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Non- pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direction, intermittent infusion, continuous infusion, or aspiration.

Pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direct infusion, continuous infusion, or aspiration. This set may be used with power injector procedures to a maximum pressure of 325psi at a flow rate of 10mL/s.

Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) are Extension Sets that are intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood or fluids. All Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) has a Neutraclear connector that is removable or bonded to the extension set tubing. Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) allows thorough and easy disinfection due to a solid flat smooth surface and eliminates the risk of needle stick injuries. Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) are sterile single patient devices that can be used for 200 activations and for 7 days. All extension set included are not made from natural rubber latex or DEHP.

The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Carefusion NeutraClear™ multi-fuse Extension Set with Needle-free Connector(s)". This document outlines the regulatory review and substantial equivalence determination for this device, comparing it to a predicate device.

It IS NOT a study report for an AI/ML powered medical device.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria and a study proving a device meets them, especially for an AI/ML device. The document describes a traditional medical device (an IV extension set) and its non-clinical performance testing. It does not mention any AI/ML components, nor does it conduct studies involving human reader performance, ground truth establishment by experts, or training/test sets for AI models.

The "Performance Data" section (Section VI on pages 7 and 8) lists various ISO standards and specific tests that were performed. These are standard tests for the physical and biological properties of IV administration sets, such as:

• Physical performance: Leakage, connection/disconnection cycles, resistance to alcohol/lipids, pressure resistance (325 psi at 10mL/s flow rate), luer connector dimensions and integrity, tensile strength, flow rate.
• Biocompatibility: Cytotoxicity, intracutaneous injection, systemic injection, sensitization, hemolysis, hemocompatibility, pyrogenicity, particulate contamination, endotoxin levels, extractable/leachable agents.
• Sterilization: Validation of ethylene oxide sterilization (bioburden, sterility, EOR/ECH residuals).
• Packaging: Sterility barrier after aging.
• Functional performance: Microbial ingress, shelf life, harsh infusates, priming volume/flow rate.

The conclusion (Section IX on page 9) states: "The results of the non-clinical testing exhibited that Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility and other performance criteria, which verify it to be substantially equivalent to the predicate devices."

In summary, this document does not contain the information requested in the prompt because it pertains to a mechanical medical device, not an AI/ML one. It describes standard engineering and biological testing, not clinical performance studies with human readers or AI algorithms.

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The MaxZero Intravascular Administration set with needleless connector(s) is a device used to administer fluids from a container to a patient's vascular system. The administration set is for single patient use only. The administration set can be used for direct injection, intermittent infusion or continuous infusion.

The CareFusion MaxZero Administration Sets are intravascular administration sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion of drugs, blood and fluids. All MaxZero Administration Sets include the previously cleared zero reflux MZ1000 Needleless Connector (K132413) bonded to the extension set tubing. The MZ1000 needleless connector allows thorough and easy disinfection due to a solid, flat smooth surface and eliminates the risk of needlestick injuries. The MaxZero Administration Sets are sterile single patient devices. All extension sets included in this submission are not made from material containing natural rubber latex or DEHP.

This document is a 510(k) premarket notification for a medical device (MaxZero Administration Set) and therefore primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving a comparison of the AI device with human performance.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All test results met their acceptance criteria" and that the device "met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility and other performance criteria." However, it does not provide a specific table detailing individual acceptance criteria values and the device's measured performance against each of those criteria.

Instead, it lists the types of non-clinical testing performed:

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

The document does not specify the sample sizes used for each of the non-clinical tests. It also does not mention "test sets" in the context of clinical data or human evaluation, as the testing performed was non-clinical.

Provenance: Not applicable as the testing is non-clinical performance and material testing.

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

Not applicable. The ground truth for this device's performance is established through established engineering and scientific testing standards, not expert consensus on interpretation of medical data.

4. Adjudication Method for the Test Set:

Not applicable. This device is not an AI/imaging device requiring expert adjudication of results.

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:

No. This document explicitly states: "There is no clinical data included in this submission." Therefore, no MRMC study or AI-human performance comparison was performed.

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

Not applicable. This is a physical medical device (administration set), not a software algorithm.

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

The "ground truth" for this device's performance is based on established engineering principles, material science, and standards for biocompatibility, sterility, fluid dynamics, and microbial barrier properties. These are measured objectively through laboratory tests rather than subjective human interpretation.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. See point 8.

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