*for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
- to create lesions in nervous tissue when used in combination with Thermi RF Generator.

Device Description

The Thermi Injectable RF® Electrodes are designed to provide finely-controlled radiofrequency (RF) energy in combination with the Thermi RF Generator. They are not intended to function with other RF generators or other non-Thermi branded products.
The Injectable RF® Electrodes are a combination of a RF electrode and a RF cannula to allow percutaneous application of RF energy. The RF electrode delivers the RF signal from the generator to the active tip of the cannula. The device utilizes an insulated shaft along the outside of the cannula to avoid transition of the RF signal outside of the tip area. From the active tip, the RF signal causes the tissue molecules to vibrate resulting in the formation of heat. The heated area is a function of the active tip size (length, gauge). The device is offered in different sizes to accommodate multiple anatomies and desired heating areas. The device connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit.
The Injectable RF® Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the Thermi Injectable RF® Electrodes range from 5 cm to 20 cm. The cannula portion is coated with an insulation layer such that only the tip will transmit the RF signal and ablate the tissue. The tip exposures available for the Thermi Injectable RF® Electrodes range from 5 mm to 10 mm. The diameters available for the Thermi Injectable RF® Electrodes range from 16 GA to 20 GA. The cannula electrodes have a blunt tip. All the RF electrodes have a 264 cm long silicone cable. The disposable cannula electrode is provided sterile in a sealed tray for single use only.

AI/ML Overview

The provided text describes the Thermi Injectable RF® Electrodes, a medical device for electrosurgical cutting and coagulation, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device meets acceptance criteria.

Specifically, the document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study report with specific acceptance criteria, sample sizes, expert qualifications, or comparative effectiveness study results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Electrical safety (compliance to standards)	Demonstrated compliance to IEC 60601-1: 2006, IEC 60601-1-2: 2001, IEC 60601-1-4: 1996, IEC 60601-1-6: 2006 and IEC 60601-2-2: 2009.
Dimensional accuracy	Met design specifications.
Functional performance	Performed as intended; met all performance and functional testing.
Design features	Met design specifications.
Tensile strength	Met design specifications.
Packaging integrity	Met design specifications.
Shipping integrity	Met design specifications.
Shelf-life	Met design specifications.
Simulated use performance	Functioned as intended when used with the Thermi RF Generator.
No new safety or performance questions	Did not raise new safety or performance questions.

Missing Information: The document states that the device "met all performance and functional testing and performed as intended," but it does not provide specific quantitative acceptance criteria for each test (e.g., "tensile strength must be >X Newtons"). It also doesn't provide specific quantitative results for each test.

Regarding the Study: The document describes "performance data" which includes electrical safety testing and bench testing. These are more akin to verification and validation activities rather than a "study" in the sense of a clinical trial or comparative effectiveness study.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document generically mentions "testing" or "a series of bench testing" but does not give the number of devices or components tested for any specific test.
Data Provenance: Not specified. The tests are bench tests, so they are likely conducted in a controlled lab environment. No information on country of origin or whether it's retrospective/prospective in the clinical sense is provided, as these are not clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The "ground truth" for these engineering and electrical safety tests would be the established international standards (e.g., IEC 60601 series) and internal design specifications. There's no mention of human experts establishing ground truth for individual test outcomes in the way one would for image interpretation or diagnosis.

4. Adjudication Method for the Test Set:

Not applicable. This concept typically applies to clinical studies where multiple reviewers assess a case and their interpretations need to be reconciled. For bench testing, results are typically objective measurements or pass/fail against predetermined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. An MRMC study was not done. The document does not describe any clinical study involving human readers or comparative effectiveness for this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is hardware (electrodes) used with a generator. It's not an algorithm or AI system. Its performance is inherent to its physical and functional characteristics when operated by a human user.

7. The Type of Ground Truth Used:

For electrical safety: International standards (IEC 60601 series).
For bench testing (dimensional, functional, tensile strength, etc.): Internal design specifications and validated test protocols.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware device; there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, no training set.

In summary: The provided document is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to a predicate device through engineering and electrical safety testing. It is not a detailed clinical study report and therefore lacks the specific details requested regarding clinical acceptance criteria, expert involvement, and comparative effectiveness studies.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, representing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 13, 2017

Thermi Ms. Suzanne Cheang Regulatory Affairs Manager 8304 Esters Boulevard Irving, Texas 75063

Re: K170116

Trade/Device Name: Thermi Injectable RF Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and acessories Regulatory Class: Class II Product Code: GEI Dated: December 21, 2016 Received: January 13, 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 devicerelated 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.

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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 yours,

Jennifer R. Stevenson -S

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)

K170116

Device Name

Thermi Injectable RF® Electrodes

Indications for Use (Describe)

The Thermi Injectable RF® Electrodes used with the Thermi RF Generator System are indicated:

*for use in dermatological and general surgical procedures for electrocoagulation and hemostasis

to create lesions in nervous tissue when used in combination with Thermi RF Generator.

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 5: 510(k) SUMMARY

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 8.7.87 and 807.92.

I. SUBMITTER

Date Prepared	March 09, 2017
Company	Thermi8304 Esters Boulevard Ste 890Irving, TX 75063
Contact	Ms. Suzanne Cheang, BSRegulatory Affairs ManagerTelephone: 214-888-0683Fax: 214-279-0101scheang@thermi.com
II. DEVICE
Trade Name	Thermi Injectable RF® Electrodes
Common Name	Electrosurgical Cutting and Coagulation Device andAccessories
ClassificationName	21 CFR 878.4400 Electrosurgical Cutting and CoagulationDevice and Accessories
Regulatory Class	II
Product Code	GEI

III. PREDICATE DEVICE

Predicate Name Thermi RF Accessories, K161661

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IV. DEVICE DESCRIPTION

The Injectable RF® Electrodes are a combination of a RF electrode and a RF cannula to allow percutaneous application of RF energy. The RF electrode delivers the RF signal from the generator to the active tip of the cannula. The device utilizes an insulated shaft along the outside of the cannula to avoid transition of the RF signal outside of the tip area. From the active tip, the RF signal causes the tissue molecules to vibrate resulting in the formation of heat. The heated area is a function of the active tip size (length, gauge). The device is offered in different sizes to accommodate multiple anatomies and desired heating areas. The device connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit.

The Injectable RF® Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the Thermi Injectable RF® Electrodes range from 5 cm to 20 cm. The cannula portion is coated with an insulation layer such that only the tip will transmit the RF signal and ablate the tissue. The tip exposures available for the Thermi Injectable RF® Electrodes range from 5 mm to 10 mm. The diameters available for the Thermi Injectable RF® Electrodes range from 16 GA to 20 GA. The cannula electrodes have a blunt tip. All the RF electrodes have a 264 cm long silicone cable. The disposable cannula electrode is provided sterile in a sealed tray for single use only.

V. INDICATIONS FOR USE

The Thermi Injectable RF® Electrodes used with the Thermi RF Generator System are indicated:

- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
- to create lesions in nervous tissue when used in combination with Thermi RF Generator.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Thermi Injectable RF® Electrodes are substantially equivalent to the Thermi RF Accessories, cleared under 510(k) K161661, in terms of design, functional performance, and intended use. The Thermi Injectable RF® Electrodes combine the separate electrodes and cannulas described in the Thermi RF Accessories 510(k) K161661 into single devices, which reduces procedure steps and time. There is no change to the fundamental scientific technology of the previously cleared devices or their indications for use as compared to the Thermi RF Accessories.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Electrical safety

Electrical safety testing was conducted on the Thermi Injectable RF® Electrodes and ThermiRF Generator. Compliance was demonstrated through testing to IEC 60601-1: 2006, IEC 60601-1-2: 2001, IEC 60601-1-4: 1996, IEC 60601-1-6: 2006 and IEC 60601-2-2: 2009.

Bench testing

A series of bench testing was conducted on the Thermi Injectable RF® Electrodes in accordance with protocols to verify design specifications as follows: dimensional testing, functional testing, design features, tensile strength, packaging, shipping and shelf-life.

The functional and simulated use verification testing was completed to demonstrate that the Thermi Injectable RF® Electrodes will function as intended when used with the Thermi RF Generator.

The results of testing show that the Thermi Injectable RF® Electrodes, met all performance and functional testing and performed as intended; and did not raise new safety or performance questions.

VIII. CONCLUSIONS

The results of testing show that the Thermi Injectable RF® Electrodes, met all performance and functional testing and performed as intended; and did not raise new safety or performance questions when use with Thermi RF Generator. The means of achieving electrocoagulation and hemostasis and creating lesions in nervous tissue in dermatological and general surgical procedures with the Thermi Injectable RF® Electrodes is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.