The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer 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.

Device Description

The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are a family of hemodialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The membrane used in the device is Cuprophan which is substantially equivalence to the Cuprophan membranes utilized in the cobe centry System 160E and Baxter CF25 Dialyzers, which have been previously approved for marketing in the United States. The Cobe Cnetry System 160E was approved under a 510(k) Notification (K864831). The Cuprpohan membranes utilzed in both Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer and Cobe Centry System 160E Dialyzers are manufactured by Akzo (Enka) of Germany. Cuprophan membrane is also utilized in Baxter CF25 Dialyzers. Hemophan membrane is also manufactured by Akzo (Enka) and is also cellulose membrane but derivative from Cuprophan membrane.

Blood enters a blood inlet port where it is distributed to Cuprophan and Hemophan membrane. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The fibers used in this device are substantially equivalence in design to the previously approved Cobe Centry System. The wall thickness of the Cuprophan and Hemophan fibers in Cobe Centry System 160E Dialyzers, Baxter CF25 Dialyzers and the proposed device is 8 microns. The inner diameter o Cuprophan and Hemophan in both Baxter CF25 Dialyzer and the proposed device is 200 microns.

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

AI/ML Overview

The provided text describes the acceptance criteria and a study for the Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer.

Here's the breakdown:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Predicate Devices: Terumo Clirans T175, Baxter CF25, Cobe Centry System 160E)	Reported Device Performance (Haidylena Hollow Fiber Dialyzer - Cuprophan HL 100, 120, 130 and Hemophan HL 100H, 120H, 130H)
Physical Characteristics:	Haidylena Cuprophan:
Blood priming volume: ~95-120 ml (T175, CF25, 160E varied)	HL 100: 57 ml; HL 120: 68 ml; HL 130: 79 ml
Effective surface (S.Q.M.): ~0.9-1.75	HL 100: 1.0; HL 120: 1.2; HL 130: 1.3
Wall thickness (µm): 8-9 µm	8 µm for all models
Clearance (ml/min.):	Haidylena Cuprophan:
Urea: ~190-192	HL 100: 174; HL 120: 179; HL 130: 184
Creatinine: ~161-177	HL 100: 149; HL 120: 156; HL 130: 162
Phosphate: ~151-159	HL 100: 124; HL 120: 138; HL 130: 141
Vitamin B12: ~61-97 (T175, CF25, 160E varied)	HL 100: 48; HL 120: 55; HL 130: 58
Ultrafiltration rate (ml/hr/mmHg): ~4.3-8.8	HL 100: 4.9; HL 120: 6.0; HL 130: 6.6
Maximum TMP: 500 mmHg	500 mmHg for all models
Haidylena Hemophan:
Blood priming volume: ~95-120 ml	HL 100H: 57 ml; HL 120H: 68 ml; HL 130H: 79 ml
Effective surface (S.Q.M.): ~0.9-1.75	HL 100H: 1.0; HL 120H: 1.2; HL 130H: 1.3
Wall thickness (µm): 8-9 µm	8 µm for all models
Clearance (ml/min.):	Haidylena Hemophan:
Urea: ~190-192	HL 100H: 170; HL 120H: 175; HL 130H: 179
Creatinine: ~161-177	HL 100H: 149; HL 120H: 154; HL 130H: 160
Phosphate: ~151-159	HL 100H: 129; HL 120H: 140; HL 130H: 149
Vitamin B12: ~61-97	HL 100H: 46; HL 120H: 55; HL 130H: 60
Ultrafiltration rate (ml/hr/mmHg): ~4.3-8.8	HL 100H: 4.9; HL 120H: 6.0; HL 130H: 6.0
Maximum TMP: 500 mmHg	500 mmHg for all models
Sterilization: Consistent with BS EN 550 and AAMI guidelines for SAL of 10^-6	Validated according to BS EN 550 and AAMI guidelines to provide a Sterility Assurance Level of 10^-6. Ethylene oxide residuals not exceeding maximum limits.

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the "in vitro performance" testing. It presents consolidated results for multiple models of the Haidylena dialyzer (Cuprophan HL 100, 120, 130 and Hemophan HL 100H, 120H, 130H).
- The data provenance is from "in vitro testing" performed on the proposed devices. No country of origin for this specific test data is mentioned, but the submitter is Haidylena Medical, located in Cairo, Egypt. It is not specified if the data is retrospective or prospective, but in vitro tests are typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth for in vitro performance data is typically based on standardized testing protocols and measurements, not expert consensus in the way a diagnostic image might be.
Adjudication method for the test set:
- This information is not applicable/provided for the type of in vitro performance study described. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, primarily in clinical or image-based studies.
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 type of study is for evaluating human performance, often with AI assistance, usually in a diagnostic context. The provided study is an in vitro performance assessment of a medical device (a dialyzer), not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone performance assessment was done. The study evaluates the device's intrinsic physical and clearance performance (Urea, Creatinine, Phosphate, Vitamin B12 clearance, and ultrafiltration coefficient) in a laboratory setting ("In Vitro Performance") without human interaction influencing the core measurement results. It is important to note that this is not an "algorithm" in the sense of AI, but rather the performance of the physical device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the in-vitro performance testing is based on direct physical and chemical measurements of the dialyzer's function in a controlled laboratory environment. This includes quantitative measurements of:
  - Blood priming volume
  - Effective surface area
  - Wall thickness
  - Clearance rates for specific solutes (Urea, Creatinine, Phosphate, Vitamin B12)
  - Ultrafiltration rate
  - Maximum Transmembrane Pressure (TMP)
- Sterilization efficacy is based on standardized validation protocols (BS EN 550 and AAMI guidelines) to achieve a specified Sterility Assurance Level (SAL).
The sample size for the training set:
- This study does not involve a training set. The described study is an in vitro performance test of a physical medical device (blood dialyzer), not a machine learning or AI model that requires training data.
How the ground truth for the training set was established:
- This question is not applicable as there is no training set for this type of device and study.

Summary

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DEC 2 9 1998

HAIDYLENA MEDICAL

510(k) SUMMARY

Submitter

Haidylena Medical 26, Makrame Ebeid St., Nasr City, Cairo. EGYPT Telephone: 002-02-2750513 002-02-2706151 002-02-2706150 Facsimile: 002-02-2750552

Date summary was prepared

June 15, 1998

Name of the device

Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer

ldentification of predicate device

The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are substantially equivalence in construction, design, intended use, and function to other hemodialyzers currently marketed in the United States. The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are substantially equivalence in function, design and operation to the Cobe Centry Syatem 160E, Baxter CF25, and Terumo Clirans T175 Dialyzers, which have been previously approved for marketing in the United States.

Description of the device

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this device are substantially equivalence in design to the previously approved Cobe Centry System. The wall thickness of the Cuprophan and Hemophan fibers in Cobe Centry System 160E Dialyzers, Baxter CF25 Dialyzers and the proposed device is 8 microns. The inner diameter o Cuprophan and Hemophan in both Baxter CF25 Dialyzer and the proposed device is 200 microns.

Intended use

Technological Characteristics

Comparing the proposed device to the predicate device, some similarities are noted in the design and materials employed to accomplish the same intended use. Both the proposed device and Cope Centry Sytem 160E Dialyzers utilize the same Cupropohan hollow fiber membrane manufactured by Akzo (Enka) of Germany. Both the proposed device and Cobe Centry Syatem 160E Dialyzers utilize polycarbonate for the header material and polyurethan for membrane potting material. The proposed device and predicate devices are sterilized by ethylene oxide gas.

Hadylena Dialyzer	Cobe Centrysystem 160E	Baxter CF 25	Terumo CliranceT175
- with assistance of alpha plancompany (German company)- according to internationalstandard	The same	The same	The same

Design

Materials

Materials	HaidyelnaDialyzer	Cobe Centrysystem 160E	BaxterCF 25	TerumoClirance T175
Housing	Polycarbonate	Polycarbonate	Polycarbonate	Polycarbonate
Membrane	AkzoCuprophan& Hemophan	AkzoCuprophan& Hemophan	AkzoCuprophan& Hemophan	AkzoCuprophan& Hemophan
Puttingmaterials	Polyurethane	polyurethane	polyurethane	polyurethane
Blood caps	Polycarbonate	Polycarbonate	Polycarbonate	Polycarbonate
Vented caps	Polyethylene	Polyethylene	Polyethylene	Polyethylene

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p:3/3 HAIDYLENA MEDICAL

In Vitro Performance

In vitro testing was performed on the proposed device to determine the following: Urea, Creatinine, Phosphate, and Vitamin B12 clearance, and ultrafiltration coefficient. The results are listed on the next page with the data from the predicate device. The result indicates that the proposed device is substantially equivalent to Terumo Clirans T175 and Baxter CF25 for in vitro performance.

	Haidylena Hollow fiber Dialyzer						Terumo	Baxter	Cobe
Physical	Cuprophan			Hemophan			CliransT175	CF25	CentryS. 160E
	HL100	HL120	HL130	HL100 H	HL120 H	HL130 H	HL160 H
Blood primingvolume (ml)	57	68	79	57	68	79	95	120	112	42
Effective surface(S.Q.M.)	1.0	1.2	1.3	1.0	1.2	1.3	1.6	1.75	1.6	0.9
Wall thickness(µm)	8	8	8	8	8	8	8	9	8	8
Clearance (ml/min.)
Urea	174	179	184	170	175	179	190	192	191
Cretonne	149	156	162	149	154	160	161	177	170	130
Phosphate	124	138	141	129	140	149	151	151	159
Vitamin	48	55	58	46	55	60	61	97	62	35
Ultrafiltration rate(ml/hr/mmHg)	4.9	6.0	6.6	4.9	6.0	6.0	8.0	8.8	6.5	4.3
Maximum TMP	500	500	500	500	500	500	500	500	500

Additional safety Information

Sterilization conditions have been validated according to BS EN 550: Sterilization of medical devices, Validation and remote control of Ethylene oxide sterilization, and AAMI guidelines to provide a Sterility Assurance Level of 10 to the negative sixth.

Ethylene oxide residuals will not exceed the maximum residuals limits proposed for part 821 of Tittle 21 in the Federal register of June 23, 1978 (or as finalized or amended).

Conclusions

Testing performed on the Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer indicate it is safe, effective, and performs as well as the predicate devices, when used in accordance with instruction for use.

Signature

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three wavy lines representing the branches of government.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 29 1998

Mr. Saneh Tamim Laboratories and Sterilization Manager, Plant Quality Coordinator, and Registration Specialist Haidylena Medical 26 Makram Ebeid St. Nasr City, Cairo, Egypt

Re: K982337 Cuprophan and Hemophan Hollow Fiber Dialyzer Received: October 23, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 FJI

Dear Mr. Tamim:

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 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. 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(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 and additionally 809.10 for in vitto 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,

t Daniel G. Schultz, M.D.

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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PREMARKET NOTIFICATION STATEMENT FOR INDICATIONS FOR USE [ As required by 510(k)]

certify that, in my capacity as a laboratories and sterilization manager, plant quality coordinator and registration specialist of Haidylena Medical company, that the device submitted in this premarket notification are intended for use whenever a patient is in acute or chronic renal failure and hemodialysis is prepared by a physician. 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.

	Signature
	Sameh Tamim
	(Typed Name)
	Sameh Abdel Rahman Tamim
	(Dated)
	15/06/1998
	(premarket Notification [ 510 (k) ] Numk
For Prescription use
See Below
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number	K982337
	12/29/98

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.