DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20

K101372 · Baylis Medical Co., Inc. · GXI · Aug 10, 2010 · Neurology

Device Facts

• Record ID: K101372
• Device Name: DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
• Applicant: Baylis Medical Co., Inc.
• Product Code: GXI · Neurology
• Decision Date: Aug 10, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DuoCool Pain Management Probe is intended for use in Radio-Frequency (RF) heat lesion procedures for relief of pain.

Device Story

DuoCool Pain Management Probe is a sterile, single-use radiofrequency (RF) lesion probe. Device delivers RF energy to tissue while simultaneously providing cooling to the probe tip. Used by clinicians in pain management procedures to create heat lesions for pain relief. Operates as a component of an RF lesioning system. Cooling mechanism allows for controlled thermal delivery to target tissue. Benefits include targeted pain relief through precise lesion creation.

Technological Characteristics

Sterile, single-use radiofrequency (RF) lesion probe. Features integrated cooling mechanism for tip temperature control during RF energy delivery. Classified as a radiofrequency lesion probe (21 CFR 882.4725).

Indications for Use

Indicated for patients requiring radiofrequency (RF) heat lesion procedures for pain relief. Prescription use only.

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

• Pain Management Optima (K092337)

Submission Summary (Full Text)

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# (101372

## DuoCool Pain Management Probe

Baylis Medical Company

AUG 1 0 2010

#### 6. 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: 13-May-2010

#### Device Identification

A. Device Trade Name: DuoCool Pain Management Probe

B. Device Model Number: OSP-17-180-20 (Probe); OSK-17-180-20 (Kit)

C. Device Common Name: Radiofrequency Probe

D. Classification Name: Radiofrequency Lesion Probe, 21 CFR 882.4725

E. Device Class: Class II

F. Device Code: GXI

#### Identification of Predicate Device

Predicate device is the Pain Management Optima, which is cleared under 510(k) Premarket Notification Number K092337

#### Device Description

The DuoCool Pain Management Probe is a sterile, single-use probe used to deliver Radio-Frequency (RF) energy while being cooled.

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# Intended Use

The DuoCool Pain Management Probe is intended for use in Radio-Frequency (RF) heat lesion procedures for relief of pain.

# Substantial Equivalence

The indications for use of the DuoCool Pain Management Probe are identical to the Pain Management Optima. Both the DuoCool Pain Management Probe and the Pain Management Optima are used to create radiofrequency lesions for relief of pain. 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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-W-O66-0609 Silver Spring, MD 20993-0002

Baylis Medical Company Incorporated % Ms. Meghal Khakhar Regulatory and Scientific Affairs Manager 2645 Matheson Boulevard East Mississauga, Ontario Canada L4W 5S4

Re: K101372

Trade/Device Name: DuoCool Pain Management Probe Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: Class II Product Code: GXI Dated: June 24, 2010 Received: June 28, 2010

Dear Ms. Kahkhar:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

AUG 1 0 2010

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Page 2- Ms. Meghal Khakhar

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kesia Alexander

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101372

# Indications for Use

AUG 1 0 2010

510(k) Number (if known):

Device Name: DuoCool Pain Management Probe

Indications For Use:

The DuoCool Pain Management Probe (probe model number: OSP-17-180-20; kit model number: OSK-17-180-20) is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain

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)

M.L.B. Nicholas

sion Sign-Off Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K101372