Search Results

This notification describes the Baylis Pain Management Cooled Probe, a sterile, single-use device intended to deliver Radio Frequency (RF) energy while being cooled, for the creation of radiofrequency lesions in nervous tissue. The device is a Class II device (21 CFR 882.4725) with product code GXI.

The substantial equivalence is based on the predicate device, the Baylis Pain Management Probe (K002389). The indications for use and intended use are identical to the predicate device, and the fundamental scientific technology is also the same.

Based on the provided documentation, the submission is focused on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel technology. Therefore, much of the requested information regarding acceptance criteria and a study to prove the device meets them, as well as details about sample sizes, expert involvement, and ground truth establishment, is not present in the provided text.

Here is a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not described in the provided text. The submission focuses on substantial equivalence to a predicate device, implying that the performance is expected to be similar to the cleared predicate. Specific performance metrics or acceptance criteria for the "Cooled Probe" itself are not mentioned.	Not described in the provided text. No specific performance data (e.g., lesion size, temperature control accuracy, safety endpoints) for the Baylis Pain Management Cooled Probe is reported. The equivalence is based on indications for use and fundamental technology being the same as the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable/Not provided. The document describes a 510(k) submission for substantial equivalence based on the predicate device, not a new clinical study with a test set of data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable/Not provided. There is no mention of a test set requiring expert interpretation or ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is not mentioned in the provided text.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is an RF probe for creating lesions, not an AI algorithm.

7. The Type of Ground Truth Used:

Not applicable/Not provided. As there's no mention of a study with a test set, ground truth is not discussed in this context. Substantial equivalence generally relies on comparison of design, materials, and intended use to a legally marketed predicate.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This is not an AI/algorithm-based device requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/Not provided.

Summary of Device and Regulatory Action:

Device Trade Name: Baylis Pain Management Cooled Probe
Intended Use: To be used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Predicate Device: Baylis Pain Management Probe (K002389)
Basis for Substantial Equivalence: Identical indications for use and intended use, and the same fundamental scientific technology as the predicate device.
Regulatory Outcome: Cleared by the FDA on November 30, 2005, based on a finding of substantial equivalence to the predicate device.

Ask a Question

Ask a specific question about this device

Page 1 of 1