(318 days)
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.
| Feature / Test Category | Acceptance Criteria (Implied by Specification/Objective) | Reported Device Performance |
|---|---|---|
| mFTPRO Machine | ||
| Blood Flow Rate | Range: 10–500 mL/min, Increment: 10 mL/min | Met range and increment specifications. (Statement: "All testing met predetermined acceptance criteria.") |
| Dialysate Flow Rate | CVVHD, CVVHDF: Range: 600-4800 mL/hr, Increment: 10 mL/hr | Met range and increment specifications. (Statement: "All testing met predetermined acceptance criteria.") |
| Replacement Solution/Substitution Fluid Flow Rate | CVVH, CVVHDF: Range: 600-4800 mL/hr, Increment: 10 mL/hr | Met range and increment specifications. (Statement: "All testing met predetermined acceptance criteria.") |
| Patient Fluid Removal Performance | Range: 0-990 mL/hr, Increment: 10 mL/hr | Met range and increment specifications. (Statement: "All testing met predetermined acceptance criteria.") |
| Software | Verification and Validation conducted to demonstrate efficacy and confirm operation. Followed FDA guidance. | Successfully verified and validated. (Statement: "All testing met predetermined acceptance criteria.") |
| Functional Design | Verified functional design. | Verified. (Statement: "All testing met predetermined acceptance criteria.") |
| Electrical Safety & EMC | Compliant with ANSI/AAM ES 60601-1:2005/(R) 2012 and IEC 60601-1-2:2014. | Compliant with specified standards. (Statement: "All testing met predetermined acceptance criteria.") |
| Essential Performance | Demonstrated essential performance. | Demonstrated. (Statement: "All testing met predetermined acceptance criteria.") |
| Simulated Shipping & Distribution | Demonstrated ability to withstand simulation conditions. | Withstood conditions. (Statement: "All testing met predetermined acceptance criteria.") |
| Human Factors Validation | Validated for safe and effective use in accordance with FDA guidance. | Validated for safe and effective use. (Statement: "All testing met predetermined acceptance criteria.") |
| mFTPRO HDF Cassette | ||
| Maximum Blood Flow Rate | 500 mL/min | Achieved 500 mL/min. (Statement: "All testing met predetermined acceptance criteria.") |
| Minimum Arterial (Access) Pressure | -300 mmHg | Maintained -300 mmHg. (Statement: "All testing met predetermined acceptance criteria.") |
| Maximum Venous (Return) Pressure | 500 mmHg | Maintained 500 mmHg. (Statement: "All testing met predetermined acceptance criteria.") |
| Blood Pump Segment (ID/OD) | 6.4 mm (ID), 10.0 mm (OD) | Conformed to specifications. (Statement: "All testing met predetermined acceptance criteria.") |
| Sterility Assurance Level (SAL) | 10^-6 | Achieved SAL of 10^-6. (Statement: "All testing met predetermined acceptance criteria.") |
| EO Residuals |
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”