BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 by BAYLIS MEDICAL CO., INC.

This document is a 510(k) premarket notification decision letter from the FDA to Baylis Medical Company, Inc. regarding their BMC Catheter Connector Cable, Model RFP-101.

This type of document (a 510(k) clearance letter) generally does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and study design.

The 510(k) process primarily evaluates substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. While a manufacturer provides evidence to support this, the FDA's clearance letter itself doesn't typically publish the specific acceptance criteria, study methodologies, or detailed performance results in the way you've requested. Those details would be in the company's 510(k) submission, which is a much more extensive document.

Therefore, for this specific document, I cannot provide the requested information.

To be clear, here's why the questions cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The letter simply states the device is "substantially equivalent."
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is a cable, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. Again, this is a cable, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Summary

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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

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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 (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

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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

Over - The - Counter (Optional Forma

Muriam C. Provost

Avision Sign. ivision of General, Restorative Neurological Devices

Number K02 3334

Regulation Number and Section

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
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.(b)
Classification. Class II (performance standards).