BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE

K071745 · Baylis Medical Co., Inc. · GXI · Jul 19, 2007 · Neurology

Device Facts

• Record ID: K071745
• Device Name: BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
• Applicant: Baylis Medical Co., Inc.
• Product Code: GXI · Neurology
• Decision Date: Jul 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Baylis Pain Management Single-Use Probe will be used in conjunction with a Baylis Pain Management Connector Cable and the Baylis Pain Management Generator to create radiofrequency lesions in nervous tissue.

Device Story

The Baylis Pain Management Single-Use Probe is a sterile, single-use device designed to deliver radiofrequency (RF) energy to nervous tissue. It functions as part of a system including a Baylis Pain Management Connector Cable and a Baylis Pain Management Generator. The probe is used by clinicians to create targeted RF lesions in nervous tissue for pain management purposes. The device operates by transmitting energy from the generator through the cable to the probe tip, which is placed in the target tissue. This process enables the creation of controlled lesions to modulate nerve function, potentially providing therapeutic benefit to patients suffering from pain. The device is intended for prescription use only.

Technological Characteristics

Sterile, single-use radiofrequency lesion probe. Operates via RF energy delivery in conjunction with a compatible generator and connector cable. Classified under 21 CFR 882.4725 (Product Code GXI).

Indications for Use

Indicated for the creation of radiofrequency lesions in nervous tissue.

Regulatory Classification

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.

Predicate Devices

• Baylis Pain Management Probe (K002389)

Submission Summary (Full Text)

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\$\frac{K071745}{1. 510(k) Summary}\$

Submitter Information

A. Company Name: Baylis Medical Company Inc.

B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada

C. Company Phone: [phone]; ext 252

D. Company Facsimile: [phone]

E. Contact Person: Meghal Khakhar

F. Summary Prepared on: 22-June-2007

# Device Identification

A. Device Trade Name: Baylis Pain Management Single-Use Probe

B. Device Common Name: Radiofrequency lesion 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 Single-Use Probe is a sterile, single-use device that delivers Radiofrequency (RF) energy.

### Intended Use

The Baylis Pain Management Single-Use Probe will be used in conjunction with a Baylis Pain Management Connector Cable and the Baylis Pain Management Generator to create radiofrequency lesions in nervous tissue.

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JUL 1 9 2007

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## Substantial Equivalence

Baylis Medical Company Inc.

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The indications for use of the Baylis Pain Management Single-Use Probe are identical to the Baylis Pain Management Probe. Both the probes in conjunction with the Radiofrequency Generator are used to create radiofrequency lesions in nervous tissue. The fundamental scientific technology of both these devices is also the same.

KO 7194

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 9 2007

Baylis Medical Company, Inc. % Meghal Khakhar, MBBS, CerRAP, RAC Regulatory Affairs Manager 2645 Matheson Boulevard East Mississauga Ontario, Canada L4W 5S4

Re: K071745

Trade/Device Name: Baylis Pain Management Single-Use Probe Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: June 22, 2007 Received: June 27, 2007

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. Iisting 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, MBBS, CerRAP, RAC

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director

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

Enclosure

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K071745

# Indications for Use

KO 7/745

510(k) Number (if known):

Device Name: Baylis Pain Management Single-Use Probe

Indications For Use:

Baylis Pain Management Single-Use Probe will be used in conjunction with a Baylis Pain Management Connector Cable and the Baylis Pain Management Generator to create radiofrequency lesions in nervous tissue.

Prescription Use × (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)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
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510(k) Number L071745