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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of Intravascular Administration Sets. These devices include Basic, Secondary, and CONTINU-FLO solution sets. They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

The provided text is a 510(k) summary for Baxter Healthcare Corporation's Intravascular Administration Sets (K203609). It details the substantial equivalence determination for this medical device to a predicate device (Solution Administration Sets, K112893).

However, the summary does not contain the specific information requested in the prompt regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Device Description: What the Intravascular Administration Sets are, their components, and how they function.
• Predicate Device Comparison: A detailed table comparing the technological characteristics of the proposed device to the predicate device, highlighting differences in length, priming volume, dimensions, and material components.
• Discussion of Differences: Explanations for each technological difference and assurance that these differences do not raise new questions of safety or effectiveness.
• Nonclinical Tests: A list of bench tests (Luer tests, particulate matter, non-DEHP claim, solvent bond tests, flow rate tests, pump compatibility), biocompatibility tests (cytotoxicity, sensitization, toxicity, hemolysis), and sterility tests (barrier packaging, fluid path, shelf life, sterilization dose establishment, pyrogen testing, microbial ingress). It states that all test results meet their acceptance criteria.

Therefore, I cannot populate the table or provide detailed answers to questions 1-9 as the necessary information is not present in the provided document. The document states that "All test results meet their acceptance criteria," but it does not define what those criteria are or report specific performance metrics against those criteria. It also does not discuss any studies involving human readers or expert consensus for ground truth.

Here's what I can infer from the document, though it falls short of the requested detail:

• Acceptance Criteria & Reported Performance: The document states, "All test results meet their acceptance criteria." This implies that acceptance criteria were established for each of the listed bench, biocompatibility, and sterility tests. However, the specific quantitative acceptance criteria (e.g., maximum allowable particulate matter, minimum burst pressure, flow rate accuracy range) and the reported device performance (e.g., actual particulate count, measured burst pressure, achieved flow rate accuracy) are not provided.
• Sample Sizes: The document does not specify sample sizes used for any of the tests.
• Data Provenance: The tests are described as "bench tests," "biocompatibility," and "sterility" tests conducted by the manufacturer (Baxter Healthcare Corporation). The data would therefore be prospective, internal testing data. No country of origin for data is specified beyond the manufacturer's location (Round Lake, Illinois).
• Experts for Ground Truth / Adjudication / MRMC Study / Standalone Performance: This section of the prompt is highly relevant for AI/ML device clearances (e.g., software as a medical device). This document describes a traditional Class II medical device (intravascular administration sets). There is no mention of AI/ML components, human readers, expert panels, or comparative effectiveness studies in the context of diagnostic or interpretive performance. Therefore, questions regarding these aspects are not applicable to the content provided.
• Type of Ground Truth: For this type of physical device, "ground truth" would be established by the physical and chemical properties and performance characteristics measured in the listed bench, biocompatibility, and sterility tests, compared against established engineering standards (e.g., ISO, USP, ASTM) and internal specifications. There is no subjective human interpretation or diagnostic outcome data involved.
• Training Set Sample Size / Ground Truth Establishment (for AI/ML): These questions are entirely irrelevant to this device and the provided document, as it is not an AI/ML product. The "training set" here would metaphorically be the design and manufacturing processes refined over time.

In summary, the provided document is a regulatory submission for a physical medical device, not an AI/enabled one. Therefore, many of the questions asked, particularly those related to data sets, expert involvement, and reader studies, are not applicable to the content provided.

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The Nexus I.V. Needless Access Cannula are intended for use to administer IV fluids / medication to the patients vascular system through a needle free system that aids in the prevention of necdle stick injuries.

Not Found

I am sorry, but the provided text does not contain any information regarding the acceptance criteria, device performance, or study details. The document is an FDA 510(k) clearance letter for an "I.V. Needless Access Cannula for Intravascular Administration," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The letter mentions:

• Trade/Device Name: I.V. Needless Access Cannula for Intravascular Administration
• Regulation Number: 21 CFR 880.5440
• Regulation Name: Intravascular Administration Set
• Regulatory Class: II
• Product Code: FPA
• Indications for Use: To administer IV fluids/medication to the patients' vascular system through a needle-free system that aids in the prevention of needle stick injuries.
• 510(k) Number: K081123

However, it does not include any data from studies, acceptance criteria, sample sizes, expert qualifications, or ground truth information that would allow me to answer your specific questions about device performance and the study details. This type of information is typically found in the 510(k) summary or in the full 510(k) submission, neither of which is provided here.

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