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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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510K Summary - BK090083

PDF Version (32KB)

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

CharacteristicsPredicate Device-
Cymbal Automated Blood Collection System
And
MCS+8150
Proposed Device –
Cymbal Automated Blood Collection System
ProtocolTwo Unit Filtered Red Cell (Cymbal)
Two Unit Unfiltered Red Cell (MCS+8150)
Two Unit Filtered Red Cell (Cymbal)
HardwareCymbal Automated Blood Collection SystemCymbal Automated Blood Collection System
DisposableList number: 311-00, 832FList number: 311-00
Intended UseThe 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___