(222 days)
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No
The summary describes a mechanical device for fluid removal and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes.
The device is designed to remove excess fluid and low molecular weight blood constituents from the extracorporeal circuit during cardiopulmonary bypass surgery, and for patients with acute or chronic fluid overload. These actions directly treat physiological conditions.
No
The device is a hemoconcentrator designed to remove excess fluid and low molecular weight blood constituents; it performs a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components such as membranes, ports, caps, and tubing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) during cardiopulmonary bypass surgery and for treating fluid overload in patients. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a device that interacts directly with blood in an extracorporeal circuit, not a device that analyzes samples.
- Performance Studies: The performance studies focus on the device's physical performance, blood compatibility, and heparin characteristics, not on the accuracy or reliability of diagnostic measurements from biological samples.
The device is a medical device used for therapeutic purposes (removing fluid from the blood), not for diagnostic purposes.
N/A
Intended Use / 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.
Product codes
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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 m² 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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
Key Metrics
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Predicate Device(s)
Quick-Prime Hemoconcentrators Models: HQ-7000TM HQ-7005™ with tubing set HQ-7005L™ with tubing set/male luer adapters
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
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).
(b)
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.”
0
Image /page/0/Picture/1 description: The image shows handwritten text. The first line reads "K963203". The second line reads "P 1/2". The text is written in a simple, clear font, making it easily readable.
510(k) Summary Prepared 7/31/96
Name and Address of Contact Person 1.
MAR 2 5 1997
Scott Beggins Baxter Healthcare Corporation CardioVascular Group Bentley Division P.O. Box 19522 Irvine, California 92713-9522
Name of Device: 2.
Quick-Prime Hemoconentrators with Duraflo® Treatment Models: HQ-7000™ GOLD HQ-7005™ GOLD with tubing set HQ-7005L™ GOLD with tubing set with luer fittings
Predicate Device: 3.
Quick-Prime Hemoconentrators Models: HQ-7000TM 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 m² 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 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.
1
Image /page/1/Picture/1 description: The image shows handwritten text. The top line reads "K963203". The bottom line reads "P,2/2" and is underlined. The handwriting is somewhat messy but legible.
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.
a. Technology Comparison 6.
The proposed device and predicate device are essentially identical, with the only exception being associated with the addition of Duraflo® treatment to the bloodcontacting 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.