Search Results

The SUPERCATH Z3V is intended to access a vein or artery and to administer fluids. The SUPERCATH Z3V is designed for single use, is intended for short-term use (less than 30 days), and is intended to minimize inadvertent needlesticks and to reduce accidental needlesticks.

The SUPERCATH Z3V (PROPOSED) is an intravascular catheter and is available in following eight models.

1. with a check valve
2. with a wing
3. with a filter adapter
4. with a check valve and a wing
5. with a check valve and a filter adapter
6. with a wing and a filter adapter
7. with a check valve, a wing, and a filter adapter
8. without a check valve, a wing, or a filter adapter
   The SUPERCATH Z3V (PROPOSED) is intended to access a vein or artery and to administer fluids. The SUPERCATH Z3V (PROPOSED) is designed for single use, is intended for short-term use (less than 30 days), and is intended to minimize inadvertent needlesticks and to reduce accidental needlesticks by the safety system. In the safety system, the metallic introducer needle is retracted into the extendable needle casing.
   The SUPERCATH Z3V (PROPOSED) catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely.
   Some of the SUPERCATH Z3V (PROPOSED) has a filter adapter. The filter adapter can be removed and the SUPERCATH Z3V (PROPOSED) can be connected to a syringe in place of the filter adapter, under negative pressure and assist visual confirmation of blood access.
   The SUPERCATH Z3V (PROPOSED) is available in 14G, 18G, 20G, 22G, and 24G.

The provided text is a 510(k) summary for a medical device (intravascular catheter) and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device with specific performance metrics and a clinical study as typically described for such products.

Therefore, many of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable to this document as it describes a non-AI/ML medical device.

I will extract the relevant information available for this type of device (bench testing and a simulated clinical study for a sharps injury prevention feature).

Here's the analysis of the provided text, focusing on the available information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI/ML devices like this catheter, performance is typically demonstrated through compliance with established international standards (e.g., ISO) and in-house standards through bench testing. The document lists several bench tests and their outcomes.

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

• Bench Testing: The document states "All SUPERCATH Z3V (PROPOSED) samples were compliant..." but does not specify the sample size for each bench test.
• Simulated Clinical Study (Sharps Injury Prevention Feature): The document mentions a "Simulated Clinical Use of Study" was performed to confirm a statistically significant safety feature. However, no specific sample size or data provenance (country of origin, retrospective/prospective) is provided for this study.

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

• Not Applicable. For a medical device like an intravascular catheter, "ground truth" established by experts in the context of clinical interpretation (e.g., reading images) is not relevant. The performance is assessed via engineering tests and biological safety tests.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No. An MRMC study is relevant for diagnostic imaging devices where multiple readers interpret cases. This document describes an intravascular catheter, not an AI/ML diagnostic system.

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

• Not Applicable. This is not an AI/ML device, so there is no "algorithm only" performance to evaluate. The device is a physical, mechanical product.

7. The Type of Ground Truth Used

• For Bench Testing: The "ground truth" is typically defined by the ISO standards or in-house engineering specifications that dictate acceptable performance limits (e.g., minimum tensile strength, maximum leakage).
• For Biocompatibility Testing: The "ground truth" reflects the absence of adverse biological reactions as assessed by standard biological safety tests (e.g., cytotoxicity, irritation).
• For Sharps Injury Prevention Feature: The "ground truth" would be the quantifiable reduction in simulated needlesticks compared to a control or a defined safety threshold. The study confirmed a "statistically significant safety feature."

8. The Sample Size for the Training Set

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

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

• Not Applicable. See point 8.

Ask a specific question about this device

The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to administer fluids. The SUPERCATH Z3V is designed for short-term use (less than 30 days), is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.

The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to administer fluids. The SUPERCATH Z3V is designed for short-term use (less than 30 days), is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.

The catheter hub has a built-in hemostatic valve, which assists compression hemostasis when the introducer needle is withdrawn following blood vessel puncture. The introducer needle is retracted into the telescope casing to prevent needle stick injury.

This document is a 510(k) Premarket Notification for the Supercath Z3V intravascular catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving performance against those criteria in the way one might expect for a novel diagnostic or AI-driven device.

Therefore, many of the requested elements (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance of an algorithm) are not applicable or not provided in this type of submission. This document highlights a regulatory pathway based on showing similarity to already approved devices, not necessarily a de novo clinical validation study with specific performance metrics.

Here's the information that can be extracted from the provided text, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of intended use and technological characteristics. The "performance" is implicitly deemed acceptable if it matches or is sufficiently similar to the predicate devices. There are no explicit quantitative acceptance criteria or reported device performance metrics in the provided text.

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

• Sample Size for Test Set: Not applicable. This is not a study that involved a test set of data in the context of diagnostic performance. The substantial equivalence is based on device design, materials, and intended use comparison.
• Data Provenance: Not applicable.

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

• Not applicable. There was no "test set" requiring ground truth established by experts for performance evaluation in this 510(k) submission.

4. Adjudication method for the test set

• Not applicable.

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 device is an intravascular catheter, not an AI-driven diagnostic tool.

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

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

7. The type of ground truth used

• Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices. The Supercath Z3V aims to show it is equivalent.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

Ask a specific question about this device