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.

Summary

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1. 510(k) Summary

Submitter Information

A. Company Name: Baylis Medical Company Inc.

B. Company Address: 2580 Matheson Blvd. E. Mississauga, Ontario L4W 4J1 Canada

C. Company Phone: (905) 602-4875; ext 252
D. Company Facsimile: (905) 602-5671
E. Contact Person: Meghal Khakhar
F. Summary Prepared on: October 26. 2005

Device Identification

A. Device Trade Name: Baylis Pain Management Cooled Probe
B. Device Common Name: RF Probe
C. Classification Name: Probe, Radiofrequency lesion. 21 CFR 882.4725
D. Device Class: Class II
E. Device Code: GXI

Identification of Predicate Device

Predicate device is the Baylis Pain Management Probe, which is cleared under 510(k) Premarket Notification Number K002389.

Device Description

The Baylis Pain Management Cooled Probe is a sterile, single use device that delivers Radio Frequency (RF) energy while being cooled.

Intended Use

Baylis Pain Management Cooled Probe will be used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.

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Baylis Pain Management Cooled Probe

Baylis Medical Company Inc.

K053082

Substantial Equivalence

53082

Page 2 of 2

The indications for use and intended use of the Baylis Pain Management Cooled Probe are identical to the Baylis Pain Management Probe. Both the probes in conjunction with the Radio Frequency Generator are used to create radiofrequency lesions in nervous tissue. The fundamental scientific technology of both these devices is also the same.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2005

Meghal Khakhar, MBBS, CerRAP, RAC Regulatory Affairs Manager Baylis Medical Company, Inc. 2580 Matheson Boulevard E. Mississauga, Ontario L4W 4JI Canada

Re: K053082

Trade/Device Name: Baylis Pain Management Cooled Probe Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: October 26, 2005 Received: November 2, 2005

Dear Dr. Khakhar:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your beeermined 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 conniner of the ritas 20, 1977, 1977, 1977, 1977, 1997, 1999, 1999, 1999, 1999, 1999, 1999, 1999, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometer For (110) and the device, subject to the general controls provisions of the Act. The r ou may, arove, mans 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 If your device to such additional controls. Existing major regulations affecting your device can may be babyeet to Sater as 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 r lease of acrised a determination that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I odota bithe 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 OFF in the quality systems (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, MBBS, CerRAP, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will anow you to begin mating of substantial equivalence of your device to a legally premarket notification: "The Pressification 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 If you dosire specific darroliance at (240) 276-0115. Also, please note the regulation entitled, Connact the Office of Court to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mornational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ковава Виенит
for

Mark N. Melkerson Acting 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

053082

510(k) Number (if known):

Device Name: Baylis Pain Management Cooled Probe

Indications For Use:

Baylis Pain management Cooled Probe will be used in conjunction with a Daylis Fair managomont Cooreate radiofrequency lesions in nervous tissue.

Prescription Use X_

Over-The-Counter Use AND/OR

Over the counter or

(Part 21 CFR 801 Subpart D)

(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)

harbare Bneun

Division of General, Restorative, and Neurological Devices

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510(k) Number K053082

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).