The Optiflux F180NR dialyzer is a high-flux, single-use, ethylene oxide (EO) sterilized hemodialyzer. The dialyzer is provided blood pathway sterile and non-pyrogenic. The membrane surface area is 1.7 m2.

AI/ML Overview

This document is a 510(k) summary for the Fresenius Medical Care Optiflux F180NR Dialyzer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML medical device.

Therefore, many of the requested points are not applicable to this type of submission.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" against "reported device performance" similar to what might be found for a new AI/ML device where specific metrics (e.g., sensitivity, specificity, AUC) are presented against predefined thresholds.

Instead, the document states:

"All testing met predetermined acceptance criteria. Results of the proposed device design verification tests met the requirements and demonstrated that, like the predicate device, the Optiflux F180NR dialyzer is safe and effective for its intended use." (Page 6)

The "key performance characteristic" explicitly mentioned is Urea clearance, with Sodium clearance being used as a marker.

Acceptance Criteria	Reported Device Performance
Urea Clearance (as measured by Sodium clearance)	278 (Typical Urea Clearance for Optiflux F180NR, from Table 1, page 5)
Blood Compartment Volume	Met requirements (details not quantified in this summary)
Clearance (Sodium, Vitamin B12, Creatinine, Phosphate, Lysozyme)	Met requirements (details not quantified in this summary)
Protein Sieving Coefficient	Met requirements (details not quantified in this summary)
Ultrafiltration	Met requirements (details not quantified in this summary)
Pressure Drop	Met requirements (details not quantified in this summary)
Structural Integrity	Met requirements (details not quantified in this summary)
Blood Compartment Integrity	Met requirements (details not quantified in this summary)
Simulated Shipping and Distribution	Met requirements, maintaining product and package integrity and sterility (details not quantified in this summary)
Biocompatibility (various tests listed on pages 6-7)	Met requirements
Human Factors Validation Testing	Leveraged to demonstrate safe and effective use

Note: The document states that performance testing was conducted in accordance with ISO 8637:2010 and FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. The specific numerical acceptance criteria for each test are not provided in this summary.

2. Sample size used for the test set and the data provenance

The document provides a summary of tests performed, but does not specify the sample sizes (number of devices, or specific data points) used for each test. It also does not mention data provenance (e.g., country of origin, retrospective/prospective) for these engineering and performance tests, as these are typically bench-top or in vitro tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical hemodialyzer, not an AI/ML device that relies on expert interpretation for ground truth. The "ground truth" for its performance is established through standardized engineering and in vitro testing methods.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert ground truth establishment for AI/ML devices. For this physical device, performance is evaluated against engineering specifications and standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (dialyzer), not an AI/ML software. Therefore, MRMC studies and AI assistance for human readers are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established through standardized in vitro bench testing following recognized international standards (ISO 8637:2010) and FDA guidance documents. This includes:

Calculated measurements (e.g., blood compartment volume, ultrafiltration, pressure drop).
Analytical testing of samples (e.g., clearance of various substances, protein sieving coefficient).
Physical integrity tests (e.g., structural and blood compartment integrity).
Biocompatibility tests (e.g., cytotoxicity, sensitization, hemolysis).
Simulated shipping and distribution tests.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no "training set" for a physical dialyzer.

Summary

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September 21, 2020

Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, Massachusetts 02451

Re: K192707

Trade/Device Name: Optiflux F180NR Dialyzer Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI Dated: August 20, 2020 Received: August 21, 2020

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 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,

Carolyn Y. Neuland, Ph.D. 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) K192707

Device Name Optiflux® F180NR Dialyzer

Indications for Use (Describe)

Optiflux Dialyzers are intended for patients with acute kidney disease when conservative therapy is judged to be inadequate.

Type of Use (Select one or both, as applicable)

X 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, also in blue. The symbol is made up of three downward-pointing chevron shapes stacked on top of each other.

510(K) SUMMARY 5.

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 DirectorRegulatory Affairs – Devices
Preparation Date:	26 September 2019

5.2. Device Name

Trade Name:	Optiflux F180NR Dialyzer
Common Name:	Dialyzer
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
Classification Panel:	Gastroenterology/Urology

5.3. Legally Marketed Predicate Device

The legally marketed predicate device is the Optiflux F180NRe dialyzer cleared under K152367. This device has not been subject to a design-related recall.

Device Description 5.4.

5.4.1. Device Identification

The Optiflux F180NR dialyzer is the subject of this 510(k).

5.4.2. Device Characteristics

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Image /page/4/Picture/0 description: The image shows the logo for Fresenius Medical Care. 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 and is also blue.

5.4.2.1. Environment of Use

The Optiflux F180NR dialyzer is used in environments where acute and chronic hemodialysis are performed.

5.4.2.2. Brief Written Description of the Device

The Optiflux F180NR dialyzer is a high-flux, sterile device designed for single-use acute and chronic hemodialysis. The dialyzer is configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzer contains a semi-permeable membrane that allows for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

5.4.2.3. Materials of Use

The Optiflux F180NR dialyzer 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" (16 June 2016).

Component	Material
Housing	Polycarbonate
Potting Resin	Polyurethane
Fiber Bundle	Polysulfone
Screw Flange	Polycarbonate
O-Ring	Silicone
Blood Port Cap(s)	High Density Polyethylene
Dialysate Port Cap	High Density Polyethylene

The Optiflux F180NR dialyzer is composed of the following materials:

5.4.2.4. Key Performance Characteristics

Urea clearance is a key performance specification of the Optiflux F180NR dialyzer. FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across a membrane. Sodium clearance data from the Instructions for Use (IFU) for the Optiflux F180NR dialyzer is provided in Table 1.

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In vitro Urea Clearance for the F180NR Dialyzer* Table 1:

Trade Name	Typical Urea Clearance(Sodium Used as Marker)
Optiflux F180NR	278

*Qb = 300 mL/min, Qd = 500 mL/min, Quf = 0 mL/min

Intended Use 5.5.

Optiflux dialyzers are designed for single use acute and chronic hemodialysis.

Indications for Use 5.6.

Optiflux Dialyzers are intended for patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

5.7. Comparison of Technological Characteristics with the Predicate Device

The following technological characteristics of the Optiflux F180NR dialyzer are substantially equivalent to those of the predicate Optiflux F180NRe dialyzer (K152367).

Intended use ●
Principle of operation
Design characteristics
Patient fluid-contacting materials: polysulfone, polycarbonate, polyurethane, and silicone

5.8. Performance Data

Performance testing was conducted in accordance with ISO 8637:2010 and Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. Testing conducted to support the determination of substantial equivalence is summarized in Table 2.

Test Conducted	Test Method Description
Blood Compartment Volume	Calculated, considering the fiber inner diameter, fiber crimp,the minimum and maximum blood volume, O-ringcompression volume, dialyzer housing length, andpolyurethane height.
Clearance – Sodium (marker forurea), Vitamin B12, Creatinine,Phosphate, and Lysozyme	Calculated by analyzing the test samples over the specifiedrange of blood and dialysate flow rates.
Protein Sieving Coefficient	The test circuit was stabilized for blood and filtrate flows. Allair was removed from the dialyzer. Paired samples for bloodand filtrate flows were collected after 15 min. Samples were

Performance Testing Summary Table 2:

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Test Conducted	Test Method Description
	taken again after another 15 min. Sieving coefficient wascalculated in accordance with Section 5.6.2.4 of ISO8637:2010.
Ultrafiltration	Calculated as the slope from a plot of the measuredtransmembrane pressure versus the ultrafiltration rate.
Pressure Drop	The dialysate and blood compartments were filled withdialysate and bovine blood, respectively. Inlet and outletpressures of the blood and dialysate compartments weremeasured across the range of flow rates with the dialyzers in ahorizontal position.
Structural Integrity	The positive and negative pressure decay was measured by apressure monitor connected at one end of the dialyzer whileapplying 900 mmHg and -700 mmHg from opposite ends.
Blood Compartment Integrity	Air and water were added to the top blood port and thedialysate side, respectively. A pressure differential wasapplied across the dialyzer membrane.
Simulated Shipping andDistribution	Testing was conducted per ASTM D4169-16. Performancetesting was conducted before and after simulated shipping todemonstrate that the product and package integrity andsterility are maintained throughout the intended product shelflife.

Performance Testing Summary Table 2:

All testing met predetermined acceptance criteria. Results of the proposed device design verification tests met the requirements and demonstrated that, like the predicate device, the Optiflux F180NR dialyzer is safe and effective for its intended use.

5.8.1. Biocompatibility Testing

Testing was performed to support the biological safety of the Optiflux F180NR dialyzer.

Chemical Analysis - Extractables and Leachables
. Cytotoxicity, ISO Elution Method with MEM
Sensitization, Guinea Pig Maximization
Intracutaneous Irritation
Acute Systemic Toxicity
Systemic Toxicity, Short-Term Repeated Exposure ●
Material-Mediated Pyrogenicity
Genotoxicity, Bacterial Reverse Mutation Assay ●

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Image /page/7/Picture/0 description: The image contains 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, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.

. Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay
. Hemocompatibility, ASTM Hemolysis (Direct and Indirect - Extract)
Hemocompatibility, Complement Activation - SC5b-9 fragment
Hemocompatibility, ASTM Partial Thromboplastin Time ●
Hemocompatibility, Mechanical Hemolysis
Hemocompatibility, in vitro Thrombogenicity Assay ●
Hemocompatibility, Platelet and Leukocyte Function
PVP Testing .

A toxicological risk assessment was also performed.

5.8.2. Human Factors Validation Testing

Human factors (HF) validation testing was leveraged for Optiflux F180NR dialyzer to demonstrate its safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).

5.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)

Not applicable. The Optiflux F180NR dialyzer is not an electrical mechanical device.

Software Verification and Validation Testing 5.8.4.

Not applicable. The Optiflux F180NR dialyzer does not contain software.

5.8.5. Animal Studies

No animal studies were performed.

5.8.6. Clinical Studies

No clinical studies were performed.

5.9. Conclusion

The intended use, principle of operation, design characteristics, and patient fluid-contacting materials of the Optiflux F180NR dialyzer are substantially equivalent to that of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the Optiflux F180NR device 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.”