BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD

K031950 · Baylis Medical Co., Inc. · GEI · Jul 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031950
• Device Name: BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD
• Applicant: Baylis Medical Co., Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Baylis Pain Management Generator-TD; Model PMG-115-TD (For Domestic Use) and Model PMG-230-TD (For International Use) is indicated for use to create lesions during neurological lesion procedures, and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The Baylis PMG-TD is to be used in conjunction with separately approved probes such as Baylis Transdiscal Probe, Oratec Spinecath™ and Baylis Pain Management Probes.

Device Story

The Baylis Pain Management Generator-TD (Models PMG-115-TD/PMG-230-TD) is an electrosurgical unit designed for neurological lesioning and disc decompression. It functions by delivering energy to separately approved probes (e.g., Baylis Transdiscal Probe, Oratec Spinecath™) to create thermal lesions or coagulate/decompress disc tissue. Used in clinical settings by physicians, the device provides controlled energy output to facilitate minimally invasive spinal procedures. By enabling precise tissue coagulation and decompression, the generator assists in treating symptomatic contained herniated discs, potentially reducing patient pain and improving clinical outcomes.

Clinical Evidence

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

Technological Characteristics

Electrosurgical generator for cutting and coagulation (21 CFR 878.4400). Operates with compatible probes for thermal lesioning and disc decompression. Available in two models: PMG-115-TD (domestic) and PMG-230-TD (international).

Indications for Use

Indicated for symptomatic patients with contained herniated discs requiring neurological lesion procedures, coagulation, or decompression of disc material.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Reference Devices

• Baylis Transdiscal Probe
• Oratec Spinecath™

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, with three human profiles incorporated into the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2003

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

Re: K031950

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

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 20, 2003 Received: June 24, 2003

Dear Mr. Shah:

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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2 - Mr. Kris Shah

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]. 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) you may obtain. 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 vours.

Miriam C. Provoost

( 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

{2}------------------------------------------------

510(k) NUMBER (IF KNOWN):

Kc31950

DEVICE NAME:

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

INDICATIONS FOR USE:

Baylis Pain Management Generator-TD; Model PMG-115-TD (For Domestic Use) and Model PMG-230-TD (For International Use) is indicated for use to create lesions during neurological lesion procedures, and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The Baylis PMG-TD is to be used in conjunction with separately approved probes such as Baylis Transdiscal Probe, Oratec Spinecath™ and Baylis Pain Management Probes.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter-Use |
|---------------------------------------|----|----------------------|
|---------------------------------------|----|----------------------|

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

| 510(k) Number | K031950 |
|---------------|---------|
|---------------|---------|