This device is intended for use in hemodialysis for the treatment of acute and chronic renal failure. The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone(PVP), which is equivalent to the membrane utilized in the Gambro Polyflux H single use hemodialyzers cleared for marketing in the United States under 510K Notification (K030592). Blood enters a blood inlet port where it is distributed to the hollow fibers. 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 text describes a 510(k) premarket notification for a medical device, the Gambro Polyflux HD-C4 Capillary Dialyzer for Single Use. This filing primarily demonstrates substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Predicate Device or Industry Standards)	Reported Device Performance (Gambro Polyflux HD-C4)
Performance characteristics similar to predicate device (Polyflux 210H Hemodialyzer / Filter K030592) in terms of:	Non-clinical in vitro testing indicated similar performance characteristics to the predicate configurations.
- Design	Similar design
- Function	Similar function
- Composition	Similar composition (membrane blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone(PVP))
- Operation	Similar operation
Safety and Effectiveness	Testing indicated the device is safe and effective when used as instructed.

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

Sample Size: Not explicitly stated. The document mentions "in vitro testing was conducted to compare the performance...". It does not specify the number of devices or iterations tested.
Data Provenance: The testing was "non-clinical in vitro testing." The country of origin for the data is not specified, but the submitter is Gambro Renal Products, located in Lakewood, Colorado, USA. The testing would be considered prospective for the specific purpose of this 510(k) submission, even if the methods are established.

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

Not applicable. This submission relies on performance testing against a predicate device and does not involve human expert interpretation of data to establish a ground truth for a diagnostic or AI-driven device. The ground truth for performance is derived from established engineering and scientific principles for dialyzer function, and comparison to the well-characterized predicate device.

4. Adjudication Method for the Test Set

Not applicable. As the "ground truth" is based on objective in vitro performance metrics compared to a predicate device, an adjudication method for 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

No, an MRMC comparative effectiveness study was not done. This device is a capillary dialyzer, not an AI-assisted diagnostic tool or an imaging device that would require human interpretation.

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

Not applicable. This is a medical device (a dialyzer), not an algorithm or AI system. Its performance is evaluated through its physical and functional characteristics.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established performance characteristics of surgically implanted devices (specifically, hemodialyzers) and direct comparison to a legally marketed predicate device (Polyflux 210H, K030592). This includes measurements of design, function, composition, and operation in an in vitro setting.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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AFR 2 4 2006

Image /page/0/Picture/1 description: The image shows the logo for GAMBRO Renal Products. The logo consists of a stylized "G" symbol on the left, followed by the word "GAMBRO" in a larger, bold font. To the right of "GAMBRO" is the phrase "Renal Products" in a smaller, less bold font. The overall design is simple and professional, suggesting a company that specializes in renal-related products.

510(k) Summary

Gambro Renal Products Submitter: 10810 West Collins Avenue Lakewood, Colorado 80215 Thomas B. Dowell, Manager, Regulatory Affairs Contact: Phone: 303-231-4094 Fax: 303-542-5138 January 24, 2006 Date prepared: Gambro Polyflux HD-C4 Capillary Dialyzer for Single Use Device name: Common name: Capillary Dialyzer High Permeability Hemodialysis System Accessory (876.5860) Classification name: Predicate Devices: Polyflux 210H Hemodialyzer / Filter K030592

Device Description:

This device is intended for use in hemodialysis for the treatment of acute and chronic renal failure.

The intended population of this device is identical to those of the Polyflux 210H, cleared for marketing in the United States under 510K notification K030592.

The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone(PVP), which is equivalent to the membrane utilized in the Gambro Polyflux H single use hemodialyzers cleared for marketing in the United States under 510K Notification (K030592).

Blood enters a blood inlet port where it is distributed to the hollow fibers. 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.

Indications For Use:

The capillary dialyzer is intended for hemodialysis for the treatment of chronic and acute renal failure.

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CONC 15 page Ext 2

Image /page/1/Picture/1 description: The image shows the logo for GAMBRO Renal Products. The logo consists of a stylized "G" symbol followed by the text "GAMBRO Renal Products". The text is in a simple, sans-serif font and is black. The logo is clean and professional.

Technological Characteristics:

The proposed device configurations have the same technological characteristics and are similar in design, function, composition, and operation, to the currently marketed configurations.

Summary of Non-Clinical Tests:

In vitro testing was conducted to compare the performance of the proposed device configurations to the predicate configurations.

Summary of Clinical Tests:

N/A

Conclusion:

Testing performed on the Gambro Polyflux Dialyzers indicates that they are safe, effective and perform as well as the predicate devices, when used in accordance with the instructions for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned.

APR 2 4 2006

Mr. Thomas B. Dowell Manager Regulatory Affairs Gambro Renal Products 10810 West Collins Avenue LAKEWOOD CO 80215

Re: K060195

Trade/Device Name: Gambro Polyflux HD-C4 Capillary Dialyzer for Single Use Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: March 27, 2006 Received: March 28, 2006

Dear Mr. Dowell:

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 Americants, 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 mass 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 (Premarket Approval), it may be subject to such additional controls. [Special Dontrols) or class Iff i Finance 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.

Image /page/2/Picture/9 description: The image shows a circular logo for the FDA Centennial from 1906-2006. The letters FDA are in large bold font in the center of the circle. The word Centennial is written in cursive below the letters FDA. Three stars are below the word Centennial.

romoting Public .

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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.

This letter will allow you to begin marketing your device as described in your Section 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:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology).	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. 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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KU60145 page 10

"GAMBRO Renal Products

Indications for Use Statement

510(k) number: (if known)	K060195
Device Name:	Gambro Polyflux HD-C4 Capillary Dialyzer for Single Use
Indications for Use:	The capillary dialyzer is intended for hemodialysis for the treatment of chronic and acute renal failure.
Prescription Use (Per 21 CFR 801 Subpart D)	X
	AND / OR
	Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Gordon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 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.”