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In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents into the vessel wall and perivascular area, or intraluminally.

The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, singleoperator, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a semi-rigid polymer actuator balloon. The device is designed to be advanced to target vasculature and hydraulically actuated to move the microneedle through the external elastic lamina to deliver substances to adventitial and perivascular tissues. A compliant stabilizing balloon inflates with the actuator to provide a force opposite the needle tip for proper seating of the needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.

This document is a 510(k) summary for the Mercator MedSystems Bullfrog Micro-Infusion Device.

Based on the provided information, no new performance testing was conducted to support substantial equivalence for the current submission (K161402). The document explicitly states: "No new performance testing was conducted to support substantial equivalence, since the predicate and subject devices are identical in terms of technological characteristics."

Therefore, the requested information about acceptance criteria and reported device performance from a new study proving the device meets those criteria for the K161402 submission cannot be extracted from this document because no such new study was performed.

However, the document mentions that performance testing of the predicate device (K153501) was conducted. This predicate device is also the "Bullfrog Micro-Infusion Device" by Mercator MedSystems, implying the subject device is identical to its predicate in design and performance, except for an update in the Indications for Use.

The document states that the predicate device's performance testing included:

• Mechanical and fluid delivery performance
• Biocompatibility
• Sterilization validation
• In-vivo safety and effectiveness studies

It further notes: "All tests met the pre-determined specifications and acceptance criteria."

Since no new study directly addressing acceptance criteria for K161402 is provided, I cannot populate the table or answer the specific questions (2-9) about a study from this application. The information provided pertains to the predicate device's testing, for which details like specific acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies are not included in this 510(k) summary.

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