Vaccines, Blood & Biologics

BK060004 Summary

Contact Person: Kim Kelly
Smith & Nephew. Inc.
1980 Nonconnah Blvd.
Memphis , TN 38116

Date Prepared: May 1 , 2006 (revised)

Device: Smith & Nephew Platelet Rich Concentrate (PRC) Preparation System

Classification: 21 CFR 864.9050; Product Code KSS: Class I: Supplies Blood Bank and 21 CFR 864.9100, Product Code KSR; Class II; Container. Empty. for Collection & Processing of Blood & Blood Components

Predicate Device: Harvest PRP Separation System -BK000037
GPS II Platelet Concentrate Separation Kit - BK040036 & BK0S0016

Device Description: The Smith & Nephew PRC System consists of a blood filter contained in a plastic housing and processing reagents. The kit is supplied with syringes for drawing blood and processing the sample to produce approximately 8mL of Platelet Rich Concentrate.

Intended Use: The Smith and Nephew PRC System is intended for the rapid preparation of autologous platelet-rich concentrate (PRC) from a small sample of blood at the patient's point of care. The PRC can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.

Comparison to Predicates:

The Smith & Nephew PRC System consists of a Platelet Rich Concentrator and accessories. The device is similar to both the Harvest PRP Separation System and the GPS II Platelet Concentrator Kit in that it produces a platelet rich concentrate (PRC) from a small sample of the patient's blood The PRC Is intended to be mixed with autograft or allograft bone and placed in an orthopedic surgical site. The Smith & Nephew System differs from the predicates in that it uses filtration to separate the cells; whereas, the predicate devices separate cells by centrifugation.

Testing has shown that the concentration of platelets processed through the proposed filter device is equivalent to the concentration of platelets processed by centrifugation.

Synopsis of Test Methods and Results:

Laboratory tests were performed on platelet rich concentrate produced by processing blood samples from human donor(s) through the Smith & Nephew proposed filter device and comparing test results obtained to a platelet rich concentrate produced by processing blood from the same donor(s) in the predicate device. The laboratory tests, as determined following meetings and discussion with CBER, were performed and used to determine the acceptability of the platelet concentrate after processing. The laboratory tests can be found in the draft guidance document entitled "Guidance for Industry: For Platelet Testing and Evaluation of Platelet Substitute Products."

The results provided in the testing section of the submission demonstrate that platelets prepared using the Smith & Nephew PRC System and the predicate device were concentrated in equivalent amounts and that the concentrated platelets retained their ability to be stimulated by a strong agonist (high concentration of TRAP) regardless of whether they were processed using filter technology or the predicate device's currently marketed centrifuge technology.

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