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

K072478 · Baylis Medical Co., Inc. · GEI · Dec 19, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072478
• Device Name: BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD
• Applicant: Baylis Medical Co., Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Special
• 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 with separately approved probes such as Baylis TransDiscal Probe, Oratec Spinecath™ and Baylis Pain Management Probes.

Device Story

Radiofrequency (RF) lesion generator; modification of predicate K031950. Adds multi-RF mode to create multiple lesions simultaneously. Connects 1 to 4 RF probes via Multi-RF cable. Used by clinicians in neurological lesion procedures. Transforms electrical energy into RF output for tissue coagulation/decompression. Facilitates treatment of contained herniated discs. Output allows physician to perform multiple monopolar RF lesions at once, improving procedural efficiency.

Clinical Evidence

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

Technological Characteristics

Radiofrequency lesion generator; 21 CFR 882.4400. Multi-RF mode for simultaneous monopolar lesion creation. Connects 1-4 probes via Multi-RF cable. Compatible with Baylis TransDiscal, Oratec Spinecath, and Baylis Pain Management probes.

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.

Predicate Devices

• Baylis Pain Management Generator - TD (K031950)

Submission Summary (Full Text)

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Baylis Pain Management Generator - TD

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#### Baylis Medical Company Inc.

## 1. 510(k) Summary

#### Submitter Information

A. Company Name: Baylis Medical Company Inc.

- B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada
DEC I 9 2007.

- C. Company Phone: [phone]; ext 252
D. Company Facsimile: [phone]

E. Contact Person: Meghal Khakhar

F. Summary Prepared on: 31-August-2007

#### Device Identification

A. Device Trade Name: Baylis Pain Management Generator - TD

B. Device Common Name: Radiofrequency lesion generator

C. Classification Name: Generator; Lesion; Radiofrequency, 21 CFR 882.4400; Electrosurgical cutting and coagulation device and accessories, 21 CFR 878.4400

- D. Device Class: Class II
E. Device Code: GXD, GEI

#### Identification of Predicate Device

Predicate device is the Baylis Pain Management Generator - TD, which is cleared under 510(k) Premarket Notification Number K031950.

# Device Description

The Baylis Pain Management Generator - TD is a modification of the previously 510(k) cleared Baylis Pain Management Generator -TD (510(k): K031950). The modification includes the addition of a multi-radiofrequency (Multi-RF) mode to create multiple lesions during neurological lesion procedures. The generator is used with its accessory, the Multi-RF cable that connects 1 to 4 radiofrequency probes to facilitate multiple monopolar RF lesions at a given time.

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Baylis Pain Management Generator - TD

# 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 with separately approved probes such as Baylis TransDiscal Probe, Oratec Spinecath™ and Baylis Pain Management Probes.

## Substantial Equivalence

The indications for use of the proposed design of the Baylis Pain Management Generator - TD are identical to the Baylis Pain Management Generator - TD (510(k) #: K031950). The fundamental scientific technology of both these devices is also the same.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design of three human profiles, stacked on top of each other, with flowing lines extending from the top profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 9 2007

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

Re: K072478

Trade/Device Name: Baylis Pain Management Generator - TD Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GEI, GXD Dated: November 26, 2007 Received: November 27, 2007

Dear Meghal Khakhar:

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

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Page 2 - Meghal Khakhar

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely vours.

Mark N Millman

- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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K072478

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# Indications for Use

510(k) Number (if known):

Device Name: Baylis Pain Management Generator - TD

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 discs. The Baylis PMG-TD is to be used with separately approved probes such as Baylis TransDiscal Probe, Oratec Spinecath™ and Baylis Pain Management Probes.

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)

Division Sign-Off

Division Division C and New

S(unk) Number