(510 days)
Fresenius F80 A Hemodialyzer, Gambro HC 14R Hemoconcentrator
Not Found
No
The summary describes a hemodialysis device based on membrane technology and physical processes (diffusion, convection, ultrafiltration). There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or device control. The performance studies focus on physical characteristics and clearances, not algorithmic performance.
Yes.
The device is a hemodialysis dialyzer used for removing uremic toxins and waste products from a patient's blood, which directly treats a medical condition.
No
The device is a dialyzer used for hemodialysis, which is a treatment to remove waste products and excess fluid from the blood when the kidneys are no longer functioning properly. It is a therapeutic device, not diagnostic.
No
The device description clearly describes a physical medical device (a dialyzer) with a membrane, hollow fibers, and ports for blood and dialysate flow. It also details in vitro and clinical testing of this physical device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for hemodialysis, which is a treatment performed directly on the patient's blood to remove waste products. This is a therapeutic procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a hemodialyzer, a device that filters blood. This aligns with a therapeutic device used in a clinical setting, not a device for analyzing samples in a laboratory.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Detecting or measuring specific analytes.
- Providing results used for diagnosis, monitoring, or screening.
The device is clearly described as a hemodialyzer used in the process of hemodialysis, which is a life-sustaining treatment.
N/A
Intended Use / Indications for Use
The Centrysystem 14 PES Gamma 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 this device is polyether sulfone which is substantially equivalent to the polysulfone membrane utilized in the Fresenius F80A dialyzers and the polyether sulfone membrane utilized in the Gambro HC 14 R Hemoconcentrators. Both devices have been previously approved for marketing in the United States under 510K Notifications. The polyether sulfone membrane is manufactured by Gambro.
Blood enters a blood inlet port where it is distributed to polyether sulfone hollow fiber has an inner diameter of approximately 215 microns and a wall thickness of 50 microns. The effective length of the fibers is 267 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro HC 14R Hemoconcentrator. 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 Polyether sulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate Removal of uremic toxins and waste products are removed from the compartment of the devices. patient's blood in this device by means of both diffusion and convection through the Polyether sufone 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
In vitro testing was performed on the Centrysystem 14 PES Gamma 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 performed utilizing 24 Cobe Centrysystem 14 PES Hemodialyzers in six patients. Parameters studied during these clinical tests included pressure drops across the blood compartment and dialysate compartment, blood flows, transmembrane pressures, ultrafiltration rates, urea clearances, creatinine clearances, phosphate clearances, beta 2 microglobulin clearances, residual blood volumes and handling and safety evaluations.
It can be concluded from the results of the investigation that the Cobe Centrysystem 14 PES Gamma Hemodialyzer fulfills the performance criteria stated by Gambro.
Key Metrics
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Predicate Device(s)
Fresenius F80 A Hemodialyzer, Gambro HC 14R Hemoconcentrator
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
APR 30 1997
Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '955592'. The characters are written in a bold, black font, and they appear to be slightly uneven, suggesting they were written by hand.
510K Notification Cobe Centrysystem CS 14 PES Gamma Supplemental Information: 10/10/96
510K(k) SUMMARY
| SUBMITTER: | Gambro Healthcare
Formerly: Cobe Renal Care, Inc.
1185 Oak Street
Lakewood, CO 80215
(303) 231-4436 |
| ------------ | ----------------------------------------------------------------------------------------------------------------- |
|---|
| DATE PREPARED: | October 9 th , 1996 |
|---|---|
| DEVICE NAME: | Cobe Centrysystem 14 PES Gamma |
| CLASSIFICATION NAMES: | High Permeability Hemodialyzer |
| PREDICATE DEVICE: | Fresenius F80 A Hemodialyzer |
| Gambro HC 14R Hemoconcentrator |
Device Description:
The membrane used in this device is polyether sulfone which is substantially equivalent to the polysulfone membrane utilized in the Fresenius F80A dialyzers and the polyether sulfone membrane utilized in the Gambro HC 14 R Hemoconcentrators. Both devices have been previously approved for marketing in the United States under 510K Notifications. The polyether sulfone membrane is manufactured by Gambro.
Blood enters a blood inlet port where it is distributed to polyether sulfone hollow fiber has an inner diameter of approximately 215 microns and a wall thickness of 50 microns. The effective length of the fibers is 267 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro HC 14R Hemoconcentrator. 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 Polyether sulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate Removal of uremic toxins and waste products are removed from the compartment of the devices. patient's blood in this device by means of both diffusion and convection through the Polyether sufone membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.
Predicate Devices:
The Cobe Centrysystem 14 PES Gamma hemodialyzer is substantially equivalent in construction, design, intended use, function and materials to other hemodialyzers currently marketed in the United States. Cobe Centrysystem 14 PES Gamma hemodialyzer is substantially equivalent in function, design, composition, materials, and operation, to the Fresenius F80A hemodialyzer and Gambro HC 14R Hemoconcentrator which are currently in commercial distribution in the United States.
Intended Use:
The Centrysystem 14 PES Gamma 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,
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510K Notification Cobe Centrysystem CS 14 PES Gamma Supplemental Information: 10/10/96
monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.
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 Polyether sulfone, hollow fiber membrane manufactured by Gambro. 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 different membrane surface area, is gamma sterilized rather than ethylene oxide sterilized.
Summary of Non-Clinical Tests:
In vitro testing was performed on the Centrysystem 14 PES Gamma 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 performed utilizing 24 Cobe Centrysystem 14 PES Hemodialyzers in six patients. Parameters studied during these clinical tests included pressure drops across the blood compartment and dialysate compartment, blood flows, transmembrane pressures, ultrafiltration rates, urea clearances, creatinine clearances, phosphate clearances, beta 2 microglobulin clearances, residual blood volumes and handling and safety evaluations.
It can be concluded from the results of the investigation that the Cobe Centrysystem 14 PES Gamma Hemodialyzer fulfills the performance criteria stated by Gambro.
Conclusions:
Testing performed on the Cobe Centrysystem 14 PES Gamma indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use.