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The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to Intravascular administration set.

This submission for the ICU Medical Inc. CLAVE CONNECTOR is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance criteria. Therefore, the provided text does not contain the detailed information necessary to complete most of the requested sections about acceptance criteria and a study.

Here's an analysis based on the provided text:

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

This information is not provided in the 510(k) summary. 510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance against acceptance criteria in the way a new efficacy study might.

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

This information is not provided. The document outlines a comparison to a predicate device, not a performance study with a test set.

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 provided. Ground truth establishment, if any, would be relevant for a de novo or PMA submission, not a 510(k) in this format.

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

This information is not provided.

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

This information is not provided. The device is an "Intravascular Administration Set" and not an AI-powered diagnostic device, so an MRMC study is not applicable.

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

This information is not provided. As mentioned, this is a physical medical device, not an algorithm.

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

This information is not provided.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this is not an AI/ML device.

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

This information is not provided.

Summary of what is present:

The document is a 510(k) Summary of Safety and Effectiveness for the ICU Medical Inc. CLAVE CONNECTOR. It demonstrates substantial equivalence to the IVAC SmartSite™.

• Device Description: A single-use, sterile, non-pyrogenic device intended as an accessory to intravascular administration sets for fluid administration.
• Intended Use: As an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
• Comparison to Predicate Device (IVAC SmartSite™):
  • Product Labeling: Both are sterile, non-pyrogenic (for CLAVE), and include directions for use.
  • Intended Use: CLAVE - Needleless injection port to access any vein or artery. IVAC - Needleless valve (luer lock). These appear equivalent in function.
  • Design: Both are one-piece designs activated by luer connection to allow fluid flow.
  • Materials: Specific materials are listed for the CLAVE (Polycarbonate, Polyester, Silicone Rubber, Polypropylene, Flurosilicone), while the predicate's materials are "Unknown" in this comparison table. This implies that the materials chosen for the CLAVE were deemed acceptable.

The FDA's letter (K970855) indicates that the device was found substantially equivalent to devices marketed prior to May 28, 1976, or to reclassified devices. This decision assumes compliance with Good Manufacturing Practice (GMP) regulations.

Conclusion:

The provided text is a 510(k) premarket notification. It focuses on comparison to a predicate device to establish substantial equivalence for market clearance, rather than detailing a study that directly proves the device meets specific performance acceptance criteria using quantitative metrics from a test set. Therefore, most of the requested fields regarding acceptance criteria, study details, and AI-specific information cannot be filled from the given text.

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