Purema H Hemoconcentrator - Pediatric

The Purema® H Hemoconcentrator - Pediatric is a single-use hollow fiber filter device designed to remove excess fluid from blood during cardiopulmonary bypass in pediatric patients. It maintains proper hematocrit and protein concentration by using a polyethersulfone membrane with high permeability, allowing ultrafiltration through transmembrane pressure gradients similar to glomerular filtration.

The device uses polyethersulfone hollow fibers with a 0.3 m² surface area and smaller pediatric specifications compared to the predicate. It has a maximum transmembrane pressure of 500 mmHg, maximum blood flow of 300 ml/min, minimum blood flow of 50 ml/min, and a priming volume of 21 ml. It is sterilized with ethylene oxide and features twist-lock blood ports and female Luer Lock filtrate ports.

ISO 10993-1 (biocompatibility evaluation), ISO 10993-5 and ISO 10993-11 (cytotoxicity and acute systemic toxicity), ISO 10993-12 (irritation and sensitization), ISO 10993-3 and ISO/TR 10993-33 (genetic toxicity), ISO 10993-4:2017 (complement activation), ASTM F2382-18 (PTT assay), ASTM F2888-19 (platelet and leukocyte count), and USP <151> (pyrogen testing).

Both the Purema® H and predicate CAPIOX® Hemoconcentrator share identical intended use (fluid removal during cardiopulmonary bypass), same technological principle (ultrafiltration via transmembrane pressure), identical maximum TMP (500 mmHg), EtO sterilization, and comparable performance characteristics including solute clearance, sieving coefficients, and hemocompatibility. The main difference is the Purema® H is intentionally sized smaller (0.3 m² vs. 0.5 m²) specifically for pediatric patients, which is a reasonable variation within the same device category with similar clinical function.