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:

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.

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.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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.
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.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K062937

2.0 510(k) Summary

2.1 Submitter Information

A. Company Name: Baylis Medical Company Inc.

B. Company Address: 2580 Matheson Blvd. E. Mississauga, Ontario Canada L4W 4J1
C. Company Phone: (905) 602-4875
D. Company Facsimile: (905) 602-5671
E. Contact Person: Meghal Khakhar
F. Summary Prepared on: August 23, 2006

2.2 Device Identification

A. Device Trade Name: Baylis TransDiscal™ System
B. Device Common Name: TransDiscal System
C. Classification Name: Probe, Radiofrequency lesion
D. Device Class: II
E. Device Code: GXI

2.3 Identification of Predicate Device

Predicate devices are the Baylis TransDiscal™ System, which is cleared under 510(k) Premarket Notification Number K031951, and the Baylis Pain Management Cooled Probe, which is cleared under 510(k) Premarket Notification Number K053082.

JAN - 8 2007

1/a

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2.4 Device Description

2.5 Intended Use

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

2.6 Substantial Equivalence

This device is identical to the original Baylis TransDiscal System cleared for market release under Premarket Notification Number K031951, and is substantially equivalent to the Baylis Pain Management Cooled-Probe K053082 with respect to fundamental scientific technology. There have been no modifications to the original device. The purpose of this 510(k) application is to combine the indications of both the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with flowing ribbons or lines beneath it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Baylis Medical Company, Inc. % Meghal Khakhar Regulatory Affairs Manager 2580 Matheson Boulevard, East Mississauga, Ontario L4W 4J1 Canada

JAN - 8 2007

Re: K062937

Trade/Device Name: Transdiscal System Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: December 19, 2006 Received: December 20, 2006

Dear Meghal Khakhar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Meghal Khakhar

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KO62937

Device Name:_Baylis TransDiscal System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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$D6RNO/ODE$

510(k) N

$4062937$

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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).