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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK120041 Summary - AMICUS Separator System

510(k) Summary

Date Prepared:

September 25, 2012

Owner and Contact Person:

Owner/Operator
Owner/Operator #: 9098803
Fenwal, Inc.
Three Corporate Drive
Lake Zurich, IL  60047

Contact Name: John Maibauer

Title: Regulatory Affairs Specialist

Address: Three Corporate Drive
Lake Zurich, IL  60047 

 Telephone: 847-550-2966

Fax: 847-550-2960

E-mail: john.maibauer@fenwalinc.com

Device Name(s):

AMICUS Separator System

Common Name:

Automated Blood Cell Separator (Centrifugal Separation Principle)

Classification Name:

21 CFR 864.9245 Automated Blood Cell Separators
Automated blood cell separators which are based on centrifugation type technology have been classified by the Center for Biologics Evaluation and Research as Class II devices with Special Controls (Docket 2005N-0017, Final Rule, 30-Nov-07).

Classification Panel:

81 GKT (Hematology panel) - Separator, Automated, Apheresis

Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:

Fenwal, Inc. is claiming substantial equivalence with the currently marketed version of the AMICUS Separator System. The AMICUS Separator System was most recently cleared to market under 510(k) K111702 on March 22, 2012 by CDRH and was last cleared by CBER under BK110030 on December 23, 2011.
AMICUS is currently cleared for the collection of plasma in ACD-A anticoagulant.  This application does not change the collection procedures, only the amount of time allowed before freezing plasma for transfusion.

Device Description

The AMICUS Separator System is a continuous-flow, centrifugal device that separates whole blood into its components. The operator is responsible for preparing and monitoring the donor as well as operating and monitoring the AMICUS instrument during the procedure.

The operator controls the instrument through a touch screen. When necessary, the operator is notified of potential problems with the procedure or instrument via messages on the screen with corresponding audible alarms.
Blood components are collected using sterile fluid path, single-use, apheresis kits. These kits are provided in either closed or functionally closed configurations. The cells are centrifugally separated within the kit by density differences.

The AMICUS instrument can collect plasma concurrently with other blood components.  During this process whole blood is collected from the donor and separated by centrifugation into plasma and cellular components. 

Indications for Use

The AMICUS separator system is an automated blood cell separator indicated for the collection of blood components and mononuclear cells.

The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post platelet count greater than or equal to 100,000 platelets/μL.

Depending on the AMICUS separator system apheresis kit used in the collection of products, the AMICUS separator system has been cleared to collect:

  • Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)
  • Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double or triple units)
  • Red Blood Cells, Leukocytes Reduced (by apheresis)
  • Mononuclear Cells
  • Therapeutic Plasma Exchange (TPE)
  • Plasma
    • Fresh Frozen Plasma
      • Must be prepared and placed in a freezer at -18° C or colder within 8 hours of collection.
    • Source Plasma
    • Plasma Frozen Within 24 Hours After Phlebotomy (PF24)*
      • Must be stored at 1-6°C within 8 hours of collections and prepared and frozen within 24 hours after phlebotomy.
      • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
    • Plasma Frozen Within 24 Hours after Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24)*
      • Can be stored at room temperature for up to 24 hours after collection. Product must be prepared and frozen within 24 hours after phlebotomy.
      • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.

Platelets Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet, Pheresis, Platelet Additive Solution (lntersol) (single, double, triple).

*This is the new intended use associated with this 510(k) submission

Technological Characteristics as Compared to the Predicate Device

The technological characteristics of the AMICUS Separator System remain the same as the currently marketed device. They are both continuous flow centrifugal separation devices. They both use sterile fluid path disposable kits made of non-PVC polyolefin and PVC plastics.  No changes have been made to the instrument or the disposable devices used. The AMICUS Separator System is already cleared for the collection of plasma from donors.  This application allows for a longer holding time prior to freezing for plasma collected for transfusion.

Performance Data:

A study, FCRP-0109: Evaluation of Apheresis ACD-A Plasma Frozen Within 24 Hours of Collection, was conducted to support this application. The study conditions were intended to evaluate worst case parameters, including storage of the plasma for up to 24 hours at RT prior to freezing. Apheresis-derived ACD-A plasma collected and stored at RT for up to 8 hours (FFP) prior to freezing was also tested for informational purposes only. The study plan included collection of 52 evaluable paired ACD-A plasma products, divided into two products with half frozen within 8 hours of collection (FFP) and the other half within 24 hours of collection (PF24RT24).  The products were stored frozen for at least one month, thawed, and evaluated.

A summary of the results are presented on the next page.

Summary of PF24RT24 Plasma Product Parameters (N=54)

 

Coagulation
Factor

Mean
(SD)

 

Median

(Minimum, Maximum)

Mean Difference
(Test- Control)
(95% Confidence Interval)

Control

Test

Control

Test

Control

Test

Antithrombin III (%)

90.9
(11.5)

88.3
(11.4)

89.5

87.5

63, 117

60, 114

-2.63 (-4.67, -0.63)

Factor V (%)

90.2
(19.1)

89.2
(18.2)

90

88

35, 136

35, 131

-0.98 ( -2.59, 0.62)

Activated Factor
VII (mU/mL)

78.1
(36.9)

71.5
(33.3)

70

68

9, 182

9, 162

-6.58 (-9.78, -3.37)

Factor VIII (%)

99.3
(31.7)

86.1
(26.9)

96.5

87

49,193

40, 156

-13.2 (-16.0, -10.5)

Factor XI (%)

103.8
(18.3)

103.9
(20.0)

101.5

98.5

77, 150

74, 158

0.17 ( -1.28, 1.61)

Protein C (%)

100.4
(18.1)

99.8
(17.4)

99

99

56, 148

56, 143

-0.54( -1.59, 0.52)

Protein S (%)

82.2
(17.8)

73.2
(14.1)

80.5

73.5

29, 124

47, 109

-8.98 (-11.7, -6.24)

PT (seconds)

12.4
(0.68)

12.6
(0.65)

12.4

12.5

11.1, 14.7

11.2,
14.2

0.16 (0.09, 0.22)

aPTT (seconds)

30.8
(3.0)

31.5
(3.1)

31.1

31.5

23.9,
37.2

24.3,
38.3

0.66 (0.42, 0.89)

Von Willebrand
Factor (%)

94.2
(43.1)

94.1
(42.9)

82.5

84

36, 225

34, 214

-0.04 ( -3.03, 2.95)

Note: TAT Complex was not able to be computed since raw values below the assay detection level (less than 2.0 ng/mL) are not quantifiable

Conclusions:
In this study of PF24RT24 from apheresis, the values for the assays of interest were consistent with those previously reported for FP24 from whole blood.  The mean and median values for all the assays of interest were within the Central Laboratory’s normal reference range.  The coagulation proteins and natural anticoagulants were well maintained in ACD-A plasma stored for 24 hours at RT prior to freezing for a minimum of one month. This study supports the ability to prepare apheresis-derived ACD-A plasma for use as PF24 or PF24RT24.

 

Owner/Operator:

Owner/Operator #: 9098803
Fenwal, Inc.
Three Corporate Drive
Lake Zurich, IL  60047