BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)

K020354 · Baylis Medical Co., Inc. · GXD · May 3, 2002 · Neurology

Device Facts

• Record ID: K020354
• Device Name: BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
• Applicant: Baylis Medical Co., Inc.
• Product Code: GXD · Neurology
• Decision Date: May 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Baylis Pain Management Generator; Model PMG-115 (For Domestic Use) and Model PMG-230 (For International Use) is indicated for use to create lesions during neurological lesion procedures. The Baylis PMG is to be used with separately approved lesion/temperature probes such as Baylis Pain Management Probes and Oratec Spinecath™.

Device Story

The Baylis Pain Management Generator (Models PMG-115/PMG-230) is an electrosurgical device designed for use in clinical settings by physicians. It functions as a radiofrequency (RF) lesion generator, providing energy to separately approved lesion/temperature probes (e.g., Baylis Pain Management Probes, Oratec Spinecath™). The device transforms electrical energy into RF output, which is delivered through the probe to target tissue to create controlled lesions during neurological procedures. The physician operates the generator to manage the lesioning process, monitoring the output to achieve the desired clinical effect. By enabling precise tissue lesioning, the device assists in pain management interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiofrequency lesion generator; electrosurgical cutting and coagulation device. Models PMG-115 (domestic) and PMG-230 (international). Designed for use with compatible lesion/temperature probes. Class II device (Product Codes GEI, GXD).

Indications for Use

Indicated for patients undergoing neurological lesion procedures requiring the creation of lesions. Used with compatible lesion/temperature probes.

Regulatory Classification

Identification

A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

Reference Devices

• Baylis Pain Management Probes
• Oratec Spinecath™

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kris Shah Vice President, Product Development Baylis Medical Company, Inc. 5160 Explorer Drive, Unit 33 Mississauga, Ontario, Canada L4W 4T7

Re: K020354

Trade/Device Name: Bayliss Pain Management Generator Model PMG - 115 (For Domestic Use) Model PMG - 230 (For International Use)

Regulation Number: 878.4400, 882.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Radiofrequency lesion generator

MAY 0 3 2002

Regulatory Class: II Product Code: GEI, GXD Dated: January 28, 2002 Received: February 4, 2002

Dear Mr. Shah:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device American Device American D commerce prior to they 2011-03-11 accordance with the provisions of the Federal Food, DNI, a devices that mave ocen require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, dierelore, mains of the Act include requirements for annual registration, listing of general other is provision 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 rr your device 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 r louse of actived that I termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vith 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 – Mr. Kris Shah

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lower will and hy a the FDA finding of substantial equivalence of your device to a legally prestitution of a lovice 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost
for Celia M. Witten, Ph.D., M.D.

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

Enclosure

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510(k) NUMBER (IF KNOWN):

K020354 ______________________________________________________________________________________________________________________________________________________________________

DEVICE NAME:

Baylis Pain Management Generator PMG - 115 (For Domestic Use) Model: PMG - 230 (For International Use)

INDICATIONS FOR USE:

Baylis Pain Management Generator; Model PMG-115 (For Domestic Use) and Model PMG-230 (For International Use) is indicated for use to create lesions during neurological lesion procedures. The Baylis PMG is to be used with separately approved lesion/temperature probes such as Baylis Pain Management Probes and Oratec Spinecath™.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR |
| | Over-The-Counter-Use _______ |

| Miriam C. Provost |
|--------------------------------------------------------------|
| (Division Sign-Off) |
| Division of General, Restorative<br>and Neurological Devices |

| 510(k) Number | K020354 |
|---------------|---------|
|---------------|---------|