Search Results

The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube, blood culture bottle, or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. For blood culture, the device can be used at initial placement of the peripheral IV catheter.

The PIVOTM Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular (IV) catheter system for use to obtain venous blood specimens. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing and winged clip on the distal end. The winged clip attaches to the catheter system The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV. The device is also suitable for use for blood culture collection at initial placement of peripheral IV catheters. The device is available in three sizes: 20GA, 22GA and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPortTM IV Access.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "PIVO™ Pro Needle-free Blood Collection Device." This document details the device's indications for use, technological characteristics, and comparison to a predicate device, along with a summary of performance tests. However, it does not describe an AI/ML powered device or a study involving human experts for ground truth establishment, MRMC studies, or training/test set sample sizes in the context of AI/ML.

The document primarily focuses on establishing substantial equivalence for the device itself (a needle-free blood collection device), specifically for the addition of blood culture collection and an extended shelf life. The performance tests mentioned (e.g., Insertion Test, Blood Leak Test, Package Integrity) are related to the physical and functional aspects of the hardware device, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML powered device, the study proving its performance (in terms of AI metrics), sample sizes for AI test/training sets, expert involvement in ground truth, or MRMC studies, as this information is not present in the provided text.

The text does state:

• "Clinical studies are not required to demonstrate substantial equivalence to the predicate device."
• "Summary of Performance tests completed on the subject devices were limited to those tests required Performance to support a determination of substantial equivalence to the predicate device."
• "Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance test, demonstrating substantial equivalence to the predicate device."

This indicates that internal performance tests were conducted against pre-determined acceptance criteria, but these are for the physical device's functionality and safety, not for an AI/ML algorithm's diagnostic or predictive performance.

Ask a specific question about this device

The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.

The PIVO™ Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular catheter (IV) system. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing, and winged clip on the distal end. The winged clip attaches to the IV system. The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV.

The device is available in three sizes: 20GA, 22GA, and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPort™ IV Access.

The provided document is a 510(k) summary for the PIVOTM Pro Needle-free Blood Collection Device, which seeks to demonstrate substantial equivalence to a predicate device (PIVOTM Needle-free Blood Collection Device). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than proving absolute safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence, primarily through non-clinical performance testing and a comparison of technological characteristics.

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

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists the performance tests conducted and states that the device "met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."

However, we can infer some "acceptance criteria" based on the tests performed:

2. Sample sizes used for the test set and the data provenance

The document does not specify the exact sample sizes (N values) for each individual performance test (e.g., how many devices were tested for catheter perforation, how many for flow rate). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that these are bench and lab tests for device clearance, they are inherently prospective.

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 in the context of this 510(k) summary. The "ground truth" for this device is based on objective measurements and compliance with recognized standards and internal design requirements, not expert consensus on interpretations like with diagnostic imaging. Usability testing would involve users, but the number and qualifications of those users are not detailed.

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

This concept is not applicable here as these are performance and engineering tests, not studies requiring human interpretation and adjudication (e.g., clinical trials for diagnostic algorithms).

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

An MRMC study was not conducted. This type of study applies to AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) devices where human readers (e.g., radiologists) use AI assistance to improve their diagnostic performance. The PIVOTM Pro is a physical blood collection device, not an AI software. The submission explicitly states: "Clinical studies are not required to demonstrate substantial equivalence to the predicate device."

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

This concept is not applicable as the device is a physical medical device, not an algorithm or AI system. Its performance is evaluated through physical and functional testing.

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

For this device, the "ground truth" relates to meeting engineering specifications, material properties, sterility, and functional performance benchmarks derived from industry standards (e.g., ISO, ASTM), internal design requirements, and prior knowledge from the predicate device. It is primarily based on:

• Physical measurements and criteria: e.g., acceptable flow rates, specified dimensions, absence of leaks, specified pull force.
• Compliance with recognized standards: e.g., ISO 10993-1 for biocompatibility, ISO 11137-1 for sterilization, ASTM D4169 and ISO 11607-1 for packaging.
• Functional tests: verifying proper insertion, alignment, and absence of catheter perforation.

8. The sample size for the training set

This is not applicable. This is a physical device, not an AI/machine learning model, so there is no "training set."

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

This is not applicable for the same reason as above.

Ask a specific question about this device

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.

Ask a specific question about this device

BD Nexiva 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 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 22-18GA (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 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 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, vent plug and, with dual port configurations, a pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. For dual port configurations, a BD Q-Syte device or 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. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green).

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 (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green).

The document describes the BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems and their substantial equivalence to predicate devices, based on performance testing.

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 sample sizes used for each performance test. It notes that "Performance testing performed to support the design modifications included" a list of tests. The data provenance is industrial, conducted by the manufacturer (Becton Dickinson Infusion Therapy Systems Inc.) for regulatory submission to the FDA. The tests are prospective in nature, assessing the physical and mechanical characteristics of the devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This section is not applicable. The device is a physical medical device (intravascular catheter system), and its performance is evaluated based on objective physical and mechanical tests, not through human interpretation or expert ground truth establishment for a test set in the same way an AI algorithm for image analysis would be.

4. Adjudication method for the test set:
This section is not applicable for the reasons outlined in point 3. Performance is determined by meeting pre-determined objective criteria in physical tests.

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:
This section is not applicable. The device is not an AI-assisted diagnostic tool or an algorithm that human readers would use. It is a medical device for vascular access.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This section is not applicable for the reasons outlined in point 5.

7. The type of ground truth used:
The "ground truth" for the performance tests are the objective engineering and regulatory standards and specifications for the physical and mechanical properties of intravascular catheter systems. These are not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:
Not applicable. This is not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML model, so there is no "training set" or ground truth establishment for it.

Ask a specific question about this device

An intravascular catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Insyte™, Insyte-N™, and Insyte-W™ are available in 14-24 gauge and are made of BD Vialon™ Material. Angiocath™ is available in 14-24 gauge and is made of FFP Polymer material

This is an IV catheter from Becton Dickinson, which is a class II device under 21 CFR 880.5200. This device, named BD Angiocath™ and Insyte™ IV Catheters, did not have any AI/ML components in 2015. So, the request for acceptance criteria for such components cannot be fulfilled.

However, I can provide the acceptance criteria and performance data for the mechanical and physical tests performed on the device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test. It states that "design verification tests were performed based on the risk analysis." The data provenance is internal, as these were tests conducted by the manufacturer, Becton Dickinson Infusion Therapy Systems Inc., as part of their design control process for regulatory submission. The document defines these as "design verification tests."

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

Not applicable. This device is a physical medical device, and its performance criteria are established through standardized international and internal engineering test methods, not through expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. Performance testing is based on objective measurements against defined standards and specifications, not on subjective interpretations requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that humans interact with, which is not the case for this physical medical device.

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

Not applicable. This device is a physical medical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests presented are established international standards (ISO standards like ISO 10993-1, ISO 594-1, ISO 594-2, ISO 10555-1, ISO 10555-5) and internal design inputs that set specific thresholds for physical and mechanical properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable, as there is no training set.

Ask a specific question about this device

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.

Ask a specific question about this device

The BD Intima II IV Catheter is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly.

The Intima II IV Catheter consists of a Vialon® material catheter, a notched needle to enhance flashback visualization, septum, extension tubing and either a straight or Y Luer connector. A needle-accessed PRN is attached to the Luer connector. An end cap is attached to the second Luer connector on the Y design. Blood is contained within the device. A slide clamp is provided on the extension tube. A notched needle resides within the catheter until it is withdrawn through the septum after the catheter has been threaded into the vein. The needle unit includes a paddle that is held during the insertion process. This device does not include a needle-shielding mechanism.

The provided 510(k) summary for the BD Intima II™ IV Catheter (K100775) describes non-clinical tests to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting with defined performance metrics for AI.

Therefore, the requested information elements related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI are not applicable to this document. This submission focuses on traditional medical device testing for safety and effectiveness.

However, I can extract information regarding the non-clinical test results which serve as the "acceptance criteria" and "reported device performance" in the context of this traditional device submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BD Intima II™ IV Catheter are based on compliance with various ISO standards and in-house protocols. The reported device performance is indicated by "Passed" for each test.

Study Details (Relevant to this Traditional Device Submission)

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

   • The document does not explicitly state the sample sizes for the individual non-clinical tests (e.g., number of catheters tested for bond strength). It refers to "in-house protocol" for some tests and specifies compliance with ISO standards, which typically outline sample size requirements, but the specifics are not detailed in this summary.
   • All data provenance is in vitro or in vivo animal testing (for biocompatibility components like implantation, sensitization), conducted by the submitting company (Becton Dickinson Infusion Therapy Systems Inc.) or their contracted labs. This is not human clinical data.

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

   • Not applicable in the context of this non-clinical submission. "Ground truth" in this context is defined by objective measurements against established international standards (ISO) and internal protocols. Expert opinion is not used to establish truth for these performance metrics.

3. Adjudication method for the test set:

   • Not applicable. Results are typically based on quantitative measurements and pass/fail criteria defined by the test methods and standards, not human adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This is a non-clinical submission for a physical medical device, not an AI software.

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

   • Not applicable. This is not an AI algorithm.

6. The type of ground truth used:

   • The "ground truth" for the non-clinical tests is established by objective measurements against the specified requirements and methodologies of international standards (ISO) and validated in-house protocols. For biocompatibility, this includes biological responses observed in in vitro or in vivo models according to the relevant ISO 10993 parts.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm.

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

   • Not applicable. This is not an AI algorithm.

Conclusion:

The BD Intima II™ IV Catheter's substantial equivalence was demonstrated through non-clinical testing against established physical, chemical, and biological performance standards (primarily ISO standards) and validated in-house protocols. All enumerated tests "Passed" or were "Determined substantially equivalent," indicating that the device meets the defined acceptance criteria for safety and effectiveness in a non-clinical context. No clinical studies or AI-related evaluations were conducted or are relevant to this 510(k) submission.

Ask a specific question about this device

The BD Posiflow Positive Displacement Valve is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids. The BD Positive Displacement Valve can be used by itself or as a component on an extension/infusion set, a vial adapter, or as a connector to convert a standard access site to a needleless access site.

The BD Posiflow Positive Displacement Valve is a needleless alternative to an IV set injection port. It is accessed by a standard luer taper connection for continuous or intermittent infusion or withdrawal of fluids. The positive displacement feature is intended to eliminate fluid retrograde, which normally results when disconnecting a connector from an IV injection site.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) summary for a medical device and not a detailed clinical study report. Therefore, specific details about study methodology for clinical performance (like expert consensus, sample sizes for training sets in AI, etc.) are unlikely to be present.

It's important to note that this document concerns a physical medical device (a valve), not an AI/software device. Therefore, many of the questions related to AI-specific study details (like multi-reader multi-case studies, AI model performance metrics, training set details) are not applicable in this context. The "acceptance criteria" here refer to the performance standards for the physical device.

Acceptance Criteria and Reported Device Performance

Overall Conclusion: Based on the nonclinical tests for flow rate, backpressure leakage, and vacuum leakage, the current and modified BD Posiflow Positive Displacement Valves are substantially equivalent. This implies that the modified device met the performance standards demonstrated by the predicate device for these parameters. The document does not specify quantitative acceptance thresholds for these categories, but rather indicates that the modified device performed equivalently to the predicate.

Study Details (for a physical medical device)

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

   • Sample Size: Not explicitly stated. The document refers to "the current and modified devices" being compared, implying a number of units of each were tested, but no specific sample size (N) is provided for these nonclinical tests.
   • Data Provenance: Not explicitly stated, but these would be laboratory-based nonclinical tests, likely conducted at Becton Dickinson's facilities in the USA (based on their address).
   • Context: These are nonclinical (bench) tests, not clinical trials involving patient data.

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

   • Not Applicable. As these are nonclinical physical device performance tests (flow rate, leakage), there's no "ground truth" established by human experts in the way it would be for an AI diagnostic device. The ground truth here would be derived from physical measurements against scientific principles and engineering standards.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods (like 2+1) are typically used in clinical studies to resolve discrepancies in expert interpretations (e.g., radiologists diagnosing images). These nonclinical tests involve objective physical measurements, not subjective interpretations requiring adjudication.

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 physical medical device (a valve), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

   • No. This is a physical medical device. The concept of an "algorithm only" or "human-in-the-loop" performance is not applicable to a physical valve.

6. The type of ground truth used:

   • For the nonclinical tests (flow rate, backpressure leakage, vacuum leakage), the "ground truth" is established through physical measurements and engineering standards/specifications. The comparison is against the performance of the predicate device, which itself would have met certain engineering and safety standards.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, not an AI model. There is no concept of a "training set" in this context.

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

   • Not Applicable. Since there is no training set, this question is not relevant.

Ask a specific question about this device

The BD OneCath™ midline 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. This intravascular catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The BD OneCath midline products are similar in design to other midline catheters. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer.

The provided documentation (K042862) describes the BD OneCath™ Midline Catheter. However, it does not include detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device. This submission is for a traditional medical device (catheter) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, for aspects related to AI/ML device performance, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for training, the information is not applicable or not provided in this document.

Here's the information that can be extracted or inferred from the document:

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

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

• Sample Size for Test Set: Not specified. The document refers to "biocompatibility testing" and "physical testing" but does not detail the number of units or samples tested for each.
• Data Provenance: Not specified. These are non-clinical (laboratory/bench) tests conducted by the manufacturer, Becton Dickinson.

3. 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. This device is a physical medical device (catheter), not an AI/ML diagnostic or image analysis tool. Ground truth is established through laboratory measurements and established biocompatibility standards, not expert interpretation of outputs.

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

• Not Applicable. Ground truth is based on objective laboratory measurements and standardized test results rather than expert 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. This is not an AI/ML device, and no MRMC study was conducted or is relevant to this submission.

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

• No. This is not an AI/ML device.

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

• The ground truth for the non-clinical tests would be based on objective laboratory measurements (e.g., tensile strength, elongation, burst pressure, material composition analysis, radiopacity measurements) and established industry standards for biocompatibility (e.g., ISO 10993 series). Performance measurements would be compared against defined specifications or the performance of the predicate device.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Ask a specific question about this device

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.

Ask a specific question about this device