(112 days)
The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.
The Nitinol Thermocouple (TCN) Electrode is a reusable nitinol Radio Frequency (RF) electrode that has a Thermocouple (TC) sensor at the tip and is used in conjunction with a Ground Pad and a Generator to deliver therapeutic RF power to treat the peripheral nerve tissue. The electrode shaft is composed of Nitinol to allow for flexibility. The TCN electrode has a hub that connects to the Active Output Jack on the Generator. The TCN - 3M Electrode configurations are provided with a 3-meter cable.
This document describes the 510(k) clearance for the Nitinol Thermocouple (TCN) Electrode, a reusable radiofrequency (RF) electrode used for RF heat lesioning of peripheral nerve tissue. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device (K050084).
Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets in a formal table style. Instead, the acceptance criteria are implicitly defined by the successful completion of various non-clinical tests demonstrating that the modified device maintains the safety and performance characteristics of the predicate device. The "reported device performance" is that the device successfully passed all these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional / Performance: | |
| Ability to perform simulated RF lesioning. | Passed: "Simulated Radiofrequency (RF) Lesioning with Reusability, Reprocessing and Reliability Testing" showed continued functionality. |
| Accurate temperature sensing. | Passed: "Temperature Sensing" testing confirmed continued accurate temperature measurement. |
| Continued functionality during Monopolar RF procedure. | Passed: "Monopolar RF Procedure" validation testing ensured the modified device met all user requirements. |
| Continued functionality during Bipolar RF procedure. | Passed: "Bipolar RF Procedure" validation testing ensured the modified device met all user requirements. |
| Cleaning and Sterilization Effectiveness: | Passed: "Cleaning and Sterilization" validation testing confirmed the modified device could be effectively cleaned and sterilized. |
| Biocompatibility: | |
| No cytotoxicity. | Passed: "Cytotoxicity" testing showed the device did not cause cell toxicity. |
| No sensitization. | Passed: "Sensitization" testing indicated no allergic reactions. |
| No irritation/intracutaneous reactivity. | Passed: "Irritation/intracutaneous reactivity" testing confirmed no adverse local tissue reactions. |
| No acute systemic toxicity. | Passed: "Acute systemic toxicity" testing showed no harmful effects on the body after short-term exposure. |
| No material-mediated pyrogenicity. | Passed: "Material-mediated pyrogenicity" testing indicated the materials did not cause fever. |
| Substantial Equivalence: | |
| Maintained equivalence to predicate in intended use, fundamental scientific technology, packaging, cleaning, and sterilization. | Passed: The conclusion states that "the proposed TCN electrode with the modified hub, shaft and strain relief has been shown to be appropriate for its intended use and is substantially equivalent to its predicate (K050084)." No new safety or performance issues were raised during the device testing. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify human test set data. All testing described is bench testing for verification and validation of the device's physical and functional characteristics. Data provenance refers to the testing being performed in a controlled laboratory environment by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. The testing described is non-clinical bench testing. The "ground truth" is defined by the technical specifications and performance requirements of the device, established by engineering and regulatory standards, rather than expert interpretation of patient data.
4. Adjudication Method for the Test Set:
Not applicable. This was non-clinical bench testing against established engineering and performance specifications. There was no need for adjudication by experts on "ground truth" derived from patient data.
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 device is a medical instrument (an electrode) and not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device. It does not contain an algorithm that operates in a standalone capacity like an AI imaging analysis tool.
7. The Type of Ground Truth Used:
The ground truth used for this premarket notification is based on engineering specifications, performance standards, and established biocompatibility norms. For example, temperature sensing accuracy would be compared against a known standard. Biocompatibility tests are performed according to recognized international standards (e.g., ISO 10993). The "ground truth" for substantial equivalence is the performance and safety profile of the cleared predicate device (K050084).
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).