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BK120026 Summary

Date 510(k) Summary Prepared: June 28, 2012

Proposed Device Name:
Proprietary Name: Pall® Celeris™ fPC System
Common Name: Platelet and plasma separator for bone graft handling
Classification Name: Automated blood cell/ separator (21 CFR 864.9245)
Classification: II
Product Code: ORG

Predicate Device: Pall® Celeris™ fPC System (BK100058)

Description of Device:
The Pall® Celeris™ fPC System is a complete system that includes all of the components, both single use disposable and solutions, needed for the preparation of a platelet concentrate (PC). The device is a single-use and disposable product that provides a rapid, safe system for use in the clinical laboratory and/or intra-operatively. Total processing time is approximately 15-30 minutes.

Filtration technology is used to capture the platelets from peripheral blood, and a simple one-step back-flush of the filter with the wash solution (called Harvest Solution) provides a platelet concentrate fraction as well as white blood cell populations and some red cells. This system is very easy to use, rapid, minimizes processing manipulations, and can be available at any time with no requirement for capital equipment. The entire filtration/capture process is performed in a sterile flu id path with minimal points of access, minimizing the risk of contamination.

The System prepares a platelet concentrate from a small amount (10-60 ml) of autologous peripheral whole blood. The platelet concentrate can be mixed with autograft and/or allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.

Intended Use:
The Pall® Celeris™ fPC System is intended for the rapid preparation of autologous platelet concentrate (PC) from a small sample of blood at the patient's point of care. The PC can be mixed with autograft and/or allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.

Indications for Use Statement:
The Pall® Celeris™ fPC System is indicated for use in the rapid preparation of autologous platelet concentrate (PC) from a small sample of blood at the patient's point of care. The PC can be mixed with autograft and/or allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.

Comparison to Predicate Devices:
The proposed Celeris TM fPC System is substantially similar to the predicate device (BK100058). With the minor componentry modifications, of which all replacement components have been previously approved/cleared by FDA, the proposed Celeris TM fPC System employs the identical Pall filtration technology as well as the same plastic bags and tubing components. Additionally, the proposed device employs the same anticoagulant, platelet capture solutions and saline harvest solution . The intended use of both the proposed device and the predicate device is identical and remains for the rapid preparation of autologous platelet concentrate (PC) from a small sample of blood at the patient's point of care. The range of influent whole blood and harvest solution has been expanded.

Conclusion:
Based on the similarity of intended use, materials, basic scientific technology, and design, substantial equivalence is claimed.