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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK080003 Summary

Section 7 – 510(k) Summary

Applicant:

Medsep Corporation
A Subsidiary of Pall Corporation
1630 Industrial Park Street
Covina, CA  91722

     
Primary Contact: Edward J. Nelson
Medsep Corporation
Director, Regulatory and Scientific Affairs
16 Pepperwood Lane
Pepper Pike, OH 44124
     
   

Telephone Number:    216-464-8866
Fax Number:               216-464-8877

     
     
Date 510(k) Summary Prepared:     March 24, 2008
     
Proposed Device Name:
Proprietary Name:   Pall® Acrodoseä PLus System, Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter
     
Common Name:   Platelet Pool and Store Set with Filter
     
Classification Name:   Empty container for the collection and processing of blood and blood components (21 CFR 864.9100)
     
Classification:    II
     
Product Code:   81 KSR
     
Predicate Device:   Pall® Acrodoseä PLus System, Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter (BK070057)

Description of Device:
The Pall® Acrodose™ PLus System, Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter is a sterile, single-use set consisting of a multi-lead tubing manifold for sterile connection to platelet concentrate units, a transfer bag for containing the pooled platelets, a breakaway closure to permit transfer of the pool through the filter to the storage bag, an air vent, an Acrodose™ PL Leukocyte Reduction Filter to leukoreduce the pool, a pouch for residual system air, and a CLX® HP extended storage platelet container.

Intended Use:
The Pall® Acrodose™ PLus System, Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter is intended to be used to pool, leukocyte-reduce, and store whole-blood-derived platelets in the CLX® HP extended storage bag for up to 5 days after collection when used with a device cleared by FDA for detection of bacterial contamination in pooled whole-blood-derived platelets.

Indications for Use Statement:
The Pall® Acrodose™ PLus System, Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter (Acrodose™ PL Leukocyte Reduction Filter), is indicated for use to pool, leukocyte-reduce, and store ABO identical, whole-blood-derived platelets in the CLX® HP extended storage bag for up to 5 days after collection when used with a device cleared by FDA for detection of bacterial contamination in pooled, whole-blood-derived platelets.

The Pall® Acrodose™ PLus System, Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter (Acrodose™ PL Leukocyte Reduction Filter) should be used with whole-blood-derived platelet concentrates collected in either CPD or CP2D anticoagulant, stored in plasma, and leukoreduced using the Acrodose™ PL Leukocyte Reduction Filter. Each CLX® HP extended storage bag can store 2.2 - 5.8 x 1011 platelets, from 4 to 6 platelet concentrates, at a platelet concentration of ≤ 2.0 x 106/µL, in a volume of 180 - 420 mL.

Comparison to Predicate Device:
The FDA has previously cleared all of the materials and components used in the proposed device. The proposed device includes the use of sterile, single-use, plastic containers and tubing sets, the use of the CLX® HP extended storage bag and the Acrodose™ PL Leukocyte Reduction Filter. These are the exact, same, components used in the predicate device. The intended use of both devices includes pooling, filtration, and extended storage of a therapeutic dose of platelets to be used for transfusion. Based on the similarity of intended use, materials and basic scientific technology, substantial equivalence is claimed.

Performance Testing:
Studies were conducted which demonstrated that acceptable filtration performance, as determined by satisfactory platelet recoveries and post-filtration WBC counts, was achieved when pooling and filtering PCs which were two days old. These data supported the change in the Instructions for Use extending the allowable filtration time range to day 2 products.

Conclusion:
Substantial equivalence to the predicate device is claimed based on similarity of intended use and identical materials, basic scientific technology, and performance.