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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 text does not describe an AI/ML-driven device or study. Instead, it is a 510(k) premarket notification for a medical device (BD Cathena™ Safety IV Catheter), which is an intravascular catheter. The submission outlines the device, its intended use, comparison to predicate devices, and performance tests conducted to demonstrate substantial equivalence, but it does not involve any AI/ML components or studies that would require the specific criteria requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies).

Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance from the provided text in the context of an AI/ML study. The performance tests mentioned (e.g., time to visualize flashback, force to break adhesion, burst pressure, flow rate, power injection) are specific to the mechanical and functional properties of an IV catheter, not AI/ML model performance.

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The Mini-Midline™ Extended Dwell Safety Catheter is inserted into a patient's vascular system for short term use (

The Mini-Midline Extended Dwell Safety Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device provides peripheral vascular access and administration of fluids, medications and nutritional therapy as prescribed. The device consists of an introducer needle, passive safety mechanism and single lumen catheter. The Mini-Midline Extended Dwell Safety Catheter is 20 gauge.

The provided text describes a medical device, the "Mini-Midline™ Extended Dwell Safety Catheter," and its substantial equivalence to predicate devices, but does not include acceptance criteria for a study demonstrating AI/algorithm performance. The document focuses on regulatory approval (510(k) submission) for a physical medical device, not a software algorithm.

Therefore, most of the requested information regarding AI/algorithm performance (acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, MRMC studies, standalone performance) cannot be extracted from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

This information is not present for an AI/algorithm-based device. The document lists "Technical Characteristics" and "Performance Data" for the physical catheter.

However, the document does list technical characteristics and performance data for the physical device:

Technical Characteristics and Performance Data (for the physical catheter):

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A properly placed ViaValve™ Safety I.V. Catheter provides access to a vein or artery to sample blood, monitor blood pressure, or administer fluids. The needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 18 to 24 gauge catheters may be used with power injectors up to 300 PSI.

The Via Valve™ Safety I.V. Catheter provides access to a vein or artery. The ViaValve™ Safety I. V. Catheter incorporates a valve inside the catheter hub which is designed to reduce blood exposure during initial catheter placement. The valve will open and allow flow once the Luer connector is attached and will remain oven after initial activation. The needle assembly incorporates a needle guard which locks over the needle as the ViaValve™ Safety.I.V. Catheter is threaded into the vessel to help reduce the risk of accidental rieedlesticks.

The provided text describes the ViaValve™ Safety I.V. Catheter, an intravascular catheter designed to reduce blood exposure during placement and prevent accidental needlesticks.

Here's an analysis of the acceptance criteria and supporting studies based on the provided information, organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for any specific "test set" in terms of how many devices were tested or how many participants were involved in the usability studies.

• Bench Testing & ISO Standard Compliance Testing: No sample size or specific data provenance (e.g., country of origin) is mentioned. This testing is inherently retrospective in nature, as it evaluates the manufactured product.
• Simulated Clinical Use Studies: No specific sample size is provided. The nature of "simulated clinical use" implies prospective data collection in a controlled environment, likely within the manufacturing country (USA, given the company information).
• Human Factors Engineering (HFE) and Usability Testing: No specific sample size is provided. This is typically prospective data collection involving human participants. The provenance is not explicitly stated but would likely be within the USA.

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

The document does not mention the use of "experts" to establish ground truth in the context of the device's technical or clinical performance. The evaluation relies on:

• Bench testing: Against established ISO standards and FDA guidance.
• Simulated clinical use: To confirm operational aspects like needle shielding.
• Human Factors/Usability testing: To assess user interaction for safety and effectiveness.

Therefore, there is no information provided about a specific number of experts or their qualifications for establishing a "ground truth" as it might be understood in an AI/diagnostic context (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned. This type of method is typically used in studies involving expert interpretation of data (like medical images) where there might be inter-reader variability, which is not the primary focus of the described device testing.

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

No, an MRMC comparative effectiveness study was not reported. The information describes testing to demonstrate substantial equivalence to predicate devices and confirm safety and effectiveness, not to compare the performance of human readers with and without AI assistance.

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

This question is not applicable to the described medical device. The ViaValve™ Safety I.V. Catheter is a physical medical device, not an algorithm or AI system. Therefore, "standalone" performance in the context of an algorithm is not relevant. The device's performance is inherently "standalone" in its function as a physical catheter, evaluated through bench and simulated clinical tests.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Compliance with validated standards: ISO standards for I.V. catheters and FDA Guidance "Medical Devices with Sharps Injury Prevention Features."
• Engineering specifications and design intent: For features like blood control and needle-stick prevention, confirmed through testing.
• Usability metrics: Derived from Human Factors and Usability testing to ensure the device is "adequately safe and effective for its intended users, uses and use environments."

There is no mention of "expert consensus," "pathology," or "outcomes data" in the typical sense for establishing ground truth for the device's fundamental function.

8. The Sample Size for the Training Set

This question is not applicable. The ViaValve™ Safety I.V. Catheter is a physical medical device, not an AI model that requires a "training set."

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

This question is not applicable, as there is no "training set" for this physical device.

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