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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resources for You

BK120040 Letter

Terumo BCT, Inc.
Attention:  Ms. Isabel McGann
10811 West Collins Avenue
Lakewood, CO  80215

Re:    BK120040
Trade Name:  Trima Accel® System
Regulation Number:  21 CFR 864.9245
Regulation Name:  Automated Blood Cell Separators
Regulatory Class:  Class II
Product Code:  GKT
Dated:  September 26, 2012
Received:  September 27, 2012

Dear Ms. McGann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA).  You may, therefore, market the device, subject to the general controls provisions of the Act.  The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls.  Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898.  In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.  You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance.  Also, please note the regulation entitled, ²Misbranding by reference to premarket notification² (21CFR Part 807.97).  For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638‑2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

If you have any questions concerning the contents of the letter, please contact the Regulatory Project Manager, Alisha Miller, at (301) 827-3927. 

Sincerely yours,

/s/

Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics  
    Evaluation and Research                                             

Enclosures:
Indications for Use


                                                       Indications for Use                                                                            
510(k) Number: BK120040

Device Name:  Trima Accel® System

Indications for Use:

The Trima Accel system is an automated blood cell separator intended for use in collecting blood components for later transfusion into patients.

Depending on the disposable tubing set used, the Trima Accel system has been cleared to collect:
•   Double ACD-A/AS-3 Red Blood Cells (leukocytes reduced or non leukoreduced) Or the following products, alone or in combination:
•   ACD-A/AS-3 Red Blood Cells
•   ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced utilizing an integrated filter
(TLR gravity drain filter or AutoRBC filter)
•   Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)
•   Plasma

  • Fresh Frozen Plasma and Fresh Frozen Plasma, Leukocytes Reduced
  • 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) and Plasma Frozen Within  24 Hours After Phlebotomy, Leukocytes Reduced
  • Must be stored at 1-6°C within 8 hours of collection 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)  and  Plasma  Frozen  Within  24  Hours  After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy, Leukocytes Reduced
  • 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.

The Trima Blood Component Sampling Assembly, which is either integrated into the disposable tubing sets or as an accessory for sterile connection, is intended to allow aseptic removal of a sample from the platelet bag for subsequent bacterial or other applicable testing. The Sampling Assembly does not have contact with blood fluids that are reinfused to a donor or patient.

  • Adequate studies have not been performed to evaluate the effect of gamma irradiation or freezing on the quality of ACD-A/AS-3 red blood cells products (RBCs) collected with gravity drain leukoreduction process (TLR filter) on the Trima Accel system.
  • Studies have not been performed to support gamma irradiation or freezing of ACD-A/AS- 3 RBCs collected with an integrated in-line RBC leukoreduction filter(s) (AutoRBC filter) on the Trima Accel system.

RBCs collected on the Trima Accel system using the AutoRBC feature as either a single unit or double units, with continuous RBC leukoreduction, and stored in ACD-A/AS-3 for 42 days met the following acceptance criteria required by the FDA-CBER:

Primary Outcomes

  • 95% probability and a one-sided 95% confidence limit:

    -    the number of contaminating leukocytes per unit is less than 5 million
    -    the recovery of RBCs after leukoreduction is greater than 85%
    -    RBC hemolysis is less than 1.0%

  • The mean recovery at 24 hours for each unit is ≥75% with standard deviation ≤9%; and  the  one  sided  95%  lower  confidence limit  for  the  population  proportion of successes is >70% (successes = individual units recovery ≥75%).

Secondary Outcomes
The results of biochemical tests for ATP and Potassium levels at the end of storage failed to show with 95% confidence that greater than 95% of the products will be within 20% of the Control product. Results of ATP levels for Test for a single RBC collection were not significantly different from Control by a paired t test analysis (p-value = 0.80). Results of ATP levels for Test for double RBC collections were significantly better than Control by a paired t test analysis (two-sided p-value = 0.014). Results of Potassium levels for Test for a single RBC collection were significantly better than Control by a paired t test analysis (p- value = 0.0354). Results of Potassium levels for Test for double RBC collections were not significantly different from Control by a paired t test analysis (two-sided p-value = 0.566).

The pH results support the conclusion with 95% confidence that more than 95% of the products will have a difference between Test and Control of less than 0.5 pH units at the end of RBC shelf life. The clinical significance of the secondary outcomes is unknown.

The Trima Accel system includes a modified platelet post-count algorithm. U.S. customers should not set the minimum post-count below 100,000/μL. This clearance applies only to plasma-stored platelets.

The Auto PAS feature has not been cleared for use in the United States. This feature is disabled in the software.

The table below summarizes the plasma product parameters from a paired study comparing PF24RT24 (apheresis plasma held at room temperature and frozen 24 hours post-collection) and FFP (apheresis plasma held at room temperature and frozen 8 hours post- collection).

 

Summary of PF24RT24 (Test) and FFP (Control) Plasma Product Parameters (N=52)

Coagulation
Assay

 

Mean (SD)

 

Median

 

(Minimum, Maximum)

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

 

Control

 

Test

 

Control

 

Test

 

Control

 

Test

PT (seconds)

12.0 (0.6)

12.1 (0.6)

11.8

12.0

10.7, 13.7

10.9, 13.8

0.1 (0.1, 0.2 )

aPTT (seconds)

37.9 (3.9)

38.5 (3.8)

37.7

38.5

31.1, 47.7

31.6, 48.6

0.6 (0.2, 0.9)

Factor V (IU/dL)

100.4 (17.6)

99.5 (16.5)

102.5

100.5

52, 138

52, 136

-0.9 (-2.0, 0.2)

Factor VIII (IU/dL)

79.8 (25.0)

72.6 (24.1)

74.0

67.5

37, 163

36, 157

-7.2 (-9.3, -5.1)

Factor XI (IU/dL)

73.5 (11.4)

73.8 (11.0)

71.5

71

53, 109

52, 103

0.3 (-0.4, 1.0)

vWF (IU/dL)

91.7 (29.1)

89.4 (28.2)

90.5

87

44, 145

41, 145

-2.3 (-4.2, -0.4)

Protein C (IU/dL)

97.9 (14.0)

94.3 (13.4)

99

98

65, 123

62, 126

-3.7 (-5.5, -1.9)

Protein S (IU/dL)

93.3 (20.0)

83.0 (19.2)

91.5

80.5

53, 161

48, 145

-10.3 (-12.4,-8.2)

AT III (IU/dL)

103.1 (7.7)

102.8 (7.8)

103

102.5

85, 120

85, 116

-0.3 (-1.4, 0.9)

Factor VIIa

2.6 (1.2)

2.7 (1.3)

2.4

2.3

0.6, 6.1

1.2, 6.4

0.1 (-0.3, 0.4)

FPA

9.2 (12.2)

9.9 (11.1)

4.0

4.9

0.6, 57.5

0.4, 44.9

0.6 (-3.4, 4.7)