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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK130081 Summary

510(k) Summary


Date: December 19, 2013

Submitter:
Haemonetics Corporation
400 Wood Road
Braintree, MA 02184

Contact:
Julie Ryan
Manager, Regulatory Affairs
Phone: 781-356-9682
Fax: 781-356-3558
Email: julie.ryan@haemonetics.com

Device Information:
Trade Name: Cymbal Automated Blood Collection System
Regulation Number: 21 CFR 864.9245
Regulation Name: Automated Blood Cell Separator
Device Class: 2
Product Code: GKT

Device Characteristics Summary:
The Cymbal Automated Blood Collection System is an automated apheresis device designed to collect whole blood and separate it into its component parts. The Cymbal System retains two units of Red Blood Cells and returns the rest of the blood to the donor.

The Cymbal System consists of the automated apheresis device hardware, the single-use disposable sets used for collection of the Red Blood Cells, and the software protocol run on the device.

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 during the third draw phase.

Testing Summary:
The subject of this Special 510(k) submission is a labeling change to the user manuals. There are no changes to the device hardware, software, or disposable sets. Therefore, no clinical or non- clinical testing is submitted to support the change.

Comparison to Predicate:
The proposed Cymbal Automated Blood Collection System is substantially equivalent to the Cymbal Automated Blood Collection System (BK090083) and the MCS+8150 System (BK050048 & BK940064).

A summary comparison is presented below in Table 1.

Table 1: Comparison of the Cymbal Automated Blood Collection System to the Predicates
  Predicate
MCS+8150 System
(BK050048 & BK940064)
Predicate
Cymbal Automated Blood
Collection System (BK090083)
Subject
Cymbal Automated Blood
Collection System
Manufacturer Haemonetics Corporation Same Same
Trade Name MCS+ 8150 Cymbal Cymbal
Regulation Number 21 CFR 864.9245 Same Same
Regulation Name Automated Blood Cell Separator Same Same
Device Class 2 Same Same
Product Code GKT Same Same

Indications for Use

The MCS+ 8150 may be used to collect the following blood components from allogeneic and autologous donors.

  • Two units of red cells collected in CP2D/AS-3, non-leukocyte reduced (832) Two Unit Red Cell Protocol
  • Two units of red cells collected in CPDA-1, non-leukocyte reduced (833) Two Unit Red Cell Protocol
  • One unit of red cells collected in CP2D/AS-3, non-leukocyte reduced and one unit of plasma (822) Red Cells and Plasma Protocol
  • One unit of red cells collected in CPDA-1, non-leukocyte reduced and one unit of plasma (823) Red Cells and Plasma Protocol

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 during 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 during the third draw phase.

  • Two units of red cells collected in CP2D/AS-3, leukocyte reduced (832F). Filtration must be done within 8 hours if the red cells are at room temperature or within 72 hours ifthe red cells are stored at l-6°C. Two Unit Red Cell Protocol
Hardware There are no changes to the Cymbal Automated Blood Collection System hardware.
Disposables There are no changes to the Cymbal Automated Blood Collection System disposables.
Software There are no changes to the Cymbal Automated Blood Collection System software.


 

 

/s/ December 19, 2013
Julie A. Ryan
Manager, Regulatory Affairs
Haemonetics Corporation
Date