KIDS Arterial Filters

The KIDS Arterial Filters are single-use, sterile medical devices made of PVC plastic and silicon filtering material designed for use on the arterial line of cardiopulmonary bypass circuits. They trap and remove gaseous emboli and particulate debris from the arterial line during cardiac surgery procedures and are indicated for use up to 6 hours.

The modified KIDS Arterial Filters have the same fundamental technological characteristics, principles of operation, and control mechanisms as the predicate devices (KIDS D130 and D131). Key modifications include: replacement of PVC tubing in the purge/recirculation line to remove diethylhexyl phthalate (DEHP) plasticizer, and reformulation of the silicon diaphragm in the purge/recirculation valve. Updated technical specifications were tested to reflect current device design standards.

The devices comply with all applicable voluntary standards related to arterial filters and passed testing in accordance with national and international standards; however, specific standards (ISO, IEC, ASTM) are not identified in this summary.

The KIDS Arterial Filters are substantially equivalent because they maintain the same intended use (arterial line filtration during cardiopulmonary bypass) and the same fundamental technological principles as the predicate devices KIDS D130 (K063255) and KIDS D131 (K072308), which have been safely marketed for several years. The design modifications (DEHP removal and silicon valve reformulation) do not create new safety or effectiveness concerns, and comprehensive non-clinical verification and validation testing confirms equivalent performance. No clinical testing was necessary because the technical characteristics and indications remain equivalent to proven predicate devices.