety or performance questions.
Conclusions
The subject Thermi Temperature Controlled Radiofrequency System is similar with regards to indications for use, design, operation principle and technological characteristics to the predicate devices that were cleared in K130689, ThermiRF System (previously named the Symphony RF System), K170116, Thermi Injectable RF Electrode and K171094, Thermi Reusable Noninvasive RF Electrode. The results of testing demonstrate that the Thermi Temperature Controlled Radiofrequency System is safe and effective; and no new questions of safety or efficacy are raised.