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The OptiLock Implantable Port is designed for patients who require repeated long term access to the vascular system for intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.

The OptiLock Introducer Kit is designed to assist in obtaining access to the vascular system for OptiLock Port catheter placement

The OptiLock Anti-coring needle is designed to gain intracutaneous access to the OptiLock Port septurn for injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.

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This document is a 510(k) clearance letter from the FDA, which confirms that a medical device is substantially equivalent to a predicate device already on the market. It does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would be found in a clinical study report or a premarket approval (PMA) application.

Therefore, I cannot provide the requested information as the provided text does not contain a description of an acceptance criteria study for a device. The letter simply states that the FDA has reviewed the 510(k) premarket notification and determined the device (LeMaitre Vascular OptiLock Implantable Port Kit, OptiLock Introducer Kit, OptiLock Port Compatible Anti-coring Needles) is substantially equivalent to legally marketed predicate devices.

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