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The ICU Needleless Connector is a single use , sterile, non pyrogenic Intravascular Administration Set for the administration of fluids to a patient through a cannula placed In the vein or artery

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I am sorry, but the provided text is a 510(k) clearance letter for the "Y Clave Connector Will Integrated Check Valve, Model XI-3432", an intravascular administration set.

This document describes the regulatory approval of a physical medical device, not a software algorithm or AI model. Therefore, the information you're asking for, such as acceptance criteria, study details (sample sizes, ground truth, expert qualifications, etc.), MRMC studies, or standalone algorithm performance, is not contained within this regulatory letter. These types of details are typically found in the scientific studies or technical documentation submitted as part of the 510(k) application, but they are not summarized or presented in the clearance letter itself.

To answer your request, I would need a description of a study or documentation related to an AI/algorithm-based medical device.

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The 'Blood Tubing Accessory with CLAVE Connector' is intended for use in hemodialysis and other chronic applications where blood sampling is required. Luer-locking adaptors allow secure, in-line placement between the blood tubing set and the catheter or venipuncture device. Use of a CLAVE Connector allows the clinician needle-free blood withdrawal.

The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

This submission describes a medical device, the "Blood Tubing Accessory with CLAVE Connector," not an AI/ML powered device. As such, the information provided does not align with the requested categories for AI/ML device studies. I will provide the acceptance criteria and study information that is available in the provided text.

Acceptance Criteria and Device Performance (based on non-AI/ML device information):

Study Details (based on non-AI/ML device information):

1. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are non-clinical laboratory studies, not based on patient data in the context of an "AI/ML test set."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical studies like hemolysis and microbial challenge is typically established by laboratory testing methodologies and standards, not expert consensus in the diagnostic sense.
3. Adjudication method: Not applicable. This applies to diagnostic assessments, not non-clinical device performance studies.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a non-AI/ML device; an MRMC study is not relevant.
5. If a standalone study was done: Yes, the described studies (hemolysis and microbial challenge) are standalone performance tests for the device's physical and biological properties.
6. The type of ground truth used:
   • Hemolysis: The ground truth would be based on established laboratory methods and standards for quantifying hemolysis in blood samples.
   • Microbial challenge: The ground truth would be based on microbiological techniques to assess sterility and barrier integrity, likely quantifying microbial growth or penetration under controlled conditions.
7. The sample size for the training set: Not applicable. This device does not involve AI/ML.
8. How the ground truth for the training set was established: Not applicable. This device does not involve AI/ML.

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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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