- 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 RF Accessories (electrodes, cannula, adapter cable) are designed to provide finely-controlled radiofrequency (RF) energy in combination with the predicate device Thermi RF Generator (K130689).

AI/ML Overview

This document is a 510(k) premarket notification for Thermi RF Accessories (electrosurgical cutting and coagulation devices and accessories). It states that the accessories are substantially equivalent to previously cleared devices. It describes performance data related to electrical safety and bench testing, but these are general engineering qualifications for device function, not specific clinical performance metrics related to diagnostic accuracy or AI performance.

Therefore, the requested information specifically regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device cannot be fully extracted as this is not an AI/ML device. The document does not describe studies with test sets, ground truth, expert consensus, or MRMC studies.

Here's what can be extracted based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (from this document)	Reported Device Performance
Electrical Safety Standards:
IEC 60601-1: 2006	Compliance shown
IEC 60601-1-2: 2001	Compliance shown
IEC 60601-1-4: 1996	Compliance shown
IEC 60601-1-6: 2006	Compliance shown
IEC 60601-2-2: 2009	Compliance shown
Bench Testing (Design Specifications):
Temperature measurement	Met all performance
Tensile strength	Met all performance
Functional testing	Met all performance
Design features	Met all performance
Heat shrink	Met all performance
Active tip length	Met all performance
Packaging	Met all performance
Shelf-life	Met all performance
Functional and Simulated Use Verification:
Function as intended with Thermi RF Generator	Functioned as intended

2. Sample sized used for the test set and the data provenance: Not applicable. The document describes engineering and bench testing, not clinical studies with test sets of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not mentioned as this is not an AI/ML device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set involving human interpretation/adjudication is 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 is not an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical electrosurgical accessory, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be engineering specifications and standards, not clinical ground truth.

8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set or its ground truth.

Summary

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

August 12, 2016

Thermi Ms. Carrie Eddings Regulatory Manager 8304 Esters Blvd Ste 890 Irving, Texas 75063

Re: K161661

Trade/Device Name: Thermi RF Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 24, 2016 Received: June 16, 2016

Dear Ms. Eddings:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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,

Christopher J. Ronk -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) K161661

Device Name Thermi RF Accessories

Indications for Use (Describe)

The Thermi RF accessories 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)
X 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

I. SUBMITTER

Thermi

8304 Esters Boulevard Ste 890 Irving, TX 75063 Telephone: 214-612-5819 Fax: 214-279-0101

Contact Person: Ms. Carrie Eddings, BA Regulatory Manager Contact Telephone: 214-612-5819 Contact Email: ceddings@thermi.com Date Prepared: May 24, 2016

II. DEVICE

Name of Device: Thermi RF Accessories Common or Usual Name: Electrosurgical Cutting and Coagulation Device and Accessories Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Regulatory Class: II Product Code: GEI

III. PREDICATE DEVICE

Thermi RF Generator and Accessories, K130689 NeuroTherm ElectroThermal 20S, K033981

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Thermi RF accessories 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.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of both the subject and predicate devices are identical since the accessories currently used with the Thermi RF Generator have been manufactured by St. Jude Medical Inc. (formerly NeuroTherm) and marketed under Thermi's 510(k) clearance (K130689). St. Jude Medical Inc. will begin private labeling these devices for Thermi, and as such, Thermi is submitting this 510(k) to obtain its own clearance for these devices. There are no design or manufacturing changes, other than manufacturing location (equipment being moved from Wilmington, MA to Minnetonka, MN), and the reflective labeling changes. The Thermi RF Accessories are substantially equivalent to the NeuroTherm accessories cleared under Thermi 510(k) K130689 and NeuroTherm 510(k) K033981, in terms of indications for use and functional performance.

VII. PERFORMANCE DATA

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

Electrical safety

Electromagnetic Compatibility and Electrical safety testing was conducted on the Thermi Symphony RF accessories and Thermi RF Generator. Compliance was shown 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

Bench testing was performed on the Thermi RF Accessories to verify all design specifications (including the following): temperature measurement, tensile strength, functional testing, design features, heat shrink, active tip length, packaging, and shelflife.

Functional and Simulated Use Verification was also completed to show that the Thermi RF Accessories when used with the Thermi RF Generator, will function as intended.

The Thermi RF accessories met all performance and functional testing and performed as intended.

VIII. CONCLUSIONS

The Thermi RF Accessories passed all electrical safety and verification testing, and no new issues of safety or efficacy were raised. The testing demonstrates the Thermi RF Accessories can be safely and effectively used with the 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 RF Accessories is substantially equivalent to the NeuroTherm RF Accessories for the generator.

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.