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BK100066 Summary

510(k) Summary – BK100066

Submitter Information:
  ThermoGenesis Corp.
2711 Citrus Road
Rancho Cordova, CA 95742
USA

Contact:
    Jorge Artiles
Phone: 916-858-5113
Fax: 916-858-5199

Date of Preparation: May 26th, 2011

Device Information:

Trade Name:
Common Name:
Classification Name:
Res-Q™ 60 PRP
Autologous Platelet Preparation Kit
Automated blood cell separator. (21 CFR § 864.9245)
   
Product Code: ORG
Device Class: II
Panel: Hematology
 

Predicate Information:

Predicate Name: GenesisCS Component Concentrating System
Predicate Clearance: BK050055

Description of the Device

The Res-Q™ 60 PRP device is a self-contained disposable kit containing the Res-Q 60 device, clot filter, 10cc syringe, and tubing. Use of the disposable Res-Q™ 60 PRP kit entails the use of a re-usable processing tray, sold separately. Res-Q™ 60 PRP kit must be used in conjunction this re-usable processing tray and with a desktop centrifuge (also sold separately).

The Res-Q™ 60 PRP kit disposable separates ACD-A anticoagulated whole blood through centripetal partitioning of blood components based on density. A movable baffle separates the packed red blood cells from the buffy coat and platelet depleted plasma.

The user withdraws the buffy coat fraction, plasma enriched with platelets, with a syringe through an orifice in the movable baffle. Recover of the platelets is enhanced through agitation supplied by the processing tray.

Intended Use

The Res-Q™ 60 PRP device is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

Technological Quantification and Testing

Performance of the Res-Q™ 60 PRP device Kit was compared with standard methods for preparing volumes of platelet rich plasma using centrifugation including PRP isolation with the predicate device. Equivalent platelet yields and platelet concentration factors as the predicate device were obtained. Use of the device did not activate the platelets.

Determination of Substantial Equivalence

The proposed kit uses essentially the same technological characteristics, materials and performs similarly to the legally marketed predicate device, the GenesisCS Component Concentrating System. The technical interchangeability of the proposed Res-Q™ 60 PRP and predicate GenesisCS devices supports the determination of equivalence.

Substantial Equivalence Conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.