Nitinol Thermocouple (TCN) Electrode

K183177 · Boston Scientific Corporation · GXI · Mar 8, 2019 · Neurology

Device Facts

• Record ID: K183177
• Device Name: Nitinol Thermocouple (TCN) Electrode
• Applicant: Boston Scientific Corporation
• Product Code: GXI · Neurology
• Decision Date: Mar 8, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Nitinol Thermocouple (TCN) Electrode is a reusable RF electrode used for therapeutic RF power delivery to peripheral nerve tissue. Device consists of a flexible nitinol shaft with a thermocouple sensor at the tip and a hub for connection to an RF generator. Used in conjunction with a ground pad and generator; operated by clinicians in a medical setting. The thermocouple provides temperature feedback to the generator to control lesioning. The device is designed for reusability and requires reprocessing. Benefits include precise thermal treatment of nerve tissue for pain management or related therapeutic applications.

Clinical Evidence

Bench testing only. Verification testing included simulated RF lesioning, reusability, reprocessing, reliability, and temperature sensing. Validation testing included monopolar and bipolar RF procedures, and cleaning/sterilization validation. Biocompatibility testing included cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity. All testing passed.

Technological Characteristics

Reusable RF lesion probe. Shaft material: Nitinol (vs. 304 stainless steel in predicate). Sensor: Thermocouple (Constantan and copper wire). Connectivity: Hub connects to RF generator; available with 3-meter cable. Sterilization: Reusable/reprocessable. Design features: Flexible nitinol shaft, modified hub length, and strain relief geometry.

Indications for Use

Indicated for RF heat lesioning of peripheral nerve tissue.

Regulatory Classification

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.

Predicate Devices

• Radiofrequency Lesion Probe (K050084)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 Corporation<br>25155 Rye Canyon Loop<br>Valencia, CA 91355, USA | |
| Contact Name and Information | Bansari Shah<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Email: [e-mail] | |
| 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 Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>USA<br><br>ERN: 99120587 |
| | Manufacturing Facility: | Boston Scientific Corporation - Coyol<br>2546 First Street, ProPark<br>Coyol, Alajuela<br>Costa Rica<br><br>ERN: 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: <ul><li>Simulated Radiofrequency (RF) Lesioning with Reusability, Reprocessing and Reliability Testing</li><li>Temperature Sensing</li></ul> |
| | The following validation testing was completed on the TCN electrode to ensure that the modified device continues to meet all user requirements: <ul><li>Monopolar RF Procedure</li><li>Bipolar RF Procedure</li><li>Cleaning and Sterilization</li></ul> |
| | 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: <ul><li>Cytotoxicity</li><li>Sensitization</li><li>Irritation/intracutaneous reactivity</li><li>Acute systemic toxicity</li><li>Material-mediated pyrogenicity</li></ul> |
| | 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). |