510K Summary - BK090083

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7.1 Statement	This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92
7.2 Submitter	Haemonetics Corporation 400 Wood Road Braintree, MA. 02184-9114
7.3 Company Contact	Susan Finneran Director Clinical and Regulatory Affairs 355 Wood Road Braintree, MA. 781-356-9220
7.4 Device Name	Proprietary Name: Cymbal Automated Blood Collection System Common Name: Cymbal Classification Name: Automated Blood Cell Separator
7.5 Predicate Legally Marketed Devices	The Haemonetics Cymbal Automated Collection System that is the subject of this submission is substantially equivalent to the Cymbal Automated Blood Collection System that was previously cleared via BK060057 and to the previously cleared MCS+8150 device which has been the subject of many premarket notifications most notably BK050048.
7.6 Device Description	The Cymbal Automated Blood Collection System is an automated blood cell separation system intended to be used to collect two units of Red Blood Cells, Leukocytes Reduced
7.7 Device Indications and Intended use	Indications for use: The Cymbal Automated Blood Collection System is intended to collect two units of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced from autologous and allogeneic donors. One unit of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced may be collected in the event of a terminated procedure in the third draw phase

The following page contains a table comparing the new versus the predicate device.

TABLE 7.1 TABLE OF SUSTANTIAL EQUIVALENCE

Characteristics	Predicate Device- Cymbal Automated Blood Collection System And MCS+8150	Proposed Device – Cymbal Automated Blood Collection System
Protocol	Two Unit Filtered Red Cell (Cymbal) Two Unit Unfiltered Red Cell (MCS+8150)	Two Unit Filtered Red Cell (Cymbal)
Hardware	Cymbal Automated Blood Collection System	Cymbal Automated Blood Collection System
Disposable	List number: 311-00, 832F	List number: 311-00
Intended Use	The Cymbal Automated Blood Collection System is intended to collect two units of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced from autologous and allogeneic donors. One unit of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced may be collected in the event of a terminated procedure in the third draw phase.	The Cymbal Automated Blood Collection System is intended to collect two units of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced from autologous and allogeneic donors. One unit of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced may be collected in the event of a terminated procedure in the third draw phase.
Product Quality Non-Filtered (MCS+8150 as predicate device)	Absolute Red cell volume +/-15% of target Hemolysis level <1% at day 42 of storage.	Absolute Red cell volume +/-15% of target Hemolysis level <1% at day 42 of storage.

Applicant___________________ Date_______1-21-2010___