(53 days)
The Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.
Autotransfusion is indicated for patients who meet at least one of the following criteria:
- The patient is expected to lose sufficient blood in the perioperative period, so as to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
- Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.
- Compatible allogeneic blood is not available.
- The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
- The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.
The cardioPAT system is designed to provide perioperative autotransfusion for patients undergoing cardiovascular surgery. The system consists of an electromechanical device and a sterile single-use disposable set, which together collect and process red blood cells (RBCs) lost during and after surgery. It is a small portable system which mounts on an IV pole. It is designed to be used in the operating room to recycle blood lost during cardiovascular surgical procedures and in the recovery room to recycle blood lost after surgery, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™):
The provided document describes a 510(k) submission for a medical device (cardioPAT™), which is for autotransfusion. The study presented here is a comparative study to demonstrate substantial equivalence to a predicate device (OrthoPAT®), rather than a standalone clinical trial establishing new efficacy. The "acceptance criteria" are implied by the comparison to the predicate device's performance.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by acceptable deviations from the predicate device's performance, specifically less than 2% difference in washout values and less than 3% difference in red blood cell (RBC) recovery.
| Performance Metric | Acceptance Criteria (Difference vs. Predicate) | Reported cardioPAT™ Performance (Difference vs. Predicate) | Meets Criteria? |
|---|---|---|---|
| Mean Washout (Supernate Heparin) |
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).