10811 W. Collins Ave.
Lakewood, CO 80215
|Contact Person:||Isabel A. McGann, Senior Regulatory Affairs Specialist|
|Date of Summary Preparation:||December 16 2011|
|Trade Name of Device:||Trima Accel Automated Blood Component Collection System|
|Common Name:||Automated Blood Component Collection System|
|Classification Name:||Automated Blood Cell Separator|
|Predicate Devices:||Trima Accel Automated Blood Component Collection System
The Trima Accel system is an automated blood component collection system that uses centrifugal force to separate blood into platelet, plasma, and red blood cell components. These components are either collected into storage bags, or returned to the donor depending on the blood components needed by the blood center.
Indications for Use:
The Trima Accel system is an automated blood cell separator intended for use in collecting blood components for later transfusion into patients.
Depending on the disposable tubing set used, the Trima Accel system has been cleared to collect:
- Double ACD-A/AS-3 Red Blood Cells (leukocytes reduced or not leukoreduced)
Or the following products alone or in combination:
- Plasma and Plasma, Leukocytes Reduced
- ACD-A/AS-3 Red Blood Cells
- ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced utilizing an integrated filter (TLR gravity drain filter or AutoRBC filter)
- Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)
Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards.
The Trima Blood Component Sampling Assembly, which is either integrated into the disposable tubing sets or as an accessory for sterile connection, is intended to allow aseptic removal of a sample from the platelet bag for subsequent bacterial or other applicable testing. The Sampling Assembly does not have contact with blood fluids that are reinfused to a donor or patient.
- Adequate studies have not been performed to evaluate the quality of gamma irradiation or freezing of ACD-A/AS-3 red blood cells products (RBCs) collected with gravity drain leukoreduction process (TLR filter) on the Trima Accel system.
- Studies have not been performed to support gamma irradiation or freezing of ACDA/ AS-3 RBCs collected with an integrated in-line RBC leukoreduction filter(s) (AutoRBC filter) on the Trima Accel system.
RBC's collected on the Trima Accel system using the AutoRBC feature as either a single unit or double units, with continuous RBC leukoreduction, and stored in ACD-A/AS-3 for 42 days met the following acceptance criteria required by the FDA-CBER:
- 95% probability and a one-sided 95% confidence limit:
- the number of contaminating leukocytes per unit is less than 5 million
- the recovery of RBCs after leukoreduction is greater than 85%
- RBC hemolysis is less than 1.0%
- 70% probability and a one-sided 95% confidence limit, recovery in the circulation of radiolabeled RBCs 24 hours after transfusion is greater than 75%, and the average recovery is greater than 75% with a standard deviation less than 9%.
The results of biochemical tests, ATP and Potassium failed to show with 95% confidence that greater than 95% of the products will be within 20% of the Control product. Results of ATP levels for Test for a single RBC collection were not significantly different from Control by a paired t test analysis (p-value = 0.80). Results of ATP levels for Test for double RBC collections were significantly better than Control by a paired t test analysis (two-sided p-value= 0.014). Results of Potassium levels for Test for a single RBC collection were significantly better than Control by a paired t test analysis (p-value = 0.0354). Results of Potassium levels for Test for double RBC collections were not significantly different from Control by a paired t test analysis (two-sided p-value = 0.566).
The pH at end of RBC shelf life showed with 95% probability and a two-sided 95% confidence limit, the difference in pH between Test and Control was less than or equal to 0.5 pH units. The clinical significance of secondary outcomes is unknown.
The Trima Accel system includes a modified platelet post-count algorithm. U.S. customers should not set the minimum post-count below 100,000/ μL. This clearance applies only to plasma-stored platelets. The Auto P.A.S. feature has not been cleared for use in the United States. This feature is disabled in the software.
Trima Accel system Version 5.1.8, with the changes proposed in this submission (disposable tubing set changes including changes to the manufacturing process of the collection chamber and a new Multiplasma tubing set, hardware changes, software changes, and labeling changes) was found substantially equivalent to the predicate.