(29 days)
The HALYARD* COOLIEF* Cooled Radiofrequency Kit, in combination with the HALYARD* Radiofrequency (RF) Generator (PMG-BASIC/PMG-ADVANCED) (formerly Baylis Pain Management Generator or KIMBERLY-CLARK® Pain Management Generator) is intended for the creation of Radio-Frequency (RF) heat lesions in nervous tissue for the relief of pain, and 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 (RF) Kit is similar in construction, materials, energy source, and intended use to the predicate TransDiscal Cooled Radiofrequency Kit, which is a part of the cleared TransDiscal System (K062937) that also includes a "Y connector cable for the probes, a cooling pump, and a pump connector cable that connects to the RF generator. The COOLIEF* Cooled RF Kit includes fluid delivery introducers, cooled probes, and a burette tubing assembly. The subject COOLIEF* Cooled Radiofrequency Kit is available in several configurations based on the anatomic region of use (i.e., available in various introducer and probe lengths, and active tip lengths). The kit is sterilized to a SAL of 10-6 by EO terminal sterilization. The Fluid Delivery Introducer is a sterile, non-pyrogenic single-use cannula with a fluid delivery port. It is used with cooled radiofrequency probes in conjunction with the Halyard Radiofrequency Pain Management Generator, with cooling pump, to create lesions in nervous tissue for the relief of pain.
This document is a 510(k) Pre-Market Notification for the HALYARD* COOLIEF* Cooled Radiofrequency Kit, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the new device meets specific acceptance criteria in the way a clinical trial or algorithm validation study would.
The information provided describes the device, its intended use, and comparisons to a predicate device (TransDiscal Cooled RF Kit, K062937) and a reference device (Diros OWL Sterile Single-Use Trident R.F. Insulated Cannula models DTR and DTRH, K150371). The "acceptance criteria" here are implicitly the standards and features of the predicate device and the relevant biocompatibility and mechanical test standards.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of numerical thresholds for clinical efficacy or diagnostic accuracy. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics, materials, and a series of non-clinical performance tests against established standards and the predicate device.
The "acceptance criteria" can be inferred as:
- Compliance with ISO standards for biocompatibility, sterility, mechanical properties, and electrical safety.
- Similar performance to the predicate device in terms of RF lesion creation, if not explicitly quantified.
- Functionality of the new fluid delivery system (side port with extension tubing).
Here’s a summary table based on the provided "Summary of Non-Clinical Testing (Performance Testing)" and "Biocompatibility Testing":
| Acceptance Criteria (Inferred from Standards & Predicate) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Biocompatibility (ISO 10993 Series) | |
| Cytotoxicity (ISO 10993-5): Non-cytotoxic | Passed |
| Sensitization (ISO 10993-10): Non-sensitizing | Passed |
| Irritation (ISO 10993-20): Non-irritant | Passed |
| Systemic Toxicity (ISO 10993-11): No signs of systemic toxicity | Passed |
| Material Mediated Pyrogenicity (ISO 10993-11): Non-pyrogenic | Passed |
| EO Residuals (ISO 10993-7): Below limits | Passed |
| Electrical Safety & EMC | |
| Electrical safety & High Frequency testing (as K062937) | "Same as existing cleared product (K062937)" |
| EMC (Emissions & Immunity) testing (as K062937) | "Same as existing cleared product (K062937)" |
| Mechanical Testing | |
| ISO 9626: Stainless steel needle tubing | Implied compliance by testing |
| ISO 7864: Bond force (hub-needle, extension-hub/Luer) | Tested |
| ISO 594-2:1998: Conical fittings (Luer) | Tested |
| ISO 11070:2014(E) Annex C: Tensile Strength | Tested |
| ISO 80369-20: Small-bore connectors | Tested |
| Dimensional Testing: To Specification | Tested |
| Fluid Flow: To Design Requirement of side lumen | Tested |
| Performance Testing | |
| Compatibility: Probe Luer and cannula hub Luer | Verified by measurements and performance testing |
| Temperature Accuracy | Verified by measurements and performance testing |
| RF Lesion Size: In tissue model | Measured |
| Injection Force: Comparison of fluid viscosity | Compared |
| Human Factors Usability | |
| Usability of device user interface for safety/effectiveness | Study conducted |
| Extension tubing with Luer connector functionality | Simulated use in intended environment |
The "study that proves the device meets the acceptance criteria" is the collection of non-clinical tests summarized, demonstrating compliance with various ISO standards and equivalence in performance to the predicate and reference devices.
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 describes non-clinical (bench) testing. For such tests, "sample size" refers to the number of units tested for mechanical properties, biocompatibility, etc. This specific numerical sample size is not explicitly provided in the summary for individual tests (e.g., how many cannulas were tested for bond strength). The data provenance is from internal testing conducted by the manufacturer (Halyard Health, Inc.), implicitly in the USA. These are prospective tests conducted on the newly designed device components.
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. The "ground truth" concept is typically relevant for diagnostic or AI-based devices where human expert interpretation is compared to device output. For a physical medical device like a radiofrequency kit, performance is evaluated against engineering specifications, material standards, and functional tests, not against expert-established ground truth in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the reasons stated above (non-clinical testing of a physical device).
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 section is not applicable. An MRMC study is relevant for diagnostic imaging devices or AI tools involving human interpretation. This submission is for a therapeutic radiofrequency ablation kit.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. This is not an AI algorithm. The device performance is the physical device's ability to create lesions and deliver fluids, which is tested directly.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As mentioned, true "ground truth" as typically defined for AI or diagnostic devices is not applicable. The "ground truth" for this device's performance validation is its adherence to:
- Established ISO standards for biocompatibility and mechanical properties.
- Functional requirements (e.g., fluid flow, lesion size in a tissue model).
- Equivalence to the predicate device's known performance.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The device is validated through engineering and bench testing, not through training on data.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated above.
§ 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).