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.

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.

AI/ML Overview

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	< 4.6 mg/device for EO and ECh (in accordance with AAMI/ANSI/ISO 10993-7:2008/(R)2012)	Successfully met the specified limit. (Statement: "Acceptable results (i.e., < 4.6 mg/device for EO and ECh) were obtained.")
Bacterial Endotoxin (Pyrogenicity)	< 20 EU/device (using principles of ANSI/AAMI/ST72:2019)	Successfully determined to be non-pyrogenic. (Statement: "Determined to be non-pyrogenic (< 20 EU/device).")
Sterile Barrier Testing	Maintained product and package integrity and sterility for intended shelf life.	Maintained integrity and sterility. (Statement: "FMCRTG concludes that the product and package integrity and sterility...is maintained for its intended shelf life.")
Structural Integrity (Bloodlines)	Withstand 1.5X labeled maximum positive and negative pressures.	Withstood pressures. (Statement: "All testing met predetermined acceptance criteria.")
Connectors to Hemodialyzers, etc.	Compliant with ISO 8637:2010 and ISO 8638:2010, and compatible with blood dialyzer ports.	Compliant and compatible. (Statement: "All testing met predetermined acceptance criteria.")
Connectors to Vascular Access Devices	Compliant with ISO 80369-7 and compatible with patient access.	Compliant and compatible. (Statement: "All testing met predetermined acceptance criteria.")
Connectors to Ancillary Components	Meet ISO 80369-7 requirements.	Met requirements. (Statement: "All testing met predetermined acceptance criteria.")
Color Coding	Meet ISO 8638 requirements.	Met requirements. (Statement: "All testing met predetermined acceptance criteria.")
Access Ports	Withstand 1.5X manufacturer's recommended maximum positive and negative pressures after multiple accesses.	Withstood pressures after multiple accesses. (Statement: "All testing met predetermined acceptance criteria.")
Blood Pathway Volume	Specify volume (implied: accurate specification).	Volume specified. (Statement: "All testing met predetermined acceptance criteria.")
Air-Capture Chamber Fill Level	IFU includes instructions related to recommended fill level.	Instructions included. (Statement: "All testing met predetermined acceptance criteria.")
Transducer Protectors (TPs)	Maintain secure and leak-free connection at 1.5X manufacturer's maximum pressure.	Maintained connection. (Statement: "All testing met predetermined acceptance criteria.")
Pump Segment Performance	Verify actual blood pump segment flow rate over 72 hours.	Verified flow rate over 72 hours. (Statement: "All testing met predetermined acceptance criteria.")
Tubing Compliance	Capable of being occlusively clamped at 1.5X recommended maximum pressure.	Capable of being clamped. (Statement: "All testing met predetermined acceptance criteria.")
Endurance Tests	Withstand maximum labeled flow rate (500 mL/min) and maximum pressure (-300 and 500 mmHg) for 63 hours.	Withstood conditions for 63 hours. (Statement: "All testing met predetermined acceptance criteria.")
Tensile Testing (Gluing Strength Connection Test)	Resistance load of gluing between tubes and components above 50% of stress resistance or relevant force.	Met resistance load criteria. (Statement: "All testing met predetermined acceptance criteria.")
Burst Test	Resistance of packaging to 1.5X maximum labeled pressure.	Resisted burst pressure. (Statement: "All testing met predetermined acceptance criteria.")
Dye Penetration	No channel in packaging per ASTM F1929.	No dye penetration. (Statement: "All testing met predetermined acceptance criteria.")
Seal Strength	≥ 3 N per ASTM F88.	Achieved ≥ 3 N. (Statement: "All testing met predetermined acceptance criteria.")
Visual Inspection for Packaging	Maintain product's structural integrity during handling and freight.	Maintained integrity. (Statement: "All testing met predetermined acceptance criteria.")
Biocompatibility	Compliant with ISO 10993-1:2018 and FDA guidance.	Demonstrated biological safety (Cytotoxicity, Sensitization, Intracutaneous Irritation, Material-Mediated Pyrogenicity, Systemic Toxicity, Genotoxicity, Hemocompatibility tests, Chemical Characterization, Toxicological Risk Assessment). (Statement: "All testing met predetermined acceptance criteria.")

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample sizes used for each individual test. It lists various tests conducted (e.g., sterilization tests, structural integrity tests, biocompatibility tests), but the number of units or repetitions for each test is not disclosed.

Provenance: This information is not explicitly stated. The tests were conducted by the manufacturer, Fresenius Medical Care Tidal Therapies Group, LLC. It is implied these are internal lab tests, not clinical data from patients.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable because:

The document describes engineering bench testing, sterilization validations, and biocompatibility assessments, not a study involving expert readers to establish ground truth for image or clinical data interpretation.
No experts were used to establish ground truth for a test set in the context of diagnostic interpretation, as this device is a therapeutic system (Continuous Renal Replacement Therapy).

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. There was no test set requiring human adjudication for diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The device is a therapeutic system, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not directly applicable. The "standalone" performance here relates to the mechanical, electrical, software, and biological performance of the multiFiltratePRO System itself as a medical device, which was extensively tested without human input influencing its intrinsic function once programmed. The software and machine functions were verified and validated independently.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests was established through:

Engineering specifications and standards: e.g., pressure ranges, flow rates, dimensions.
Regulatory standards and guidance: e.g., ISO 10993 for biocompatibility, AAMI/ANSI/ISO 10993-7 for EO residuals, ANSI/AAMI/ST72 for bacterial endotoxin, ISO 11607-1 for sterile barrier testing, ISO 8637/8638 for connectors and color coding, ISO 80369-7 for connectors.
Functional verification and validation protocols: Designed to confirm the device operates as intended.
Human factors validation: Ensuring safe and effective use based on usability principles.

8. Sample Size for the Training Set

Not applicable. This device is a therapeutic system and does not involve AI/machine learning models that require a "training set" of data in the typical sense. Its software is verified and validated through traditional software engineering methods, not by training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set in the context of an AI/machine learning model. The software's functionality and logic are based on predetermined algorithms and engineering designs, verified against specifications derived from medical, safety, and performance requirements.

Summary

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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

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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)

K220281

Device Name multiFiltratePRO System

Indications for Use (Describe)

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 StreetWaltham, MA02451-1457
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

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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 GlycolPolypropylene (PP)Acrylonitrile Butadiene Styrene (ABS)High density PolyethylenePolycarbonate (PC)PolyamideSiliconePolybutylene TerephthalatePolytetrafluoroethylenePolyisopreneThermoplastic ElastomerPolystyrenePentaerythritol 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/minIncrement: 10 mL/min
Dialysate Flow Rate	CVVHD, CVVHDFRange: 600-4800 mL/hrIncrement: 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/SubstitutionFluid Flow Rate	CVVH, CVVHDFRange: 600-4800 mL/hrIncrement: 10 mL/hr
Patient Fluid Removal Performance(Range)	0-990 mL/hrIncrement: 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/OuterDiameter (ID/OD)]	6.4 mm (ID), 10.0 mm (OD)

Table 2: Key Performance Specifications/Characteristics

5.5. Indications for Use

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., < 4.6 mg/device for EO and ECh) were obtained for the mFTPRO HDF Cassette.

Bacterial Endotoxin (Pyrogenicity) Testing 5.7.1.2.

The mFTPRO HDF Cassette was tested for bacterial endotoxin (pyrogenicity) with Limulus Amebocyte Lysate (LAL) and determined to be non-pyrogenic (< 20 EU/device) using principles of ANSI/AAMI/ST72:2019 Bacterial Endotoxins – Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.

Sterile Barrier Testing 5.7.1.3.

Sterility of the mFTPRO HDF Cassette is maintained by the Tyvek porous packaging bag (pouch). The package integrity tests were performed on the mFTPRO HDF Cassette packaging. Test selections included, but were not limited to, the application of principles established by ISO 11607-1. Based on the results, FMCRTG concludes that the product and package integrity and sterility of the mFTPRO HDF Cassette is maintained for its intended shelf life.

5.8. Performance Data

5.8.1. 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.

5.8.2. 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.

Test Conducted	Test Objective
Structural Integrity	Demonstrate that the bloodlines can withstand 1.5X the labeledmaximum positive and negative pressures
Connectors to Hemodialyzers,Hemodiafilters, or Hemofilters(Compatibility)	Verify that the design of the connectors is in compliance with ISO8637:2010 and ISO 8638:2010, and is compatible with the blooddialyzer ports
Test Conducted	Test Objective
Connectors to Vascular AccessDevices (Compatibility)	Verify that the design of the blood patient connectors of the Arterial andVenous lines is in compliance with ISO 80369-7 and is compatible withArterial line to the blood inlet access of the patient and the Venous lineto the blood return access of the patient
Connectors to AncillaryComponents (Compatibility)	Demonstrate that the connectors to ancillary components meet ISO80369-7 requirements
Color Coding	Demonstrate that the color-coded components meet the requirements ofISO 8638
Access Ports	Demonstrate that the injection ports can withstand 1.5X themanufacturer's recommended maximum positive and negativepressures after multiple accesses
Blood Pathway Volume	Specify the blood pathway volume of the subject device (arterial andvenous 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 thehemodialysis machine when subjected to pressures 1.5X themanufacturer'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 thevenous line clamp of the hemodialysis machine at 1.5X therecommended maximum pressure
Endurance Tests	Verify that the device can withstand maximum labeled flow rate(500 mL/min) and maximum pressure (-300 and 500 mmHg) for63 hours, which is equivalent to the runtime for the maximum labeledvolume
Tensile Testing (Gluing StrengthConnection Test)	Verify that the resistance load of the gluing between tubes andcomponents is above 50%. With respect to the stress resistance (daN) ofthe type of tube or above the force resulting from the analysis done,consider the mass of the tubing set filled with blood, the force identifiedat the interface between the pump tube and the machine pump, andstudies performed on specific components.
Burst Test	Demonstrate resistance of the packaging to 1.5X the maximum labeledpressure
Dye Penetration	Verify that there is no channel in the packaging to allow dye penetrationper ASTM F1929
Seal Strength	Verify that the seal strength of the packaging is ≥ 3 N per ASTM F88
Test Conducted	Test Objective
Visual Inspection for Packaging(Shipping Study)	Demonstrate that shipping case, packaging configuration, andpalletization pattern maintain the product's structural integrity duringmanual handling and motorized freight

Table 3: mFTPRO HDF Cassette Performance Testing Summary

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Image /page/8/Picture/0 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 chevrons pointing downwards. The text is in a bold, sans-serif font, with "FRESENIUS" on top of "MEDICAL CARE".

mFTPRO HDF Cassette Performance Testing Summary Table 3:

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Table 3: mFTPRO HDF Cassette Performance Testing Summary

5.8.3. 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.

5.8.4. 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).

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Electrical Safety and Electromagnetic Compatibility (EMC) 5.8.5.

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.

5.8.6. 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)

5.8.7. Animal Studies

No animal studies were conducted.

5.8.8. Clinical Studies

No clinical studies were conducted.

5.9. Conclusion

The information provided in this submission, including design verification, risk management, electrical safety, EMC, biocompatibility, and usability testing, demonstrates the mFTPRO System functions as intended and supports the determination of substantial equivalence to the predicate devices. Test results demonstrate that the differences between the proposed and the predicate devices do not raise any new concerns with regard to safety or effectiveness.

The Indications for Use, technological characteristics, design, and performance of the mFTPRO System are substantially equivalent to those of the predicate devices. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the mFTPRO System is safe and effective for its intended use.

Regulation Number and Section

§ 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.”