(504 days)
The Gambro Polyflux 14, 17, and 21 hemodialyzers 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 these devices is Polyamide which is identical to the polyamide membrane utilized in the Gambro Polyflux 11 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K933818). This membranes is manufactured by Gambro Dialysatoren of Germany.
Blood enters a blood inlet port where it is distributed to polyamide hollow fibers. Each hollow fiber has an inner diameter of approximately 220 microns and a wall thickness of 50 microns. The effective length of the fibers is 210 mm for the Polyflux 14 and 250 mm for the Polyflux 17 and 21. The fibers used in this device are substantially equivalent in design to the previously approved Gambro Polyflux 11 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 Polyamide 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 Polyamide membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.
This 510(k) notification describes a medical device, not an AI/ML powered device, therefore, the requested information about acceptance criteria and study details for an AI/ML device is not applicable.
The document discusses the substantial equivalence of the Gambro Polyflux 14, 17, and 21 Hemodialyzers to a predicate device (Gambro Polyflux 11 Hemodialyzer) based on technological characteristics and non-clinical in vitro testing.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative table format as one might find for an AI/ML performance study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed through in vitro testing to ensure that certain parameters are comparable or within acceptable ranges relative to the predicate device.
| Parameter | Reported Device Performance (Gambro Polyflux 14, 17, 21) | Comparator (Gambro Polyflux 11) | Conclusion |
|---|---|---|---|
| Blood side priming volume | Tested (results not quantified in text) | Reference predicate device | Confirmed substantially equivalent |
| Dialysate side priming volume | Tested (results not quantified in text) | Reference predicate device | Confirmed substantially equivalent |
| Dialysate and blood flow resistance | Tested (results not quantified in text) | Reference predicate device | Confirmed substantially equivalent |
| Ultrafiltration coefficient | Tested (results not quantified in text) | Reference predicate device | Confirmed substantially equivalent |
| Urea clearance (varying blood flows) | Tested (results not quantified in text) | Reference predicate device | Confirmed substantially equivalent |
| Creatinine clearance (varying blood flows) | Tested (results not quantified in text) | Reference predicate device | Confirmed substantially equivalent |
| Phosphate clearance (varying blood flows) | Tested (results not quantified in text) | Reference predicate device | Confirmed substantially equivalent |
| Vitamin B12 clearance (varying blood flows) | Tested (results not quantified in text) | Reference predicate device | Confirmed substantially equivalent |
| Residual blood volume | Tested (results not quantified in text) | Reference predicate device | Confirmed substantially equivalent |
The "acceptance criteria" here is implicitly that the in vitro test results for the proposed devices demonstrate performance that is "substantially equivalent" to the previously approved predicate device (Gambro Polyflux 11).
Regarding the other requested points (2-9), these are not applicable to the provided document as it describes a traditional medical device, not an AI/ML system.
Here's why each point is not applicable:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set in the context of AI/ML data is used. The "testing" refers to non-clinical in vitro performance evaluations of the physical device.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No ground truth established by experts in this context. The "ground truth" is based on the measurable physical and chemical performance of the device in a lab setting, compared to a known predicate device.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical in vitro 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 for AI/ML diagnostic or assistive devices, not hemodialyzers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" is the established performance characteristics of the predicate device and the physical measurements from the in vitro tests of the new devices.
- 8. The sample size for the training set: Not applicable; there is no AI/ML model to train.
- 9. How the ground truth for the training set was established: Not applicable; there is no AI/ML model to train.
In summary, the document demonstrates substantial equivalence through a comparison of technological characteristics and non-clinical in vitro performance data, rather than through AI/ML specific validation studies. The key "study" here is the series of in vitro tests performed on the proposed devices, comparing their performance against the established predicate 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.”