BMC CATHETER CONNECTOR CABLE, MODEL RFP-101

K023334 · Baylis Medical Co., Inc. · DSA · Dec 31, 2002 · Cardiovascular

Device Facts

• Record ID: K023334
• Device Name: BMC CATHETER CONNECTOR CABLE, MODEL RFP-101
• Applicant: Baylis Medical Co., Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Dec 31, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The BMC Catheter Connector Cable is intended to be used to Connect the BMC RF Perforation Generator to Baylis Medical perforation catheters.

Device Story

BMC Catheter Connector Cable (Model RFP-101) serves as electrical interface between BMC RF Perforation Generator and Baylis Medical perforation catheters; facilitates transmission of radiofrequency energy for perforation procedures; used in clinical environment by trained medical personnel; ensures secure connection for energy delivery; supports intended therapeutic function of perforation catheters.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cable assembly for transducer/electrode connection; electrical interface; Class II device (Product Code DSA).

Indications for Use

Indicated for use in connecting the BMC RF Perforation Generator to Baylis Medical perforation catheters in a clinical setting.

Regulatory Classification

Identification

A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 31 2002

Baylis Medical Company, Inc. Amanda Hartley R & D Engineer 5160 Explorer Drive, #33 Mississauga, Ontario Canada L4W 4T7

Re: K023334

Trade/Device Name: BMC Catheter Connector Cable, Model RFP-101 Regulation Number: 870.2900 Regulation Name: Cable, transducer and electrode, patient, including connector Regulatory Class: Class II Product Code: DSA Dated: September 27, 2002 Received: October 7, 2002

Dear Ms. Hartley:

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

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Page 2 -- Ms. Amanda Hartley

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.

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). 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for 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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SI.O (K) NUMBER (IF KNOWN) KO2 3334 BMC Catheter Connector Cable DEVICE NAME : INDICATIONS FOR USE:

The BMC Catheter Connector Cable is intended to be used to Connect the BMC RF Perforation Generator to Baylis Medical perforation catheters.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 21 CFR 801.1

OR

Over - The - Counter (Optional Forma

Muriam C. Provost

Avision Sign. ivision of General, Restorative Neurological Devices

Number K02 3334