(445 days)
The Optiflux Ultra dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
The Optiflux Ultra dialyzers are the next generation of the Fresenius Optiflux family of single use dialyzers, which allow for the transfer of water and solutes between the blood and the dialysate through a semipermeable membrane. Available in five sizes, the dialyzers are differentiated by membrane surface area.
The provided text describes the 510(k) notification for the Optiflux Ultra Dialyzers, a medical device used for hemodialysis. This document is a regulatory submission for substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this specific document.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical study comparing performance outcomes. Instead, it details that testing was conducted to support the determination of substantial equivalence to predicate devices. The "reported device performance" is essentially that the device was found to be "substantially equivalent" to its predicates based on the outlined tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterility and non-pyrogenicity | Validation and verification testing supports substantial equivalence. |
| Structural integrity (filter assembly positive and negative pressure testing, blood compartment integrity/transmembrane pressure testing) | Validation and verification testing supports substantial equivalence. |
| Performance (clearance testing, ultrafiltration performance testing, membrane performance) | Validation and verification testing supports substantial equivalence. |
| Biological Safety (Biocompatibility testing) | Validation and verification testing supports substantial equivalence. |
| Design/Configuration | Equivalent to predicate (Fresenius Optiflux F250NR). |
| Basic Scientific Technology membrane | Equivalent to predicate (Fresenius Optiflux F250NR). |
| Sterility | Equivalent to predicate (Fresenius Optiflux F250NR). |
| Materials | Equivalent to predicate (Fresenius Optiflux F250NR). |
| Intended Use | Equivalent to predicate devices (Fresenius Optiflux F250NR and Baxter Xenium XPH). |
| Design Characteristics (effective surface area, priming volume) | Equivalent to predicate devices (Fresenius Optiflux F250NR and Baxter Xenium XPH). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify general "sample sizes" for its performance tests. It mentions "results of validation and verification testing," which are typically internal engineering and laboratory tests and often don't refer to large patient cohorts in the way clinical studies might. Specific numbers of units tested are not provided.
- Data Provenance: Not specified, but likely laboratory/manufacturing data. No information on country of origin or whether it's retrospective or prospective. This is not a study on clinical data.
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)
Not applicable. This is not a clinical study involving expert interpretation of data. The "ground truth" for device performance is based on established engineering and biocompatibility standards and comparison to predicate devices, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document describes regulatory clearance based on engineering and performance testing for substantial equivalence, not a clinical trial requiring adjudication of patient outcomes or interpretations.
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 document is for a physical medical device (dialyzer), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical medical device (dialyzer), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the Optiflux Ultra dialyzers is based on technical specifications, established industry standards (e.g., for sterility, biocompatibility, filtration efficiency), and direct comparison to the performance characteristics of previously cleared predicate devices. It is not based on clinical expert consensus, pathology, or patient outcomes data in the context of this 510(k) summary.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning study, so there is no "training set" or ground truth for it.
Summary of Study (as described in the document):
The "study" described in the document is a series of validation and verification tests conducted by Fresenius Medical Care North America (the manufacturer) to demonstrate that their new Optiflux Ultra dialyzers are substantially equivalent to legally marketed predicate devices (Fresenius Optiflux F250NR and Baxter Xenium XPH dialyzers).
The tests covered:
- Sterility and non-pyrogenicity
- Structural integrity (filter assembly positive and negative pressure testing, blood compartment integrity/transmembrane pressure testing)
- Performance (clearance testing, ultrafiltration performance testing, membrane performance)
- Biological Safety (Biocompatibility testing)
The objective of these tests was to show that the Optiflux Ultra dialyzers are equivalent in design, principle of operation, technology, materials, intended use, indications for use, and performance to the predicate devices, thereby being safe and effective for their intended use. This is a regulatory submission process, not a clinical trial.
§ 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.”