(26 days)
No
The document describes a simple RF electrode and generator system for electrocoagulation and hemostasis, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis, which are therapeutic medical procedures.
No
The device is indicated for electrocoagulation and hemostasis in dermatological and general surgical procedures, which are therapeutic functions, not diagnostic. It delivers RF energy to tissue to create heat, rather than to gather information for diagnosis.
No
The device description explicitly details a physical electrode that connects to a generator and delivers RF energy, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatological and general surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical intervention performed directly on a patient's tissue, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a device that delivers radiofrequency energy to tissue to create heat for coagulation. This is a direct interaction with the body, not an analysis of a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to directly modify tissue through the application of energy.
N/A
Intended Use / Indications for Use
The Thermi Reusable Non-Invasive RF Electrodes used with the Thermi RF Generator System are indicated:
- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
Product codes
GEI
Device Description
The Thermi Reusable Non-Invasive RF Electrode is a transcutaneous thermal/coagulation electrode designed to provide finely-controlled radiofrequency (RF) energy in combination with Thermi RF Generator. They are not intended to function with non-Thermi branded products. The electrode connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit. The Electrode delivers the RF signal from the generator to the electrode active tip. From the active tip, the RF signal triggers the tissue molecules to vibrate resulting in the formation of heat.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
All testing performed on the modified transcutaneous electrodes derived from the risk assessment which evaluated the safety and effectiveness of the design modification. The test methodology and acceptance criteria were developed from within Thermi and from related standards.
A series of bench testing was conducted on the modified Thermi Reusable Non-Invasive RF Electrode in accordance with protocols to verify design specifications as follows: dimensional testing, functional testing, design features, and tensile strength. The results of the verification testing shown that the modified Thermi Reusable Non-invasive RF Electrodes will function as intended when used with the Thermi RF Generator.
Electromagnetic Compatibility and Electrical Safety testing was conducted on the ThermiRF accessories and ThermiRF Generator. Compliance was demonstrated through testing to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6 and IEC 60601-2-2.
The results of testing show that the modified electrode Thermi Reusable Non-Invasive RF Electrode, met all performance and functional testing and performed as intended; and did not raise new safety or performance questions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2017
ThermiGen, L.L.C Ms. Suzanne Cheang Regulatory Affairs Manager 8304 Esters Boulevard Suite 890 Irving, Texas 75063
Re: K171094
Trade/Device Name: Thermi Reusable Non-invasive RF Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 10, 2017 Received: April 12, 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 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 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S" in a large, sans-serif font. The text is dark, and the background is light. The letters are well-defined and easy to read. There is a faint FDA logo in the background.
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
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Indications for Use
510(k) Number (if known) K171094
Device Name
Thermi Reusable Non-Invasive RF Electrode
Indications for Use (Describe)
The Thermi Reusable Non-Invasive RF Electrodes used with the Thermi RF Generator System are indicated:
- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
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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SECTION 7: 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 April 10, 2017 [21 CFR 807.92(a)(1)].
General Information
| Trade Name | Thermi Reusable Non-Invasive RF Electrode |
|---|---|
| Classification Name | 21 CFR §878.4400 Electrosurgical Cutting and Coagulation and |
| Accessories | |
| Regulatory Class | Class II |
| Product Code | GEI |
| Submitter | ThermiGen, L.L.C. |
| 8304 Esters Blvd Suite 890 | |
| Irving, TX 75063 | |
| Contact | Suzanne Cheang |
| Regulatory Affairs Manager | |
| Phone: (214) 888-068 | |
| Fax: (214) 279-0101 | |
| Email: scheang@thermi.com |
Predicate Device
K130689 The Symphony RF System
Indications for Use
The Thermi Reusable Non-Invasive RF Electrodes used with the Thermi RF Generator System are indicated:
- for use in dermatological and general surgical procedures for electrocoagulation and ● hemostasis
Device Description
The Thermi Reusable Non-Invasive RF Electrode is a transcutaneous thermal/coagulation electrode designed to provide finely-controlled radiofrequency (RF) energy in combination with Thermi RF Generator. They are not intended to function with non-Thermi branded products.
The electrode connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit. The Electrode delivers the RF signal from the generator to the electrode active tip. From the active tip, the RF signal triggers the tissue molecules to vibrate resulting in the formation of heat.
4
Technological Characteristics
The Thermi Reusable Non-Invasive RF Electrode is similar with regards to materials, intended use, principles of operation and technological characteristics to the legally marketed electrode that was cleared as part of accessories to be used with Thermi RF generator by FDA in 510(k) K130689, ThermiRF System (previously named the Symphony RF System). Results of bench testing demonstrate Thermi Reusable Non-invasive RF Electrode is as safe and effective as the legally marketed predicate device.
Modification to Existing Technology
Add new Thermi Reusable Non-Invasive RF Electrodes, 15mm (RFE-15-D) to the current legally marketed device offering, 10mm (RFE-10-D) electrode. The RFE-15-D has a 15mm diameter active tip which provides larger working surface without raising any new issues of safety and efficacy.
In addition, the Thermi Reusable Non-Invasive RF Electrodes have thinner active tip profile compared to the legally marketed electrode. The thinner active tip profile reduces the thermal mass of the electrode which facilitates the measurement of changes in temperature without any new issues raise of safety and efficacy.
Performance Data
All testing performed on the modified transcutaneous electrodes derived from the risk assessment which evaluated the safety and effectiveness of the design modification. The test methodology and acceptance criteria were developed from within Thermi and from related standards.
A series of bench testing was conducted on the modified Thermi Reusable Non-Invasive RF Electrode in accordance with protocols to verify design specifications as follows: dimensional testing, functional testing, design features, and tensile strength. The results of the verification testing shown that the modified Thermi Reusable Non-invasive RF Electrodes will function as intended when used with the Thermi RF Generator.
Electromagnetic Compatibility and Electrical Safety testing was conducted on the ThermiRF accessories and ThermiRF Generator. Compliance was demonstrated through testing to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6 and IEC 60601-2-2.
The results of testing show that the modified electrode Thermi Reusable Non-Invasive RF Electrode, met all performance and functional testing and performed as intended; and did not raise new safety or performance questions.
Conclusions
The Thermi Reusable Non-Invasive RF Electrode was found to be substantially equivalent to the predicate devices in terms of technology, function and intended use. The design is similar to the legally marketed transcutaneous thermal/coagulation electrode cleared by FDA in 510(k)
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K130689. No new questions of safety or efficacy are raised by the introduction of the modified transcutaneous electrode.