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The Braun Hemostasis Valve Introducer Kits are designed to facilitate percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.

Braun Hemostasis Introducer Kits consist of a hemostasis valve introducer sheath packaged with a corresponding dilator. One or more of the following accessories may also be packaged with the sheath/dilator; guidewire, and/or obturator. The introducer sheaths are available in both straight and contralateral curve versions. They will be available in 5 - 9 French sizes, in lengths from 30 - 60 cm in the cuved version and 10 - 60 cm in the straight version. Each will be packaged with an appropriately sized dilator. Optional items to be kitted with the sheath and dilator include a guidewire, and/or obturator. The components, their materials and accessories, are similar to those previously cleared under Braun 510(k)s; K894446, K930057, K931743, K945396. and K950882.

This document (K960406) describes a medical device, specifically Braun Hemostasis Introducer Kits, and its comparison to similar devices already on the market (K895044 and K945396). The text focuses on the technical characteristics and claims of substantial equivalence.

Therefore, the following information regarding acceptance criteria and study details cannot be extracted from the provided text, as it describes a premarket notification (510(k)) for a medical device that has been cleared based on substantial equivalence to existing devices, not a study evaluating an AI algorithm's performance.

The provided information is for a physical medical device (introducer kits), not an AI/software as a medical device. The concepts of "acceptance criteria," "test set," "training set," "ground truth," "MRMC study," and "standalone performance" are relevant to the evaluation of AI models or diagnostic tests, not for the technical comparison of physical medical devices like introducer sheaths.

The tables and descriptions provided focus on device specifications (French sizes, lengths, materials, tensile strength, leak tests, kink resistance, radiopacity) and compare them to predicate devices to demonstrate substantial equivalence, which is a regulatory pathway.

Therefore, I cannot fulfill your request for the specific information regarding AI/algorithm performance and study design as it is not present in the provided text.

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For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.

16 Et 18 french versions of the Braun Hemostasis Introducer with silicone gasket, in lengths of 10 - 40 cm.

The provided document is a 510(k) summary for a medical device (catheter introducer and vessel dilator) and does not contain information about a study proving device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. It focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies in the context of AI/ML, human readers, ground truth, or training sets from this document.

The document mainly includes:

• Device Classification and Common Name: Catheter introducer and Vessel dilator (21 CFR 870.1340 and 870.1310).
• Substantial Equivalence: A comparison table demonstrating similarities to predicate devices (K894446, K931743, K871153, K930057, K945396).
• Device Description: 16 and 18 French versions of the Braun Hemostasis Introducer with specific gasket and length details.
• Intended Use: For percutaneous introduction of catheters into the vasculature while preventing blood backflow.
• Summary/Comparison of Technological Characteristics: Detailed comparison of labeling, packaging, intended use, physical characteristics (French sizes, lengths, materials), and anatomical sites with predicate devices.

This document is for a traditional medical device submission and does not describe a study involving algorithms, AI, or human reader performance.

Ask a specific question about this device