TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6

K031951 · Baylis Medical Co., Inc. · GEI · Sep 11, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031951
• Device Name: TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6
• Applicant: Baylis Medical Co., Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Transdiscal system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs

Device Story

Transdiscal System used with Baylis Pain Management Generator-TD (PMG-TD); system performs coagulation and decompression of disc material. Used in clinical setting by physicians to treat symptomatic patients with contained herniated discs. Device applies electrosurgical energy to target tissue; intended to reduce disc volume/pressure. Physician operates system via generator interface; output affects clinical decision-making by providing therapeutic intervention for disc-related pain. Benefits include minimally invasive treatment option for contained herniations.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison to predicate devices.

Technological Characteristics

Electrosurgical cutting and coagulation device; operates via Baylis Pain Management Generator-TD (PMG-TD). Class II device (Product Code GEI).

Indications for Use

Indicated for symptomatic patients with contained herniated discs requiring coagulation and 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP. 1 1 2003

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

Re: K031951

Trade/Device Name: Transdiscal System 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 (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) 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]. 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 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

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):

1031951

DEVICE NAME:

Transdiscal System

INDICATIONS FOR USE:

The Transdiscal system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div>X</div> |
|------------------------------------------|--------------|
|------------------------------------------|--------------|

OR

| Over-The-Counter-Use | |
|----------------------|--|
|----------------------|--|

Miriam C. Provost

(Division Sign-Off) (Division Sign Coral, Restorative and Neurological Devices

510(k) Number K031951