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BD Nexiva™ Diffusics™ Closed IV Catheter Systems are intended to be inserted into a patient's 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 performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.

BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter with side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device

This document is a 510(k) summary for the BD Nexiva Diffusics Closed IV Catheter System (K173354). It describes a modification to an existing device (predicate device K170283), specifically a change in the extension tubing polyurethane material formulation and manufacturer. The submission aims to demonstrate substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample sizes for each test. It broadly mentions "Summary of Performance tests completed on the subject device were limited to those tests Performance required to support a determination of substantial equivalence to the predicate Tests devices." It also states, "When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device."

• Sample size: Not explicitly stated. The tests are industrial-standard tests for medical device components.
• Data provenance: Not explicitly stated, though it implicitly refers to "design verification" and "risk analysis" conducted by the manufacturer, Becton Dickinson Infusion Therapy Systems Inc. The testing results are presented as having met internal, pre-determined criteria. Given the nature of a 510(k) submission for a material change, the testing would be prospective for the modified component.

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

This information is not applicable to this type of device and submission. The tests are physical, chemical, and biological performance tests for a medical device, not clinical studies requiring expert interpretation of outcomes. The "ground truth" is defined by the technical specifications and standards (e.g., ISO 10993-1, USP <788>) that the device must meet.

4. Adjudication Method for the Test Set

This information is not applicable. The nature of the tests (e.g., measuring pull force, pressure, or biological response) does not involve adjudication by human readers or experts in the sense of clinical image interpretation or diagnostics. The results are objective measurements compared against pre-defined acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a Class II medical device (intravascular catheter) involving a material change. MRMC studies are typically associated with diagnostic imaging devices where human interpretation is a key component of the clinical workflow.

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

No, a standalone performance study was not done. This device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests is derived from engineering specifications, recognized industry standards (e.g., ISO 10993-1 for biocompatibility, USP <788> for particulate analysis), and internal design requirements developed by BD according to 21 CFR 820.30 Design Controls. These objective criteria define what constitutes acceptable performance for the device and its material components.

8. The Sample Size for the Training Set

This information is not applicable. This is a submission for a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as there is no training set for this device.

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BD Nexiva Diffusics closed IV catheter systems are intended to be inserted into a patient's 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 performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.

BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter with side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap 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 along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. 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 is an FDA 510(k) summary for a medical device (BD Nexiva Diffusics Closed IV Catheter System) and does not contain information about an AI/ML-driven medical device, nor does it detail a study proving such a device meets acceptance criteria.

The document is a premarket notification to the FDA for a medical device (intravenous catheter), asserting its substantial equivalence to a legally marketed predicate device. The "performance tests" mentioned are engineering tests to ensure the physical integrity and function of the catheter after a minor design modification, not clinical studies of an AI algorithm.

Therefore, I cannot extract the requested information related to AI/ML device acceptance criteria and study details from the provided text. The questions refer to concepts like "test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "ground truth," and "training set," which are relevant to evaluating AI/ML models, but not to the type of device and submission described in the document.

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The BD Noxiva™ Diffusics™ intravascular catheter is inserted into a patient's vascular system to mo be Norte - binonice of administer fluids. The BD Nextra Diffusics catheters are suitable for use with power injectors when a direct connection is made. The maximum flow rate and maximum power injector pressure setting for each catheter size are listed in the table below:

The BD Nexiva Diffusics device is designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of a radiopaque Vialon® material catheter, a notched needle to enhance flashback visualization, a septum designed to remove visible blood from the needle surface that seals after needle removal, a stabiliization platform, extension tubing, a clamp, a vent plug and a Luer connector. The 18-24 gauge catheter systems are capable of withstanding high pressure injection procedures. The stabilization platform and Luer adapter are color-coded.

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

Important Note: The provided text is a 510(k) summary and FDA clearance letter. It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive clinical study report. Therefore, some of the requested information (like specific sample sizes for training/test sets, data provenance for clinical studies, number/qualifications of experts for ground truth, and MRMC study details) is not present in this type of regulatory document. The responses below reflect what can be extracted from the given text.

Acceptance Criteria and Reported Device Performance

The core of the study described here is to demonstrate that the modified BD Nexiva™ Diffusics™ Closed IV Catheter System meets predetermined requirements, particularly in relation to its maximum flow rate specifications. The provided document doesn't list specific acceptance criteria as distinct quantitative metrics beyond the specified flow rates and pressure.

Study Information

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: The document does not specify the sample sizes used for the "design verification and validation" testing.
   • Data Provenance: Not specified. As a 510(k) submission, the data is typically generated internally by the manufacturer through laboratory and engineering tests, rather than a multi-center clinical trial with patient data. It is implied to be prospective testing carried out for regulatory submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not specified. The "testing" primarily involves engineering and performance verification against established standards and internal protocols, not interpretation by medical experts.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. No adjudication method is mentioned as the testing is performance-based and objective against specified metrics.

4. 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 is a medical device clearance for an IV catheter, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI-related effectiveness are not relevant or described.

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

   • Not applicable. This is not an algorithmic or AI device.

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

   • The "ground truth" for this device's performance is established by engineering specifications, recognized national and international standards (e.g., ISO, ANSI/AAMI), and internal protocols. For example, the maximum flow rates are determined through physical testing in a laboratory setting, not through expert consensus or clinical outcomes data in the context of this 510(k) summary.

7. The sample size for the training set:

   • Not applicable/Not specified. This is a traditional medical device, and the concept of a "training set" in the context of machine learning or AI is not relevant here. Device design and validation follow a different paradigm (design controls, risk analysis, verification/validation testing).

8. How the ground truth for the training set was established:

   • Not applicable. (See point 7).

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The BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure or administer fluids. The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.

The BD Nexiva Diffusics device is designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of a radiopaque Vialon® material catheter, a notched needle to enhance flashback visualization, a septum designed to remove visible blood from the needle surface that seals after needle removal, a stabiliization platform, extension tubing, a clamp, a vent plug and a luer connector, The 18-24 gauge catheter systems are capable of withstanding high pressure injection procedures. The stabilization platform and luer adapter are color-coded.

The provided text describes the BD Nexiva™ Diffusics™ Closed IV Catheter System, primarily focusing on its substantial equivalence to predicate devices based on bench testing. It does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, or standalone performance. The document explicitly states: "No clinical test results were included in this submission."

Therefore, I cannot fulfill most of your request directly from the provided text. However, I can extract the information that is present concerning the testing done.

Here's a summary of what can be inferred and what is missing:

Summary of Device Performance and Testing (from provided text):

The submission for the BD Nexiva™ Diffusics™ Closed IV Catheter System relies on bench testing to demonstrate performance and substantial equivalence.

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The text states, "Studies were designed and performed to demonstrate that the BD Nexiva Diffusics device met-predetermined product specifications." However, the specific predetermined product specifications (acceptance criteria) are not detailed in the provided document.
• Reported Device Performance: The document generally states, "Nonclinical test results and technological characteristics of like gauge size catheters were shown to be equivalent between the subject device and the predicate device." And "The BD Nexiva Diffusics (subject) device met the minimum requirements and are substantially equivalent in design, materials, sterilization, principles of operations and indications for use to the predicates."
  • Specific performance metrics or numerical outcomes from the bench tests are not provided.
  • The testing performed included:
    • In-vitro testing in accordance with ISO 10555-1 and ISO 10555-5 (which generally cover sterile, single-use intravascular catheters).
    • Flow rate testing.
    • Catheter strength and performance.
    • Clamp performance.
    • Labeling durability.
    • Extension tube and septum integrity.
    • Biocompatibility evaluation in accordance with ISO 10993-1.

2. Sample size used for the test set and the data provenance:

• Sample Size: The sample sizes used for the bench tests are not specified in the provided text.
• Data Provenance: The data provenance (country of origin, retrospective/prospective) for the bench tests is not specified. Given it's bench testing, it would likely be conducted in a laboratory setting, not tied to a country of patient data, and inherently prospective for that specific test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as there were no clinical studies or human expert evaluations mentioned for establishing ground truth. The submission relies solely on bench testing and comparison to predicate devices, not on human diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This question is not applicable as there were no human evaluations or a "test set" in the context of diagnostic interpretation that would require adjudication.

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 MRMC study was done. The document explicitly states: "No clinical test results were included in this submission." The device is a physical medical device (IV catheter), not an AI diagnostic tool.

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

• This question is not applicable as the device is an IV catheter, not an algorithm or AI system.

7. The type of ground truth used:

• For the bench testing, the "ground truth" would be established by the predefined product specifications and performance standards (e.g., ISO 10555, ISO 10993) which the device had to meet. These are objective engineering and material science standards, not expert consensus, pathology, or outcomes data from patients.

8. The sample size for the training set:

• This question is not applicable as the device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established:

• This question is not applicable as the device is not an AI/ML algorithm.

In summary, the provided document focuses on demonstrating substantial equivalence through bench testing against established industry standards and comparison to predicate devices. It explicitly states that no clinical tests were included, meaning there are no details about human or AI performance, expert involvement, or related statistical measures.

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