(90 days)
The intended use of the RFP-100A Connector Cable (Single Use) is to connect the RFP-100A Generator to separately cleared compatible RF devices.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "RFP-100A Connector Cable (Single Use)". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
Crucially, this document does not include information about acceptance criteria, performance studies, or ground truth establishment for an AI/ML device.
The device described, a connector cable, is a passive component used to connect two other cleared medical devices (a generator and RF devices). Its function is likely to transmit electrical signals, and its acceptance criteria would focus on electrical safety, biocompatibility, mechanical integrity, and compatibility with the specified devices, rather than the kind of performance metrics (sensitivity, specificity, AUC) typically associated with AI/ML-driven diagnostic or prognostic tools.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because it is not relevant to the type of device being discussed.
To provide the information you've requested, I would need a 510(k) summary or a similar document for an AI/ML-enabled medical device that performs a diagnostic, prognostic, or therapeutic function.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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§ 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).