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510(k) Data Aggregation
K Number
K113480Device Name
SPECTRA OPTIA APHERESIS SYSTEM
Manufacturer
Date Cleared
2012-01-20
(58 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CARIDIANBCT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spectra Optia® Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.
Device Description
The Spectra Optia® Apheresis System is a centrifugal system that separates whole blood into its cellular and plasma components. The system is used therapeutically to remove and replace the removed plasma with healthy donor plasma (i.e. plasma exchange) from patients who suffer from adverse hematologic and other conditions.
The system includes a disposable Exchange Set through which the patient's blood passes, and a machine that controls the separation of blood and the removal and replacement of plasma. The Spectra Optia system's embedded software has been enhanced to reduce the likelihood of excessive platelet loss/removal during Therapeutic Plasma Exchange (TPE) procedures when there are repeated RBC spillover alerts and no remedial action is taken.
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K Number
K103090Device Name
SPECTRA OPTIA R APHERESIS SYSTEM
Manufacturer
Date Cleared
2010-11-19
(31 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CARIDIANBCT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.
Device Description
The Spectra Optia Apheresis System is a centrifugal system that separates whole blood into its cellular and plasma components. The system is used therapeutically to remove and exchange blood plasma in patients who suffer from adverse hematologic and other conditions.
The system includes a disposable Exchange Set through which the patient's blood passes. and a machine that controls the separation of blood into its components and monitors the exchange procedure for patient safety. The Spectra Optia machine and its embedded software have been modified to include and support a return line air detector, respectively. The return line air detector serves as a backup air detection system and represents an enhancement to the system's overall safety profile. This additional sensor actively monitors the return line and detects the presence of air, prior to its reaching the patient. In the unlikely event that the extracorporeal circuit is improperly anticoagulated and clotted material in the disposable set interferes with the system's primary air detection sensors, the modified device "alarms" when air is detected and instructs the operator to clear the return line. Because the operator must clear the line before the apheresis procedure can be continued, patients are protected from receiving potentially unsafe quantities of air - even when the operator has sub-optimally anticoagulated the circuit. In the further unlikely event that the operator disregards the system's instructions to clear air in the line, the software safely terminates the apheresis procedure.
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