(504 days)
No
The description focuses on the physical components and function of a hemodialyzer, with no mention of AI or ML capabilities.
Yes
The device is a hemodialyzer, which is used in hemodialysis therapy to remove uremic toxins and waste products from a patient's blood, thereby treating a medical condition.
No
Explanation: The device is described as a hemodialyzer used for dialysis therapy to remove uremic toxins and waste products from a patient's blood, which is a therapeutic function rather than 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 process of filtering a patient's blood to remove waste products and excess fluid. This is a therapeutic procedure performed directly on the patient's blood within the body's circulatory system, not on a sample of blood or other bodily fluid outside the body for diagnostic purposes.
- Device Description: The description details how the device interacts with the patient's blood and dialysate to remove waste products. This is consistent with a therapeutic device used for blood purification.
- Lack of Diagnostic Language: The text does not mention any diagnostic tests, analysis of samples, or the generation of diagnostic information.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is used in vivo (within the body) to treat a condition.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Gambro Polyflux 11 Hemodialyzer K933818
Reference Device(s)
Not Found
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/0 description: The image shows handwritten text on a white background. The top line reads 'K955487', with the 'K' slightly separated from the numbers. Below this, the second line reads 'P192', with the 'P' also slightly separated from the numbers. The handwriting appears to be in black ink and has a somewhat rough or uneven quality.
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 Polytlux 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.
0000020
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.