TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU

• K Number: K062937
• Device Name: TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
• Manufacturer: BAYLIS MEDICAL CO., INC.
• Date Cleared: 2007-01-08 ( 102 days)
• Product Code: GXI
• Regulation Number: 882.4725
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K031951 , K053082

Intended Use

The Baylis TransDiscal System, used in combination with the Baylis Pain Management Generator, is intended for the creation of Radio Frequency (RF) lesions in nervous tissue including that which is situated in intervertebral disc material.

Device Description

The Baylis TransDiscal System is designed to deliver controlled RF energy via two electrodes. Two TransDiscal Probes and the Pain Management Pump Unit, connected to the Baylis Pain Management Generator, work in concert to deliver the RF energy.

AI/ML Overview

This 510(k) premarket notification (K062937) is for the Baylis TransDiscal™ System. The document states that the device is identical to a previously cleared device (K031951) and is substantially equivalent to another predicate device (K053082) with respect to fundamental scientific technology. The purpose of this 510(k) is to combine the indications for use of both predicate devices.

Therefore, this submission does not contain acceptance criteria or performance data from a new study for the device. Instead, the substantial equivalence assertion relies on the prior clearances.

Here's a breakdown based on your request, noting the absence of new study data:

1. Table of Acceptance Criteria and Reported Device Performance:

   Feature	Acceptance Criteria (from this submission)	Reported Device Performance (from this submission)
   Device Performance	Not applicable (no new study conducted)	Not applicable (no new study conducted)
   Substantial Equivalence	Claimed based on identity to K031951 and fundamental scientific technology equivalence to K053082.	Device is identical to original Baylis TransDiscal System cleared under K031951.

Device is substantially equivalent to the Baylis Pain Management Cooled-Probe K053082 with respect to fundamental scientific technology. |

2. Sample size used for the test set and the data provenance: Not applicable. No new test set or data provenance mentioned as no new study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

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 device is a radiofrequency lesion system, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device in the context of standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Regulation Number and Section

§ 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).