(282 days)
The. Cobe Arylane Hemodialyzers/Filters H1, H4, H9 are intended for use in hemodialysis and hemofiltration and associated modalities for the treatment of chronic renal failure.
The size, weight, state of uremia, cardiac status and general physical condition of the patient must be evaluated by the prescribing physician before each treatment. The choice of the appropriate heomdialyzer/filter and associated equipment as well as the treatment operating parameters are the sole responsibility of the physician.
The Hospal Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/filters are identical in construction in function to other hemodialyzers 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 polyarylethersulfone (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 polyarvlethersulfone hollow fibers in each hemodialyzer are 6400 for the H1, 8300 for the H4, 8300 for the H6, and 10600 for the H9. These dialyzers have effective membrane lengths of either 240mm (H1 & H4) or 280 mm (H6 & H9). In the Cobe Arylane H1 hemodialyzers/filter solid polyester filaments are interspersed in between the polyarylethersulfone hollow fibers and act as spacers to accommodate fewer numbers of fibers in the same housing used for the Cobe Arylane H4 hemodialyzer/filter. These same polyester spacing filaments have been used previously in other Cobe hemodialyzers for the same purpose. The effective membrane surface areas are 1.04 m2 for the H1, 1.35 m2 for the H4, 1.57 m2 for the H6, and 2.01 m2 for the H9. At either end of the device, the hollow fibers (and polyester filaments in the Cobe Arylane HI only) are potted in polyurethane to isolate the blood compartment from the filtrate compartment. 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.
The provided text describes a 510(k) notification for the Cobe Arylane H1, H4, H6, and H9 Hemodialyzers/filters. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. No clinical study information, acceptance criteria for an AI device, or performance data for an AI device are present in the provided text.
Therefore, I cannot fulfill the request as it pertains to an AI device's acceptance criteria and studies. The document describes a medical device approval process for hemodialyzers, not an AI device.
However, I can provide a summary of the non-clinical tests performed for the hemodialyzers, which are analogous to how a non-AI medical device would be evaluated for substantial equivalence.
Summary of Non-Clinical Tests (for the hemodialyzers):
| Test Parameter | Reported Device Performance |
|---|---|
| Blood side priming volume | Performed (Specific values not provided) |
| Dialysate side priming volume | Performed (Specific values not provided) |
| Dialysate flow resistance | Performed (Specific values not provided) |
| Blood flow resistance | Performed (Specific values not provided) |
| Ultrafiltration coefficient | Performed (Specific values not provided) |
| Urea clearance | Performed (Specific values not provided) |
| Creatinine clearance | Performed (Specific values not provided) |
| Phosphate clearance | Performed (Specific values not provided) |
| Inulin clearance | Performed (Specific values not provided) |
Regarding the requested points for an AI device, based on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable, as this is a non-AI medical device. The table above summarizes the non-clinical tests performed.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the in vitro tests conducted on the physical hemodialyzer units. The number of units tested is not specified. Data provenance is not applicable in the context of a software algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for the hemodialyzer performance is established through laboratory measurements and established analytical methods, not expert consensus.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: For the hemodialyzer performance, the ground truth would be the direct measurement of physical and functional properties in a laboratory setting (e.g., precise volume measurements, flow rate measurements, chemical analysis for clearance).
- The sample size for the training set: Not applicable. This is for a physical device, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
Conclusion stated in the document for the hemodialyzers:
"Testing performed on the Cobe Arylane Hemodialyzers indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance with the instructions for use." This statement implies that the non-clinical tests' results met the criteria established for substantial equivalence to the predicate device (Cobe Centrysystem 14 PES hemodialyzer, K95-5592). The specific numerical acceptance criteria themselves are not detailed in the summary.
§ 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.”