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The SUPERCATH 6 is intended to access a vein or artery and to administer fluids. The SUPERCATH 6 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 -22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi.

The SUPERCATH 6 is intended to access a vein or artery and to administer fluids. The SUPERCATH 6 is designed for single use and for short-term use (less than 30 days) and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi.

The SUPERCATH 6 has technological characteristics as follows;

Its 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finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture.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.

Pressing the button on the needle hub activates the coiled spring in the hub, retracting the metallic introducer needle into the needle hub.

The introducer needle of the SUPERCATH 6 has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the vein, blood flows upward into side-notch and returns down along the inside of the catheter tube.

The SUPERCATH 6 has a slide in order to assist insertion of the catheter. The user can choose either to push the catheter hub forward or push the slide forward to insert the catheter. When pushing the slide, the slide is stopped 12 mm forward by a stopper.

The SUPERCATH 6 is available in 14G, 16G, 18G, 20G, 22G and 24G.

The provided text describes a 510(k) premarket notification for a medical device called SUPERCATH 6, an intravascular catheter. The submission argues for substantial equivalence to a predicate device (SUPERCATH 5) and a reference device (Introcan Safety® 3 Closed IV Catheter).

However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive device. Instead, it outlines the bench testing, biocompatibility testing, and comparison of technological characteristics to demonstrate substantial equivalence to its predicate device, which is a requirement for 510(k) clearance for medical devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication, MRMC studies, and standalone performance is not applicable to this document as it does not describe an AI/algorithm-based study.

Here's a breakdown of the relevant information from the document that can be mapped to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several bench tests with their corresponding standards or in-house criteria. The "reported device performance" is generally stated as "meets acceptable minimum force," "meets allowable limits," "exceeds peak pressure," or "is impervious to air/liquid infiltration." Specific quantitative values for acceptance criteria or performance numbers are largely absent.

Information Not Found or Not Applicable (N/A) to this document:

2. Sample sizes used for the test set and data provenance: N/A. The document describes bench testing on the device itself, not a clinical test set with data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No expert-based ground truth is established for this type of device testing.
4. Adjudication method: N/A.
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: N/A. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an algorithm.
7. The type of ground truth used: For the bench tests, the "ground truth" is determined by the physical properties of the device meeting pre-defined engineering and safety standards (e.g., tensile strength, leakage, flow rate). For biocompatibility, it's the absence of adverse biological reactions.
8. The sample size for the training set: N/A. This document does not describe an AI/algorithm.
9. How the ground truth for the training set was established: N/A.

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The Valved Safety Centesis Catheter is indicated for the therapeutic aspiration of fluids from body cavities.

The Valved Safety Centesis Catheter is a drainage, centesis catheter with a self sealing valve and a passive safety needle-shielding feature. The catheter is designed with drainage holes located around the distal tip of the catheter to facilitate the drainage of fluid. The catheter surface and tapered end is designed for smooth transition through the tissue, while the inner surface is designed for easy retraction of the insertion needle. The insertion needle comes with a vent plug that allows air to exit and does not allow fluid to exit. The echogenic needle tip provides a guidance for proper catheter placement using ultrasound. The needle hub is clear and locks within the catheter hub. The catheter is radiopaque and can be visualized using fluoroscopy. The hub of the catheter contains a luer adapter to facilitate attachment of drainage collection devices and a bevel indicator for needle bevel orientation reference. The device is provided individually packaged sterile.

The provided text is a 510(k) summary for a medical device called the "Valved Safety Centesis Catheter." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the information required to answer your specific questions related to acceptance criteria, a study proving performance against acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

This document focuses on demonstrating substantial equivalence through performance testing (functional and biocompatibility) and comparing technical characteristics to a predicate device, rather than a clinical study establishing performance against predefined acceptance criteria for AI or diagnostic purposes.

Here's why the requested information isn't present in this document:

• Device Type: This is a physical medical device (a catheter), not a software or AI-driven diagnostic tool. The questions you've asked (e.g., sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are typically relevant for AI/ML-driven diagnostic devices or software that provides interpretations.
• Regulatory Focus: The 510(k) process for this type of device primarily aims to show that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is often achieved through bench testing (functional and biocompatibility) and comparing design features, not clinical trials requiring human reader analysis or complex ground truth establishment for diagnostic accuracy.
• Lack of AI/Diagnostic Component: There is no mention of any AI component, image analysis, or diagnostic output from this catheter that would necessitate the kind of rigorous validation against human expert performance or established ground truth that your questions imply.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device meets acceptance criteria, as the provided document does not contain this type of information for a device like the Valved Safety Centesis Catheter.

The document does mention "Performance Testing" which includes flow rate, tensile strength, pressure testing, and safety feature verification. These are functional performance criteria for a physical device, not diagnostic performance criteria.

To be absolutely clear, here's what the document does say about testing:

• Performance Testing Areas: Visual Inspection, Radio-detectability, Echogenicity, Flow rate, Occlusion, Tensile strength, Pressure testing, Penetration force, Safety feature verification.
• Biocompatibility Testing: Completed considering ISO 10993-1 recommendations.
• Clinical Testing: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."

This explicitly states that no clinical studies were performed, which further confirms why information on human readers, ground truth establishment by experts, or MRMC studies would not be present.

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