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Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.

The HBiofluids HMB32 is a bicarbonate-based dialysis solution packaged in a ready to mix, sterile, non-pyrogenic, two-chambered solution container system. One chamber contains the acidic solution and one chamber contains the basic solution. At the point of use, the membrane between the two chambers is opened, and the acidic and basic solutions are mixed to form the final ionic composition of the solution to be used in the Continuous Renal Replacement Therapy (CRRT) treatment. This solution is delivered to the patient while undergoing CRRT treatment in a healthcare facility.

The HBiofluids HMB32 solution will be offered in one formulation, in two different volumes: 500 mL +4500mL and 500mL +1500mL.

The provided text is a 510(k) Premarket Notification from the FDA to Haemopharm Biofluids S.r.l. regarding their HMB32 Dialysis Solution.

This document does not describe acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device. Instead, it is a declaration of substantial equivalence for a dialysis solution, which is a medical device and not an AI/ML algorithm.

Therefore, I cannot provide the requested information based on the input text. The information requested (acceptance criteria table, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is specific to the validation of AI/ML algorithms, which is not applicable to the HMB32 Dialysis Solution as described in this FDA clearance letter.

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