(318 days)
Not Found
No
The description mentions software controlling the machine for fluid flow, mixing, heating, and alarms, but there is no mention of AI or ML capabilities for decision-making, pattern recognition, or adaptive control beyond standard programming.
Yes
The device is indicated for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure, which is a therapeutic intervention.
No
This device is designed to provide Continuous Renal Replacement Therapy (CRRT) dialysis, which is a treatment for acute renal failure. It does not perform diagnostic functions.
No
The device is described as a system consisting of an electromechanical machine, a tubing cassette, and accessories, all of which are hardware components. While software controls the machine, the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Continuous Renal Replacement Therapy (CRRT) for patients weighing 40 kilograms or more with acute renal failure with or without fluid overload." This describes a therapeutic treatment performed directly on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a system for filtering blood and removing waste products and excess fluid from the patient's body. This is a life-support and therapeutic function, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The multiFiltratePRO System's function is to treat a condition (acute renal failure) through a physical process (dialysis), not to diagnose or monitor a condition through the analysis of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients weighing 40 kilograms or more
Intended User / Care Setting
The mFTPRO System is intended to be used in healthcare facilities.
All treatments administered by the multiFiltratePRO System must be prescribed by a physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
mFTPRO Machine Performance Testing Summary
The following performance tests were conducted on the mFTPRO Machine to support the determination of substantial equivalence:
- Software Verification and Validation
- Functional Design Verification
- Electrical Safety and Electromagnetic Compatibility (EMC)
- Essential Performance ●
- Simulated Shipping and Distribution
All testing met predetermined acceptance criteria.
mFTPRO HDF Cassette Performance Testing Summary
Testing conducted to support the determination of substantial equivalence for the mFTPRO HDF Cassette is summarized in Table 3.
- Structural Integrity: Demonstrate that the bloodlines can withstand 1.5X the labeled maximum positive and negative pressures
- Connectors to Hemodialyzers, Hemodiafilters, or Hemofilters (Compatibility): Verify that the design of the connectors is in compliance with ISO 8637:2010 and ISO 8638:2010, and is compatible with the blood dialyzer ports
- Connectors to Vascular Access Devices (Compatibility): Verify that the design of the blood patient connectors of the Arterial and Venous lines is in compliance with ISO 80369-7 and is compatible with Arterial line to the blood inlet access of the patient and the Venous line to the blood return access of the patient
- Connectors to Ancillary Components (Compatibility): Demonstrate that the connectors to ancillary components meet ISO 80369-7 requirements
- Color Coding: Demonstrate that the color-coded components meet the requirements of ISO 8638
- Access Ports: Demonstrate that the injection ports can withstand 1.5X the manufacturer's recommended maximum positive and negative pressures after multiple accesses
- Blood Pathway Volume: Specify the blood pathway volume of the subject device (arterial and venous lines)
- Air-Capture Chamber Fill Level: Verify the instructions related to the recommended fill level of the air-capture chambers are included in the Instructions for Use (IFU)
- Transducer Protectors (TPs): Verify the TP can maintain a secure and leak-free connection to the hemodialysis machine when subjected to pressures 1.5X the manufacturer's maximum pressure
- Pump Segment Performance: Verify the actual blood pump segment flow rate over 72 hours
- Tubing Compliance: Verify that the tubing is capable of being occlusively clamped by the venous line clamp of the hemodialysis machine at 1.5X the recommended maximum pressure
- Endurance Tests: Verify that the device can withstand maximum labeled flow rate (500 mL/min) and maximum pressure (-300 and 500 mmHg) for 63 hours, which is equivalent to the runtime for the maximum labeled volume
- Tensile Testing (Gluing Strength Connection Test): Verify that the resistance load of the gluing between tubes and components is above 50%. With respect to the stress resistance (daN) of the type of tube or above the force resulting from the analysis done, consider the mass of the tubing set filled with blood, the force identified at the interface between the pump tube and the machine pump, and studies performed on specific components.
- Burst Test: Demonstrate resistance of the packaging to 1.5X the maximum labeled pressure
- Dye Penetration: Verify that there is no channel in the packaging to allow dye penetration per ASTM F1929
- Seal Strength: Verify that the seal strength of the packaging is ≥ 3 N per ASTM F88
- Visual Inspection for Packaging (Shipping Study): Demonstrate that shipping case, packaging configuration, and palletization pattern maintain the product's structural integrity during manual handling and motorized freight
Biocompatibility Testing
Biocompatibility testing for the mFTPRO System patient-contacting components was conducted in accordance with ISO 10993-1:2018 and FDA guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (04 September 2020). The following testing was conducted to support the biological safety of the mFTPRO HDF Cassette:
- Cytotoxicity, ISO MEM Elution
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation
- Material-Mediated Pyrogenicity
- Systemic Toxicity, Acute
- Systemic Toxicity, Subchronic
- Genotoxicity, Gene Mutation
- Genotoxicity, Chromosome Aberration
- Hemocompatibility, ASTM Hemolysis (Direct)
- Hemocompatibility, In Vitro Thrombosis
- Hemocompatibility, Prothrombin Time
- Hemocompatibility, Platelet Count
- Hemocompatibility, Leukocyte Count
- Hemocompatibility, Complement 3a
- Chemical Characterization
A Toxicological Risk Assessment was also performed.
Human Factors Validation Testing
The mFTPRO System was validated for safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety testing for the mFTPRO Machine was conducted in accordance with ANSI/AAM ES 60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
EMC for the mFTPRO Machine was performed in accordance with IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
Software Verification and Validation Testing
Unit, integration, and system level software verification testing were performed to demonstrate the efficacy of the software and to confirm operation of the device. Software verification information within this submission is provided in accordance with the following FDA guidance documents:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (11 May 2005)
- Guidance for Off-The-Shelf Software Use in Medical Devices (27 September 2019)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (02 October 2014)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 16, 2022
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, Massachusetts 02451
Re: K220281
Trade/Device Name: multiFiltratePRO System Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: January 31, 2022 Received: February 1, 2022
Dear Denise Oppermann:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jade M. Noble -S
For
Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name multiFiltratePRO System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons, stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5. 510(K) SUMMARY
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
5.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Preparation Date: | 31 January 2022 |
5.2. Device Name
| Trade Name: | multiFiltratePRO System |
|---|---|
| Common Name: | Dialyzer, High Permeability With or Without Sealed Dialysate System |
| Regulation Name: | High Permeability Hemodialysis System |
| Regulatory Class: | Class II per 21 CFR § 876.5860 |
| Product Code: | KDI |
| Product Code Name: | Dialyzer, High Permeability With or Without Sealed Dialysate System |
| FDA Review Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The predicate device for the multiFiltratePRO System is the PrisMax cleared under K163530. The predicate device for the multiFiltratePRO Hemodiafiltration (HDF) Cassette is the Prismaflex HF 1000 Set and HF 1400 Set cleared under K042938.
Neither of the predicate devices has been subject to an open design-related recall.
5.4. Device Description
5.4.1. Device Identification:
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 .
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Image /page/4/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
- । 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
5.4.2. Device Characteristics
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.
5.4.3. Environment of Use
The mFTPRO System is intended to be used in healthcare facilities.
Brief Written Description of the Device 5.4.4.
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.
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Image /page/5/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
multiFiltratePRO System Traditional 510(k)
5.4.5. Materials of Use
The mFTPRO HDF Cassette is classified as externally communicating, circulating blood, prolonged contact (> 24 hours to 30 days) duration, Class II (Category B) device in accordance with FDA guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (04 September 2020). The materials for the cassette components are listed in Table 1.
| Component | Material |
|---|---|
| Tubing and Components | Polyvinylchloride (PVC) |
| Terephthalate Glycol | |
| Polypropylene (PP) | |
| Acrylonitrile Butadiene Styrene (ABS) | |
| High density Polyethylene | |
| Polycarbonate (PC) | |
| Polyamide | |
| Silicone | |
| Polybutylene Terephthalate | |
| Polytetrafluoroethylene | |
| Polyisoprene | |
| Thermoplastic Elastomer | |
| Polystyrene | |
| Pentaerythritol Triacrylate | |
| Bonding Solvent | TetraMEK (95% Tetrahydrofuran/5% MEK) |
Table 1: Cassette Materials
Key Performance Specifications/Characteristic 5.4.6.
The key performance specifications and characteristics for the mFTPRO System (mFTPRO Machine and mFTPRO HDF Cassette) are outlined in Table 2.
Key Performance Specifications/Characteristics Table 2:
| Feature | Specification/Characteristic |
|---|---|
| mFTPRO Machine | |
| Blood Flow Rate | Range: 10–500 mL/min |
| Increment: 10 mL/min | |
| Dialysate Flow Rate | CVVHD, CVVHDF |
| Range: 600-4800 mL/hr | |
| Increment: 10 mL/hr |
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Image /page/6/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue abstract symbol on the left, resembling a stylized downward-pointing arrow or chevron made up of three stacked shapes. To the right of the symbol is the text "FRESENIUS" in a bold, sans-serif font, stacked above "MEDICAL CARE", also in a bold, sans-serif font. The color of the text is the same blue as the symbol.
| Feature | Specification/Characteristic |
|---|---|
| Replacement Solution/Substitution | |
| Fluid Flow Rate | CVVH, CVVHDF |
| Range: 600-4800 mL/hr | |
| Increment: 10 mL/hr | |
| Patient Fluid Removal Performance | |
| (Range) | 0-990 mL/hr |
| Increment: 10 mL/hr | |
| mFTPRO HDF Cassette | |
| Maximum Blood Flow Rate | 500 mL/min |
| Minimum Arterial (Access) Pressure | -300 mmHg |
| Maximum Venous (Return) Pressure | 500 mmHg |
| Blood Pump Segment [Inner/Outer | |
| Diameter (ID/OD)] | 6.4 mm (ID), 10.0 mm (OD) |
Table 2: Key Performance Specifications/Characteristics
5.5. Indications for Use
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.
5.6. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the mFTPRO System and its components (i.e., mFTPRO HDF Cassette) are substantially equivalent to the primary predicate device PrisMax (K163530) and secondary predicate Prismaflex HF 1000 Set/HF 1400 Set (K042938):
- Indications for Use ●
- Technological Characteristics
- Anticoagulation Method
- . Therapy Modes
5.7. Sterilization Testing (Cassette)
The mFTPRO HDF Cassette is sterilized by exposure to EO. The sterility assurance level (SAL) is 10-6. Sterility and non-pyrogenicity are claimed for the fluid pathway of the cassette.
EO Residual Testing 5.7.1.1.
Residual testing for EO and ethylene chlorohydrin (ECh) was performed in accordance with AAMI/ANSI/ISO 10993-7:2008/(R)2012 Biological Evaluation of Medical Devices – Part 7: Ethylene
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Image /page/7/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The abstract symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
Oxide Sterilization Residuals. Acceptable results (i.e.,