May 6-7, 2014 8:00 a.m. to 6:00 p.m.: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement.
May 6-7, 2014 8:00 a.m. to 6:00 p.m.: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Hilton Washington DC North/Gaithersburg
Salons A, B, C, and D
620 Perry Pkwy.
Gaithersburg, MD 20877
On day 1 of this meeting, the Circulatory System Devices Panel of the Medical Devices Advisory Committee will discuss, make recommendations, and vote on information related to the premarket approval application for the RESQCPR System sponsored by Advanced Circulatory Systems, Inc. The RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP Active Compression Decompression CPR Device. These devices are used together during manual cardiopulmonary resuscitation (CPR) in an attempt to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from out of hospital cardiac arrest. The RESQCPR System is intended for use in the performance of CPR to increase survival with favorable neurologic function in adult patients with non-traumatic cardiac arrest.
On day 2 of the meeting, the panel will discuss and make recommendations regarding the classification of membrane lung for long-term pulmonary support systems, one of the remaining preamendment Class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient’s blood when an acute (reversible) condition prevents the patient’s own body from providing the physiologic gas exchange needed to sustain life. The circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump, cannulae, heat exchanger, tubing, filters, monitors/detectors, and other accessories; the circuit components and configuration (e.g., arteriovenous, veno-venous) may differ based on the needs of the individual patient or the condition being treated. ECMO is currently used for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management.
On January 8, 2013 the FDA issued a proposed order which, if made final, would make the class III ECMO devices class II subject to premarket notification (510(k)) and special controls. On September 12, 2013, the classification of ECMO was discussed at a meeting of the Circulatory System Devices Panel. The Panel agreed with FDA’s proposal to reclassify ECMO to class II (special controls) as outlined in the January 8, 2013, proposed order, but recommended that a panel be reconvened to discuss use of ECMO in adult patient populations. Therefore, the discussion at this meeting will involve making recommendations regarding regulatory classification to either reconfirm to class III (subject to premarket approval application (PMA)) or reclassify to class II and comment on whether special controls are adequate to assure the safety and effectiveness of this device in adult patient populations.
During the afternoon session of Day 2, the committee will also discuss and make recommendations regarding the classification of More-than-Minimally Manipulated Allograft Heart Valves (MMM Allograft HVs). An MMM Allograft HV is a human valve or valved-conduit that has been aseptically recovered from qualified donors, dissected free from the human heart, and then subjected to a manufacturing process(es) which alters the original relevant characteristics of the tissue. MMM Allograft HVs are considered preamendment devices because they were found substantially equivalent to devices in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. MMM Allograft HVs are currently regulated as unclassified devices and reviewed under the premarket notification (510(k)) authority. FDA is seeking committee input on the safety and effectiveness of MMM Allograft HVs and the regulatory classification for MMM Allograft HVs.
Please click here for the current roster of the Circulatory System Devices Panel of the Medical Devices Advisory Committee.
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