Search Results
Found 3 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
(163 days)
COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.
The COOLIEF* Radiofrequency Generator (CRG) System uses controlled radiofrequency energy to generate heat that is used to create lesions in neurological tissues or to coagulate and decompress disc material to treat symptomatic patients with contained herniated discs. The following components of the predicate Pain Management Generator-TD (K072478), which must be used together, have been modified and are the subject of this 510(k): a) COOLIEF* Radiofrequency Generator (CRG), b) COOLIEF* Quad Pump Unit (QPU), and c) COOLIEF* Therapy Cables.
The provided text describes the 510(k) premarket notification for the COOLIEF* Radiofrequency Generator (CRG) System. It lists general and technological characteristics of the device and compares them to a predicate device, along with non-clinical performance data.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum accuracy percentages). Instead, it lists various performance tests conducted and their successful completion, implying that "Pass" is the acceptance criterion for each test.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| COOLIEF* RF Generator Hardware Performance | Pass |
| Quad Pump Unit Flow-Rate Verification | Pass |
| Therapy Cable Mechanical Testing | Pass |
| Software Verification and Validation | Pass |
| Temperature Control - Benchtop and Perfused Tissue | Pass |
| Bench-Top Lesion Validation | Pass |
| Transportation and Handling (Packaging) | Pass |
| IEC 60601-1 (Medical Electrical Equipment – General Requirements for basic safety and essential performance 2012, Edition 3.1, Class 1) | Pass |
| IEC 60601-1-2: 2014 (Medical Electrical Equipment - General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests) | Pass |
| IEC 60601-2-2: 2009 (Fifth Ed.) Medical electrical equipment Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | Pass |
| IEC 62366-1:2015 (Part 1: Application of Usability Engineering to Medical Devices) | Pass |
| IEC 62304:2006 A1:2015 (Medical device software – software life cycle processes) | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical testing (performance testing). For these tests, specific sample sizes are not explicitly stated. For example, "Therapy Cable Mechanical Testing" implies that multiple cables were tested, but the number is not provided. Similarly, for "Bench-Top Lesion Validation," the number of lesions or trials is not detailed.
No clinical data was used for this submission, therefore, none of the typical provenance information (country of origin, retrospective/prospective) applies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the submission relies on non-clinical performance data and engineering verification tests. The "ground truth" for these tests would be established by the expected technical specifications and standards (e.g., a flow rate of >18mL/min, successful completion of a software test protocol). It doesn't involve subjective expert review in the way medical image analysis or diagnostic decision-making would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the submission focuses on non-clinical performance testing and engineering verification. Adjudication methods are typically used in clinical studies or studies involving expert interpretation where there might be disagreements on ground truth.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not applicable to this submission. The device is a radiofrequency generator, not an AI-powered diagnostic or assistive tool for human readers. No AI assistance or human reader performance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a hardware system (radiofrequency generator, pump, cables) and is not an algorithm or AI product capable of standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical performance tests is based on engineering specifications, established standards (e.g., IEC 60601 series), and expected functional performance. For instance, for "Quad Pump Unit Flow-Rate Verification," the ground truth is whether the measured flow rate meets the specified >18mL/min. For "Software Verification and Validation," the ground truth is compliance with the software requirements and absence of critical bugs. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this type of submission.
8. The sample size for the training set
This section is not applicable. The submission describes a medical device (radiofrequency generator system), not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set for this device.
Ask a specific question about this device
(125 days)
The COOLIEF* Cooled Radiofrequency Probe is to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue. 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 osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.
The COOLIEF* Cooled Radiofrequency (RF) Probe is a sterile, single-use device that delivers RF energy within the area of the active probe tip, while the probe tip is cooled by sterile water that circulates within the probe. Cooling the probe tip creates a larger. more homogenous RF heating area that results in a larger RF lesion in the target tissue. COOLIEF* Cooled RF Probe is used in conjunction with the Halyard RF Generator to create RF lesions in nervous tissue. The shaft of the probe is insulated with a polyimide sheath, and the distal tip consists of a medical grade stainless steel electrode. Sterile water circulates through a cavity in the electrode to cool the electrode tip during the cooled RF ablation procedure. The COOLIEF* Cooled Radiofrequency (RF) Probe is sterilized by ethylene oxide.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a singular section for clinical performance. Instead, it describes the effectiveness endpoint and provides the results.
| Characteristic / Test Type | Acceptance Criteria (Implied) | Reported Device Performance (COOLIEF* Cooled RF Probe) |
|---|---|---|
| Clinical Effectiveness (Primary Endpoint) | Superiority to corticosteroid injection in achieving ≥ 50% pain reduction at 6 months post-treatment in patients with moderate to severe knee pain due to radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block. | 67.2% of the COOLIEF* Cooled RF study group achieved ≥50% pain relief at 6 months, compared to 15.7% of the corticosteroid injection group (p-value for superiority not explicitly stated but implied by "superior to steroid injection"). |
Mean NRS pain reduction: 4.9 points (from 7.3 to 2.5) at 6 months.
Significant functional improvement: 39.7% reported "Satisfactory Joint Function" vs. 3% in comparison group.
Global Perceived Effect: 91.4% reported "improved" knee condition vs. 23.9% in comparison group. |
| Cytotoxicity | Qualitative Grade = 0; Quantitative = cell death
Ask a specific question about this device
Page 1 of 1