(112 days)
Not Found
No
The summary describes a physical electrode and its function in delivering RF power, with no mention of AI or ML in its operation or data processing.
Yes
The device is used for "RF heat lesioning of peripheral nerve tissue," which is a therapeutic intervention designed to treat medical conditions.
No.
The device is used to deliver therapeutic RF power for lesioning nerve tissue, which is a treatment, not a diagnostic process.
No
The device description clearly outlines a physical electrode with a thermocouple sensor, cable, and hub, indicating it is a hardware device used in conjunction with other hardware components (Ground Pad, Generator).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "RF heat lesioning of peripheral nerve tissue only." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is an electrode used in conjunction with a generator and ground pad to deliver RF power for treatment. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly designed for a therapeutic intervention (lesioning nerve tissue) rather than for diagnosing or providing information about a patient's health status through in vitro analysis.
N/A
Intended Use / Indications for Use
The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.
Product codes (comma separated list FDA assigned to the subject device)
GXI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Testing
- Temperature 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 Procedure
- Bipolar RF Procedure
- Cleaning 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:
- Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity
- Acute systemic toxicity
- Material-mediated pyrogenicity
All testing was acceptable, and the results were passing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 Corporation | |
| 25155 Rye Canyon Loop | ||
| Valencia, CA 91355, USA | ||
| Contact Name and Information | Bansari Shah | |
| Senior Regulatory Affairs Specialist | ||
| Phone: 661-949-4210 | ||
| Email: 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 Corporation |
| 300 Boston Scientific Way | ||
| Marlborough, MA 01752 | ||
| USA |
ERN: 99120587 |
| | Manufacturing Facility: | Boston Scientific Corporation - Coyol
2546 First Street, ProPark
Coyol, Alajuela
Costa Rica
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: 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). |