(74 days)
The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed ostecarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.
The COOLIEF® SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADV ANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVAN CED) to create RF lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.
The COOLIEF* Cooled Radiofrequency Kit Advanced is a modification to the predicate COOLIEF* Cooled Radiofrequency Kit cleared under K163461. The subject device consists of the following:
- COOLIEF* Cooled Radiofrequency Probe Advanced
- COOLIEF* Cooled Radiofrequency Fluid Tubing Kit ●
- COOLIEF* Cooled Radiofrequency Fluid Delivery Introducer ●
The modifications to the subject device are specific to the probe and fluid tubing kit.
The subject probe and fluid tubing kit are also included in the COOLIEFSINERGY Cooled Radiofrequency Kit Advanced.
The subject device has several configurations based on the anatomic region of use, length of the introducer and probe, and the length of the active electrode. The COOLIEF* Cooled Radiofrequency Kit Advanced is composed of fluid delivery introducers, probes, and fluid tubing kit. The kit is sterile, non-pyrogenic, and single-use. The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue.
The COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVANCED) to create RF lesions in nervous tissue. This device includes the same components as the COOLIEF* Cooled RF Kit Advanced, but also includes an Epsilon The Epsilon Ruler is a circular stainless-steel ruler that may be used during the COOLIEF Ruler. SINERGY* procedure to assist the user in providing a 'template' around the foramen, which is specific to performing procedure around the sacroiliac (SI) nerve.
This document is a 510(k) summary for the COOLIEF® Cooled Radiofrequency Kit Advanced, a medical device for creating lesions in nervous tissue. It details the device's characteristics, comparison to predicate devices, and non-clinical testing results.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name / Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization and Shelf-Life (ANSI/AAMI/ISO 11135:2014) | Compliance with standard | Pass |
| Bacterial Endotoxins Testing (ST72:2019) | Compliance with standard | Pass |
| Human Factors (62366-1:2015) | Compliance with standard | Pass |
| Biocompatibility (10993-5: 2009, 10993-10: 2010, 10993-11: 2006) | Compliance with standards | Pass |
| Electromagnetic Compatibility and Electrical Safety (60601-1:2005+AM1 (2012), 60601-1-6: 2010+A1:2013, 60601-1-9:2013, 60601-2-2:2017) | Compliance with standards | Pass |
| Performance Verification: Lesion Size Testing | As intended | Pass |
| Performance Verification: Probe Thermocouple Accuracy Testing | As intended | Pass (± 3°C as per Table 3) |
| Performance Verification: Probe Fluid Delivery Port Injection Force Testing | As intended | Pass |
| Performance Verification: Flow Rate Testing | As intended | Pass |
| Performance Verification: High Pressure Leak Testing | As intended | Pass |
| Performance Verification: Probe Mass Testing | As intended | Pass |
| Performance Verification: Structural Strength Testing | As intended | Pass |
| Performance Verification: Sterile Water and Saline Cooling Fluids Testing | As intended | Pass |
| Performance Verification: Packaging Verification (ANSI/AAMI/ISO 11607-1:2019) | Compliance with standard | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that clinical data was not applicable for the subject device and therefore was not provided. All testing mentioned is "non-clinical testing" or "bench performance testing." The sample sizes for these non-clinical tests are not specified in the provided text, nor is the provenance of the data beyond being "bench performance testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no clinical study described that involved establishing a ground truth with experts. The stated tests are non-clinical, focusing on device performance and safety parameters.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical study described. Adjudication methods are typically relevant for human-led assessments in clinical trials.
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
This information is not applicable. The device described is a radiofrequency kit, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI or MRMC studies in the provided text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is hardware (a radiofrequency kit) and not an algorithm.
7. The Type of Ground Truth Used
This information is not applicable as no clinical studies with a ground truth were conducted or described. The "ground truth" for the non-clinical tests would be the established engineering and safety standards and specifications to which the device was tested.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, the device does not involve a training set or ground truth in the context of an algorithm.
§ 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).