BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6

K053082 · Baylis Medical Co., Inc. · GXI · Nov 30, 2005 · Neurology

Device Facts

• Record ID: K053082
• Device Name: BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
• Applicant: Baylis Medical Co., Inc.
• Product Code: GXI · Neurology
• Decision Date: Nov 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Baylis Pain Management Cooled Probe is a sterile, single-use device designed to deliver radiofrequency (RF) energy to nervous tissue. It functions in conjunction with an external RF generator. The probe incorporates a cooling mechanism to manage thermal delivery during the lesioning process. It is intended for use by clinicians in a medical setting to create targeted lesions for pain management. The device output is the delivery of RF energy, which the clinician uses to ablate nervous tissue to achieve the desired therapeutic effect.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Sterile, single-use radiofrequency lesion probe. Features integrated cooling mechanism for thermal management during energy delivery. Operates in conjunction with an external radiofrequency generator. Class II device (21 CFR 882.4725).

Indications for Use

Indicated for use in conjunction with a radiofrequency generator to create 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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### 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: [phone]; ext 252
- D. Company Facsimile: [phone]
- 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

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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 [phone]. 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 [phone] or [phone] 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