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The multiFiltratePRO System is indicated for the following use: Continuous Renal Replacement Therapy (CRRT) for patients weighing 40 kilograms or more with acute renal failure with or without fluid overload.

All treatments administered by the multiFiltratePRO System must be prescribed by a physician.

The multiFiltratePRO System (hereinafter referred to as the "mFTPRO System") is designed to provide Continuous Renal Replacement Therapy (CRRT) dialysis.

The mFTPRO System consists of the following components:

• . mFTPRO Machine
• . mFTPRO HDF Cassette
• mFTPRO Accessories .
• । multiEffluent Bag, 10 L
• Adapter Hemofiltration (HF) Female Luer Lock Male ।
• Hemofiltration (HF) Female Spike Adapter -
• | Pressure Line for MTS (Medizin Tecknik Schweinfurt)
• । Vented Spike

The mFTPRO Machine is an electromechanical device. Software controls the machine during treatment, including fluid flow, mixing, heating, and alarms.

The mFTPRO HDF Cassette is single-use, ethylene oxide (EO) sterilized tubing cassette.

The mFTPRO System provides CRRT dialysis. The following CRRT modalities will be available with the mFTPRO System:

• CVVHD Continuous Veno Venous Hemodialysis .
• CVVH Continuous Veno Venous Hemofiltration, with pre-dialyzer dilution, post-● dialyzer dilution, and pre-post-dialyzer dilution
• . CVVHDF - Continuous Veno Venous Hemodiafiltration, with both pre-dialyzer dilution and post-dialyzer dilution

A high-resolution touchscreen monitor and four (4) operating buttons allow the user to view, monitor, input, and change parameters to manage the treatment on the mFTPRO Machine. In the extracorporeal blood circuit, blood is pumped from the patient through a dialyzer attached to the tubing cassette and back to the patient. Blood, filtrate, dialysate, substitution fluid, and heparin pumps are used as indicated to meet individual patient needs and various therapy modes. Integrated heaters can be used to heat the dialysate and/or substitution fluids as necessary.

The mFTPRO HDF Cassette is indicated for use with the mFTPRO System and can be used for the following CRRT treatment modes: CVVHD, CVVH, and CVVHDF. The cassette is part of the extracorporeal circuit. During treatment, the extracorporeal circuit transports blood from the patient's venous access (e.g., double or two (2) single lumen venous catheters) through a hemodialyzer and back to the patient's venous access.

Anticoagulation of the patient's blood is accomplished by systemic heparin anticoagulation via an integrated heparin pump. This pump can also be used to administer a bolus when required. An infusion line for anticoagulation is included in the cassette.

The acceptance criteria and study proving device performance are not explicitly detailed in the provided text in the format requested. The document is a 510(k) summary for the Fresenius Medical Care multiFiltratePRO System, focusing on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a single study with specific performance metrics and statistical analyses.

However, based on the information provided, I can extract the general categories of performance testing undertaken and state that "all testing met predetermined acceptance criteria." Specific performance values are given for some characteristics, which could be considered the "reported device performance."

Here's an attempt to structure the answer based on the provided text, while acknowledging the limitations in detail:

Acceptance Criteria and Device Performance Study for the multiFiltratePRO System

The multiFiltratePRO System underwent various performance tests to demonstrate substantial equivalence to its predicate devices (PrisMax cleared under K163350 for the system and Prismaflex HF 1000 Set/HF 1400 Set cleared under K042938 for the HDF Cassette). All testing met predetermined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria for each test (e.g., minimum required tensile strength, maximum allowable pressure deviation) are not provided, the table below lists the performance specifications or objectives that implicitly served as acceptance criteria, alongside the reported performance indicating these were met.

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