Who is the manufacturer of GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS?

Cobe Renal Care, Inc. filed the 510(k) submission for GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS (K955487).

What is the FDA product code for GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS?

KDI. It is classified under 21 CFR 876.5860 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS?

Gambro Polyflux 11 Hemodialyzer (K933818).

Who can help prepare an FDA 510(k) submission like GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS

K955487 · Cobe Renal Care, Inc. · KDI · Apr 18, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K955487
Device Name	GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
Applicant	Cobe Renal Care, Inc.
Product Code	KDI · Gastroenterology, Urology
Decision Date	Apr 18, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5860
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Gambro Polyflux 14, 17, and 21 hemodialyzers 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 removal of uremic toxins and waste products from blood; utilizes polyamide hollow fiber membrane. Blood enters inlet port, flows through hollow fibers; dialysate flows counter-current in dialysate compartment. Solutes and plasma water removed via diffusion and convection driven by hydrostatic/transmembrane pressure. Used in clinical settings under physician direction. Output is filtered blood returned to patient; waste-laden dialysate exits device. Benefits include effective toxin clearance for chronic or acute renal failure patients.

Clinical Evidence

No clinical data. Bench testing performed to evaluate blood/dialysate priming volumes, flow resistance, ultrafiltration coefficient, and clearance rates for urea, creatinine, phosphate, and vitamin B12.

Technological Characteristics

Hollow fiber hemodialyzer. Membrane: Polyamide. Housing: Polycarbonate. Potting: Polyurethane. Fiber dimensions: 220 micron inner diameter, 50 micron wall thickness. Fiber length: 210 mm (Polyflux 14) or 250 mm (Polyflux 17, 21). Principle: Diffusion and convection. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring hemodialysis, including both long-term chronic and acute 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

Gambro Polyflux 11 Hemodialyzer (K933818)

Related Devices

K955592 — COBE CENTRYSYSTEM 14 PES HEMODIALYZERS · Cobe Renal Care, Inc. · Apr 30, 1997
K982414 — GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS · Gambro Healthcare · Mar 26, 1999
K072232 — GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL · Gambro Renal Products, Inc. · Sep 7, 2007
K043342 — POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR · Gambro Renal Products · May 27, 2005
K030592 — GAMBRO POLYFLUX, MODEL 140H, 170H, 210H · Gambro Renal Care Products · May 23, 2003

Submission Summary (Full Text)

{0} K955487 P192 APR 18 1997 510K Notification Gambro Polyflux 14, 17 and 21 Hemodialyzers Supplemental Information: 7/10/96 # 510K(k) SUMMARY **SUBMITTER:** Gambro Healthcare Formerly: Cobe Renal Care, Inc. 1185 Oak Street Lakewood, CO 80215 (303) 231-4436 **DATE PREPARED:** July 10th, 1996 **DEVICE NAME:** Gambro Polyflux 14, 17, and 21 Hemodialyzers **CLASSIFICATION NAMES:** High Permeability Hemodialyzers **PREDICATE DEVICE:** Gambro Polyflux 11 Hemodialyzer ## Device Description: The membrane used in these devices is Polyamide which is identical to the polyamide membrane utilized in the Gambro Polyflux 11 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K933818). This membranes is manufactured by Gambro Dialysatoren of Germany. Blood enters a blood inlet port where it is distributed to polyamide hollow fibers. Each hollow fiber has an inner diameter of approximately 220 microns and a wall thickness of 50 microns. The effective length of the fibers is 210 mm for the Polyflux 14 and 250 mm for the Polyflux 17 and 21. The fibers used in this device are substantially equivalent in design to the previously approved Gambro Polyflux 11 hemodialyzers. 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 Polyamide 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 Polyamide membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port. ## Predicate Devices: The Gambro Polyflux 14, 17, and 21 hemodialyzers are substantially equivalent in construction, design, intended use, function and materials to other hemodialyzers currently marketed in the United States. The Gambro Polyflux 14, 17, and 21 hemodialyzers are substantially equivalent in function, design, composition, materials, and operation, to the Gambro Polyflux 11 Hemodialyzers (K933818) which are currently in commercial distribution in the United States. ## Intended Use: The Gambro Polyflux 14, 17, and 21 hemodialyzers 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. 000040 {1} K955487 P292 510K Notification Gambro Polyflux 14, 17 and 21 Hemodialyzers Supplemental Information: 7/10/96 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 Polyamide, hollow fiber membrane manufactured by Gambro Dialysatoren. 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 smaller membrane surface area, and has a smaller blood side priming volume. ## Summary of Non-Clinical Tests: In vitro testing was performed on the Polyflux 14, 17, and 21 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 not performed ## Conclusions: Testing performed on the Gambro Polyflux 14, 17, and 21 hemodialyzers indicates that they are safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use. 000021