| Date Summary Prepared: |
February 22, 1994 |
| Trade/Proprietary Name of Device: |
Optipress™ Automated Blood Component Extractor |
| Common or Usual Name of Device: |
Blood Component Extractor |
| Classification Name of Device: |
Blood Bank Supplies (21CFR 864.9050) |
| Predicate Device Under Which Substantial Equivalence Is Being Claimed: |
Optipress™ Automated Blood Component Extractor cleared for market entry under 510(k) BK910032 |
| Device Description: |
The product provides for the semi-automated separation of centrifuged whole blood into blood components. The outflow of blood components from the container is accomplished by a pressure plate. The blood components are expressed from the bottom and/or top ports of the container depending on the program selected. An optical sensing system controls clamps on the outlet tubing and thereby maintains the cellular interface at the appropriate
level. |
| Intended Use of Device: |
Semi-automated separation of whole blood into blood components. |
| Comparison of Technological Characteristics of the Device vs. the Original Predicate Device: |
The product has not been revised from the predicate device. A new indication for use has been added; Program B will allow for the semi-automatic separation of Platelet Rich Plasma (contained in Fenwal polyvinyl chloride plastic transfer packs) into Platelet Concentrates and Platelet Poor Plasma. |
| Brief Discussion of Tests and Their Results Submitted in the Application: |
A clinical study in two centers has demonstrated that the Program B on the Optipress™ Extractor can be used in conjunction with polyvinyl chloride plastic transfer packs on either Optipac™ Units or conventional Blood-Pack® Units to produce Platelet Concentrates and Platelet Poor Plasma in a reproducible manner from centrifuged Platelet Rich Plasma. A total of 36 units of Platelet Concentrates were prepared in this manner. The platelet yield averaged 7.84 x 1010 platelets per unit with 89% of the units meeting the minimum FDA requirement of 5.5 x 1010 platelets per unit at outdate. Acceptable in vitro indices were found in all units after 5 days of storage. |
| Conclusions Drawn from the Nonclinical and Clinical Tests that Demonstrate that the Device is Safe, Effective, and Performs As Well As or Better than the Predicate Device: |
Based on the data from the clinical study, it is concluded that Program B of the Optipress™ Extractor is acceptable for the production of Platelet Concentrates and Platelet Poor Plasma from Platelet Rich Plasma Contained within Fenwal polyvinyl chloride transfer packs. |
