← Product Code [KDI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDI) · K963203 # BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT (K963203) _Baxter Healthcare Corp · KDI · Mar 25, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDI/K963203 ## Device Facts - **Applicant:** Baxter Healthcare Corp - **Product Code:** [KDI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDI.md) - **Decision Date:** Mar 25, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5860 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510 K Submission for Bentley Quick-Prime Hemoconcentrator with Duraflo® Treatment 510(k) Summary Prepared 7/31/96 K963203 p1/2 1. Name and Address of Contact Person MAR 25 1997 Scott Beggins Baxter Healthcare Corporation CardioVascular Group Bentley Division P.O. Box 19522 Irvine, California 92713-9522 2. Name of Device: Quick-Prime Hemoconcentrators with Duraflo® Treatment Models: HQ-7000™ GOLD HQ-7005™ GOLD with tubing set HQ-7005L™ GOLD with tubing set with luer fittings 3. Predicate Device: Quick-Prime Hemoconcentrators Models: HQ-7000™ HQ-7005™ with tubing set HQ-7005L™ with tubing set/male luer adapters 4. Device Description The HQ-7000™ GOLD, HQ-7005™ GOLD, and HQ-7005L™ GOLD devices are coated with the Duraflo® Treatment. The Duraflo® Treatment may improve the blood compatibility of non-biological surfaces. Devices with this treatment are used when a heparin-treated blood path is desired. The Duraflo® Treatment provides a heparin-treated blood path containing up to 900 USP units of heparin on the hemoconcentrator. The Quick-Prime Hemoconcentrator devices have a $1.25\mathrm{m}^2$ total planar membrane area and a priming volume of approximately 81 mL. Hansen port caps are provided with the Quick-Prime Hemoconcentrator. A yellow adapter connector covers the upper port to allow for filtration. A white cap seals the port at the base of the device. The HQ-7005™ GOLD, and HQ-7005L™ GOLD devices contain pre-connected blood inlet and outlet tubing. Tubing is graduated in size with 1/4 inch (6.35 mm) I.D. ends that are ready for connection to the extracorporeal circuit. The HQ-7005L™ GOLD has male Luer fittings at each end for connection in the extracorporeal circuit. 055 {1} 510 K Submission for Bentley Quick-Prime Hemoconcentrator with Duraflo® Treatment K963203 P. 2/2 ## 5. 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. ## 6. a. Technology Comparison The proposed device and predicate device are essentially identical, with the only exception being associated with the addition of Duraflo® treatment to the blood-contacting surfaces of the treated devices. The components remain the same for both the treated and non-treated versions. ## b. Testing Summary The following studies were conducted to qualify the Quick-Prime Hemoconcentrators with Duraflo® Treatment: - Prime Volume - Leak Test - Ultrafiltration Rate vs. Transmembrane Pressure Testing - Blood Chemistry - Generated Plasma Hemoglobin - Blood Damage - Heparin Leaching - Heparin Quantitation ## c. Rational for Substantial Equivalence Determination The coated and uncoated versions of the Quick-Prime Hemoconcentrators are essentially identical. The basic materials remain the same, with the only exception being associated with the addition of the Duraflo® Treatment to the blood contacting surfaces of the treated versions. Testing has demonstrated that units with the proposed addition of the Duraflo® Treatment are substantially equivalent to the predicate (uncoated) device, and that there were no adverse effects on overall hemoconcentrator performance. 056 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDI/K963203](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDI/K963203) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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