The. Cobe Arylane Hemodialyzers/Filters H1, H4, H9 are intended for use in hemodialysis and hemofiltration and associated modalities for the treatment of chronic renal failure.

The size, weight, state of uremia, cardiac status and general physical condition of the patient must be evaluated by the prescribing physician before each treatment. The choice of the appropriate heomdialyzer/filter and associated equipment as well as the treatment operating parameters are the sole responsibility of the physician.

Device Description

The Hospal Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/filters are identical in construction in function to other hemodialyzers 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 polyarylethersulfone (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 polyarvlethersulfone hollow fibers in each hemodialyzer are 6400 for the H1, 8300 for the H4, 8300 for the H6, and 10600 for the H9. These dialyzers have effective membrane lengths of either 240mm (H1 & H4) or 280 mm (H6 & H9). In the Cobe Arylane H1 hemodialyzers/filter solid polyester filaments are interspersed in between the polyarylethersulfone hollow fibers and act as spacers to accommodate fewer numbers of fibers in the same housing used for the Cobe Arylane H4 hemodialyzer/filter. These same polyester spacing filaments have been used previously in other Cobe hemodialyzers for the same purpose. The effective membrane surface areas are 1.04 m2 for the H1, 1.35 m2 for the H4, 1.57 m2 for the H6, and 2.01 m2 for the H9. At either end of the device, the hollow fibers (and polyester filaments in the Cobe Arylane HI only) are potted in polyurethane to isolate the blood compartment from the filtrate compartment. 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

The provided text describes a 510(k) notification for the Cobe Arylane H1, H4, H6, and H9 Hemodialyzers/filters. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. No clinical study information, acceptance criteria for an AI device, or performance data for an AI device are present in the provided text.

Therefore, I cannot fulfill the request as it pertains to an AI device's acceptance criteria and studies. The document describes a medical device approval process for hemodialyzers, not an AI device.

However, I can provide a summary of the non-clinical tests performed for the hemodialyzers, which are analogous to how a non-AI medical device would be evaluated for substantial equivalence.

Summary of Non-Clinical Tests (for the hemodialyzers):

Test Parameter	Reported Device Performance
Blood side priming volume	Performed (Specific values not provided)
Dialysate side priming volume	Performed (Specific values not provided)
Dialysate flow resistance	Performed (Specific values not provided)
Blood flow resistance	Performed (Specific values not provided)
Ultrafiltration coefficient	Performed (Specific values not provided)
Urea clearance	Performed (Specific values not provided)
Creatinine clearance	Performed (Specific values not provided)
Phosphate clearance	Performed (Specific values not provided)
Inulin clearance	Performed (Specific values not provided)

Regarding the requested points for an AI device, based on the provided text:

A table of acceptance criteria and the reported device performance: Not applicable, as this is a non-AI medical device. The table above summarizes the non-clinical tests performed.
Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the in vitro tests conducted on the physical hemodialyzer units. The number of units tested is not specified. Data provenance is not applicable in the context of a software algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for the hemodialyzer performance is established through laboratory measurements and established analytical methods, not expert consensus.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: For the hemodialyzer performance, the ground truth would be the direct measurement of physical and functional properties in a laboratory setting (e.g., precise volume measurements, flow rate measurements, chemical analysis for clearance).
The sample size for the training set: Not applicable. This is for a physical device, not an AI algorithm.
How the ground truth for the training set was established: Not applicable.

Conclusion stated in the document for the hemodialyzers:

"Testing performed on the Cobe Arylane Hemodialyzers indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance with the instructions for use." This statement implies that the non-clinical tests' results met the criteria established for substantial equivalence to the predicate device (Cobe Centrysystem 14 PES hemodialyzer, K95-5592). The specific numerical acceptance criteria themselves are not detailed in the summary.

Summary

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4-21-99	510K NotificationCobe Arylane H1, H4, H6 and H9 HemodialyzersJune 1st, 1998
	510K(k) SUMMARY	K982413
SUBMITTER:	Gambro Healthcare1185 Oak StreetLakewood, CO 80215(303) 231-4436	Page
DATE PREPARED:	June 1st, 1998
DEVICE NAME:	Cobe Arylane H1, H4, H6, and H9Hemodialyzers/filters
CLASSIFICATION NAMES:	High Permeability Hemodialyzer
PREDICATE DEVICE:	Cobe Centrysystem 14 PES Hemodialyzer

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Device Description:

Cobe Arylane H1, H4, H6, & H9 Hemodialyzers/filters

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K982413
Page 2/3

PES (K95 5592) The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.

Predicate Devices:

The Cobe Arylane H1, H4, H6, and H9 hemodialyzers/filters are substantially equivalent in construction, design, intended use, function and materials to other high permeability hemodialyzers currently marketed in the United States. The Cobe Arylane H1, H4, H6, and H9 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 Cobe Arvlane H1, H4, H6, and H9 hemodialyzers can be used whenever hemodialysis and hemofiltration is indicated. This can be used for acute or chronic hemodialysis. 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 polycarbonate 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. clearances, etc.).

Summary of Non-Clinical Tests:

In vitro testing was performed on the Cobe Arvlane hemodialyzers hemofilter to determine the following: blood side priming volume, dialysate side priming volume, dialysate and blood flow resistance, ultrafiltration coefficient, urea, creatinine, phosphate. Inulin and

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K982413
Page 3/3

Clinical Test Results:

Clinical testing was not performed

Conclusions:

Testing performed on the Cobe Arylane Hemodialyzers indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance with the instructions for use.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 1999

Jeffrey R. Shideman, Ph.D. GAMBRO Healthcare 1185 Oak Street Lakewood, Colorado 80215-4498 Re: K982413

Cobe Arylane Hemodialyzers/Hemofilters H1, H4, H6, and H9 Dated: January 20, 1999 Received: January 21, 1999 Regulatory Class: III 21 CFR §876.5860/Product Code: 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 Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject 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 Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. 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(t) 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 and additionally 809.10 for in vitro diagnostic 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, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information 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".

Sincerely yours,

CAPT 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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510 (k) NUMBER (IF KNOWN): K982413

DEVICE NAME: Cobe Arylane Hemodialyzers Filters H1, H4, H6, H9

INDICATIONS FOR USE:

Indications for Use Statement

The. Cobe Arylane Hemodialyzers/Filters H1, H4, H9 are intended for use in hemodialysis and hemofiltration and associated modalities for the treatment of chronic 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)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K982413/S⁰⁰¹

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.”