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The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter is inserted percutaneously and is preferentially placed into the internal jugular (II) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter is intended for use in adult patients.

The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is intended for use in adult patients.

The Arrow VectorFlow Retrograde Replacement Hub Set is indicated for use in the replacement of a Arrow VectorFlow Retrograde hub connection assembly that has been damaged.

The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter (herein referred to as the proposed VFA catheter) and the Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter (herein referred to as the proposed VFR catheter) are long-term, single use catheters designed to provide access to the central venous system in a healthcare facility environment. The VFA catheter is a one piece catheter, two lumen, 15 French symmetrical-tipped catheter designed for antegrade placement. The VFR catheter is two-piece, two-lumen, 15 Fr, symmetrical tipped catheter designed for retrograde placement. The VFA and VFR catheters are available in multiple lengths. The Arrow VectorFlow Retrograde Replacement Hub Set (herein referred to as the proposed Hub Set) is sold separately to perform a repair of the VFR, replacing cracked or broken luer connectors, clamps, and/or damaged extension lines.

The VFA and VFR catheters and Hub Set will be packaged sterile with various components to facilitate insertion.

The provided text describes a 510(k) summary for Arrow VectorFlow catheters and a replacement hub set. This document is a premarket notification for a medical device seeking substantial equivalence to existing predicate devices, not a study describing the performance of an AI/ML-driven device with acceptance criteria.

Therefore, I cannot extract the information required to populate the fields you specified (e.g., acceptance criteria for an AI/ML device, sample size for test sets, number of experts for ground truth, MRMC study, training set details) because this document is for a physical medical device (hemodialysis catheters) and does not involve AI/ML.

The "Nonclinical Testing" section mentions "Bench testing" and compliance with ISO standards, which are typical for physical medical devices to demonstrate safety and performance. The "Clinical Data" section explicitly states, "Clinical performance data was not used to determine substantial equivalence."

Key takeaway: This document does not describe an AI/ML device or its performance evaluation in the context of your request.

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