(256 days)
The Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers / filters can be used whenever hemodialysis or hemofiltration is indicated. These can be used for acute or chronic hemodialysis or hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration and clotting times should be performed under the supervision / direction of a physician.
The Gambro Polyflux 11S, 14S, & 21S Hemodialyzers/Hemofiters are identical in construction in function to other hemodialyzers/filters currently marketed in the United States. These devices are intended for use in hemodialysis and hemofiltration for the treatment of acute and chronic renal failure and for certain types of intoxications. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylether sulfone (polyethersulfone) (PES) which is identical to the membrane utilized in the Cobe Centrysystem 14 PES hemodialyzer which has been previously approved for marketing in the United States under a 510K Notification (K95-5592).
Blood enters a blood inlet port where it is distributed to polyarylethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyarylethersulfone hollow fibers in each hemodialyzer / hemofilter are 8000 for the 11S. 10000 for the 14S, 10000 for the 17S, and 12500 for the 21S. These dialyzers have effective membrane lengths of either 210mm (11S & 14S) or 250 mm (17S & 21S). The effective membrane surface areas are 1.1 m2 for the 11S, 1.4 m2 for the 14S, 1.7 m2 for the 17S, and 2.1 m2 for the 21S. The housing of this hemodialyzer is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592). 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 polyarylethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. 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 polyarylethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Gambro Polyflux 11S, 14S, 17S, and 21S Hemodialyzers/Filters:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a pass/fail format. Instead, it relies on demonstrating substantial equivalence to a predicate device (Cobe Centrysystem 14 PES Hemodialyzer) across several functional and material parameters. The "reported device performance" in this context refers to the results of in vitro testing and the overall conclusion of substantial equivalence.
| Parameter Evaluated | Predicate Device Performance / Reference | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Material/Design equivalence: | Cobe Centrysystem 14 PES Hemodialyzer (K95-5592) | Substantially equivalent in: |
- Polyarylethersulfone (PES) hollow fiber membrane
- Polycarbonate housing and header
- Polyurethane potting material | "The membrane used in this device is polyarylether sulfone (polyethersulfone) (PES) which is identical to the membrane utilized in the Cobe Centrysystem 14 PES hemodialyzer."
"The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592)."
"Both the proposed and predicate devices use polycerbonate for the housing and header material and polyurethane for the membrane potting material." |
| Blood side priming volume | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
| Dialysate side priming volume | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
| Dialysate flow resistance | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
| Blood flow resistance | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
| Ultrafiltration coefficient | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
| Urea clearance | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
| Vitamin B12 clearance | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
| Overall Safety & Effectiveness | Implied by predicate device approval (K95-5592) | Safe, effective, and performs as well as the predicate device. | "Testing performed on the Gambro Polyflux 11S, 14S, 17S, and 21S indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance the instructions for use." |
2. Sample Size Used for the Test Set and Data Provenance
- The document states: "In vitro testing was performed on the Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers/hemofilter..."
- It does not specify the sample size (N) for the in vitro tests (e.g., how many units of each model were tested).
- Data Provenance: The data is from in vitro testing. No country of origin is specified for the testing itself, but the submission is for the US market. The study is prospective in the sense that the sponsor performed these tests to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this submission. The "ground truth" for this medical device (hemodialyzer) is established through measurable physical and chemical performance parameters (e.g., flow resistance, clearance rates) and direct comparison to a predicate device's established performance based on its 510(k) approval. It does not involve expert consensus on interpreting data in the way a diagnostic AI might.
4. Adjudication Method for the Test Set
- This is not applicable. The data presented relies on objective measurements from in vitro tests, not expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. Such studies are typically for diagnostic devices where human readers interpret medical images or data, and AI assists them. This document is for a therapeutic device (hemodialyzer).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a hemodialyzer, not an algorithm or AI. The in vitro testing performed is inherently "standalone" in that it measures the device's physical performance directly.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by objective, measurable physical and chemical characteristics obtained through in vitro testing, combined with the successful approval and marketing history of the predicate device (Cobe Centrysystem 14 PES Hemodialyzer, K95-5592). The data itself (e.g., clearance rates, flow resistance) constitutes the ground truth for performance, and the comparison to the predicate device validates its clinical relevance.
8. The Sample Size for the Training Set
- This information is not applicable. Hemodialyzers are not "trained" like AI algorithms. Their performance is inherent in their design and materials.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as point 8.
§ 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.”