February 6, 2007
Baxter Healthcare Corporation
Route 120 and Wilson Road
Round Lake, IL 60073
|Name:||Barbara K. Barbeau|
|Address (street, suite #):||1620 Waukegan Road, MPGR-AL|
|Address (City, state, zip code):||McGaw Park, IL 60085|
|Title:||Senior Director Global Regulatory Affairs
Baxter Healthcare Corporation
ALYX Component Collection System: ALYX 2RBC-NLR Kit
Automated Centrifugal Blood Cell Separator
Automated Blood Cell Separator
(21 CFR 864.9245)
ALYX Component Collection System (BK010033)
The ALYX apheresis instrument and disposable apheresis kits constitute a system for centrifugal blood separation. It is intended for use in blood collection establishments for the collection of multiple blood components.
The modified device, the subject of this submission, is the ALYX 2RBC-NLR Kit. It is intended for the collection of two red blood cell products using the ALYX System. This single-use, sterile and nonpyrogenic fluid path disposable kit is made of PVC and non-PVC plastics. It contains a separation chamber, a cassette, an umbilicus, collection containers, storage containers, tubing, an attached apheresis needle and attached solution containers.
The instrument operates using pumps, clamps and valves that move donor blood through a single-use, sterile fluid path disposable kit. Blood components are collected using ACD-A anticoagulant, and saline is administered intermittently to the donor throughout the procedure. The instrument has been cleared under BK010033 for the collection of two units of red blood cells that are leukoreduced during post-processing on the instrument and subsequently stored at 1-6oC for up to 42 days. This submission expands the indication for use to include two units red blood cells stored at 1-6oC in Adsol Red Cell Preservation Solution for up to 42 days, either with or without leukoreduction.
STATEMENT OF INTENDED USE
The ALYX System is intended for use in blood collection establishments to collect and separate whole blood into its components.
The ALYX 2RBC-NLR Kit is indicated for the collection of two red blood cell products: for use with the ALYX System.
The collection of two units of red blood cells without subsequent automated leukoreduction is an expanded indication for the ALYX System. The ALYX 2RBC-NLR Kit is an apheresis kit that incorporates tubing, a donor needle, a separation chamber, an umbilicus and PVC blood product containers. It interfaces with the ALYX Instrument with the same configuration as the predicate device and is made of substantially equivalent materials, but without the leukoreduction filter.
ASSESSMENT OF NON-CLINICAL AND CLINICAL DATA
Two clinical studies were performed to evaluate the ALYX Component Collection System for the collection of two units of red blood cells. Both studies were conducted at three investigative sites. Healthy male and female subjects who met current donor safety guidelines for whole blood and apheresis donation, as set forth by the United States Food and Drug Administration (FDA), the American Association of Blood Banks (AABB), and the Standard Operating Procedures of the participating institutions participated in the studies.
FCRP-0105: Clinical Evaluation of the Alyx Component Collection System: Non-Leukoreduced 2RBC Procedure
Non-leukoreduced red blood cell units, collected with ACD-A anticoagulant using the ALYX Component Collection System, were collected from 92 donors. A total of 182 units were evaluated for in vitro storage characteristics after 42 days of storage in PL1813 plastic storage containers using Adsol Red Cell Preservation Solution. In vivo radiolabeled red cell recoveries were performed on 25 units.
The primary efficacy endpoints for non-leukoreduced RBC products were met for end of storage % Hemolysis at 360 mL and 400 mL (as independent data sets) and for the pooled data set that included both volumes. The mean % Radiolabeled Red Cell Recovery was 83.1%, which met the criteria of > 75%. The SD for in vivo Radiolabeled Red Cell Recovery also met the < 9% criterion. The one-sided lower confidence limit for the population proportion of successes for the in vivo Radiolabeled Red Cell Recovery was 71.8%. The collected ACD-A/AS-1 RBC units meet current FDA standards and are suitable for transfusion.
FCRP-0206: Clinical Evaluation of Leukofiltration of ALYX-derived Non-leukoreduced ACD-A/AS-1 RBCs
In order to show that ACD-A/AS-1 red blood cells collected using the ALYX Component Collection System can be subsequently leukoreduced using a marketed gravity flow leukoreduction filter, 124 RBC units were collected and leukoreduced using a gravity flow leukoreduction filter according to its instructions for use. The leukoreduced units were evaluated for acceptability following filtration and at Day 42 of storage at 1-6oC.
Data from the clinical evaluation of the leukofiltration of ALYX-derived non-leukoreduced ACD-A/AS-1 RBCs indicate that each non-leukoreduced ACD-A/AS-1 RBC unit collected with the ALYX Component Collection System can be subsequently leukoreduced with a marketed leukoreduction filter.
The ALYX 2RBC-NLR kit is substantially equivalent to the predicate device. Data show that the non-leukoreduced red blood cell units produced using the ALYX System meet regulatory requirements for red cell quality when stored at 1-6oC for up to 42 days. Data also show that non-leukoreduced red blood cell units subsequently leukoreduced according to the instructions for use of a marketed leukoreduction filter can meet regulatory requirements for red cell quality when stored at 1-6oC for up to 42 days.
The results of these studies demonstrated that subject safety was maintained during the 2RBC Procedures. Adverse Events (AEs) were minimal and typical of apheresis or whole blood collection procedures. None of the AEs reported were considered related to the device. Subject pre and post procedure vital signs were within clinically acceptable limits.