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BD Cathena™ Safety IV Catheter 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. This device 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. This device is suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).

BD Cathena™ Safety IV Catheter is an over-the-needle, intravascular (IV) catheter. This device includes a radiopaque BD Vialon™ catheter, a needle, a grip, a passive safety needle shield, and a flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. BD Cathena™ Safety IV Catheter has BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

BD Cathena™ Safety IV Catheter is available with or without multi-access BD Multiguard™ Technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction.

BD Cathena™ Safety IV Catheter is available with or without 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, 16 GA (1.7 mm) = Grey).

The FDA 510(k) clearance letter for the BD Cathena™ Safety IV Catheter (K251155) indicates that the submission is for manufacturing changes (new colorant supplier, new needle lubricant supplier) and the creation of new performance specifications for existing indications for use (blood sampling and blood pressure monitoring) rather than a novel AI/ML device. Therefore, a traditional acceptance criteria and study proving device meets acceptance criteria related to AI/ML performance, human reader improvement with AI assistance, or standalone algorithm performance, as typically understood in AI/ML medical devices, is not applicable here.

However, based on the provided document, the acceptance criteria and supporting studies are related to demonstrating that the modified device maintains substantial equivalence to its predicate for its stated indications for use, including the new performance specifications.

Here's an interpretation of the relevant information provided:

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally understood as the "predetermined design requirements" that the device must meet. The document states that the subject device met all predetermined acceptance criteria for the listed performance tests, demonstrating substantial equivalence to the predicate devices. Specific quantitative acceptance criteria are not explicitly detailed in this summary for each test, but the successful completion of these tests serves as evidence of meeting those criteria.

II. Sample Size and Data Provenance for Test Set

The document does not specify exact sample sizes for each performance test (e.g., number of catheters tested for Blood Fill Time, Kink Resistance, or Frequency Response). However, it implies that sufficient samples were tested to "ensure that the subject device meets pre-determined design requirements."

The "test set" in this context refers to the samples of the subject device used for physical and functional testing. The provenance of these samples would be prospective, as they are newly manufactured devices undergoing verification for the submission. No information is provided regarding the country of origin of this test data, but it would typically be generated at the manufacturer's testing facilities or authorized contract labs.

III. Number of Experts and Qualifications for Ground Truth

This question is not applicable in the context of this 510(k) submission. This is not a study assessing diagnostic or predictive performance requiring expert interpretation for ground truth. The "ground truth" for the performance tests (e.g., Blood Fill Time, Kink Resistance) is established through standardized laboratory measurement methods and engineering specifications, not expert consensus on medical images or clinical outcomes.

IV. Adjudication Method for Test Set

Not applicable. As described above, the tests are objective physical and functional performance assessments, not subjective interpretations requiring adjudication.

V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is typically conducted for diagnostic imaging devices or AI tools where human readers are interpreting cases. This submission is for an intravascular catheter, a physical medical device. The "new performance specifications" are related to the physical and functional characteristics of the catheter (e.g., how quickly blood fills, how well it resists kinking for pressure monitoring), not to aiding human interpretation of medical data. Therefore, a study comparing human readers with and without AI assistance is not relevant or reported here.

VI. Standalone (Algorithm Only) Performance

Not applicable. The BD Cathena™ Safety IV Catheter is a physical medical device and is not an AI algorithm. Its performance is assessed through physical and functional bench testing.

VII. Type of Ground Truth Used

The "ground truth" here is based on engineering specifications and standardized test methods. For example:

• Blood Fill Time: Measured against a specific time objective.
• Frequency Response: Measured against a defined physiological frequency range for accurate blood pressure monitoring.
• Kink Resistance: Measured against criteria for maintaining lumen patency under stress.
• Biocompatibility: Assessed against ISO 10993 standards.
• Sterilization: Assessed against ISO 11135 standards.
• Luer Connections: Assessed against ISO 80369-7 standards.

These are objective, quantitative measurements derived from established industry standards and internal design requirements, not from clinical outcomes, pathology, or expert consensus in a diagnostic sense.

VIII. Sample Size for the Training Set

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

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

Not applicable, as there is no training set for this type of device submission.

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BD Cathena™ Safety IV Catheters 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 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).

BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

These devices are available with or without multi-access BD Multiguard™ Technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the cather direction.

These devices are available with or without wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Green, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.

The provided document is a 510(k) summary for the BD Cathena Safety IV Catheter. It does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Instead, it describes a medical device (an IV catheter) and outlines its substantial equivalence to a predicate device based on technological characteristics and performance testing.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI device from this document. The document primarily focuses on regulatory approval for the BD Cathena Safety IV Catheter, which is a physical medical device, not an AI/ML product.

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BD Cathena™ Safety IV Catheters 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 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).

BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

These devices are available with or without multi-access BD Multiguard™ Technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction.

These devices are available with or without 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, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.

The provided document is a 510(k) premarket notification for the BD Cathena™ Safety IV Catheter. It outlines the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the detailed information required to specifically answer questions about acceptance criteria and comprehensive study details like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods for AI/human performance studies.

The document focuses on demonstrating substantial equivalence to a predicate device (K192443) for minor modifications, primarily the introduction of 16 GA configurations and updates to specifications and instructions for use. It primarily relies on leveraging data from the predicate device and internal BD studies for specific performance tests.

Here's what can be extracted and what information is missing:

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

The document states: "Per design control requirements specified in 21 CFR 820.30, the subject devices met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."

However, the specific "predetermined acceptance criteria" and the "reported device performance" are not explicitly listed in a table format in the provided text. The tests performed are:

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

This information is not provided in the document. The document mentions "BD Internal Studies" for some tests, but details about sample size or data provenance (retrospective/prospective, country of origin) are absent.

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)

This information is not applicable and not provided. This device is a physical medical device (intravascular catheter), not an AI-powered diagnostic or decision support system that typically requires expert-established ground truth for its performance evaluation (e.g., in reading medical images). The testing involves physical properties and performance characteristics of the catheter.

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

This information is not applicable and not provided. As mentioned above, this type of testing is not relevant for the evaluation of a physical medical device.

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 information is not applicable and not provided. This device is a physical invasive medical device, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its evaluation.

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

This information is not applicable and not provided. This device is a physical catheter, not an algorithm.

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

For the performance tests conducted, the "ground truth" would be defined by engineering specifications, industry standards (e.g., ISO), and known physical properties of materials. For example, the "ground truth" for "force to break adhesion" would be a specific measurable force value derived from engineering design and safety requirements. Biocompatibility relies on well-established testing protocols and standards.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical product, not an AI system that requires a "training set" in the machine learning sense. The term "training set" is not relevant here.

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

This information is not applicable and not provided. As stated above, the concept of a "training set" and its "ground truth" is not relevant to the evaluation of this physical medical device.

Ask a specific question about this device

BD Cathena Safety IV Catheters 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 catheters may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The catheters are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).

BD Cathena™ Safety IV Catheters are over-the-needle, intravascular catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices are available with or without multi-access BD Multiguard technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction. These devices are available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green, 16GA (1.7 mm)=Grey). These devices are not made with natural rubber latex.

This document describes a 510(k) premarket notification for the BD Cathena™ Safety IV Catheter, demonstrating its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance or comparative effectiveness against human readers, as it is a physical medical device. The acceptance criteria and "study" described refer to various design verification tests and compliance with recognized standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests and standards compliance that serve as the acceptance criteria. The reported device performance is that it met all predetermined acceptance criteria.

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

The document does not explicitly state the sample sizes used for each of the performance or standards tests. It generically states "Performance tests completed on the subject device were those tests required to support a determination of substantial equivalence to the predicate devices. Design verification tests were performed based on the risk analysis." It also does not specify the origin of any data (e.g., country of origin, retrospective/prospective), as these are laboratory and simulated use tests rather than clinical data from human subjects.

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

Not applicable. This is not a study involving human interpretation of medical images or data requiring expert ground truth in that sense. The "ground truth" for these tests would be derived from physical measurements and adherence to engineering specifications and international standards.

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective physical or material property measurements, and standards compliance. There is no mention of adjudication among multiple evaluators.

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 physical medical device (intravenous catheter and safety mechanism), not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the tests mentioned are:

• Engineering Specifications: The design specifications for the device, including dimensions, forces, pressures, and other physical properties.
• International Standards: Adherence to recognized international standards such as ISO 594, ISO 10555, ISO 23908, and ISO 10993 for various aspects like gauging, leakage, mechanical strength, sharps injury protection, and biocompatibility.
• Risk Analysis Outcomes: The design verification tests were performed based on a risk analysis, meaning acceptance criteria were likely set to mitigate identified risks.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in the context of physical medical device design verification described here. The development of the device involves engineering design, prototyping, and iterative testing, not machine learning training.

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

Not applicable. See point 8.

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