(88 days)
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No
The description focuses on the physical components and function of a hemodialysis dialyzer, with no mention of AI or ML.
Yes
The device, a dialyzer, is used for hemodialysis to remove uremic toxins and waste products from a patient's blood, which is a therapeutic intervention.
No
This is a hemodialyzer, a device used for treating kidney failure by filtering waste products from the blood, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical hemodialyzer with a membrane, hollow fibers, and ports for blood and dialysate, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hemodialysis," which is a medical treatment performed on a patient to remove waste products and excess fluid from the blood when the kidneys are not functioning properly. This is a therapeutic procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details how the device interacts directly with the patient's blood to filter it. It describes the flow of blood and dialysate and the removal of waste products through a membrane. This is consistent with a therapeutic device used in a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for a health issue. The device's function is to treat a condition (kidney failure) by filtering the blood.
Therefore, the Centrysystem 700 HG is a therapeutic medical device used for hemodialysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Centrysystem 700 HG 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.
Product codes
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Device Description
The membrane used in this device is Hemophane which is substantially equivalent to the Hemophane membrane utilized in the Gambro GFS Plus 20 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K902481). Both of these membranes are manufactured by Akzo (Enka) of Germany.
Blood enters a blood inlet port where it is distributed to Hemophane hollow fibers. Each hollow fiber has an inner diameter of approximately 200 microns and a wall thickness of 6.5 microns. The effective length of the fibers is 240 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro GFS Plus 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 Hemophane 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 Hemophane membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro testing was performed on the Centrysystem 700 HG 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 testing was not performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
SEP 20 1996
510(K) Notification Cobe Centrysystem 700 HG Hemodialyzer
510K(k) SUMMARY
| SUBMITTER: | Gambro Healthcare
Formerly: Cobe Renal Care, Inc.
1185 Oak Street
Lakewood, CO 80215
(303) 231-4436 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | June 17th, 1996 |
| DEVICE NAME: | Cobe Centrysystem 700 HG |
| CLASSIFICATION NAMES: | High Permeability Hemodialyzer |
| PREDICATE DEVICE | Gambro GFS Plus 20 Hemodialyzer |
Device Description:
The membrane used in this device is Hemophane which is substantially equivalent to the Hemophane membrane utilized in the Gambro GFS Plus 20 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K902481). Both of these membranes are manufactured by Akzo (Enka) of Germany.
Blood enters a blood inlet port where it is distributed to Hemophane hollow fibers. Each hollow fiber has an inner diameter of approximately 200 microns and a wall thickness of 6.5 microns. The effective length of the fibers is 240 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro GFS Plus 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 Hemophane 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 Hemophane membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.
Predicate Devices:
The Cobe Centrysystem 700 HG hemodialyzers are substantially equivalent in construction, design, intended use, function and materials to other hemodialyzers currently marketed in the United States. Cobe Centrysystem 700 HG hemodialyzers are substantially equivalent in function, design, composition, materials, and operation, to the Gambro GFS Plus 20 Hemodialyzers (K902481) which are currently in commercial distribution in the United States.
Intended Use:
The Centrysystem 700 HG 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,
000070
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