(26 days)
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
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.
The provided text describes a 510(k) summary for the Thermi Reusable Non-Invasive RF Electrode. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria in the context of diagnostic performance (like sensitivity/specificity) for an AI/CAD device.
Based on the information provided, it's not possible to extract the acceptance criteria and study details as typically defined for AI/CAD devices. The document outlines bench testing to verify design specifications and ensure the modified device (an electrode for an electrosurgical system) performs as intended and is as safe and effective as the predicate device.
Here's an attempt to answer your questions based on the available information, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria (e.g., minimum accuracy, sensitivity) and device performance statistics as would be expected for an AI/CAD system. Instead, it refers to general compliance with standards and successful completion of bench tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Specifications | Met all design specifications |
| Functional Testing | Functioned as intended |
| Dimensional Testing | Successful |
| Tensile Strength | Successful |
| Electromagnetic Compatibility (EMC) | Demonstrated compliance to IEC 60601-1-2 |
| Electrical Safety | Demonstrated compliance to IEC 60601-1, IEC 60601-1-4, IEC 60601-1-6, and IEC 60601-2-2 |
| Safety and Efficacy (Overall) | As safe and effective as the legally marketed predicate device; no new safety or performance questions raised. |
2. Sample size used for the test set and the data provenance
The document refers to "a series of bench testing" performed on modified electrodes. It does not specify a "test set" in the context of patient data or clinical images, nor does it mention a specific sample size of electrodes tested. No provenance information (country of origin, retrospective/prospective) is applicable as it's bench testing, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of device and testing. The "ground truth" here would be the engineering specifications and performance standards established by Thermi and relevant regulatory bodies.
4. Adjudication method for the test set
Not applicable, as there is no diagnostic test set or expert review process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an electrosurgical electrode, not an AI/CAD system for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm. The device, an RF electrode, functions as a tool for a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device (an RF electrode), the "ground truth" for the bench testing would be:
- Engineering Specifications: Adherence to design parameters (dimensions, materials).
- Performance Standards: Meeting predefined functional outputs (e.g., specific RF energy delivery, temperature profiles, tensile strength).
- Compliance with International Standards: Adherence to standards like IEC 60601 series for electrical safety and electromagnetic compatibility.
There is no mention of expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing to the right, arranged in a way that they resemble a bird-like shape. The profiles are black, and they are surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in black, uppercase letters.
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
{2}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 andAccessories |
| Regulatory Class | Class II |
| Product Code | GEI |
| Submitter | ThermiGen, L.L.C.8304 Esters Blvd Suite 890Irving, TX 75063 |
| Contact | Suzanne CheangRegulatory Affairs ManagerPhone: (214) 888-068Fax: (214) 279-0101Email: 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)
{5}------------------------------------------------
K130689. No new questions of safety or efficacy are raised by the introduction of the modified transcutaneous electrode.
§ 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.