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BD Nexiva closed IV catheter systems are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter (single or dual port), vent plug, and pre-attached needleless connector (BD Q-Syte or MaxZero) (dual port configurations only). The needle and catheter are protected by a needle cover. A BD Q-Syte, MaxZero, or end cap with protective cover is provided in the unit package (not available with all configurations).

The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

These devices have BD Instaflash needle technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).

This document is a 510(k) summary for the BD Nexiva™ Closed IV Catheter System. It describes the device, its intended use, a comparison to predicate devices, and a summary of performance testing to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Per the design control requirements specified in 21 CFR §820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and states that the device met the criteria.

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

The document does not specify the sample sizes used for the individual performance tests listed.
The provenance of the data is not explicitly stated as a country of origin or retrospective/prospective. The tests were likely conducted in-house by Becton Dickinson or by a contracted laboratory.

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

This study does not involve clinical data or "ground truth" established by experts in a diagnostic sense. The tests performed are engineering and biocompatibility tests for a medical device. Therefore, this question is not applicable.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study requiring adjudication of expert opinions or diagnostic findings.

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

Not applicable. This is a 510(k) submission for a physical medical device (IV catheter system), not an AI/Software as a Medical Device (SaMD).

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

Not applicable. This is a 510(k) submission for a physical medical device.

7. The Type of Ground Truth Used

Not applicable as this is a physical medical device and the performance tests are based on engineering and biocompatibility standards, not diagnostic "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set. The performance tests are for device validation.

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

Not applicable.

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BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector devices are intended to be inserted into a patient's vascular system for short term use to sample blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector devices are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter, and vent plug. The needle and catheter are protected by a needle cover. A MaxZero device with protective cover is provided in the unit package.

The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

These devices have BD Instaflash needle technology, allowing for immediate visualization of blood return along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA (0.7 mm)=Yellow, 22 GA (0.9 mm)=Blue, 20 GA (1.1 mm)=Pink, 18 GA (1.3 mm)=Green).

The provided text describes specific performance tests for the BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector. However, it does not include the acceptance criteria or reported device performance for these tests in a detailed format that would allow for a direct creation of the requested table. It only states that the device "met all predetermined acceptance criteria."

Therefore, I cannot provide a table of acceptance criteria and reported device performance.

Furthermore, the document does not detail the following information regarding a hypothetical study proving the device meets acceptance criteria:

• Sample size used for the test set or the data provenance.
• Number of experts used to establish the ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
• Whether a standalone (algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with specific performance metrics and acceptance criteria for this particular device. It describes the types of tests performed (e.g., MaxZero Insertion Force, Cytotoxicity, Sensitization) and states that "the subject device met all predetermined acceptance criteria," but it doesn't quantify those criteria or the device's exact performance against them.

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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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