The Gambro POLYFLUX 140H, 170H and 210H Capillary Dialyzers/Filters labeled for single use have the same design, materials, intended use and function as other hemodialyzers/filters currently marketed in the United States. These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylethersulfone (PES) which is identical to the membrane utilized in the Gambro POLYFLUX 14S, 17S and 21S Hemodialyzers /filters labeled for single use which have been previously cleared for marketing in the United States under 510K Notifications (K982414). Blood enters a blood inlet port where it is distributed to the hollow fibers. Each hollow fiber has an inner diameter of approximately 200 microns (hollow fiber internal diameter) and a wall thickness of 50 microns. The number of hollow fibers in each hemodialyzer / filter is 7,500 for the POLYFLUX 140H, 9,300 for the POLYFLUX 170H, and 12,000 for the POLYFLUX 210H. This effective membrane length is 270 mm for the POLYFLUX 140H, 170H and 210H. The effective membrane surface area is 1.4 square meters for the POLYFLUX 140H, 1.7 square meters for the 170H and 2.1 square meters for the 210H. The housing and end caps of this hemodialyzer / filter are made of polycarbonate. The design and incorporation of the silicone header gasket is the same as previously approved for the Gambro GFS Plus Hemodialyzers / Filters(K902481). The fibers used in the Gambro POLYFLUX 140H, 170H and 210H are of the same composition as those previously approved for the Gambro POLYFLUX S Hemodialyzers / Filters labeled for single use (K982414). 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 membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

AI/ML Overview

The provided document, a 510(k) Notification Supplement for Gambro POLYFLUX 140H, 170H & 210H Capillary Dialyzers/Filters, describes the device and its claimed substantial equivalence to predicate devices. However, the document does not contain the level of detail requested for a comprehensive acceptance criteria and study description, particularly regarding specific performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods typically found in studies proving device performance for AI/imaging devices.

The document focuses on demonstrating substantial equivalence to previously cleared devices (Gambro POLYFLUX 14S, 17S & 21S and Gambro GFS PLUS 20) based on similarities in design, materials, intended use, and functioning.

Here's an attempt to answer your questions based only on the provided text, acknowledging where information is not present:

Acceptance Criteria and Device Performance Study for Gambro POLYFLUX 140H, 170H & 210H Capillary Dialyzers/Filters

The provided 510(k) Notification Supplement outlines the intent to market the Gambro POLYFLUX 140H, 170H, and 210H Capillary Dialyzers/Filters by demonstrating substantial equivalence to predicate devices (Gambro POLYFLUX 14S, 17S & 21S and Gambro GFS PLUS 20). The primary method used to establish this equivalence and thus "prove" the device meets acceptance criteria appears to be through comparison of design, materials, intended use, and in vitro performance testing against these predicate devices. Specific quantitative acceptance criteria or detailed study methodologies that would typically be found for an AI/imaging device are not provided in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria with corresponding performance values for the new devices. Instead, the "acceptance criteria" are implicitly demonstrated through the claim of substantial equivalence to predicate devices by:

Identical design, materials, intended use, and function.
Identical membrane material (polyarylethersulfone (PES)).
Similar component parts.
Similar manufacturing processes (e.g., steam sterilization).
In vitro performance testing indicating performance "as well as" the predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Safety and Effectiveness (as predicate devices)	"safe, effective, and perform as well as the predicate devices"
Design (similar to predicate devices)	Same design as other hemodialyzers/filters currently marketed; specifics mentioned include hollow fiber dimensions, number of fibers, membrane length, surface area, housing materials.
Material Composition (identical/similar to predicate devices)	Main membrane (PES) identical to POLYFLUX S series; other blood and non-blood contact materials and silicone O-Ring similar/identical to predicate devices.
Intended Use (identical to predicate devices)	Polyflux H indications: hemodiafiltration and hemofiltration for chronic or acute renal failure. Identical to predicate device indications.
Function (similar to predicate devices)	"perform as well as the predicate devices" in removing uremic toxins and waste products by diffusion and convection.
In vitro Performance (comparable to predicate devices)	"In vitro performance testing was performed to establish and compare performance characteristics to the predicate devices." Data included in labeling.

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

This information is not provided in the document. The document refers to "in vitro performance testing," but does not specify the sample size for these tests, the type of data, or its provenance (e.g., country of origin, retrospective/prospective). Given that the testing is in vitro, typical human-subject data provenance (like country of origin or retrospective/prospective) would not apply in the same way.

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

This information is not applicable/not provided. The "ground truth" for a medical device like a dialyzer would typically be established through direct physical and chemical measurements during in vitro performance testing against established standards or predicate device performance, not through expert consensus on qualitative observations.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As the "test set" refers to in vitro performance data, adjudication methods like 2+1 or 3+1 (common in image interpretation studies) are not relevant here. Performance is measured directly.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or is not described. This type of study is relevant for evaluating the impact of AI systems on human reader performance, typically in diagnostic imaging. The device is a physical medical device (dialyzer), not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable in the context of this device. A dialyzer is a physical device, and its performance is assessed directly through in vitro measurements, not as a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used for assessing the performance of the dialyzers would be based on physical and chemical measurements of their performance characteristics in vitro. This would include metrics like clearance rates for various solutes (e.g., urea, creatinine), ultrafiltration rates, and potentially biocompatibility assessments, comparing these values to established norms or the performance of the predicate devices. The document implies that "in vitro performance data are included in the labeling."

8. The Sample Size for the Training Set

This information is not provided and is not applicable for this type of device and submission. "Training set" is a concept used in machine learning and AI development. This document describes a traditional medical device, not an AI system.

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

This information is not provided and is not applicable for this type of device and submission.

Summary

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MAY 2 3 2003

510K Notification Supplement Gambro POLYFLUX 140H, 170H & 210H Capillary Dialyzers / Filters May 23rd , 2003

510K(k) SUMMARY

K030592

SUBMITTER:	Gambro Renal Products10810 West Collins AvenueLakewood, CO 80215(303) 231-5075
DATE PREPARED:	February 19th 2002
DEVICE NAME:	Gambro POLYFLUX 140H, 170H and 210HCapillary Dialyzer/Filter Labeled for Single Use
CLASSIFICATION NAMES:	High Permeability Hemodialyzer / Hemofilter
PREDICATE DEVICE:	Gambro POLYFLUX 14S, 17S & 21SHemodialyzers/Filters Labeled for Single Use& the Gambro GFS PLUS 20

Device Description:

Gambro POLYFLUX 140H, 170H & 210H Capillary Dialyzers/Filters

These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylethersulfone (PES) which is identical to the membrane utilized in the Gambro POLYFLUX 14S, 17S and 21S Hemodialyzers /filters labeled for single use which have been previously cleared for marketing in the United States under 510K Notifications (K982414). A copy of this clearance letter is included in Section X. D of this Notification.

Blood enters a blood inlet port where it is distributed to the hollow fibers. Each hollow fiber has an inner diameter of approximately 200 microns (hollow fiber internal diameter) and a wall thickness of 50 microns. The number of hollow fibers in each hemodialyzer / filter is 7,500 for the POLYFLUX 140H, 9,300 for the POLYFLUX 170H, and 12,000 for the POLYFLUX 210H. This effective membrane length is 270 mm for the POLYFLUX 140H, 170H and 210H. The effective membrane surface area is 1.4 square meters for the POLYFLUX 140H, 1.7 square meters for the 170H and 2.1 square meters for the 210H. The housing and end caps of this hemodialyzer / filter are made of polycarbonate. The design and incorporation of the silicone header gasket is the same as previously approved for the Gambro GFS Plus Hemodialyzers / Filters(K902481). The

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Ko30592

510K Notification Supplement Gambro POLYFLUX 140H, 170H & 210H Capillary Dialvzers / Filters Mav 23rd . 2003

fibers used in the Gambro POLYFLUX 140H, 170H and 210H are of the same composition as those previously approved for the Gambro POLYFLUX S Hemodialyzers / Filters labeled for single use (K982414).

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 membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate Schematic drawings of Gambro POLYFLUX 140H, 170H and 210H outlet port. Capillary Dialyzers / Filters are included in this Section.

Predicate Devices:

The Gambro POLYFLUX 140H, 170H and 210H, Capillary Dialyzers / Filters labeled for single use have the same design, materials, component parts, intended use and function as other Gambro Hemodialyzers / Filters currently marketed in the United States. These dialyzers have been cleared for marketing / sale under 510K Notification K982414 for the Polyflux 14S, 17S & 21S and under 510K Notification K902481 for GFS Plus 20. The predicate and the proposed devices, incorporate identical membranes (Polyflux 14S, 17S & 21S) and other blood and non-blood contact materials as well as a silicone O-Ring which is not incorporated into the Polyflux S. but is incorporated into the GFS Plus 20. The Polyflux H dialyzers are therefore considered to be substantially equivalent to the listed predicate devices. The intended uses for the proposed and predicate devices are also the same, hemodialyzers indicated for hemodialysis for the treatment of acute and chronic renal failure.

Intended Use:

POLYFLUX H Indications:

The capillary dialyzer/filter is intended for use in hemodiafiltration and hemofiltration for the treatments of chronic or acute renal failure.

Technological Characteristics:

Comparing the proposed devices to the predicate devices, they are substantially equivalent to the predicate devices. Both the proposed and predicate devices use the same hollow fiber membrane and other blood and non-blood contact materials. Both the proposed and predicate devices use polycarbonate for the housing and header material and polyurethane for the membrane potting material and are steam sterilized.

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K030592

Page 3/3

510K Notification Supplement Gambro POLYFLUX 140H, 170H & 210H Capillary Dialyzers / Filters May 23rd , 2003

Summary of Non-Clinical Tests:

In vitro performance testing was performed to establish and compare performance characteristics to the predicate devices.

Conclusions:

Testing performed on the Gambro POLYFLUX H Capillary Dialyzers/Filters indicates that they are safe, effective, and perform as well as the predicate devices, when used in accordance with the instructions for use. In vitro performance data are included in the labeling.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health.

MAY 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jeffrey R. Shideman, Ph.D. Director, Therapy Group Americas Gambro Corporate Research Gambro® Renal Products 10810 West Collins Avenue LAKEWOOD CO 80215

Re: K030592

Trade/Device Name: Gambro Polyflux, 140H, 170H and 210H Capillary Dialyzers/Filters Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: February 19, 2003 Received: February 25, 2003

Dear Dr. Shideman:

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.

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket . notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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.

Sincerely yours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page / of /

510 (k) NUMBER (IF KNOWN): Not yet assigned

DEVICE NAME: Gambro Polyflux 140H, 170H and 210H Capillary Dialyzer/Filter for Single Use

INDICATIONS FOR USE:

POLYFLUX H Indications:

The capillary dialyzer/filter is intended for use in hemodialitation and hemofiltration for the treatments of chronic or acute renal failure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K030592

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.”