RFP-100A Connector Cable (Single Use)

K230571 · Baylis Medical Technologies, Inc. · DSA · May 30, 2023 · Cardiovascular

Device Facts

• Record ID: K230571
• Device Name: RFP-100A Connector Cable (Single Use)
• Applicant: Baylis Medical Technologies, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: May 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Indications for Use

The intended use of the RFP-100A Connector Cable (Single Use) is to connect the RFP-100A Generator to separately cleared compatible RF devices.

Device Story

RFP-100A Connector Cable (Single Use) serves as electrical interface between RFP-100A Generator and compatible RF devices. Device facilitates transmission of radiofrequency energy from generator to compatible medical devices. Used in clinical settings by healthcare professionals. Single-use, sterile accessory. No active processing or signal modification performed by cable; acts as passive conduit for energy delivery.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Passive electrical connector cable. Single-use. Designed for compatibility with RFP-100A Generator and associated RF devices. No active electronic components, software, or energy source. Sterilization method not specified.

Indications for Use

Indicated for use as a connector cable between the RFP-100A Generator and separately cleared compatible RF devices. No specific patient population or disease state is defined as the device is an accessory for signal transmission.

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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 30, 2023

Baylis Medical Technologies Inc. Stephanie Gallone Director of Quality, Regulatory and Scientific Affairs 2645 Matheson Blvd. East Mississauga, ON L4W 5S4 Canada

Re: K230571

Trade/Device Name: RFP-100A Connector Cable (Single Use) Regulation Number: 21 CFR 870.2900 Regulation Name: Patient transducer and electrode cable (including connector) Regulatory Class: Class II Product Code: DSA Dated: February 27, 2023 Received: March 1, 2023

Dear Stephanie Gallone :

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Marco Cannella -S

for

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230571

Device Name RFP-100A Connector Cable (Single Use)

Indications for Use (Describe)

The intended use of the RFP-100A Connector Cable (Single Use) is to connect the RFP-100A Generator to separately cleared compatible RF devices.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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