(110 days)
The capillary dialyzer is intended for use in hemodialysis and associated modalities for the treatment of chronic and acute renal failure.
The Gambro Polyflux 14L, 17L, and 21L Capillary Dialyzers/Filters, labeled for single use, have the same design, materials, intended use and function as other hemodialyzers / filters currently marketed in the United States. These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is a blend of polyarylethersulfone (PAES), PVP, and Polyamide, which is identical to the membrane used in the Gambro Polyflux H single use hemodialyzers cleared under 510K Notification (K030592) and the Polyflux L dialyzers cleared under 510(k) Notification (K010985). Blood enters a blood inlet port where it is distributed to the hollow fibers. 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 membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.
The provided text describes a 510(k) submission for the Gambro Polyflux 14L, 17L, and 21L Capillary Dialyzers/Filters. The submission argues for substantial equivalence to predicate devices (Polyflux 6L, 8L, 10L, and Polyflux 140K, 170H, 210H).
Here's an analysis of the acceptance criteria and study data based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., clearance rates, ultrafiltration rates). Instead, it relies on demonstrating substantial equivalence to predicate devices. The primary acceptance criterion appears to be that the proposed devices "meet the same acceptance criteria as the predicate devices".
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics: Similar in design, function, composition, and operation as predicate devices. | The proposed device configurations have the same technological characteristics and are similar in design, function, composition, and operation to the currently marketed configurations (predicate devices). The membrane used is identical to membranes in cleared predicate devices. |
| Safety and Effectiveness: Perform as well as predicate devices. | Non-Clinical (In vitro) Testing: Conducted to compare the performance of the proposed device configurations to the predicate configurations. (Specific results not detailed, but implied to meet equivalence). |
| Clinical Studies: Demonstrated that the proposed Polyflux 14L, 17L, and 21L meet the same acceptance criteria as the predicate devices Polyflux 6L, 8L, and 10L. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size for either the in vitro or clinical tests.
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission involving clinical studies, it is likely that for the clinical data, it would have been prospective, but this is an assumption.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies conducted are related to device performance in hemodialysis, not diagnostic accuracy where expert ground truth establishment is typical.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The evaluation methodology described focuses on comparing device performance parameters, not on interpretation or consensus among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study investigates human reader performance, often with and without AI assistance, which is not relevant to the evaluation of a hemodialyzer device. The studies described are focused on the device's functional performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to this device. A hemodialyzer is a physical medical device, not an algorithm, and its performance is inherently "standalone" in mechanical function, albeit used by human operators. The in vitro and clinical tests described would assess the device's performance in isolation (in vitro) and in a clinical setting (with human operators, but not evaluating human interpretation).
7. The Type of Ground Truth Used
For the clinical studies, the "ground truth" would likely be patient physiological parameters and outcomes related to dialysis effectiveness (e.g., solute clearance, ultrafiltration success, patient well-being, absence of device-related adverse events). For the in vitro testing, the ground truth would be measured physical and chemical properties (e.g., membrane integrity, fluid flow rates, solute removal efficiency) against established engineering and biological standards for dialysis. The document states "clinical studies demonstrated that the proposed Polyflux 14L, 17L and 21L meet the same acceptance criteria as the predicate devices," implying objective, measurable clinical outcomes were the basis.
8. The Sample Size for the Training Set
This information is not applicable and not provided. A "training set" is relevant to machine learning algorithms. This submission is for a physical medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided as a "training set" is not relevant for this 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.”