(346 days)
LCCS Radiofrequency (RF) Electrode is indicated for use in temperature-controlled RF heat lesson procedures of peripheral nerve tissue for the relief of pain.
LCCS Radiofrequency (RF) Electrode is used in conjunction with RF Generator to create RF lesions of nerve tissue or for use in percutaneous nerve blocks. The RF Electrode connects with RF Generator and thermocouple side which fits in with RF Cannula. The RF generator applies temperature-controlled RF energy into targeted nerve tissue via an RF Electrode to create a heat lesioning of peripheral nerve tissue.
LCCS RF Electrode includes LCCS Disposable RF Electrode and LCCS Reusable RF Electrode. LCCS Disposable RF Electrode Part No. includes RE2750-D-LC, RE27100-D-LC, RE27150-D-LC, and RE27200-D-LC.
LCCS Reusable RF Electrode Part No. includes RE2750-R-LC, RE27100-R-LC, RE27150-R-LC, RE27200-R-LC, RE2550-R-LC, RE25100-R-LC, RE25150-R-LC, and RE25200-R-LC.
This document describes the LCCS Radiofrequency (RF) Electrode, a device for temperature-controlled RF heat lesion procedures of peripheral nerve tissue for pain relief. The submission focuses on demonstrating substantial equivalence to predicate devices (OWL Sterile Single Use RF Probes and OWL Reusable RF Probes) through non-clinical testing.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the “Passed” status in the non-clinical testing table, indicating the device met the requirements of the specified test methods and standards. The reported device performance is that all tests passed.
| Test Category | Specific Test | Test Method Summary | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|---|
| Physical/Mechanical | Dimension | Measured the electrode nominal OD and effective length. | Met specified dimensions | Passed |
| Cleanness | Observed the surface cleanness under normal or corrected vision with 300LX to 700LC illumination. | Met visual cleanness standards | Passed | |
| Appearance | Inspect the appearance under normal or corrected vision with 300LX to 700LC illumination. | Met visual appearance standards | Passed | |
| Corrosion resistance | ISO 13402 Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure | Withstood corrosion/autoclaving | Passed | |
| Degree of connection rigidity | Verified the connection rigidity by static tensile test. | Met rigidity requirements | Passed | |
| Functional | Temperature accuracy | Verified the accuracy by performance testing. | Range: 40~100 °C, Tolerance: ± 5% | Passed |
| Biocompatibility | Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | Passed |
| Sensitization | ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization | Non-sensitizing | Passed | |
| Irritation | ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization | Non-irritating | Passed | |
| EtO and ECH residuals (Disposable only) | ISO 10993-7 Biological evaluation of medical devices -Part 7:Ethylene oxide sterilization | Met residual limits | Passed | |
| Sterilization | Sterilization (Disposable) | ISO 11135 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices | Met sterilization efficacy | Passed |
| Sterilization (Reusable) | ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Met sterilization efficacy | Passed | |
| Electrical Safety | EMC | IEC 60601-2-2 Medical electrical equipment Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | Met EMC standards | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the non-clinical tests. It only states that "All nonclinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate devices." The data provenance is implied to be from laboratory testing conducted by the manufacturer or a third-party testing facility, likely in China (given the applicant and consultant information). The studies are evidently prospective, as they were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish a "ground truth" for the non-clinical test set in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" for these engineering and biocompatibility tests is established by the specified international standards (e.g., ISO, IEC) and internal performance specifications. The tests themselves are designed to objectively measure physical and chemical properties.
4. Adjudication Method for the Test Set
Not applicable. As described above, the non-clinical tests are objective measurements against established standards, not subjective interpretations requiring adjudication.
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 is a medical device for therapeutic intervention (radiofrequency ablation), not a diagnostic device involving human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical electrode used in conjunction with an RF generator and is operated by a medical professional; it is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical studies is based on established international standards (ISO, IEC) for medical devices, materials, and electrical safety, along with the device's own design specifications (e.g., dimensions, temperature range and tolerance). For instance, for biocompatibility, the ground truth is defined by the Pass/Fail criteria outlined in the ISO 10993 series. For temperature accuracy, the ground truth is the ±5% tolerance within the 40-100 °C range.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an artificial intelligence/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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).