EXTRACORPOREAL BLOOD CIRCUIT

K982340 · Haidylena Medical Egypt · FJK · Apr 30, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K982340
• Device Name: EXTRACORPOREAL BLOOD CIRCUIT
• Applicant: Haidylena Medical Egypt
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Apr 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Haemodialysis intended for channeling blood during Haemodialysis Treatement.

Device Story

Extracorporeal blood circuit used during haemodialysis treatment. Device channels blood between patient and haemodialysis machine. Used in clinical settings by trained healthcare professionals. Facilitates extracorporeal circulation required for dialysis therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extracorporeal blood circuit for haemodialysis. Specific materials and standards not provided in the document.

Indications for Use

Indicated for patients requiring haemodialysis treatment for the channeling of blood during the procedure.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

APR 3 0 1990

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K982340 Extracorporeal Blood Circuit Dated: January 7, 1999 Received: February 1, 1999 Regulatory Class: Il 21 CFR 876.5820/Procode: 78 FJK

Dear Mr. Tamim:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have have have have be We have revewed your Security notification of the indications for use stated in the enclosure) to legally determined the device is substantially equivalle (in the naturalians and 1976, the enactment date of the enactment date of the marked predicate devices makered in merstate connerce prior in anyth the provisions of the provisions of the general con Medical Device Amendments, or to devices inal nave been escore, suice, suices in the general contrise in the general contris Federal Food, Drug, and Cosment Act (Act). You may, the Act and Goments for overy to to on on an engistration, listing of provisions of the Act. The general controls provisions of the Act industry of the more
devices, good manufacturing practice, labeling, and prohibitions against misbranding an

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may If your device is classified (see adole) nito entrely (openarent many on clevine can be found in the Code of the Code of the Code of the Code of the Code of be subject to such additions. Exismly major registering for evindin assumes compliance with
Federal Regulations, Title 21, Parts 800 to 85. A substantially equivalion (OS) Federal Regulations, Title 21, Partice requirements, as set forth in Cuality System Regulation (QS) for the Current Good Manufacturing Practice requirements, as set latt may as include of the Food and Medical Devices: General regulation Frilling Drug Administration (FDA) will vehil such assumpling. Transmoy with he ennot may be in the Edelera in the Edelera in the Edelera regulatory action. In addition, FDA may punish notification sumission does and offect any obligation you
Register. Please note: this response to your premarket notices and Register. Please note: Inis response to your premailer outsimative voor head.
might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 for This letter will allow you to begin marketing your device as described in your of the program in a classification for linding of oubstantial. Sqermits your device to proceed to the market.

lf you desire specific advice for your labeling regulation (21 CFR Pat 801 and additionally for all 601 and 10 for guestions on If you desire specific advice in your device of Online it [phone]. Additionally, for questions on with diagnostic devices), please contact the Office of Oorhiance at [phone]. Also, 1450.
the promotion and advertising of your device, please contact the Office of Co the promotion and advensing of your devices, presses to premarket notification (21 CFR 807.97). Other please note the regulation entined with the Act may be obtained from the Division of Small Manufacturers
general information on your responsibilities under the Act may be obt general interniation on your roopensions 638-2041 or [phone], 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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## PREMARKET NOTIFICATION STATEMANT FOR INDICATIONS FOR USE [ As required by 510(k)]

certify that, in my capacity as laboratories and l plant quality coordinator and manager, sterilization sterilization specialist of Haidylena Medical company, that stration specialist of Francy on market notification are the the device submitted in this premains. Haemodialysis
intended for channeling blood during Haemodialysis Treatement.

Elvin L. Ingram
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number K982340

Prescription Use
(Per 21 CFR 801.109)

Signature

Someh Tamim

(Typed Name)

Sameh Abdel Rahman Tamim

(Dated)

15/06/1998 (premarket Notification [ 510 (k) ] Numk

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