Hemodialysis with the FB-U Hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

Device Description

The Nipro FB-U hemodialyzer is a medical device intended for use as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient, through the extracorporeal system, into 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.

AI/ML Overview

Device: Nipro FB-U Hemodialyzer

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Predicate)	Reported Device Performance (Nipro FB-U Hemodialyzer)
Clearances	Not explicitly stated, implied to be equivalent to predicate.	Demonstrated to be equivalent to predicate in non-clinical tests.
Ultrafiltration coefficient	Not explicitly stated, implied to be equivalent to predicate.	Demonstrated to be equivalent to predicate in non-clinical tests.
Volume of blood compartment	Not explicitly stated, implied to be equivalent to predicate.	Demonstrated to be equivalent to predicate in non-clinical tests.
Pressure drop	Not explicitly stated, implied to be equivalent to predicate.	Demonstrated to be equivalent to predicate in non-clinical tests.
Positive and negative pressure tests	Not explicitly stated, implied to be equivalent to predicate.	Passed (included in non-clinical tests).
Blood compartment integrity	Not explicitly stated, implied to be equivalent to predicate.	Passed (included in non-clinical tests).
Transportation tests	Not explicitly stated, implied to be equivalent to predicate.	Performed and results included in submission.
Biocompatibility	Not explicitly stated, implied to be equivalent to predicate.	Performed and results included in submission.
Shelf-life testing	Not explicitly stated, implied to be equivalent to predicate.	Performed and results included in submission.
Materials - Housing	Polypropylene/polycarbonate (for predicate and/or similar devices)	Polypropylene
Materials - Membrane	Polyether sulfone/Cellulose Triacetate (for predicate and/or similar devices)	Cellulose Triacetate
Design	Mechanical device consisting of a cylindrical rigid housing enclosing hollow fibers	Same
Intended Use	As part of an artificial kidney system for removal of toxins and excess water from blood	Same
Energy Source	To be used with dialysis machines equipped with an ultrafiltration controller or accurate fluid balancing system	Same

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

The document states "Non-clinical tests submitted," which include "dimensional and performance to include: positive and negative pressure tests, blood compartment integrity, clearances, Ultrafiltration coefficient, volume of blood compartment, and pressure drop." It also mentions "Other test items include: Transportation tests, biocompatibility, and shelf-life testing."

Sample Size: The document does not explicitly state the specific sample sizes used for each of these non-clinical tests.
Data Provenance: The tests are described as "non-clinical tests submitted," implying they were conducted by Nipro Medical Corporation as part of their submission. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective, though non-clinical tests are generally prospective.

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

Not applicable. The study relies on objective physical and chemical measurements (e.g., clearances, pressure tests) rather than expert interpretation of data for establishing ground truth in non-clinical testing.

4. Adjudication Method for the Test Set:

Not applicable. As the study primarily concerns non-clinical, objective measurements, an adjudication method for a "test set" (in the sense of human interpretation) is not relevant.

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. No MRMC study was conducted. This device is a hemodialyzer, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a physical hemodialyzer, and therefore the concept of a standalone algorithm or human-in-the-loop performance is not relevant. The performance evaluation is of the device's physical and functional characteristics.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests was established through objective physical and chemical measurements and engineering standards. For example:

Clearances were measured against established methods for filtration efficiency.
Pressure tests confirmed resistance to specified pressures.
Integrity tests confirmed the physical structural soundness.
Biocompatibility tests likely adhered to ISO standards (e.g., ISO 10993).
Shelf-life tests involved stability and performance over time.

The "ground truth" for showing substantial equivalence was the performance characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set. The performance data is derived from testing of the physical device.

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

February 8, 2017

Nipro Medical Corporation Jessica Oswald-Mcleod Director, Quality and Regulatory 3150 NW 107th Avenue Doral, FL 33172

Re: K160444 Trade/Device Name: Nipro FB-U Hemodialyzer Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: January 5, 2017 Received: January 9, 2017

Dear Jessica Oswald-Mcleod:

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 yours,

Charles Viviano -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160444

Device Name Nipro FB-U Hemodialyzer

Indications for Use (Describe)

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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510(k) Summary: Nipro FB-U Hemodialyzer

Applicant:	Nipro Medical Corporation3150 NW 107th Ave.Miami FL 33172Tel: 305-599-7174
Establishment Reg.:	1056186
Contact Person:	Jessica Oswald-McLeodDirector, Quality Assurance & Regulatory Affairs
Date of summary preparation:	September 29, 2016
Description of Device
Trade Name:	NIPRO FB-U Hemodialyzer
Common Name:	Dialyzer
Classification Name:	dialyzer, high permeability with or without sealed dialysate system
Regulation Number:	21 CFR part 876.5860
Regulatory Class:	II
Panel:	Gastroenterology/Urology
Product Code:	KDI
Legally marketed substantial equivalent device:	Nipro Elisio-M (K131935)Baxter Exeltra (K030974)
Description of device:

Indications for Use:

Hemodialysis with the Nipro FB-U Hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

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Comparison of technological characteristics:

The dialyzer is substantially equivalent to the predicate device in the following technological characteristics:

Element ofComparison	Proposed	Predicate/s
Materials	Housing: PolypropyleneMembrane: Cellulose Triacetate	Housing:Polypropylene/polycarbonateMembrane: Polyether sulfone/Cellulose Triacetate
Design	Mechanical device consisting of acylindrical rigid housing enclosinghollow fibers	same
IntendedUse	Intended to be used as part of anartificial kidney system for theremoval of toxins and excess waterfrom the blood	same
EnergySource	To be used with dialysis machinesequipped with an ultrafiltrationcontroller or an accurate fluidbalancing system	same

Non-clinical tests submitted:

Dimensional and performance to include: positive and negative pressure tests, blood compartment integrity, clearances, Ultrafiltration coefficient, volume of blood compartment, and pressure drop.

Other test items include: Transportation tests, biocompatibility, and shelf-life testing. These tests along with their associated results and conclusions are included in this submission.

Clinical tests:

This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission.

Conclusions drawn from non-clinical and clinical tests:

The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Nipro FB-U Dialyzer performs equivalent to the predicate device and is safe and effective when used as intended.

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.”