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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.

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.

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.

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