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As indicated in 21 CFR Part 880.5200, The Nexiva™ intravascular catheter is inserted into a patient's vascular system for a short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port, aid in the prevention of needle-stick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The 18-22 gauge Nexiva™ catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.

The BD Nexiva™ Closed IV Catheter System consists of an over-the needle, peripheral intravascular catheter made from Vialon™ polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte™ luer access port, and a passive needleshielding mechanism.

The design of the Nexiva™ IV catheter can be described as a closed system since it protects clinicians from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the NexivaTM device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection of a BD Q-Syte™ luer access port.

Here's a breakdown of the acceptance criteria and study information for the BD Nexiva™ Closed IV Catheter System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The nonclinical tests compare the modified BD Nexiva™ Closed IV Catheter System to its predicate device (K032843). The reported device performance for all listed characteristics is "Pass," indicating that the device met the specified acceptance criteria.

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

• Sample Size: The document specifies a sample size of 2301 units for "Package Integrity (Water Leak)" and "Ship Testing (Drop/Vibration)" tests. For other tests, specific sample sizes are not explicitly stated, but the acceptance criteria are generally expressed in "DPPM" (Defective Parts Per Million) or "Cpk" (Process Capability Index), suggesting statistical process control and quality assurance testing.
• Data Provenance: The tests are described as "Nonclinical Tests" and "design verification activities," conducted by Becton Dickinson Infusion Therapy Systems, Inc. The data is retrospective in the sense that it was generated during device development and verification to support the 510(k) submission. There is no information on the country of origin of the data, but it can be assumed to be related to the manufacturer's testing facilities, potentially in the US (headquarters in Sandy, UT).

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

This document primarily describes physical and mechanical performance testing of a medical device, not diagnostic or clinical performance involving expert interpretation of data (like radiology images). Therefore, the concept of "experts" establishing ground truth in this context doesn't directly apply as it would for a software device. The ground truth for these tests is based on established engineering standards (e.g., ANSI/AAMI/ISO 10993-1 2003 (E) for biocompatibility, and presumably other relevant engineering and ISO standards for mechanical performance), internal product specifications, and quality control methodologies.

4. Adjudication Method for the Test Set

Not applicable. As described above, these are physical and mechanical tests with quantitative acceptance criteria (e.g., DPPM, Cpk, force measurements). There is no "adjudication" in the sense of reconciling differing expert opinions or classifications. The results are objective measurements compared against predefined thresholds.

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

No. This document does not describe an MRMC comparative effectiveness study. The submission relates to a physical medical device (intravascular catheter) and its modifications, not an AI or software device that would typically involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This concept is not applicable as the submission is for a physical medical device, not an algorithm or AI. The tests are focused on the device's physical and mechanical properties.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

• Engineering Standards: Adherence to established industry and international standards (e.g., ANSI/AAMI/ISO 10993-1 2003 (E), ISO Liquid Leakage, etc.).
• Product Specifications: Internal design requirements and performance targets defined by the manufacturer.
• Predicate Device Performance: The modified device is benchmarked against its predicate device (K032843) to demonstrate "substantial equivalence."

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such physical devices involves design, prototyping, and iterative testing processes, not data-driven algorithmic training.

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

Not applicable, as there is no "training set" in the context of this device.

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