The Optiflux Ultra dialyzers are the next generation of the Fresenius Optiflux family of single use dialyzers, which allow for the transfer of water and solutes between the blood and the dialysate through a semipermeable membrane. Available in five sizes, the dialyzers are differentiated by membrane surface area.

AI/ML Overview

The provided text describes the 510(k) notification for the Optiflux Ultra Dialyzers, a medical device used for hemodialysis. This document is a regulatory submission for substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this specific document.

Here's the information that can be extracted or deduced from the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical study comparing performance outcomes. Instead, it details that testing was conducted to support the determination of substantial equivalence to predicate devices. The "reported device performance" is essentially that the device was found to be "substantially equivalent" to its predicates based on the outlined tests.

Acceptance Criteria (Implied)	Reported Device Performance
Sterility and non-pyrogenicity	Validation and verification testing supports substantial equivalence.
Structural integrity (filter assembly positive and negative pressure testing, blood compartment integrity/transmembrane pressure testing)	Validation and verification testing supports substantial equivalence.
Performance (clearance testing, ultrafiltration performance testing, membrane performance)	Validation and verification testing supports substantial equivalence.
Biological Safety (Biocompatibility testing)	Validation and verification testing supports substantial equivalence.
Design/Configuration	Equivalent to predicate (Fresenius Optiflux F250NR).
Basic Scientific Technology membrane	Equivalent to predicate (Fresenius Optiflux F250NR).
Sterility	Equivalent to predicate (Fresenius Optiflux F250NR).
Materials	Equivalent to predicate (Fresenius Optiflux F250NR).
Intended Use	Equivalent to predicate devices (Fresenius Optiflux F250NR and Baxter Xenium XPH).
Design Characteristics (effective surface area, priming volume)	Equivalent to predicate devices (Fresenius Optiflux F250NR and Baxter Xenium XPH).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify general "sample sizes" for its performance tests. It mentions "results of validation and verification testing," which are typically internal engineering and laboratory tests and often don't refer to large patient cohorts in the way clinical studies might. Specific numbers of units tested are not provided.
Data Provenance: Not specified, but likely laboratory/manufacturing data. No information on country of origin or whether it's retrospective or prospective. This is not a study on clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a clinical study involving expert interpretation of data. The "ground truth" for device performance is based on established engineering and biocompatibility standards and comparison to predicate devices, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document describes regulatory clearance based on engineering and performance testing for substantial equivalence, not a clinical trial requiring adjudication of patient outcomes or interpretations.

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 document is for a physical medical device (dialyzer), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This document is for a physical medical device (dialyzer), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of the Optiflux Ultra dialyzers is based on technical specifications, established industry standards (e.g., for sterility, biocompatibility, filtration efficiency), and direct comparison to the performance characteristics of previously cleared predicate devices. It is not based on clinical expert consensus, pathology, or patient outcomes data in the context of this 510(k) summary.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study, so there is no "training set."

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

Not applicable. This is not an AI/machine learning study, so there is no "training set" or ground truth for it.

Summary of Study (as described in the document):

The "study" described in the document is a series of validation and verification tests conducted by Fresenius Medical Care North America (the manufacturer) to demonstrate that their new Optiflux Ultra dialyzers are substantially equivalent to legally marketed predicate devices (Fresenius Optiflux F250NR and Baxter Xenium XPH dialyzers).

The tests covered:

Sterility and non-pyrogenicity
Structural integrity (filter assembly positive and negative pressure testing, blood compartment integrity/transmembrane pressure testing)
Performance (clearance testing, ultrafiltration performance testing, membrane performance)
Biological Safety (Biocompatibility testing)

The objective of these tests was to show that the Optiflux Ultra dialyzers are equivalent in design, principle of operation, technology, materials, intended use, indications for use, and performance to the predicate devices, thereby being safe and effective for their intended use. This is a regulatory submission process, not a clinical trial.

Summary

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Optiflux Ultra Traditional 510(k) Notification

Section 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 in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92. A copy of this summary is also provided in Appendix 2.

5.1 Submitter's Information

Name:	Fresenius Medical Care North America
Address:	920 Winter StreetWaltham, MA 02451-1457
Phone:	(781) 699-4479
Fax:	(781) 699-9635
Contact Person:	Denise Oppermann, Senior DirectorRegulatory Affairs – DevicesRenal Therapies
Date of Preparation:	03 June 2013

5.2 Device Name

Trade Name:	Optiflux* Ultra F160, F180, F190, F210, F230
Common Name:	Dialyzer, High Permeability with or withoutSealed Dialysate System
Product Code/Classification Panel:	KDI Gastroenterology-Urology
Classification Name:	21 CFR§876.5860High Permeability Hemodialysis System

5.3 Legally Marketed Predicate Devices (unmodified devices)

Fresenius Optiflux F250NR, K082414 (10-28-2008) · Baxter Xenium XPH dialyzers, K083778 (02-20-2009)

5.4 Device Description

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5.5 Indications for Use

The Optiflux Ultra dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

Technological Characteristics 5.6

The Optiflux Ultra dialyzers and Fresenius Optiflux F250NR dialyzer (K082414) have equivalent technological characteristics:

. Design/Configuration
Basic Scientific Technology membrane of microcrimped, hollow fiber, Advanced . Fresenius Polysulfone
Sterility E-Beam, single use, non- pyrogenic .
Materials polyurethane (PU), polysulfone (PS), polycarbonate (PC), and silicone . (ટા)

The Optiflux Ultra dialyzers, Fresenius Optiflux F250NR dialyzer (K082414), and Baxter Xenium XPH dialyzers (K083778), have equivalent technological characteristics:

. Intended Use
Design Characteristics effective surface area, priming volume .

Performance Data 5.7

Testing was selected through the application of a risk management process, appropriate guidance documents and relevant standards. Results of validation and verification testing support the determination of substantial equivalence:

. Sterility and non-pyrogenicity testing
Structural integrity filter assembly positive and negative pressure testing and . blood compartment integrity (transmembrane pressure testing)
Performance clearance testing, ultrafiltration performance testing, membrane ◆ performance
Biological Safety Biocompatibility testing .

Conclusion 5.8

Based on the information and data provided in this Traditional 510(k), the Optiflux Ultra dialyzers are substantially equivalent in design, principle of operation, technology, materials to the predicate Fresenius Optiflux F250NR dialyzer (K082414). The Optiflux Ultra dialyzers are substantially equivalent in intended use, indications for use, and performance to the predicate devices, Fresenius Optiflux F250NR dialyzer (K082414) and Baxter Xenium dialyzers (K083778), and are safe and effective for their intended use.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is black and appears to be centered on a white background. The words are stacked on a single line.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2014

Fresenius Medical Care North America Denise Oppermann Senior Director, Regulatory Affairs - Devices 920 Winter Street Waltham, MA 02451

Re: K123262

Trade/Device Name: Fresenius Optiflux® Ultra F160, F190, F210, F230 dialyzers Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: December 18, 2013 Received: December 20, 2013

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. 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.

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Page 2 - Denise Oppermann

You must comply with all the Act's 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked on top of each other. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

Indications for Use Statement Section 4

510(k) Number: K123262

Device Name:

Fresenius Optiflux Ultra F160, F180, F180, F210, F230 dialyzers

Indications for Use: Optiflux Ultra F160, F190, F210, F230 dialyzers

The Optiflux Ultra dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

XPrescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner 2014.01.06 16:25:5

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.”