The IDEMSA Hemophan Hollow Fiber Dialyzers are indicated for use whenever a patient is in acute or chronic renal failure and a physician prescribes hemodialysis. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness. The indication statement is essentially the same as the indication statement of the predicate devices.

The IDEMSA Hemophan Dialyzer has been designed for use in hemodialysis and associated forms of treatment for chronic or acute kidney failure.

Device Description

The IDEMSA Hemophan Dialyzers are a family of hollow fiber dialyzers that provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The membrane used in the device is Hemophan which is substantially equivalent to the Hemophan membranes utilized in the Haidylena Cuprophan and Hemophan Hollow Fiber dialyzers (cleared for marketing in the United States under 510(k) # K982337). The Hemophan membranes utilized in both IDEMSA Hemophan dialyzers and Haidylena Cuprophan and Hemophan Hollow Fiber dialyzers are manufactured by Membrana GmbH (formerly Akzo (Enka AG)) of Germany. Hemophan® is a modified cellulose membrane that was developed by ENKA to improve the blood compatibility of the regenerated cellulose membrane Cuprophan®. Cuprophan® membranes utilized in both Cobe CentrySystem 160E dialyzers and Baxter CF25 are also manufactured by the former Akzo (Enka AG). The Terumo Clirans T175 series dialyzers also use a cellulose membrane.

Blood enters a blood inlet port where it is distributed to the Hemophan membrane. The fibers used in the proposed device are substantially equivalent in design to the previously cleared Haidylena and Cobe CentrySystem dialyzers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The wall thickness of the Hemophan and Cuprophan fibers in the Haidylena, Cobe CentrySystem 160E, Baxter CF25, and the proposed device is 8 microns. The inner diameter of Hemophan and Cuprophan in the Haidylena, Baxter CF25 dialyzer and the proposed device is 200 microns.

Blood is pumped via a roller purno from the artery of the patient into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers where water waste products pass through the membrane of the dialyzer into the dialysate, which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer back to the patient.

AI/ML Overview

This 510(k) summary describes a conventional dialyzer, a device that performs a physical function (filtration) rather than an AI/ML-driven diagnostic or therapeutic function. Therefore, many of the requested fields related to AI/ML device performance, such as sensitivity, specificity, MRMC studies, and ground truth establishment for a training set, are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IDEMSA Hemophan Dialyzers are based on demonstrating substantial equivalence to predicate devices (Haidylena Cuprophan and Hemophan Hollow Fiber, Cobe CentrySystem 160E, Baxter CF25, and Terumo Clirans T175 dialyzers) in terms of construction, design, intended use, and function. Specific performance parameters were evaluated in vitro.

Acceptance Criteria Category	Specific Parameter Evaluated	Reported Device Performance (vs. Predicate)	Basis for Acceptance
Material Equivalence	Potting Materials	Polyurethane (same as predicates)	Substantially Equivalent
	Blood Port Caps	Polycarbonate (same as most predicates)	Substantially Equivalent
	Housing	Polycarbonate (same as most predicates)	Substantially Equivalent
	"O" rings	Silicone (same as Terumo predicate)	Substantially Equivalent
	Membrane	Hemophan® (modified cellulose) (same as Haidylena predicate)	Substantially Equivalent
Technological Equivalence*	Membrane Type	Hemophan® (modified cellulose)	Substantially Equivalent to predicate Haidylena, and equivalent function to Cuprophan/Cellulose in other predicates
	Fiber Dimensions	Inner diameter: 200 micronsWall thickness: 8 microns	Substantially Equivalent to predicate Haidylena, Cobe CentrySystem, Baxter CF25
	Sterilization Method	Ethylene oxide gas (same as predicates), also gamma radiation	Substantially Equivalent
In Vitro Performance	Ultrafiltration Coefficient	Confirmed substantially equivalent	Substantially Equivalent
	Pressure Drop (blood side)	Confirmed substantially equivalent	Substantially Equivalent
	Pressure Drop (dialysate side)	Confirmed substantially equivalent	Substantially Equivalent
	Urea Clearance	Confirmed substantially equivalent	Substantially Equivalent
	Creatinine Clearance	Confirmed substantially equivalent	Substantially Equivalent
	Phosphate Clearance	Confirmed substantially equivalent	Substantially Equivalent
	Vitamin B12 Clearance	Confirmed substantially equivalent	Substantially Equivalent
Safety	Sterility Assurance Level	10-6 (validated to AAMI guidelines)	Meets AAMI guidelines
	Ethylene Oxide Residuals	Will not exceed maximum residue limits	Meets regulatory proposed limits

Note on Technological Equivalence: The document emphasizes that the Hemophan membrane in the proposed device is the same as in the Haidylena predicate, and manufactured by the same entity. Other predicates use Cuprophan or other cellulose membranes, which are described as being functionally similar or having slightly different properties (e.g., Hemophan developed to improve blood compatibility of Cuprophan).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state a "test set" sample size in the context of typical AI/ML validation. The in-vitro performance testing was conducted on samples of the proposed device. The number of units tested for each in-vitro parameter (ultrafiltration coefficient, pressure drop, clearance rates) is not specified.

Data provenance is not explicitly stated beyond "In vitro testing was performed on the proposed device." This suggests the testing was conducted prospectively on newly manufactured devices. The manufacturer is based in Segovia, Spain.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable for this type of device. "Ground truth" in this context refers to established engineering and physiological performance standards rather than expert consensus on medical images or patient outcomes. The substantial equivalence argument relies on comparing the device's measured physical and performance characteristics against those of legally marketed predicate devices, which are already accepted as safe and effective.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The performance metrics are objectively measured physical properties and clearance rates against established benchmarks or predicate device specifications, not subjective assessments requiring adjudication.

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. This is not an AI/ML diagnostic or assistive device. It is a conventional medical device whose function does not involve human "readers" or "AI assistance."

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

Not applicable. This is not an algorithm-only device. It is a physical medical device. The "performance" described is the device's physical function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on established engineering specifications, material properties, and the known performance characteristics of legally marketed predicate devices. For clearance parameters, these are objective measurements (e.g., amount of urea removed per unit time) against expected or benchmark values for effective dialysis.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

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APR 1 7 2000

510 (k) Notification Hemophan Conventional Dialyzers

510(k) SUMMARY

SUBMITTED BY:	Lachman Consultant Services, Inc.U.S. Agent for IDEMSAContact: Leon Lachman, Ph.D.1600 Stewart AvenueWestbury, New York 11550Phone: (516) 222-6222Fax: (516) 683-1887
SUBMITTED FOR:	Investigacion Y Desarrollo de Equipos Medicos, S.A (IDEMSA)Pol. Ind. "Nicomedes Garcia"40140 Valverde del MajanoSegovia, Spain
DATE PREPARED:	May 28, 1999
DEVICE NAME:	IDEMSA Hemophan Dialyzer
COMMON NAME:	Hemodialyzer
CLASSIFICATION NAME:	Conventional Hemodialyzer, Capillary, Hollow Fiber
PREDICATE DEVICES:	Haidylena Cuprophan and Hemophan Hollow Fiber, CobeCentrySystem 160E, Baxter CF25, Terumo Clirans T175 Dialyzers

The proposed family of dialyzers are substantially equivalent in construction, design, intended use, and function to other hemodialyzers currently marketed in the United States. The IDEMSA Hemophan Dialyzers are substantially equivalent in construction, design, intended use, and function to Haidylena Cuprophan and Hemophan Hollow Fiber, Cobe Centry System 160E, Baxter CF25, and Terumo Clirans T175 dialyzers.

DEVICE DESCRIPTION

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IDEMSA 510 (k) Notification Hemophan Conventional Dialyzers

1991908

membranes utilized in both Cobe CentrySystem 160E dialyzers and Baxter CF25 are also manufactured by the former Akzo (Enka AG). The Terumo Clirans T175 series dialyzers also use a cellulose membrane.

INTENDED USE

TECHNOLOGICAL CHARACTERISTICS

Comparing the proposed device to the predicate device, some similarities and differences are noted in the design and materials employed to accomplish the same intended use. Both the proposed and predicate device (Haidylena HL 100H dialyzers) utilize the same Hemophan, hollow fiber membrane manufactured by the former Enka AG (currently Membrana GmbH). Both the proposed device and predicate device (Haidylena HL 100H dialyzers) utilize polycarbonate for the header material and polyurethane for the potting materials. The proposed and predicate devices are sterilized by ethylene oxide gas. However, the proposed device may also be sterilized by gamma radiation. The proposed device and Terumo Clirans T-175 series dialyzers each contain a silicone rubber "O-ring." The proposed device utilizes polypropylene for the non-blood contact protector cap, a predicate material identified for use in the blood ports for the Terumo Clirans T-175 series dialyzers. A summary comparison is provided on the following page.

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K991908
Page 3 of 3

IDEMSA 510 (k) Notification Hemophan Conventional Dialyzers

Materials

Table 1: Predicate Device Comparison / Materials

Item	IDEMSAHemophanDialyzers	HaidylenaHL100HDialyzers	Cobe CentrySystem 160E	Baxter CF25	TerumoClirans®T-175
PottingMaterials	Polyurethane	Polyurethane	Polyurethane	Polyurethane	Polyurethane
Blood portcaps	Polycarbonate	Polycarbonate	Polycarbonate	Polycarbonate	Polypropylene
Housing	Polycarbonate	Polycarbonate	Polycarbonate	Polycarbonate	Acrylonitrile-Styrenecopolymer
"O" rings	Silicone	----------	----------	----------	Silicone
Membrane	Hemophan®(modifiedcellulose)	Hemophan®(modifiedcellulose)	Cuprophan®(regeneratedcellulose)	Cuprophan®(regeneratedcellulose)	Cellulose

IN VITRO PERFORMANCE

In vitro testing was performed on the proposed device to determine the following: ultrafiltration coefficient; pressure drop across blood and dialysate side; and urea, creatinine, phosphate, and vitamin B12 clearance. Since the proposed dialyzer does not consist of a new or altered design n comparison to the predicate devices, hemocompatibility performance testing was not berformed. Bench data developed for the proposed device is provided on the following page. The results of these tests confirmed that the proposed device is substantially equivalent to the predicate devices for these parameters.

ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated according to the AAMI guidelines to provide a sterility assurance level (SAL) of 10 the negative sixth.

Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).

CONCLUSION

The IDEMSA Hemophan hollow fiber dialyzers submitted in this 510(k) are substantially equivalent in intended use, design, technological characteristics, materials and performance to 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 seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2000

IDEMSA c/o Leon Lachman. Ph.D. President Lachman Consultant Services, Inc. 1600 Stewart Avenue Westbury, NY 11590

Re: K991908

IDEMSA Hemophan Hollow Fiber Dialyzers Dated: January 21, 2000 Received: January 24, 2000 Regulatory Class: Il 21 CFR §876.5820/Procode: 78 FJI

Dear Dr. Lachman:

We have reviewed your Section 510(k) notification of intent to market the device 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 equivation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulatory action, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitiled, "Misbranding by reference to premarket notification" (21CFR 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/odrh/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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K991908 Page 1 of 1

IDEMSA 510 (k) Notification Hemophan Conventional Dialyzers

INDICATIONS FOR USE XIV.

The IDEMSA Hemophan Dialyzer has been designed for use in hemodialysis and associated forms of treatment for chronic or acute kidney failure.

Ionid C. Syam

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.