The Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers / filters can be used whenever hemodialysis or hemofiltration is indicated. These can be used for acute or chronic hemodialysis or hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration and clotting times should be performed under the supervision / direction of a physician.

Device Description

The Gambro Polyflux 11S, 14S, & 21S Hemodialyzers/Hemofiters are identical in construction in function to other hemodialyzers/filters currently marketed in the United States. These devices are intended for use in hemodialysis and hemofiltration for the treatment of acute and chronic renal failure and for certain types of intoxications. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylether sulfone (polyethersulfone) (PES) which is identical to the membrane utilized in the Cobe Centrysystem 14 PES hemodialyzer which has been previously approved for marketing in the United States under a 510K Notification (K95-5592).

Blood enters a blood inlet port where it is distributed to polyarylethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyarylethersulfone hollow fibers in each hemodialyzer / hemofilter are 8000 for the 11S. 10000 for the 14S, 10000 for the 17S, and 12500 for the 21S. These dialyzers have effective membrane lengths of either 210mm (11S & 14S) or 250 mm (17S & 21S). The effective membrane surface areas are 1.1 m2 for the 11S, 1.4 m2 for the 14S, 1.7 m2 for the 17S, and 2.1 m2 for the 21S. The housing of this hemodialyzer is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.

By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the polyarylethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through polyarylethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Gambro Polyflux 11S, 14S, 17S, and 21S Hemodialyzers/Filters:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a pass/fail format. Instead, it relies on demonstrating substantial equivalence to a predicate device (Cobe Centrysystem 14 PES Hemodialyzer) across several functional and material parameters. The "reported device performance" in this context refers to the results of in vitro testing and the overall conclusion of substantial equivalence.

Parameter Evaluated	Predicate Device Performance / Reference	Acceptance Criteria (Implied)	Reported Device Performance
Material/Design equivalence:	Cobe Centrysystem 14 PES Hemodialyzer (K95-5592)	Substantially equivalent in: - Polyarylethersulfone (PES) hollow fiber membrane - Polycarbonate housing and header - Polyurethane potting material	"The membrane used in this device is polyarylether sulfone (polyethersulfone) (PES) which is identical to the membrane utilized in the Cobe Centrysystem 14 PES hemodialyzer." "The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592)." "Both the proposed and predicate devices use polycerbonate for the housing and header material and polyurethane for the membrane potting material."
Blood side priming volume	Not explicitly stated, implied to be comparable to predicate.	Substantially equivalent to predicate device.	"The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters."
Dialysate side priming volume	Not explicitly stated, implied to be comparable to predicate.	Substantially equivalent to predicate device.	"The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters."
Dialysate flow resistance	Not explicitly stated, implied to be comparable to predicate.	Substantially equivalent to predicate device.	"The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters."
Blood flow resistance	Not explicitly stated, implied to be comparable to predicate.	Substantially equivalent to predicate device.	"The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters."
Ultrafiltration coefficient	Not explicitly stated, implied to be comparable to predicate.	Substantially equivalent to predicate device.	"The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters."
Urea clearance	Not explicitly stated, implied to be comparable to predicate.	Substantially equivalent to predicate device.	"The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters."
Vitamin B12 clearance	Not explicitly stated, implied to be comparable to predicate.	Substantially equivalent to predicate device.	"The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters."
Overall Safety & Effectiveness	Implied by predicate device approval (K95-5592)	Safe, effective, and performs as well as the predicate device.	"Testing performed on the Gambro Polyflux 11S, 14S, 17S, and 21S indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance the instructions for use."

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

The document states: "In vitro testing was performed on the Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers/hemofilter..."
It does not specify the sample size (N) for the in vitro tests (e.g., how many units of each model were tested).
Data Provenance: The data is from in vitro testing. No country of origin is specified for the testing itself, but the submission is for the US market. The study is prospective in the sense that the sponsor performed these tests to support the 510(k) submission.

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 this submission. The "ground truth" for this medical device (hemodialyzer) is established through measurable physical and chemical performance parameters (e.g., flow resistance, clearance rates) and direct comparison to a predicate device's established performance based on its 510(k) approval. It does not involve expert consensus on interpreting data in the way a diagnostic AI might.

4. Adjudication Method for the Test Set

This is not applicable. The data presented relies on objective measurements from in vitro tests, not expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. Such studies are typically for diagnostic devices where human readers interpret medical images or data, and AI assists them. This document is for a therapeutic device (hemodialyzer).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a hemodialyzer, not an algorithm or AI. The in vitro testing performed is inherently "standalone" in that it measures the device's physical performance directly.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective, measurable physical and chemical characteristics obtained through in vitro testing, combined with the successful approval and marketing history of the predicate device (Cobe Centrysystem 14 PES Hemodialyzer, K95-5592). The data itself (e.g., clearance rates, flow resistance) constitutes the ground truth for performance, and the comparison to the predicate device validates its clinical relevance.

8. The Sample Size for the Training Set

This information is not applicable. Hemodialyzers are not "trained" like AI algorithms. Their performance is inherent in their design and materials.

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

This information is not applicable for the same reason as point 8.

Summary

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6/99		K98241Page510K NotificationGambro Polyflux 11S, 14S, 17S and 21SJuly 7th, 1998
510K(k) SUMMARY
SUBMITTER:	Gambro Healthcare1185 Oak StreetLakewood, CO 80215(303) 231-4436
DATE PREPARED:	June 1st, 1998
DEVICE NAME:	Gambro Polyflux 11S, 14S, 17S, & 21SHemodialyzers/filters
CLASSIFICATION NAMES:	High Permeability Hemodialyzer / Hemofilter
PREDICATE DEVICE:	Cobe Centrysystem 14 PES Hemodialyzer
Device Description:

3/26

Gambro Polyflux 11S, 14S, 17S, and 21S, Hemodialyzers/Filters

Blood enters a blood inlet port where it is distributed to polyarylethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyarylethersulfone hollow fibers in each hemodialyzer / hemofilter are 8000 for the 11S. 10000 for the 14S, 10000 for the 17S, and 12500 for the 21S. These dialyzers have effective membrane lengths of either 210mm (11S & 14S) or 250 mm (17S & 21S). The effective membrane surface areas are 1.1 m2 for the 11S, 1.4 m2 for the 14S, 1.7 m2 for the 17S, and 2.1 m2 for the 21S. The housing of this hemodialyzer is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592) (please refer to Parts A., B. C. and D. of Section XIV. of this Notification for information on the Cobe Centrysystem 14 PES Hemodialyzer). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.

By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the polyarylethersulfone membrane,

000083

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Page 2 cf 3 Gambro Polyflux 11S, 14S, 17S and 21S July 7th , 1998

K982414

plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through polyarylethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

Predicate Devices:

The Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers/filters are substantially equivalent in construction, design, intended use, function and materials to other high 11S 14C 17S and 215 1 115, 14S, 17S, and 21S hemodialyzers/filter are substantially equivalent in function, design, composition, materials, and operation, to the Cobe Centrysystem 14 PES hemodialyzer (K95 5592) which is currently in commercial distribution in the United States.

Intended Use:

The Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers can be used whenever hemodialysis and hemofiltration is indicated. This can be used for acute or chronic hemodialysis and hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

This indication statement is essentially the same as the indication statement for the predicate device.

Technological Characteristics:

Comparing the proposed device to the predicate device, some similarities and differences are noted in the design employed to accomplish the same intended use. Both the proposed and predicate devices use the same polyarylethersulfone, hollow fiber membrane. Both the proposed and predicate devices use polycerbonate for the housing and header material and polyurethane for the membrane potting material. The predicate device is different from the proposed device in that it uses a different membrane surface areas and has different blood side priming volumes and performance parameters (i.e. clear and "

Summary of Non-Clinical Tests:

In vitro testing was performed on the Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers/hemofilter to determine the following: blood side priming volume, dialysate side priming volume, dialysate and blood flow resistance, ultrafitration coefficient, urea, that the proposed douise and vitamin B12, clearances. The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters.

Clinical Test Results:

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K 982414
Page 3 of 3

510K Notification Gambro Polyflux 11S, 14S, 17S and 21S July 7th , 1998

Clinical testing was not performed

Conclusions:

Testing performed on the Gambro Polyflux 11S, 14S, 17S, and 21S indicates that they are
safe, effective, and perform as well as the predicate device, when used in accordance the instructions for use.

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is written in a bold, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 1999

Jeffrey R. Shideman, Ph.D. Gambro Healthcare 7307 Glouchester Drive Edina, MN 55435

Re: K982414

Gambro Polyflux 11S, 14S, 17S, and 21S Hemodialyzers/Hemofilters Dated: January 31, 1999 Received: February 3, 1999 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI

Dear Dr. Shideman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 Medical Detroo Annoneneric Act (Act). You may, therefore, market the device, subject to the general controls roder Pool, Drag, and e octors of the Act include requirements for annual registration, listing of provisions of the Not - 110 g practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may ir your do to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for the Ourient Ooo manationing the CFR Part 820) and that, through periodic QS inspections, the Food and Medial Donolar of Ochoral royalerify such assumptions. Failure to comply with the GMP regulation may result in Drug Nammondon (r Dri) mill rom) butlish further announcements concerning your device in the Federal regarder. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA This reter will and you to begin marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in if you desire tipeonic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, the promote the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other please note rogalation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerety vours,

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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rage

510 (k) NUMBER (IF KNOWN) : K982414 DEVICE NAME: Gambro Polyflux 11S, 14S, 17S, and 21S Hemodialyzers/ Filters INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De

510(k) Number

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.”