← Product Code [DSA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSA) · K023334 # BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 (K023334) _Baylis Medical Co., Inc. · DSA · Dec 31, 2002 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSA/K023334 ## Device Facts - **Applicant:** Baylis Medical Co., Inc. - **Product Code:** [DSA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSA.md) - **Decision Date:** Dec 31, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2900 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **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). ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles an eagle or bird-like figure with three stylized lines forming its body and wings. The emblem is positioned in the center of the circle. 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 {1}------------------------------------------------ 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 {2}------------------------------------------------ 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSA/K023334](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSA/K023334) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com