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CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility) and CADD Yellow Extension Sets with NRFit™ connectors.

The CADD Filling Adapter with male NRFit™ connector and female Luer is an accessory for use in filling of the CADD Medication Cassette Reservoirs with NRFit™ Connector.

CADD Yellow Extension Sets with NRFit™ connectors are designed for use only with CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors for the delivery of regional anesthetics or narcotics.

CADD Yellow Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility).

The Male Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Medication Cassette reservoirs.

The Female Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Extension sets with NRFit™ connectors and the CADD Yellow Administration sets with NRFit™ connector.

The CADD Infusion Adapter with male NRFit™ connector and female Luer is intended to be used by clinicians to convert administration sets with Luer connectors into permanently dedicated lines for use only with NRFit connectors. The NRFit™ connector with non-luer taper is intended for the injection of regional anesthetics or narcotics and may help reduce the risk of mis-connection or mis-injection.

The CADD® Infusion devices with NRFit™ connectors are part of the CADD System. The CADD System is defined as a CADD pump with an attached CADD Medication Cassette Reservoir with an integral free-flow protection feature and CADD Extension Set with an Integral Anti-Siphon Valve; or as a CADD pump with an attached CADD Administration Set with an integral free-flow protection feature. The CADD Administration Set will be connected to a medication bag to allow for infusion.

The devices are designed to deliver local or regional anesthetics, narcotics indicated for neuraxial or regional anesthetic infusion applications. The NRFit™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.

The CADD Infusion devices with NRFit™ connectors are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This 510(k) includes various configurations of CADD Infusion devices with NRFit ™ connectors.

The provided document describes a 510(k) premarket notification for the CADD® Infusion Disposables Portfolio with NRFit™ connectors. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The core change in the subject device is the incorporation of NRFit™ connectors, compliant with ISO 80369-6, for neuraxial applications, intended to reduce misconnection risks.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document provides a summary of non-clinical testing categories, the evaluations performed, and the test criteria. The reported device performance is a general statement that "All testing met pre-established specifications, and successfully demonstrated that the CADD Infusion Disposables Portfolio with NRFit™ connectors performed as intended." Specific quantitative results or direct performance values are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the non-clinical tests. The tests are purely technical/engineering assessments of physical characteristics, sterility, and biocompatibility, not clinical studies involving patient data. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The studies conducted are non-clinical, laboratory-based tests against established international standards (ISO, ANSI/AAMI, USP). "Ground truth" in the sense of expert medical diagnosis or interpretation is not relevant for these types of engineering and biological safety evaluations. The "ground truth" would be the specifications outlined in the referenced standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable, as the tests are non-clinical and do not involve human judgment or adjudication in the way clinical studies requiring ground truth establishment would.

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

A multi-reader, multi-case comparative effectiveness study was not done. This document pertains to the clearance of medical device disposables based on physical properties, materials, and safety, not on the performance of an AI algorithm or human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm was not done. This submission is for physical medical devices (infusion disposables), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests conducted is defined by the specific parameters and acceptance limits set forth in the referenced international standards (e.g., ISO 80369-6, ISO 594-2, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788). These are objective, measurable standards for device characteristics such as fluid leakage, separation forces, sterility, and biocompatibility.

8. The sample size for the training set

This information is not applicable. There is no AI component or machine learning model described that would require a training set.

9. How the ground truth for the training set was established

This information is not applicable, as no training set for an AI/ML model is mentioned in the document.

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