BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
Device Facts
| Record ID | K963203 |
|---|---|
| Device Name | BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT |
| Applicant | Baxter Healthcare Corp |
| Product Code | KDI · Gastroenterology, Urology |
| Decision Date | Mar 25, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5860 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Quick-Prime Hemoconcentrator is designed for use in cardiopulmonary bypass surgery to remove excess fluid and low molecular weight blood constituents from the extracorporeal circuit. It is also indicated for use for patients with acute or chronic fluid overload when conservative therapy is inadequate.
Device Story
Hemoconcentrator used during cardiopulmonary bypass or for fluid overload management; removes excess fluid and low molecular weight blood constituents from extracorporeal circuit. Device features 1.25m2 planar membrane area; 81 mL priming volume. Incorporates Duraflo® Treatment (heparin-treated blood path, up to 900 USP units) on blood-contacting surfaces to improve blood compatibility. Operated by perfusionists or clinicians in surgical/clinical settings. Connects to extracorporeal circuit via integrated tubing or Luer fittings. Provides filtration of blood; assists in fluid balance management.
Clinical Evidence
Bench testing only. Studies included: prime volume, leak testing, ultrafiltration rate vs. transmembrane pressure, blood chemistry, generated plasma hemoglobin, blood damage, heparin leaching, and heparin quantitation.
Technological Characteristics
Planar membrane hemoconcentrator; 1.25m2 membrane area; 81 mL priming volume. Blood-contacting surfaces coated with Duraflo® (heparin-treated). Includes Hansen port caps, yellow adapter connectors, and optional pre-connected 1/4 inch I.D. tubing or male Luer fittings. Mechanical filtration principle.
Indications for Use
Indicated for patients undergoing cardiopulmonary bypass surgery or patients with acute/chronic fluid overload where conservative therapy is inadequate.
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
- Quick-Prime Hemoconcentrators (HQ-7000, HQ-7005, HQ-7005L)
Related Devices
- K980859 — HEMOCOR HPH MINI HEMOCONCENTRATOR · Minntech Corp. · May 12, 1998
- K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) · Sorin Group Italia S.R.L. · Apr 25, 2025
- K971180 — BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT · C.R. Bard, Inc. · Jul 24, 1997
- K983085 — HEMOCOR HPH 700 HEMOCONCENTRATOR · Minntech Corp. · Nov 13, 1998
- K021732 — DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT · Dideco S.P.A. · Nov 4, 2002
