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BK100049 Summary

510(k) Summary
Charter Medical Cell-Freeze® Cryogenic Storage Container


510(k) Owner:Charter Medical, Ltd.
3948-A Westpoint Blvd.
Winston-Salem, NC 27103
   
Contact Person:Jessica Hughes
Director, Quality Assurance/Regulatory Compliance
Telephone: (336) 768-6447 ext. 4248
Fax: (336) 774-1750
   
Date Prepared:July 12, 2010
   
Device Nomenclature:  
Trade Name:Cell-Freeze® Cryogenic Storage Container
Common Name:Freezing Bag
Classification Name:unclassified
   
Predicate Device:Charter Medical Cell-Freeze® Liquid Nitrogen Freezing Container (BK060042)
   
Device Description:The Cell-Freeze® Cryogenic Storage Containers are single use, sterile (fluid path) containers intended for hematopoietic progenitor cell freezing and storage at -196°C to be followed by thawing at 37 - 40°C. The product is a bag with attached tubing segments offered with filling capacities of 10-20 ml, 30-70 ml, 55-100 ml and 80-190 ml. The bag is manufactured using polyolefin elastomer film and has a built-in label pocket that allows the user to insert written information. The product also includes Ethylene Vinyl Acetate (EVA) and Poly Vinyl Chloride (PVC) tubing segments with standard connections used in blood storage container systems.
 The device is provided sterile fluid path and intended for single use.
   
Intended Use:The Cell-Freeze® Cryogenic Storage Container is intended for the storage, preservation and transfer of hematopoietic progenitor cells (HPC) in liquid nitrogen to -196°C. The Cell-Freeze® Cryogenic Storage Container is provided sterile (fluid path) and intended for single use.
 These indications for use are functionally equivalent to the predicate device listed above.
   
Technological Characteristics:The Cell-Freeze® Cryogenic Storage Container is substantially equivalent to the predicate device in intended use, design, technology and performance requirements. Differences between the two devices do not raise any significant new risks for safety and effectiveness.

 

Table 1 Comparison to Predicate Device
 Charter Medical Cell- Freeze™ Liquid Nitrogen Freezing Container (BK060042)Charter Medical Cell- Freeze® Cryogenic Storage Container
Intended UseThe Charter Medical Cell-Freeze™ Liquid Nitrogen Freezing Container is intended for the storage, preservation and transfer of peripherally derived stem cells in liquid nitrogen to -196°C.The Cell-Freeze® Cryogenic Storage Container is intended for the storage, preservation and transfer of hematopoietic progenitor cells (HPC) in liquid nitrogen to -196°C.
SpecimenPeripherally derived stem cellsHematopoietic Progenitor Cells
(HPC)
MaterialsPolyolefinPolyolefin
DesignThe bag is manufactured using polyolefin elastomer film. The product also includes Ethylene Vinyl Acetate (EVA) and Poly Vinyl Chloride (PVC) tubing segments with standard connections used in blood storage container systems.The bag is manufactured using polyolefin elastomer film and has a built-in label pocket that allows the user to insert written information. The product also includes Ethylene Vinyl Acetate (EVA) and Poly Vinyl Chloride (PVC) tubing segments with standard connections used in blood storage container systems.
Capacity30-60 ml, 50-90ml, 70-125 ml10-20 ml, 30-70 ml, 55-100 ml, 80-190 ml

 

Nonclinical Performance Data:Verification of device performance was established with acceptable results through the following non-clinical tests: biocompatibility, durability in liquid nitrogen, cell viability, and clinical use simulation.
  
Conclusion:It is the conclusion of Charter Medical that the Cell-Freeze® Cryogenic Storage Container 50, 250, 500 and 750 are substantially equivalent to and as safe and effective as the predicate device.