(233 days)
The EMBOL-X Aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 60 years and older undergoing first time non-emergent CABG or isolated aortic or mitral valve repair/replacement.
The EMBOL • X Aortic Filter device consists of three primary components: 1.) a distal heparin-coated mesh filter, mounted onto a flexible frame to form a filter basket for particulate emboli capture and retention; 2.) a locking cartridge housing for attachment to the EMBOL•X Aortic Cannula side port, permitting access to the aorta and to ensure correct orientation of the filter during use; and 3.) a proximal syringe-like plunger mechanism to deploy and withdraw the distal basket into and from the aorta, via the cannula, during surgery. The filter is introduced surgically into the aorta via the previously placed cannula, and particulates are captured and removed as blood passes through the filter basket. The filter may remain in situ for up to 60 minutes. The EMBOL.X Aortic Filter utilizes conventional medical grade materials and processes, and is provided packaged, labeled, and sterile, intended for single-use.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Safety Measure | Composite of post-operative clinical events (Neurologic deficit, Renal insufficiency, GI complications, Perioperative MI, Limb-threatening peripheral embolism, Death) statistically equivalent to standard treatment. | 17.1% composite event rate for Treatment arm vs. 18.9% for Control arm (p |
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”