Aurora Xi Plasmapheresis System Software Version 2.0
BK241135 · Fresenius Kabi AG Lake Zurich, IL · GKT · Jan 24, 2025 · Hematology
Device Facts
Record ID
BK241135
Device Name
Aurora Xi Plasmapheresis System Software Version 2.0
Applicant
Fresenius Kabi AG Lake Zurich, IL
Product Code
GKT · Hematology
Decision Date
Jan 24, 2025
Decision
SESE
Regulation
21 CFR 864.9245
Device Class
Class 2
Indications for Use
The Aurora Xi Plasmapheresis System is intended for the automated collection of plasma by membrane filtration to be processed as Source Plasma. The Aurora Xi System is to be used with a single-use Plasmacell Xi Disposable Set and 4% sodium citrate anticoagulant and allows for Saline and No Saline Protocol options.
Device Story
Automated plasmapheresis system; uses membrane filtration to separate plasma from whole blood; draw/return cycles continue until target volume reached. Software v2.0 introduces linear nomogram targeting up to 1098 mL plasma product (1000 mL pure plasma) vs previous 880-911 mL limit. Operated by trained personnel in plasma collection centers. Output includes collected plasma and returned cellular components. Clinical decision-making supported by automated volume targeting; benefits include increased plasma collection efficiency per donation.
Clinical Evidence
Multicenter, prospective randomized controlled clinical trial comparing new nomogram (v2.0) to existing predicate nomogram. Primary endpoint: rate of significant hypotensive adverse events (SHAEs, IQPP DAE Classification 1.2-1.6). Results demonstrated the new nomogram SHAE rate was less than double the predicate rate, meeting the primary endpoint and confirming substantial equivalence.
Technological Characteristics
Automated blood cell separator using membrane filtration. System comprises instrument hardware/software and single-use Plasmacell Xi disposable set. Utilizes 4% sodium citrate anticoagulant. Supports Saline and No Saline protocols. Software v2.0 includes updated linear nomogram for volume targeting. Connectivity/sterilization details not specified.
Indications for Use
Indicated for automated collection of plasma via membrane filtration for Source Plasma processing in donors.
Regulatory Classification
Identification
An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.
Special Controls
*Classification.* Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”
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FRESENIUS KABI
Fresenius Kabi
Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 888-391-6300
www.fresenius-kabi.us
January 23, 2025
# 510(k) Summary
# Contact Details
| **Applicant Name** | Fresenius Kabi AG |
| --- | --- |
| **Applicant Address** | Else-Kröner-Str. 1 Bad Homburg 61352 Germany |
| **Correspondent Name** | Fresenius Kabi |
| **Correspondent Address** | Three Corporate Drive Lake Zurich IL 60047 United States |
| **Correspondent Contact Telephone** | 847-550-2280 |
| **Correspondent Contact** | Shuiquan Jing |
| **Correspondent Contact Email** | shuiquan.jing@fresenius-kabi.com |
# Device Name
| **Device Trade Name** | Aurora Xi Plasmapheresis System Software Version 2.0 |
| --- | --- |
| **Common Name** | Automated Blood Cell Separator |
| **Classification Name** | Separator, Automated, Blood Cell, Diagnostic |
| **Regulation Number** | 864.9245 |
| **Product Code** | GKT |
# Legally Marketed Predicate Devices
| **Predicate 510(k) Number** | BK220788 |
| --- | --- |
| **Predicate Trade Name** | Aurora Xi Plasmapheresis System |
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Product Code
GKT
# Device Description Summary
The Aurora Xi Plasmapheresis System, comprising the Aurora Xi instrument (hardware and software) and a PLASMACELL Xi disposable set, is an automated plasmapheresis system intended for Source Plasma collection. Whole blood is drawn from the donor and plasma is separated from concentrated cells using a rapidly rotating separator (membrane filter). The plasma is collected in a collection container and residual cellular components are then returned to the donor. This draw and return cycle is repeated until the target plasma collection volume is reached.
Aurora Xi Software Version 2.0 includes an alternate, linear nomogram that uses donor characteristics to target a collection volume of up to 1098 mL of plasma product (up to 1000 mL pure plasma) per donation, in addition to existing cleared nomograms that target a collection volume of up to 880-911 mL of plasma product (up to 800 mL pure plasma) per donation.
# Intended Use/Indications for Use
The Aurora Xi Plasmapheresis System is intended for the automated collection of plasma by membrane filtration to be processed as Source Plasma. The Aurora Xi System is to be used with a single-use Plasmacell Xi Disposable Set and 4% sodium citrate anticoagulant and allows for Saline and No Saline Protocol options.
# Indications for Use Comparison
The indications for use is same as predicate device.
# Technological Comparison
The Aurora Xi with Software Version 2.0 has the same technology characteristics, operational principle, separation technology, safety principle and operation system as the predicate device.
# Non-Clinical and/or Clinical Tests Summary & Conclusions
Aurora Xi Plasmapheresis System Software Version 2.0 was verified and validated at both software and system levels. Non-clinical testing demonstrated that the modified device performed as intended in a safe and effective manner that is substantially equivalent to the predicate device.
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A multicenter, prospective randomized controlled clinical trial was conducted to evaluate the new nomogram in software version 2.0 compared to the existing nomogram in the predicate device.
The primary objective of this study was to demonstrate that the overall rate of significant hypotensive adverse events (SHAEs, IQPP DAE Classification 1.2-1.6) in donors using the Aurora Xi new nomogram algorithm was less than double the SHAE rate in donors using the existing cleared nomogram algorithm. Clinical data demonstrated that the study met the primary endpoint and that the Aurora Xi system with the new nomogram is substantially equivalent to the predicate device.
Based on the non-clinical and clinical activities performed, the Aurora Xi Plasmapheresis System with Software Version 2.0 provides a device system that is substantially equivalent to the predicate device.
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