(69 days)
Optiflux Dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers, which allow for the transfer of water and solutes between blood and the dialysate through a semi-permeable membrane. They Optiflux dialyzers are available in four (4) sizes. The sizes are differentiated by membrane surface area.
Medical Device: Optiflux Dialyzers F160NR, F180NR, F200NR, and F250NR
- Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from predicate device) | Reported Device Performance (Optiflux Dialyzers NR series) |
|---|---|---|
| Urea Clearance (Sodium Used as Marker) | Not explicitly stated but inferred to be comparable to predicate (Optiflux Ultra dialyzers) | Optiflux F160NR: 271 |
| Optiflux F180NR: 277 | ||
| Optiflux F200NR: 280 | ||
| Optiflux F250NR: 287 | ||
| Sieving Coefficient | Comparable to predicate | Consistent with predicate |
| Ultrafiltration Performance | Comparable to predicate | Consistent with predicate |
| Membrane Performance | Comparable to predicate | Consistent with predicate |
| Structural Integrity (Positive pressure decay) | Pass | Passed |
| Structural Integrity (Negative pressure decay) | Pass | Passed |
| Blood Compartment Integrity | Pass | Passed |
| Biocompatibility (Chemical analysis) | Pass | Passed |
| Biocompatibility (Cytotoxicity) | Pass | Passed |
| Biocompatibility (Sensitization) | Pass | Passed |
| Biocompatibility (Irritation) | Pass | Passed |
| Biocompatibility (Systemic Toxicity) | Pass | Passed |
| Biocompatibility (Chronic Toxicity) | Pass | Passed |
| Biocompatibility (Genotoxicity) | Pass | Passed |
| Biocompatibility (Hemocompatibility) | Pass | Passed |
| Biocompatibility (Risk Assessment of potential toxicity) | Acceptable | Acceptable |
| Sterility | Sterile | Passed |
| Pyrogenicity | Non-pyrogenic | Passed |
Note: The document states "Performance testing was conducted in accordance with ISO 8637:2010. Results of the testing listed below support the determination of substantial equivalence." This implies that the acceptance criteria for these tests are the standards outlined in ISO 8637:2010 and the results met those standards, demonstrating equivalence to the predicate.
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Sample Size Used for the Test Set and Data Provenance
- The document does not specify the sample sizes used for each specific test (e.g., clearance testing, structural integrity, biocompatibility).
- The data provenance is from in vitro testing. The country of origin of the data is not specified, but the manufacturer is Fresenius Medical Care North America (Waltham, MA, USA). The study is retrospective in the sense that it relies on bench testing as opposed to prospective clinical trials.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The tests performed are primarily bench-top (in vitro) and adherence to recognized standards (ISO 8637:2010) and biocompatibility principles. Ground truth in this context is typically established by laboratory testing protocols and established scientific methods, rather than expert interpretation of results.
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Adjudication Method for the Test Set
- An adjudication method similar to 2+1 or 3+1 is not applicable for the reported performance tests. These are objective laboratory measurements against defined standards or comparisons.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed.
- This type of study is not relevant for this device, which performs a physical function (blood filtration) rather than requiring human interpretation of diagnostic images or data.
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Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Yes, the performance reported is a standalone performance of the device. The device functions mechanically/chemically based on its design and materials. There is no human interaction during the "performance" measurement itself.
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Type of Ground Truth Used
- The ground truth used for performance evaluation is based on objective laboratory measurements as defined by recognized standards (e.g., ISO 8637:2010) and established scientific principles for measuring physical parameters (clearance, ultrafiltration, structural integrity) and biological compatibility. It is not based on expert consensus, pathology, or outcomes data in the usual sense for diagnostic devices.
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Sample Size for the Training Set
- This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The "training" for such a device is its design, manufacturing processes, and adherence to engineering specifications.
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How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reasons as above.
§ 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.”