COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET

K982760 · Gambro Healthcare · KDI · Nov 4, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982760
• Device Name: COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
• Applicant: Gambro Healthcare
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COBE C Hemodialysis Delivery System is indicated for patients in acute or chronic renal failure and when the physician prescribes hemodialysis or ultrafiltration. The COBE® Cx System may be used with both high permeability and low permeability (conventional) dialyzers. The COBE® Cartridge Set is intended for use with the COBE Centrysystem 3 Hemodialysis Delivery System, or the COBE C* Hemodialysis Delivery System only.

Device Story

COBE Cx Hemodialysis Delivery System and COBE Cartridge Blood Tubing Set facilitate hemodialysis and ultrafiltration for patients with renal failure. System manages extracorporeal blood circuit; controls fluid removal; monitors dialysis parameters. Used in clinical settings by trained healthcare professionals. Physician prescribes therapy; system executes delivery via integrated tubing set. Benefits include effective solute clearance and fluid management for renal patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Hemodialysis delivery system with integrated cartridge blood tubing set. Supports high and low permeability dialyzers. Operates as a fluid management and extracorporeal circuit control system.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis or ultrafiltration. Compatible with high and low permeability dialyzers.

Regulatory Classification

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).

Special Controls

*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.”

Reference Devices

• COBE Centrysystem 3 Hemodialysis Delivery System

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 1998

Mr. William M. Townsend Senior Regulatory Affairs Specialist GAMBRO® Healthcare, Inc. 1185 Oak Street Lakewood, CO 80215-4498

Re: K982760

COBE® Cx™ Hemodialysis Delivery System and COBE Cartridge® Blood Tubing Set Dated: August 5, 1998 Received: August 6, 1998 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI

Dear Mr. Townsend:

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 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 (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 i submission does not affect any obligation you might have under sections 531 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmadsmam.html".

Sincerely yours

Lillian Yin, Ph.D.

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); K982760

Device Name: COBE® Model Cx™ Hemodialysis Delivery System

## COBE® Cartridge Blood Tubing Set

Indications For Use:

The COBE C Hemodialysis Delivery System is indicated for patients in acute or chronic renal failure and when the physician prescribes hemodialysis or ultrafiltration.

The COBE® Cx System may be used with both high permeability and low permeability (conventional) dialyzers.

The COBE® Cartridge Set is intended for use with the COBE Centrysystem 3 Hemodialysis Delivery System, or the COBE C* Hemodialysis Delivery System only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hind A. Seghman

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

510(k) Number

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Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)