Thermi Injectable RF Electrodes

K170116 · Thermi · GEI · Mar 13, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170116
• Device Name: Thermi Injectable RF Electrodes
• Applicant: Thermi
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Thermi Injectable RF Electrodes are percutaneous devices combining an RF electrode and cannula; used with Thermi RF Generator to deliver radiofrequency energy. Device features insulated shaft to focus energy at active tip; tissue molecules vibrate to generate heat. Available in various lengths (5-20 cm), gauges (16-20 GA), and tip exposures (5-10 mm) to accommodate different anatomies. Used in clinical settings by physicians for electrocoagulation, hemostasis, and nervous tissue lesioning. Requires grounding pad to complete circuit. Single-use, sterile, disposable device. Output is controlled thermal energy; allows precise tissue heating/ablation. Benefits include reduced procedure steps and time compared to separate electrode/cannula systems.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1, 60601-1-2, 60601-1-4, 60601-1-6, 60601-2-2), dimensional verification, functional testing, tensile strength, packaging, shipping, and shelf-life. Results demonstrated the device meets all design specifications and functions as intended with the Thermi RF Generator.

Technological Characteristics

RF electrode and cannula combination; insulated shaft; blunt tip. Lengths 5-20 cm; tip exposures 5-10 mm; 16-20 GA. Silicone cable (264 cm). Energy source: Thermi RF Generator. Sterilization: Sterile. Connectivity: Wired connection to Thermi RF Generator; requires grounding pad.

Indications for Use

Indicated for patients undergoing dermatological or general surgical procedures requiring electrocoagulation, hemostasis, or the creation of lesions in nervous tissue.

Regulatory Classification

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.

Predicate Devices

• Thermi RF Accessories (K161661)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | <span> </span> |
|----------------------------------------------|----------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span> </span> |

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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 | Thermi<br>8304 Esters Boulevard Ste 890<br>Irving, TX 75063 |
| Contact | Ms. Suzanne Cheang, BS<br>Regulatory Affairs Manager<br>Telephone: [phone]<br>Fax: [phone]<br>[e-mail] |
| II. DEVICE | |
| Trade Name | Thermi Injectable RF® Electrodes |
| Common Name | Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| Classification<br>Name | 21 CFR 878.4400 Electrosurgical Cutting and Coagulation<br>Device 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 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.

#### 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.