(88 days)
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.
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.
This document is a 510(k) notification for a medical device (hemodialyzer) that was submitted to the FDA in 1996. During this time, the FDA's requirements for device approval, particularly concerning software and AI, were very different from today's standards. Therefore, an AI algorithm was not applicable in this context. The following information reflects what is available in the provided document, given the historical context and the nature of the device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Cobe Centrysystem 700 HG) |
|---|---|---|
| Blood Side Priming Volume | Equivalent to Gambro GFS Plus 20 | Confirmed equivalent |
| Dialysate Side Priming Volume | Equivalent to Gambro GFS Plus 20 | Confirmed equivalent |
| Dialysate Flow Resistance | Equivalent to Gambro GFS Plus 20 | Confirmed equivalent |
| Blood Flow Resistance | Equivalent to Gambro GFS Plus 20 | Confirmed equivalent |
| Ultrafiltration Coefficient | Equivalent to Gambro GFS Plus 20 | Confirmed equivalent |
| Urea Clearance (at varying blood flows) | Equivalent to Gambro GFS Plus 20 | Confirmed equivalent |
| Creatinine Clearance (at varying blood flows) | Equivalent to Gambro GFS Plus 20 | Confirmed equivalent |
| Phosphate Clearance (at varying blood flows) | Equivalent to Gambro GFS Plus 20 | Confirmed equivalent |
| Vitamin B12 Clearance (at varying blood flows) | Equivalent to Gambro GFS Plus 20 | Confirmed equivalent |
| Residual Blood Volume | Equivalent to Gambro GFS Plus 20 | Confirmed equivalent |
Note: The acceptance criteria are implicit in the claim of "substantial equivalence" to the predicate device, Gambro GFS Plus 20 Hemodialyzer (K902481). The reported device performance is stated as having "confirmed that the proposed device is substantially equivalent to the proposed device for these parameters."
2. Sample Size for the Test Set and Data Provenance:
The document does not specify a separate "test set" in the context of AI/software validation. The testing described is non-clinical in vitro testing.
- Sample Size: Not explicitly stated for each test, but standard laboratory practices for medical device testing would involve multiple units.
- Data Provenance: The testing was "in vitro" (laboratory-based) and conducted to compare the Cobe Centrysystem 700 HG to the predicate device. The document does not specify country of origin for the data itself beyond indicating the manufacturer is Gambro Healthcare (formerly Cobe Renal Care, Inc.) in Lakewood, CO, and the membrane manufacturer (Akzo/Enka) is from Germany. The study type is non-clinical, in vitro.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a physical hemodialyzer, and the testing involves objective physical and chemical measurements (e.g., flow resistance, clearance rates), not subjective human interpretation or diagnostic accuracy assessments. Ground truth in this context is established by standardized laboratory methods and measurements, not expert consensus.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human reader studies or expert consensus in diagnostic assessments. The testing described here is objective laboratory measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with AI:
Not applicable. This is a physical medical device (hemodialyzer), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (Algorithm Only) Performance Study was Done:
Not applicable. This is a physical medical device. There is no algorithm to evaluate in a standalone capacity.
7. The Type of Ground Truth Used:
The ground truth for the performance metrics (e.g., priming volume, clearance rates) was established by objective physical and chemical measurements obtained through standard laboratory testing protocols for hemodialyzers. The predicate device's established performance was used 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 or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of device.
§ 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.”