(100 days)
The ENVOY® Distal Access (DA) Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
The ENVOY Distal Access (DA) Guiding Catheter is a variable stiffness, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The distal segment is flexible for navigation into distal vasculature. The catheter has an outer hydrophilic coating on the outer surface that reduces friction during manipulation in the vessel. The lubricious PTFE lined inner lumen is designed to facilitate movement of the guide wires and other devices. A luer fitting located on the end of the catheter hub can be used to attach accessories. The distal section of the catheter is radiopaque to aid visualization under fluoroscopy, and the distal tip is clearly distinguished by a radiopaque marker band which is approximately 3mm from the distal tip. The catheter is available with preshaped tips to facilitate positioning. A peel away introducer is included to facilitate insertion into the sheath.
I am unable to provide a description of acceptance criteria and a study proving device performance using the information provided. The document outlines a 510(k) premarket notification for a medical device (ENVOY Distal Access (DA) Guiding Catheter). This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove a device meets specific, pre-defined acceptance criteria for performance metrics.
Here's why and what the document does provide:
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Nature of the Submission (510(k)): The core purpose of a 510(k) is to show that a new device is "substantially equivalent" in terms of safety and effectiveness to a legally marketed predicate device. This is primarily done by comparing intended use, technological characteristics, and performance (often bench testing) to ensure no new questions of safety or effectiveness are raised. It is generally not about proving novel clinical or performance criteria against a predefined set of acceptance thresholds like in a clinical trial seeking primary endpoints.
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No Clinical Study for Acceptance Criteria: The document explicitly states: "No clinical studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing." This confirms that a clinical study designed to demonstrate performance against specific acceptance criteria (like sensitivity, specificity, accuracy, or human reader improvement) was not conducted or deemed necessary for this submission.
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Focus on Bench Testing and Equivalence: The document details extensive bench testing (e.g., Visual Inspection, Tensile Strength, Hydrophilic Coating Integrity, System Liquid Leakage Testing, etc.) and comparisons to predicate devices (Table 2A and 2B). These tests are designed to ensure the new device functions similarly to the predicate and meets relevant engineering standards, rather than demonstrating clinical efficacy against quantified acceptance criteria.
Therefore, since this is a 510(k) submission for a medical device that relies on substantial equivalence and non-clinical bench testing, the specific questions regarding acceptance criteria, reported device performance against those criteria, sample sizes for test/training sets, involvement of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to the provided text.
The closest information provided related to performance evaluation is the list of nonclinical (bench) tests conducted (Section H and Section on "Bench Testing"). These tests aim to demonstrate the device's physical and functional properties are adequate and comparable to the predicate.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).