BMC RF CANNULA

K972846 · Baylis Medical Co., Inc. · GXI · Jul 17, 1998 · Neurology

Device Facts

• Record ID: K972846
• Device Name: BMC RF CANNULA
• Applicant: Baylis Medical Co., Inc.
• Product Code: GXI · Neurology
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BMC RF Cannula is intended for use in radio-frequency (RF) Heat lesion procedures for relief of pain.

Device Story

BMC RF Cannula is a medical device used in radio-frequency (RF) heat lesion procedures. It functions by delivering RF energy to target tissue to create a thermal lesion, intended for pain relief. The device is used in a clinical setting by a physician. The output is the creation of a controlled thermal lesion, which interrupts pain signaling pathways. The device benefits patients by providing a minimally invasive option for chronic pain management.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

RF cannula designed for delivery of radio-frequency energy to create thermal lesions. Device is intended for use with compatible RF generators. Technical specifications and materials are consistent with standard RF lesioning electrodes.

Indications for Use

Indicated for patients undergoing radio-frequency (RF) heat lesion procedures for the relief of pain.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "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 7 1998

Mr. Kris Shah · Vice President Product Development Baylis Medical Company, Inc. 5160 Explorer Drive, Unit 5 Mississauga, Ontario Canada L4W 4T7

Re: K972846/S2 Trade Name: BMC RF Cannula Regulatory Class: II Product Code: GXI Dated: June 9, 1998 Received: June 15, 1998

Dear Mr. Shah:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Mr. Kris Shah

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Salie M. Wittwer, PhD, MD

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: BMC RF Cannula

Indications For Use:

The BMC RF Cannula is intended for use in radio-frequency

(RF) Heat lesion procedures for relief of pain.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number K972046

Prescription Use
(Per 21 CFR 801.109)

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Over-Tne-Counter Use يي

(Optional Formal 1-2-96)