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BD Nexiva™ Closed IV Catheter System - Single Port

BD Nexiva™ Closed IV Catheter System is 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 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 - Dual Port

BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood 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. 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 needle-free connector (BD Q-Syte™ or BD MaxZero™) (dual port configurations only). The needle and catheter are protected by a needle cover. A BD Q-Syte™ Needle-free Connector, BD MaxZero™ Needle-free Connector, 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 The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure.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).

The provided 510(k) clearance letter and summary discuss the BD Nexiva™ Closed IV Catheter System, not an AI/ML medical device. Therefore, information regarding acceptance criteria, study details, and ground truth establishment pertinent to AI/ML device performance (sample sizes, expert consensus, MRMC studies, etc.) is not available in the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K183399) through performance testing of the physical catheter system, rather than validating an algorithm's diagnostic or predictive capabilities.

The performance tests mentioned are:

• Frequency Response Testing
• Kink Resistance Testing
• Blood Fill Time Testing
• ISO 80369-7 Testing
• ISO 11607-1 Testing

However, the specific acceptance criteria and detailed reported performance results for these tests are not explicitly listed in a tabular format, nor are sample sizes, ground truth methodologies, or expert involvement for these physical device performance tests detailed as one might expect for an AI/ML device. The document only states that the device "met all predetermined acceptance criteria for the above-listed performance tests."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device as the input document describes a physical medical device.

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The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. 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. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access.

The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is an over-the-needle, intravenous (IV) catheter. These devices have a radiopaque Vialon™ catheter tubing, needle, needle shield, septum, stabilization platform, long extension tubing, clamp, Luer adapter, and vent plug. The needle and catheter tubing are protected by a needle cover. A MaxZero™ needle-free connector with protective cover is provided in the 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 Instaflash™ Needle Technology, allowing for immediate visualization of blood return along the catheter. Continuous blood return is seen in the long extension tubing. The vent plug and the NearPort™ IV Access prevent blood leakage from the long extension tubing during insertion. Both the long extension tubing and NearPort™ IV Access are suitable to administer fluids and/or medications and to sample blood. In addition, the NearPort™ IV Access is compatible with the PIVO™ Pro Needle-free Blood Collection Device for needle-free blood draws and is suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). These devices are available with wings. The catheter hub and wings are color coded to indicate the 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 (K231239) is a 510(k) Premarket Notification for the BD Nexiva™ Closed IV Catheter System with NearPort™ IV Access. This submission aims to demonstrate substantial equivalence to a predicate device.

The provided text describes the regulatory aspects, technical characteristics, and the summary of performance testing for the device. However, it does not contain information regarding studies that establish a ground truth through expert consensus, MRMC studies, or training set details typically found in AI/ML device submissions. This is because the device in question is an IV catheter system, a physical medical device, not an AI/ML-driven diagnostic or therapeutic system. Therefore, the concepts of "ground truth for the test set," "number of experts," "adjudication method," "effect size of human readers improving with AI," "standalone algorithm performance," and "training set details" are not applicable in this context.

The acceptance criteria here pertain to engineering and biological performance standards for medical devices, rather than accuracy metrics for AI/ML models.

Here's a breakdown of the available information relevant to "acceptance criteria and the study that proves the device meets the acceptance criteria" for this physical medical device:

Acceptance Criteria and Reported Device Performance

The device manufacturer conducted various performance tests to ensure the Nexiva™ Closed IV Catheter System with NearPort™ IV Access meets predetermined design requirements and demonstrates substantial equivalence to its predicate device (BD Nexiva™ Closed IV Catheter System, K183399).

The document states that the subject devices met all predetermined acceptance criteria for the listed performance tests, demonstrating substantial equivalence. While specific numerical outcomes of these tests are not provided in this 510(k) summary, the overall statement of meeting acceptance criteria serves as the "reported device performance."

Table of Acceptance Criteria (based on stated tests and standards):

Study Details (as applicable to a physical medical device)

1. Sample sizes used for the test set and the data provenance:

   • The document does not explicitly state specific sample sizes (e.g., number of units tested) for each performance test. It refers to "performance tests completed on the subject devices."
   • Data Provenance: The studies were conducted by Becton Dickinson Infusion Therapy Systems Inc., based in Sandy, Utah, USA. The data is from internal performance verification testing ("BD Internal Studies") and compliance testing to international (ISO, ASTM) and national (FDA guidance) standards. The studies would be considered prospective as they were conducted specifically for this submission to demonstrate compliance.

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

   • Not Applicable. This is a physical medical device (IV catheter), not an AI/ML diagnostic. "Ground truth" in this context refers to engineering specifications and performance standards established by organizations like ISO, ASTM, and FDA. The "experts" involved would be engineers, scientists, and regulatory affairs professionals ensuring the device meets these pre-defined physical and functional requirements.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in subjective interpretation tasks (e.g., radiology image review) to establish consensus ground truth. For objective physical performance tests (e.g., tensile strength, flow rate), the results are quantitative and do not require expert adjudication in this manner. Compliance is determined by meeting numerical or descriptive criteria within established standards.

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, an MRMC study was not done. This type of study is specifically designed for AI-assisted diagnostic devices where human readers interpret medical images. This document is for a physical IV catheter; AI assistance for human readers is not relevant.

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

   • Not Applicable. This is not an AI algorithm. Its performance is tested as a standalone physical 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 and quality standards, including:
     • International Standards (ISO 10993, ISO 10555, ISO 23908, ISO 594, ISO 11135, ISO 14971)
     • ASTM Standards (ASTM D4169, ASTM F2182)
     • FDA Guidance Documents (e.g., for Usability, Microbial Ingress, MR Compatibility)
     • Internal design requirements and specifications, which are based on the above standards and common medical device engineering principles.
   • "Ground truth" is not based on expert consensus for subjective interpretation or pathology/outcomes data in the way it would be for a diagnostic tool.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set.

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

   • Not Applicable. As there is no training set for a non-AI/ML device, ground truth establishment for it is irrelevant.

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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.

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The Nexiva™ intravascular catheter is inserted into a patient's vascular system for 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 needlestick 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 18-24 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 needle-shielding 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 Nexiva 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 or a BD Q-Syte luer access port.

The provided document is a 510(k) premarket notification for the BD Nexiva™ Closed IV Catheter System, seeking substantial equivalence to predicate devices. It describes the device's intended use and technological characteristics but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical data analysis, comparative effectiveness, or standalone performance metrics typically associated with AI/algorithm review.

Therefore, I cannot provide the requested information in the format of acceptance criteria, reported device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results because this information is not present in the provided text.

The document primarily focuses on:

• Description of the Device: BD Nexiva™ Closed IV Catheter System, its components, and its closed system features for blood exposure prevention.
• Intended Use: Short-term intravascular use for blood sampling, pressure monitoring, or fluid administration, with needle-shielding and luer access port for preventing needlestick injuries and blood exposure. It also notes suitability for power injectors.
• Technological Characteristics Comparison: Highlighting similarities to predicate devices (BD Saf-T-Intima™ IV Catheter and B. Braun Introcan® Safety™ IV Catheter) in materials, design features, and use with power injectors.
• Nonclinical Tests: Stating that the device materials were tested per ANSI/AAMI/ISO 10993-1 (1997) and a simulated use study compared Nexiva and Introcan catheters.
• Conclusion: The sponsor concluded substantial equivalence based on these nonclinical tests.
• FDA Communication: The FDA's letter confirming substantial equivalence to legally marketed predicate devices.

Missing Information:

The document is a regulatory submission for a medical device (intravascular catheter), not an AI/algorithm-based diagnostic or assistive system. As such, concepts like "acceptance criteria" and "device performance" in the context of sensitivity, specificity, accuracy, or other statistical measures, along with details on ground truth, expert adjudication, or MRMC studies for AI, are not applicable or reported here. The "study" mentioned is a "simulated use study" and materials testing, which are part of establishing substantial equivalence for physical medical devices rather than evaluating performance against specific diagnostic or prognostic metrics.

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