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.

AI/ML Overview

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.

Summary

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March 8, 2019

Boston Scientific Corporation Adele Shoustal Director of Regulatory Affairs 25155 Rye Canyon Loop Valencia, California 91355

Re: K183177

Trade/Device Name: Nitinol Thermocouple (TCN) Electrode Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: February 5, 2019 Received: February 7, 2019

Dear Adele Shoustal:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Matthew C. Krueger -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183177

Device Name

Nitinol Thermocouple (TCN) Electrode

Indications for Use (Describe)

The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.

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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510(k) Summary for K183177

Per 21 CFR §807.92

Common or Usual Name	TCN Electrode
Trade Name(s)	Nitinol TC Electrode
Product Code	GXI - Radiofrequency Lesion Probe
Classification of Device	Class II (performance standards) - 21 CFR 882.4725
Submitter's Name and Address	Boston Scientific Neuromodulation Corporation25155 Rye Canyon LoopValencia, CA 91355, USA
Contact Name and Information	Bansari ShahSenior Regulatory Affairs SpecialistPhone: 661-949-4210Email: Bansari.Shah@bsci.com
Date Prepared	15NOV2018
Section 514 of the Act Performance Standards	No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for radiofrequency lesion probes.
Establishment Registration Numbers	Owner /Operator:	Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752USAERN: 99120587
	Manufacturing Facility:	Boston Scientific Corporation - Coyol2546 First Street, ProParkCoyol, AlajuelaCosta RicaERN: 3004859241
Predicate Device	K050084 - Radiofrequency Lesion Probe
Device Description	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.

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Intended Use/ Indications for Use	The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.
Comparison of Technological Characteristics	The proposed TCN electrode is substantially equivalent to the existing commercial Radiofrequency Lesion Probes cleared under K050084. The modified TCN electrode has the same intended use, fundamental scientific technology, packaging materials, cleaning and sterilization method as the applicable predicate device. The proposed TCN electrode hub is slightly longer than the predicate device. The proposed TCN electrode shaft consists of a Nitinol tube with a Constantan and a copper wire. The predicate device shaft consists of a 304 Stainless Steel tube with a single Constantan wire. The proposed TCN electrode strain relief is less tapered than the predicate device. The proposed TCN electrode is available with a 3-meter cable configuration as a line extension.
Summary of Non-Clinical Test Summary	Bench testing was performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing.
	The following verification testing was completed on the TCN electrode to verify that the modified device continues to meet the specification requirements impacted by the design change: Simulated Radiofrequency (RF) Lesioning with Reusability, Reprocessing and Reliability TestingTemperature Sensing
	The following validation testing was completed on the TCN electrode to ensure that the modified device continues to meet all user requirements: Monopolar RF ProcedureBipolar RF ProcedureCleaning and Sterilization
	The following biocompatibility testing was completed on the TCN electrode to ensure that the modified device continues to meet substantial equivalence to the predicate device: CytotoxicitySensitizationIrritation/intracutaneous reactivityAcute systemic toxicityMaterial-mediated pyrogenicity
	All testing was acceptable, and the results were passing.
Conclusion	Based on the indications for use, technological characteristics, and results of verification and validation testing, 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).

Regulation Number and Section

§ 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).