COBE CENTRYSYSTEM 14 PES HEMODIALYZERS

K955592 · Cobe Renal Care, Inc. · KDI · Apr 30, 1997 · Gastroenterology, Urology

Device Facts

Record IDK955592
Device NameCOBE CENTRYSYSTEM 14 PES HEMODIALYZERS
ApplicantCobe Renal Care, Inc.
Product CodeKDI · Gastroenterology, Urology
Decision DateApr 30, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.5860
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Centrysystem 14 PES Gamma can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

Device Story

Hemodialyzer for acute/chronic renal failure; utilizes polyether sulfone hollow fiber membrane. Blood enters inlet port, flows through fibers; dialysate flows counter-current in external compartment. Solute/toxin removal via diffusion and convection driven by transmembrane hydrostatic pressure. Used in clinical settings under physician supervision. Output is purified blood returned to patient; dialysate waste removed. Benefits include uremic toxin clearance and fluid management.

Clinical Evidence

Clinical study of 24 units in 6 patients. Evaluated pressure drops, blood flows, transmembrane pressures, ultrafiltration rates, and clearance of urea, creatinine, phosphate, and beta-2 microglobulin. Results confirmed performance criteria met and safety/handling equivalent to predicates.

Technological Characteristics

Polyether sulfone hollow fiber membrane; polycarbonate housing/header; polyurethane potting material. Fiber ID ~215 microns, wall thickness 50 microns, effective length 267 mm. Energy source: external hemodialysis machine (hydrostatic/transmembrane pressure). Sterilization: Gamma radiation.

Indications for Use

Indicated for patients requiring acute or chronic hemodialysis therapy.

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.”

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} K955592 APR 30 1997 510K Notification Cobe Centrysystem CS 14 PES Gamma Supplemental Information: 10/10/96 510K(k) SUMMARY SUBMITTER: Gambro Healthcare Formerly: Cobe Renal Care, Inc. 1185 Oak Street Lakewood, CO 80215 (303) 231-4436 DATE PREPARED: October 9th, 1996 DEVICE NAME: Cobe Centrysystem 14 PES Gamma CLASSIFICATION NAMES: High Permeability Hemodialyzer PREDICATE DEVICE: Fresenius F80 A Hemodialyzer Gambro HC 14R Hemoconcentrator ## Device Description: The membrane used in this device is polyether sulfone which is substantially equivalent to the polysulfone membrane utilized in the Fresenius F80A dialyzers and the polyether sulfone membrane utilized in the Gambro HC 14 R Hemoconcentrators. Both devices have been previously approved for marketing in the United States under 510K Notifications. The polyether sulfone membrane is manufactured by Gambro. Blood enters a blood inlet port where it is distributed to polyether sulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns and a wall thickness of 50 microns. The effective length of the fibers is 267 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro HC 14R Hemoconcentrator. 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 Polyether sulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate compartment of the devices. 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 the Polyether sulfone membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port. ## Predicate Devices: The Cobe Centrysystem 14 PES Gamma hemodialyzer is substantially equivalent in construction, design, intended use, function and materials to other hemodialyzers currently marketed in the United States. Cobe Centrysystem 14 PES Gamma hemodialyzer is substantially equivalent in function, design, composition, materials, and operation, to the Fresenius F80A hemodialyzer and Gambro HC 14R Hemoconcentrator which are currently in commercial distribution in the United States. ## Intended Use: The Centrysystem 14 PES Gamma can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, 000009 {1} 510K Notification Cobe Centrysystem CS 14 PES Gamma Supplemental Information: 10/10/96 monitoring of patient vital signs, the dialysate 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 utilize the same Polyether sulfone, hollow fiber membrane manufactured by Gambro. Both the proposed and predicate devices utilize 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 utilizes a different membrane surface area, is gamma sterilized rather than ethylene oxide sterilized. ## Summary of Non-Clinical Tests: In vitro testing was performed on the Centrysystem 14 PES Gamma to determine the following: blood side priming volume, dialysate side priming volume, dialysate and blood flow resistance, ultrafiltration coefficient, urea, creatinine, phosphate and vitamin B12 clearances at varying blood flows and residual blood volume. The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters. ## Clinical Test Results: Clinical testing was performed utilizing 24 Cobe Centrysystem 14 PES Hemodialyzers in six patients. Parameters studied during these clinical tests included pressure drops across the blood compartment and dialysate compartment, blood flows, transmembrane pressures, ultrafiltration rates, urea clearances, creatinine clearances, phosphate clearances, beta 2 microglobulin clearances, residual blood volumes and handling and safety evaluations. It can be concluded from the results of the investigation that the Cobe Centrysystem 14 PES Gamma Hemodialyzer fulfills the performance criteria stated by Gambro. ## Conclusions: Testing performed on the Cobe Centrysystem 14 PES Gamma indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use. 000010
Innolitics
510(k) Summary
Decision Summary
Classification Order
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