The xevonta dialyzer is a polysulfone high flux dialyzer with the surface areas 1.2 m², 1.5 m2, 1.8 m2, 2.0 m2, 2.3 m2. It is designed for single use in acute and chronic hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.

The polysulfone hollow fiber (membrane) is housed within a plastic cylinder containing four ports: two ports for blood compartment access and two ports for dialysate access.

AI/ML Overview

This document is a 510(k) premarket notification for the "xevonta dialyzer". It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to previously marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table with formal acceptance criteria against which numerical performance metrics are directly compared for the new device. Instead, it states that the testing aimed to demonstrate equivalence with the predicate devices. This implies that the performance of the xevonta dialyzer was expected to be comparable to, or within an acceptable range of, the predicate devices for each tested parameter.

Below is a table summarizing the tested parameters and the general conclusion regarding performance, as direct numerical targets for acceptance criteria are not provided.

Performance Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Complies with ISO 10993-1 and FDA Guidance for category B device	Testing performed; results demonstrate safety.
In-vitro Ultrafiltration Rate	Comparable to predicate devices	Results demonstrate similar performance to predicate devices.
Pressure Drop (Blood Side)	Comparable to predicate devices	Results demonstrate similar performance to predicate devices.
Pressure Drop (Dialysate Side)	Comparable to predicate devices	Results demonstrate similar performance to predicate devices.
Clearances (Urea)	Comparable to predicate devices	Results demonstrate similar performance to predicate devices.
Clearances (Creatinine)	Comparable to predicate devices	Results demonstrate similar performance to predicate devices.
Clearances (Vitamin B12)	Comparable to predicate devices	Results demonstrate similar performance to predicate devices.
Mechanical Hemolysis	Comparable to predicate devices (acceptable levels)	Results demonstrate similar performance to predicate devices.
In-vitro & In-vivo Ultrafiltration Coefficient	Comparable to predicate devices	Results demonstrate similar performance to predicate devices.
Overall Safety and Effectiveness	As safe and effective as predicate devices	"The data provided for the new device demonstrates that xevonta dialyzers are as safe and effective as the marketed predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for the "test set" in any of the described studies (biocompatibility, in vitro performance, clinical testing). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

Given the nature of the device (dialyzer) and the types of tests mentioned, it is highly probable that:

Biocompatibility testing would have used standard laboratory samples according to ISO 10993.
In vitro performance testing would involve a set number of dialyzers for each model and surface area, tested under controlled laboratory conditions.
Clinical testing (comparison of in-vitro and in-vivo ultrafiltration coefficient) would have been performed on a cohort of human subjects undergoing hemodialysis. This would most likely be a prospective study, though its location is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the studies described. The "ground truth" concept, often used in AI/ML performance evaluation (e.g., for image interpretation), does not directly apply here. The studies involve objective measurements of physical and chemical properties of the dialyzer and their performance in a clinical setting, rather than subjective interpretations by experts.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the studies involve objective measurements, not subjective evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI systems that assist human readers in making diagnoses. The xevonta dialyzer is a medical device (a high permeability hemodialysis system) for which performance is assessed through biophysical and clinical parameters, not human interpretation of data.

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

Not applicable. The xevonta dialyzer is a passive medical device, not an algorithm or AI system. Its performance is inherent in its physical and chemical properties and how it functions during hemodialysis. "Standalone performance" in this context refers to the device's function independent of human interaction beyond its setup and monitoring during use. The in-vitro tests represent this form of standalone performance.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation comes from:

Established scientific and regulatory standards: For biocompatibility (ISO 10993-1).
Instrumental measurements: For in-vitro performance parameters like ultrafiltration rate, pressure drop, and clearances.
Clinical measurements: For in-vivo ultrafiltration coefficient, which would be measured directly from patients.
Predicate device performance: The performance of the legally marketed predicate devices provided the benchmark for "substantial equivalence."

8. Sample Size for the Training Set

Not applicable. The xevonta dialyzer is a manufactured 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 there is no training set for this type of device.

Summary

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

March 1, 2016

B. Braun Avitum AG % Tracy Maddock, RAC Sr. Regulatory Affairs Specialist B. Braun Medical, Inc. 901 Marcon Boulevard Allentown, PA 18109-9341

Re: K143482

Trade/Device Name: Xevonta Dialyzer Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: February 26, 2016 Received: February 29, 2016

Dear Tracy Maddock,

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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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 contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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 vours.

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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Indications for Use

510(k) Number (if known) K143482

Device Name xevonta dialyzer

Indications for Use (Describe)

The xevonta dialyzer is designed for single use in acute and chronic hemodialysis.

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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B. Braun Avitum AG 510(k) Premarket Notification xevonta dialyzers

5. 510(k) SUMMARY	K143482
APPLICANT:	B. Braun Avitum AGSchwarzenberger Weg 73-7934212 MelsungenGermany
SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500Contact: Tracy Maddock,RACSr. Regulatory Affairs SpecialistPhone: (610) 596-2545Fax: (610) 266-4962E-mail: tracy.maddock@bbraun.com
DATE:	February 29, 2016
DEVICE NAME:	xevonta dialyzerModels: xevonta 1.2 m2, xevonta 1.5 m2, xevonta 1.8 m2,xevonta 2.0 m2, xevonta 2.3 m2
COMMON ORUSUAL NAME:	High permeability polysulfone high flux dialyzer
DEVICECLASSIFICATION:	Class II21 CFR §876.5860, High permeability hemodialysis systemProduct Code: KDI
PREDICATE DEVICES:	Diacap HiFlo 23 Dialyzer, B. Braun Avitum AG, K100334,Class II, KDI, 876.5860
	Diacap HIPS Dialyzers, B. Braun Avitum AG, K071518,Class II, KDI, 876.5860

DESCRIPTION:

The xevonta dialyzer is a polysulfone high flux dialyzer with the surface areas 1.2 m², 1.5 m2, 1.8 m2, 2.0 m2, 2.3 m2. It is designed for single use in acute and chronic

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B. Braun Avitum AG 510(k) Premarket Notification xevonta dialyzers

hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.

The polysulfone hollow fiber (membrane) is housed within a plastic cylinder containing four ports: two ports for blood compartment access and two ports for dialysate access.

INTENDED USE:

The xevonta dialyzer is designed for single use in acute and chronic hemodialysis.

COMPARISON FOR SUBSTANTIAL EQUIVALENCE:

Two predicate devices, i.e. B. Braun Avitum AG's Diacap HiFlo 23 Dialyzer (K100334) and Diacap HIPS dialyzer (K071518) were used for comparison with the new device.

The new device has the same indications for use as the marketed predicate devices, i.e. for single use in acute and chronic hemodialysis.

Membrane/ housing materials and surface areas of the new device correspond to those of the predicate devices.

Modified technological characteristics of the new device are changes to membrane design, change of cap colorant in addition to alternative suppliers (potting resin, PVP).

Briefly, modified design characteristics of the membrane include changes in the number of membrane fibers and length of the fiber bundle, the inner fiber diameter, the wall thickness of the membrane and the number of pores.

These modified characteristics of the membrane are achieved by a validated manufacturing process of the membrane.

SAFETY AND EFFECTIVENESS:

To assess the effects of the modified characteristics of the new device and to demonstrate equivalence with the predicate devices, the following data assessed by scientific methods, performance and clinical data are provided:

Biocompatibility testing:

Testing was performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for an externally communicating device contacting circulating blood for prolonged contact (category B).

In vitro performance testing:

ultrafiltration rate l
pressure drop blood side and dialysate side ।

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B. Braun Avitum AG 510(k) Premarket Notification xevonta dialyzers

clearances of urea, creatinine and vitamin B12
= mechanical hemolysis

Clinical testing:

comparison of in-vitro and in-vivo ultrafiltration coefficient
Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use.

CONCLUSION:

The data provided for the new device demonstrates that xevonta dialyzers are as safe and effective as the marketed predicate devices. The differences, between subject device and predicate devices, do not raise any new issues of safety and effectiveness. The xevonta dialyzers, therefore, are substantially equivalent to the predicate devices.

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.”