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IV/Catheter Extension Set with NAC Plus Needleless Access Connector is intended to administer drugs and solutions into a patient's vascular system. The NAC Plus (integral or stand-alone) allows the user to administer or withdraw solutions. The NAC Plus Needleless Access Connector, available as a stand-alone accessory or as part of the IV/Catheter Extension set, may aid in the prevention of needlestick injury.

The IV/Catheter Extension Set with NAC Plus Luer Access Connector constitutes a set for continuous and intermittent fluid delivery into the vascular system. The extension set has luer locks, tubing, slide clamps, tip protectors, and NAC Plus Luer Access Connectors.

The NAC Plus Needleless Access Connector is a Luer activated device cleared under K011193 (Medegen) April 10, 2001. This component is purchased bulk, non-sterile and is packaged by Baxter as both a stand-alone accessory device and as a component integral to IV/Catheter sets. The devices are subsequently packaged, gamma irradiated and distributed to the end user in a cardboard carton.

The provided text is a 510(k) summary for a medical device (IV/Catheter Extension Set with NAC Plus Needleless Access Connector and NAC Plus Needleless Access Connector). It outlines the device description, intended use, and comparison to predicate devices, along with some nonclinical testing information.

However, the document does not contain the specific information required to answer your detailed questions about acceptance criteria and a study proving those criteria are met. The 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to a predicate device, not typically a detailed report of individual performance studies and their specific acceptance criteria.

Here's a breakdown of why I cannot provide the requested information from the given text:

1. A table of acceptance criteria and the reported device performance: The document states, "The results indicate that the proposed device meets or exceeds all functional requirements," but it does not list the specific functional requirements (acceptance criteria) or quantify the reported device performance against those criteria in a table or any other format.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method: This information is not present.
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 device is a physical medical device (IV/catheter extension set), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As a physical device, this concept does not apply.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: As a physical device, this concept does not apply.
9. How the ground truth for the training set was established: As a physical device, this concept does not apply.

What the document does state regarding testing:

• Nonclinical Tests:
  • Biological and chemical reactivity of materials assessed using ISO Standard 10993-1 and USP physicochemical tests. "The material was found to be acceptable for its intended use."
  • "Results regarding the functional performance of the proposed NAC Plus have been submitted."
  • "The results indicate that the proposed device meets or exceeds all functional requirements."

In summary: The provided 510(k) summary affirms that nonclinical tests were conducted and that the device met functional requirements and material biocompatibility standards. However, it does not detail the specific acceptance criteria, test methodologies, sample sizes, or the quantitative results of those tests. These granular details would typically be found in the full test reports submitted to the FDA, not necessarily in the publicly available 510(k) summary.

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The proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters, (e.g., syringes or sets) to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.

The subject of this submission is a luer access injection site which will be marketed as a stand-alone device for use as a heparin lock and will also be incorporated into currently marketed solution sets. The proposed injection site consists of a pre-slit synthetic polyisoprene septum and a polyester housing.

This submission describes a medical device, a Luer Access Injection Site, and its equivalence to a predicate device. It is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence, not necessarily on detailing rigorous clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) might.

Based on the provided text, here's a breakdown of the requested information, noting what is available and what is not available in this specific document:

Description of the Acceptance Criteria and Study to Prove Device Meets Criteria

The document reports that "Performance testing of the proposed luer access injection site has been conducted including microbiological evaluations. A description of the testing along with test results has been provided. All data indicate that the proposed device meets or exceeds all functional and microbiological requirements and thus support its suitability for use." However, the specific acceptance criteria and detailed study results are not provided in this summary. The submission focuses on substantial equivalence to a predicate device, the ICU Medical Inc. Clave™ Needleless Connector.

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that testing was conducted and met requirements, but does not enumerate the specific criteria or the quantitative results against those criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided text. The document mentions "performance testing" and "microbiological evaluations" were conducted, but does not specify sample sizes or the origin of the data. Given the nature of a 510(k) for a device like this, it's highly likely the testing was conducted in a laboratory setting, not with human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications

Not applicable/Not available for this type of device and submission. The testing described (functional and microbiological) would involve laboratory measurements and standards, not human expert interpretation of data or images.

4. Adjudication Method for the Test Set

Not applicable/Not available. As mentioned above, the testing for this type of device does not involve human expert adjudication in the context of clinical interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, not done or not reported. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). The Luer Access Injection Site is a physical medical device for fluid administration and blood sampling, and its evaluation focuses on functional performance and microbiological integrity, not human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was done. The document describes "performance testing" and "microbiological evaluations" conducted on the device itself. This refers to the device's inherent function, independent of a human operator's interpretative skills.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" would be established by validated laboratory methodologies and industry standards for functional performance (e.g., fluid flow, resealing efficacy, luer compatibility) and microbiological integrity (e.g., sterility, microbial ingress prevention). The document mentions "functional and microbiological requirements," implying a comparison against established benchmarks for these types of devices.

8. The Sample Size for the Training Set

Not applicable/Not available. This device is a physical medical component, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve engineering specifications and quality control, but not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not available. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

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