Boekel Scientific Plasma Thawer – BK100051 Summary
April 5, 2011
|Owner and Contact Person|
|Owner/Operator #:10030490 |
855 Pennsylvania Blvd.
Feasterville, PA 19053
|Contact Name:||Amy-Jo Frunzi|
|Title:||Vice President – Operations|
|Address:||855 Pennsylvania Blvd.|
|Feasterville, PA 19053|
Boekel Scientific Plasma Thawer, Model 301000
Plasma Thawer / Blood and Plasma Warming Device
Device, Warming, Blood and Plasma
21 CFR 864.9205
Product Code KZL
A blood or plasma warmer is a device that warms blood or plasma, prior to administration
Legally Marketed Device Under Which Substantial Equivalence is being Claimed:
Boekel Scientific is claiming substantial equivalence of the Boekel Scientific Plasma Thawer to the Helmer Water Plasma Thawer cleared under BK940051-0.
The Boekel Scientific Plasma Thawer is intended for use in blood banks and laboratories to thaw up to four units of Plasma, specifically Fresh Frozen Plasma (FFP), Cryoprecipitated AHF or Plasma Frozen Within 24 Hours After Phlebotomy (PF24). Two independently controlled baskets can accommodate up to two plasma bags each. A controlled temperature bath preset and fixed at 36.0°C agitates the baskets in order to thaw the Plasma (Fresh Frozen Plasma – FFP, Cryoprecipitated AHF or Plasma Frozen Within 24 Hours After Phlebotomy – PF24). The thawing process is controlled by a digital microprocessor. The user interface allows multiple time options for thawing various sized bags. Upon completion of a timed cycle, the baskets automatically rise from the bath. Safety features include an Over-Temperature Alarm, preset and fixed at 37°C, which notifies the user of unsafe conditions and raise the baskets from the bath upon alarm activation.
Statement of Intended Use:
The Boekel Scientific Plasma Thawer is intended for use in blood banks and laboratories where it is required to thaw up to four units of Plasma, specifically Fresh Frozen Plasma (FFP), Cryoprecipitated AHF or Plasma Frozen Within 24 Hours After Phlebotomy (PF24) for future infusion into a patient. This device is not intended for the thawing of, but not limited to, Red Blood Cells, Hematopoietic Progenitor Cells or Umbilical Cord Blood.
Technological Characteristics as Compared to the Predicate Device:
The technological characteristics between the proposed and predicate device are the same. Both devices use a waterbath with two independently controlled agitating baskets and can thaw up to four units of plasma product with similar thaw times. The user interface of both systems allows multiple time options for thawing various sized bags. Differences in thaw times are on the order of minutes. The Boekel Scientific Plasma Thawer has a preset and fixed Temperature Set Point of 36.0°C while the Helmer Water Plasma Thawer, cleared under BK940051-0 has an adjustable Temperature Set Point. The Boekel Scientific Plasma Thawer has a preset and fixed OverTemperature Alarm of 37.0°C, with a heater cut-off, while the Helmer Water Plasma Thawer, cleared under BK9400051-0 has an adjustable OverTemperature Alarm with a heater cut-off.
Performance testing was conducted to demonstrate satisfactory thawing times of human derived Fresh Frozen Plasma (FFP) and Cryoprecipitated AHF. This testing was conducted at an independent blood bank. Six bags of each product were used in the testing, refrozen between tests. A total of 96 thaw cycles were completed with one, two, three and four bags of varying sizes. Samples were thawed in the Boekel Scientific Plasma Thawer according to the instruction in the Operation Manual and the time for each bag to thaw was recorded. Average thawing times were calculated and are reported in the Operation Manual.
Test methods used are similar to those used for the predicate Helmer Water Plasma Thawer. All testing demonstrated that plasma products can be thawed in the Boekel Plasma Thawer according to requirements and recommendations in CFR 606.122(m)(2) and 21 CFR 606.122(n)(4), AABB Technical Manual 16th Edition, 2008 and Circular of Information for the Use of Human Blood and Blood Components (Circular) dated December 2009.
There are no significant differences between the Boekel Plasma Thawer which is the proposed device and the Helmer Water Plasma Thawer, which is the predicate device. The conclusions drawn from the nonclinical tests demonstrate equivalent performance of the Boekel Plasma Thawer and the legally marketed device, the Helmer Water Plasma Thawer. Comparisons have been made to the legally marketed predicate device, and the Boekel Scientific Plasma Thawer device is determined to be substantially equivalent to the referenced predicate device currently on the market.