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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK120065 Summary

510(k) Summary

Date: October 30, 2012

Submitter:
Haemonetics Corporation
400 Wood Road.
Braintree MA 02184

Contact: Alternate Contact:
Julie Ryan
Senior Regulatory Affairs Specialist
Phone: 781-356-9682
Fax: 781-356-3558
Email: julie.ryan@haemonetics.com
Greg Calder
Regulatory Affairs Manager
Phone: 781-356-9538
Fax: 781-356-3558
Email: gcalder@haemonetics.com

Device Information:
Trade Name: Haemonetics PCS2 Plasma Collection System
Regulation Number: 21 CFR 864.9245
Regulation Name: Automated Blood Cell Separator
Device Class: Class II (two)
Product Code: GKT

Device Characteristics Summary:
The Haemonetics PCS2 Plasma Collection System Software Revision K.1 is an update to the PCS2 Plasma Collection System Software Revision K, cleared via 510(k) BK080001 on May 28, 2008.

The Haemonetics PCS2 Plasma Collection System is designed for separation of whole blood by centrifugation, collection of Platelet Poor Plasma or Plasma and Leukocytes, and return of the remaining components to the donor. Products that can be collected using the PCS2 System with software revision K.1 are source plasma and plasma for reinfusion only.  

Software Revision K.1 includes an AC Short Prime protocol. In this protocol, the pre-load of anticoagulant (fluid volume from harness Y-connector to the donor line air detectors) will be transferred back into the anticoagulant bag during the Prime sequence, eliminating it from entering the plasma collection bottle during the first collection cycle. The elimination of this pre-load volume will reduce the amount of anticoagulant in the collected plasma, allowing for a greater total amount of plasma collected in each procedure.

The Haemonetics PCS2 Plasma Collection System Software Revision K.1 is the subject of this Special 510(k) submission.

Indications for Use:
The PCS2 System is intended for use as an automated cell separator system and blood component collector in conjunction with single use sterile disposable sets.  Products that can be collected using the PCS2 System LN6002 automated cell separator include source plasma, plasma for reinfusion and plasma & leukocytes.  

Products that can be collected using the PCS2 LN6002 System with software revision K.1 are source plasma and plasma for reinfusion only.  

The LN625HS and LN625B are disposable centrifuge bowls designed for use with the PCS2 LN6002 and the LN620 Disposable Harness, for the collection of source plasma and plasma for reinfusion, with or without saline compensation. 

Non-Clinical Testing Summary:
The following non-clinical performance testing was submitted in support of a determination of substantial equivalence between the subject and predicate device. A summary of the performance testing is presented below in Table 1: Summary of Performance Studies. Test data demonstrates that the device met all clinical and performance requirements, and that the subject device is as safe, as effective, and performs as well as or better than the predicate device.

Table 1: Summary of Performance Studies

Test Name Test Report # Test Intent Test Result
Bench Testing for Software

TP-SOF-100402
TR-SOF-100402

The intent of these studies was to validate an update to the software to include an AC Short Prime protocol. Passed

Comparison to Predicate:
The PCS2 Plasma Collection System Software Revision K.1 is an update to the PCS2 Software Revision K, cleared via 510(k) BK080001 on May 28, 2008. Software Revision K.1 includes an AC Short Prime protocol. The PCS2 Software Revision K.1 is intended for use with identical hardware and disposables as the predicate device.

A summary comparison is presented below in Table 2: Comparison of the PCS2 Software Revision K.1 to the Predicate PCS2 Software Revision K.

Table 2: Comparison of the PCS2 Software Revision K.1 to the Predicate PCS2 Software Revision K

  Predicate PCS2 System Software Revision K (BK080001) Subject PCS2 System Software Revision K.1
Manufacturer Haemonetics Corp. Same
Trade Name Haemonetics PCS2 Plasma Collection System Same
Regulation Number 21 CFR 864.9245 Same
Regulation Name Automated Blood Cell Separator Same
Device Class II Same
Product Code GKT Same
Indications for Use

The PCS2 System is intended for use as an automated cell separator system and blood component collector in conjunction with single use sterile disposable sets.  Products that can be collected using the PCS2 System LN6002 automated cell separator include source plasma, plasma for reinfusion and plasma & leukocytes.  

Products that can be collected using the PCS2 LN6002 System with software revision K are source plasma and plasma for reinfusion only.  

The LN625HS and LN625B are disposable centrifuge bowls designed for use with the PCS2 LN6002 and the LN620 Disposable Harness, for the collection of source plasma and plasma for reinfusion, with or without saline compensation. 
Same
Hardware There were no changes to the PCS2 System hardware associated with the software modifications that are subject of this 510(k) application.
Disposables There were no changes to the PCS2 System disposables associated with the software modifications that are subject of this 510(k) application.
Software Software Revision K with update of new donor flow algorithm regulating draw and return rates based on donor venous pressure use with standard (LN625B) and HS bowl (LN625HS). Software Revision K.1 with AC Short Priming protocol.

 

_____________________________
Julie Ryan
Senior Regulatory Affairs Specialist
Haemonetics Corporation
________
Date