. for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
to create lesions in nervous tissue when used in combination with NeuroTherm . (previously Smith&Nephew) thermal/coagulation probes.

Device Description

The Symphony RF is a 20 watt electro-thermal radio frequency (RF) generator with integral temperature and impedance feedback. The RF generator is the Smith&Nephew RF Delivery Device, unchanged and in clinical service since Feb 25, 2004 (K033981). The Symphony RF has software changes to allow for two types of electrode/hand-pieces. (1) percutaneous (existing Smith and Nephew thermal/coagulation probes, now owned and manufactured by Neurotherm, Inc.) and (2) the new transcutaneous thermal/coagulation probe, RFE-10-D.

The Symphony RF generator has a user interface that displays temperature set point and actual tissue temperature, procedure time, impedance, along with system error and warning codes.

The theory of operation of RF devices: The RF generator produces an oscillating electric field in the antenna (handpiece). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermistor intrinsic to the handpiece measures this increase in temperature and in the case of the Symphony RF, a feedback loop maintains a set point temperature in the tissue.

AI/ML Overview

This document is a 510(k) summary for the ThermiGen Symphony RF Generator, focusing on its substantial equivalence to predicate devices rather than a study proving the device meets specific acceptance criteria for a new clinical endpoint. Therefore, much of the requested information regarding acceptance criteria and a study meeting those criteria is not present. This device is an electrosurgical cutting and coagulation device, regulated as a Class II device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain a table of explicit acceptance criteria or a study that evaluates the device against such criteria in a performance-based manner (e.g., sensitivity, specificity, accuracy). Instead, it focuses on asserting substantial equivalence to predicate devices based on technical specifications and safety standards.

The criteria for demonstrating substantial equivalence are typically:

Same intended use as predicate device.
Same technological characteristics as predicate device, or if different, that the differences do not raise new questions of safety or efficacy.

Device Performance (as reported):

Conformance to Standards:
- The Symphony RF System has been third-party tested and found to conform to IEC 60601-2-2 (specific for RF devices).
- It was also third-party tested to IEC 60601 (3rd edition) and applicable Collateral Standards (60601-1-2, 60601-1-4, 60601-1-6).
Manufacturing and Software:
- The Symphony RF and RFE-10-D electrode meet all manufacturing and software specifications.
Comparison to Predicates:
- K033981 Smith&Nephew ElectroThermal 20S: Same power, frequency, monitoring, and safety functions.
- K000944 Thermage ThermaCool System: Same power and similar frequency, monitoring, and safety functions, as well as identical indications for use.
- K082834 Ellman Three Button Fingerswitch Handpiece (for RFE-10D): Same diameter of skin contact, monopolar, similar materials, similar temperature ranges, and both are transcutaneous.

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

Not applicable. There was no clinical test set in the traditional sense involving patient data to evaluate performance metrics like sensitivity or specificity. The submission relies on technical testing against recognized safety standards and comparison to predicate devices, not a study of patient outcomes or expert reads.

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

Not applicable. No expert review of a test set of data was conducted as part of this 510(k) summary for performance evaluation.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication was described.

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

No. This 510(k) summary does not mention or present an MRMC study. The device is a physical instrument (RF generator and handpieces), not an AI algorithm that assists human readers.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

No. The device is not an algorithm, and no standalone performance study in that context was performed. The "standalone" performance here relates to the device meeting technical and safety standards, which was done via third-party testing.

7. Type of Ground Truth Used:

The "ground truth" in this context is the established safety and efficacy of the predicate devices and the adherence to relevant international safety standards for electrosurgical equipment (e.g., IEC 60601 series). There is no "ground truth" derived from patient outcomes, pathology, or expert consensus on clinical cases as would be seen for diagnostic AI.

8. Sample Size for the Training Set:

Not applicable. The device is a physical electrosurgical system, not an AI model that requires a training set.

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

Not applicable for the same reasons as #8.

Summary

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K130689

Section 5

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 5-01-2013 [21 CFR 807.92(a)(1)].

Applicant Name and Address [21 CFR 807.92(a)(1)] A.

ThermiGen Inc.

ﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

401 Carroll Ave

Southlake, TX 76092

Tel: (866)-981-5017

Fax: (214) 279-0101

B. Contact Information

ThermiGen Inc.

401 Carroll Ave

Southlake, TX 76092

Tel: (214)-621-2525

Fax: (214) 279-0101

Contact person: Kevin O'Brien, President

kobrien@thermigen.com

NOV 15 2013

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C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name: Symphony RF Generator Device Common Name: Electrosurgical Cutting and Coagulation and Accessories Classification Name: Electrosurgical Cutting and Coagulation and Accessories 21 CFR 878.4400 Product Code: GEI Device Classification: Class II

D. Predicate Devices [21 CFR 807.92(a)(3)]

The Symphony RF System and the RFE-10-D handpiece use similar technology and physical output characteristics as the following predicate devices: K033981 Smith&Nephew ElectroThermal 20S K000944 Thermage ThermaCool System K082834, K102368 Ellman Three Button Fingerswitch Handpiece

E. Device Description [21 CFR 807.92(a)(4)]

The Symphony RF generator has a user interface that displays temperature set point and actual tissue temperature, procedure time, impedance, along with system error and warning codes.

F. Device Specifications [21 CFR 807,92(a)(6)]

Comparison to the predicate K033981 ElectroThermal 20S demonstrates both devices have the same power, frequency, and monitoring and safety functions. Comparison to the predicate K000944 ThermaCool System demonstrates both devices have the same power and similar frequency, monitoring and safety functions, as well as identical indications for use.

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Comparison of the handpiece RFE-10D to the predicate K082834 Ellman Three Button Fingerswitch Handpiece demonstrates both have the same diameter of skin contact, are monopolar, are constructed with similar materials, and have a similar temperature ranges. Both handpieces are transcutaneous in terms of operation.

The Symphony RF system includes

1. Symphony RF generator
1. Hospital-grade power cord
1. Pneumatic footswitch

The Symphony RF system requires the following accessories

1. NeuroTherm Electrosurgical Neutral Electrode (REF RDGP-S)
1. NeuroTherm RF Denervation Probes, RF Electrodes, RF cannulae for percutaneous approaches.
1. NeuroTherm RFE-10D Probe for transcutaneous approaches.

G. Indications for Use [21 CFR 807.92(a)(5)]

The Symphony RF System and the probes that are used with it 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 NeuroTherm (previously Smith&Nephew) thermal/coagulation probes.

H. Performance Data [21 CFR 807.92(b)(2)]

There are no applicable Guidance Documents specifically associated with this type of medical device. A recognized Consensus Standard, IEC 60601-2-2 exists for RF devices. The Symphony RF System has been third party tested and found to conform to IEC 60601-2-2.

The Symphony RF was also third party tested to the IEC 60601 (3rd edition) standard, along with applicable Collateral Standards (60601-1-2, 60601-1-4 and 60601-1-6). The Symphony RF and RFE-10-D electrode meet all manufacturing and software specifications. No additional performance or clinical testing was conducted.

I. Conclusion [21 CFR 807.92(b)(3)]

The ThermiGen Symphony RF was found to be substantially equivalent to the predicate devices in terms of technology, function and intended use. The indications for use are identical to the previously cleared devices (Smith&Nephew ElectroThermal 20S K033981 and Thermage ThermaCool System K000944). We believe that there are no new questions of safety or efficacy raised by the introduction of the ThermiGen Symphony RF System.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape and features the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a bird-like figure. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

ThermiGen, Inc. Mr. Kevin O'Brien President 401 North Carroll Avenue Southlake, Texas 76092

November 15, 2013

Re: K130689

Trade/Device Name: Symphony RF Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 20, 2013 Received: October 22, 2013

Dear Mr. O'Brien:

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

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Page 2 - Mr. Kevin O'Brien

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 Indications for Use

510(k) Number (if known): _ K130689

Device Name: ThermiGen Symphony RF Generator

Indications for Use:

The ThermiGen Symphony RF Generator System and the probes that are used with it 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 NeuroTherm . (previously Smith&Nephew) thermal/coagulation probes.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

... ..........................................................................................................................................................................

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-off) Division of Surgical Devices 510(k) Number K130689

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.