(194 days)
The Centrysystem 600 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.
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 267 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.
The provided 510K K960474 notification describes a hemodialyzer, the Cobe Centrysystem 600 HG. This submission is for a medical device that performs a physical function (blood filtration) rather than a diagnostic function (e.g., image analysis or disease detection). Therefore, many of the requested categories in the prompt (e.g., 'number of experts', 'adjudication method', 'MRMC study', 'standalone performance', 'training set sample size') are not applicable to this type of device and its regulatory submission.
Here's an analysis based on the provided text, focusing on applicable points and noting where the information is not relevant to this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in a tabular format as might be seen for a diagnostic algorithm. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical in vitro testing. The performance is "accepted" if it is shown to be substantially equivalent.
| Performance Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Blood side priming volume | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Dialysate side priming volume | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Dialysate and blood flow resistance | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Ultrafiltration coefficient | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Urea clearance | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Creatinine clearance | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Phosphate clearance | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Vitamin B12 clearance | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Residual blood volume | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
2. Sample size used for the test set and the data provenance
The document refers to "in vitro testing" to determine various parameters. It does not specify the sample size (e.g., number of devices tested) for these in vitro tests. Data provenance (country of origin, retrospective/prospective) is not applicable or specified for in vitro device performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a physical medical device and its performance is evaluated through measurable physical characteristics in an in vitro setting, not by human expert assessment of a "ground truth" like in diagnostic imaging.
4. Adjudication method for the test set
Not applicable for in vitro physical device testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a diagnostic AI device requiring human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. The in vitro testing represents the "standalone" performance of the device without patient involvement.
7. The type of ground truth used
The "ground truth" in this context is the established, measurable physical and chemical properties of the device and its performance in a controlled in vitro environment. For example, "urea clearance" is measured directly, rather than being an expert consensus or pathology finding. The established performance of the predicate device serves as the benchmark for "substantial equivalence."
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
Study Proving Acceptance Criteria are Met:
The study proving the acceptance criteria are met is the "Summary of Non-Clinical Tests".
- Study Design: This was an in vitro test series.
- Purpose: To determine the blood side priming volume, dialysate side priming volume, dialysate and blood flow resistance, ultrafiltration coefficient, and clearances for urea, creatinine, phosphate, and vitamin B12 at varying blood flows, as well as residual blood volume.
- Methodology: The specific tests performed were standard in vitro measurements for hemodialyzers. The document mentions "varying blood flows" for clearance measurements, indicating different operational conditions were tested.
- Results/Conclusion: "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." This statement indicates that for all the measured parameters, the Cobe Centrysystem 600 HG performed comparably to the predicate device, the Gambro GFS Plus 20 Hemodialyzer.
Key Takeaway: The entire submission for the Cobe Centrysystem 600 HG relies on demonstrating substantial equivalence to an already approved predicate device (Gambro GFS Plus 20). This is a common pathway for physical medical devices, where the "acceptance criteria" are implicitly met if the new device performs within acceptable bounds of the predicate device's established performance for critical functional parameters. Clinical testing was explicitly not performed, further solidifying the reliance on in vitro evidence of equivalence.
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510K Notification: Cobe Centrysystem 600 HG K960474
AUG 1 4 1996
510K(k) SUMMARY
| SUBMITTER: | Gambro Healthcare |
|---|---|
| Formerly: Cobe Renal Care, Inc. | |
| 1185 Oak Street | |
| Lakewood, CO 80215 | |
| (303) 231-4436 | |
| DATE PREPARED: | May 21, 1996 |
Cobe Centrysystem 600 HG DEVICE NAME: 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 267 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:
hemodialyzers are substantially equivalent in The Cobe Centrysystem 600 HG construction, design, intended use, function and materials to other hemodialyzers currently marketed in the United States. Cobe Centrysystem 600 HG hemodialyzers are
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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 600 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.
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 Hemophane, hollow fiber membrane manufactured by ENKS / AKZO. 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 larger membrane surface area, is ethylene oxide sterilized rather than gamma irradiated, and has a slightly larger blood side priming volume.
Summary of Non-Clinical Tests:
In vitro testing was performed on the Centrysystem 600 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 Test Results:
Clinical testing was not performed
Conclusions:
Testing performed on the Cobe Centrysystem 600 HG indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use.
§ 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.”