SMART M-CELL PRP Concentration System

The SMART M-CELL PRP Concentration System is a centrifuge-based medical device that separates platelet-rich plasma (PRP) from small volumes of venous whole blood through a two-phase centrifugation process. It is intended for use in clinical laboratories or at the point-of-care intraoperatively to safely and rapidly extract and transfer platelet concentrate for in vitro diagnostic use.

The device uses a molded ethylene-propylene copolymer chamber with an internal separator and drawtube for buffy coat aspiration, similar to the predicate. Key differences include centrifugation speeds of 2300 RPM then 2200 RPM for 17–20 minutes (versus the predicate's single 2500 RPM spin for 14 minutes). Both are single-use, sterile, non-pyrogenic kits sterilized by ethylene oxide with a 10⁻⁶ sterility assurance level.

Not stated in this summary. The document references FDA-recognized voluntary consensus standards and ISO 13485 quality management requirements but does not cite specific test method standards (ISO, IEC, or ASTM).

The SMART M-CELL PRP Concentration System is substantially equivalent to the predicate SmartPReP2 Centrifuge System (K052925) because both share identical intended use, similar device materials and structure, the same centrifugal fluid separation method, and comparable performance in preparing PRP with equivalent cell count profiles and platelet recovery rates. Differences in centrifugation parameters and processing time do not raise safety or effectiveness concerns.