DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

The DHF 0.2, DHF 0.6, and SH 14 hemoconcentrators are single-use, sterile plastic devices designed for use in cardiopulmonary bypass circuits to remove fluid and restore the patient's normal red blood cell concentration (hematocrit). The choice of device depends on the filtration protocol and speed required, and each device is intended for use up to six hours.

The devices maintain the same fundamental technological characteristics, principles of operation, and control mechanisms as their predicate devices. The only design change is substitution of the O-ring elastomer material between the device housing and blood header caps from Santoprene to Silicone. The devices remain ethylene oxide sterilized with a non-pyrogenic fluid path for single use only.

The DHF and SH hemoconcentrators comply with all applicable voluntary standards related to dialysers and passed all testing in accordance with national and international standards, though specific standard citations (ISO, IEC, ASTM) are not enumerated in this summary.

The devices have identical intended use and technical characteristics to their predicate devices (K021732 for DHF models, K081313 for SH 14), differing only in the O-ring elastomer material, a change that does not alter the fundamental function or performance. Non-clinical verification and validation testing confirms compliance with applicable dialyser standards. Because the indications for use and core technological design are unchanged from predicates with several years of proven clinical safety and efficacy, no new safety or effectiveness questions are raised.