SMART M-CELL Bone Marrow Concentration System

The SMART M-CELL Bone Marrow Concentration System is a centrifuge-based device intended for use in clinical laboratories or intraoperatively at point-of-care to safely and rapidly prepare cell concentrate from bone marrow samples. The device separates bone marrow into component layers (erythrocytes, platelet-poor plasma, and platelet-rich plasma) through a two-phase centrifugation process for in vitro diagnostic use.

The device uses ethylene-propylene copolymer construction with a PD chamber, floating separator, cell extraction port, and manual aspiration method similar to the predicate. Key differences include centrifugation speeds of 2300 RPM (primary) and 2200 RPM (secondary) for 17–20 minutes total, compared to the predicate's single 2500 RPM spin for 14 minutes. Both devices are single-use, sterile, sterilized via ethylene oxide, and packaged in Tyvek trays with a 10⁻⁶ sterility assurance level.

Not stated in this summary. The document references FDA-recognized voluntary consensus standards and methods consistent with prior 510(k)s but does not explicitly cite specific ISO, IEC, or ASTM standards by designation.

The SMART M-CELL is substantially equivalent to the predicate SmartPReP2 Centrifuge System (K052925) because both share identical intended use (bone marrow cell concentration preparation), similar materials and construction, equivalent fluid separation methodology, and single-use sterile design. Comparative performance testing on bone marrow samples from healthy donors demonstrated equivalent cell count profiles and platelet recovery rates between the two devices, confirming that differences in centrifugation parameters and specifications do not raise safety or effectiveness concerns.