(68 days)
The Fresenius Optiflux® F250NR dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
The Fresenius Optiflux® F250NR dialyzer is substantially equivalent in construction, design, materials, and intended use to the commercially available Baxter Xenium 210 and Asahi Rexeed 25S dialyzer.
The provided document is a 510(k) summary for a medical device called the Fresenius Optiflux® F250NR Dialyzer. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study involving AI or human readers.
Therefore, many of the requested elements pertaining to AI studies, reader performance, ground truth, and training sets are not applicable to this document. The information focuses on device characteristics, intended use, and comparison to predicate devices, not on the performance of a diagnostic algorithm.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" in the sense of predefined performance metrics (e.g., sensitivity, specificity, AUC) for an AI device. Instead, the "acceptance criteria" for the 510(k) submission are based on demonstrating substantial equivalence to existing predicate devices in terms of construction, design, materials, and intended use. Performance is implicitly assessed through bench testing to ensure safety and effectiveness for its intended use, rather than clinical efficacy studies often found with novel diagnostic tools.
| Criterion Type (Implicit for 510(k)) | Description/Performance |
|---|---|
| Intended Use | The device is intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Reported Performance: The intended use is stated to be equivalent to the predicate devices (Baxter Xenium dialyzer model 210 and Asahi Rexeed model 25S). |
| Technological Characteristics | The device's technological characteristics are equivalent to predicate devices and raise no new types of safety or effectiveness questions. Reported Performance: Directly stated that the technological characteristics are equivalent. |
| Construction, Design, Materials | Substantially equivalent to commercially available Baxter Xenium 210 and Asahi Rexeed 25S dialyzers. Reported Performance: Stated as substantially equivalent. |
| Safety and Effectiveness | Testing of the Fresenius Optiflux F250NR dialyzer indicates it is safe and effective for its intended use. This is a general claim based on bench testing (not detailed in this summary), rather than specific human efficacy metrics. |
2. Sample Size Used for the Test Set and Data Provenance:
- This document describes a medical device (dialyzer), not an AI algorithm. Therefore, there is no "test set" in the context of an AI study.
- The safety and effectiveness assessment is based on device testing (bench testing usually for dialyzers) and comparison to predicate devices. Details of specific testing parameters and sample sizes for this testing are not provided in this 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data for AI algorithm validation. The "data" involves engineering and performance characteristics of the physical dialyzer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This is not an AI-assisted diagnostic device, so there is no ground truth established by experts for a test set in that sense. The "ground truth" for a dialyzer's performance would be established through engineering specifications, validated test methods (e.g., in vitro clearance and ultrafiltration tests), and regulatory standards.
4. Adjudication Method for the Test Set:
- Not Applicable. No expert adjudication process for image interpretation or diagnosis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is not an AI device. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, for diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This is not an AI algorithm.
7. The Type of Ground Truth Used:
- For a dialyzer, the "ground truth" for its performance characteristics (e.g., solute clearance, ultrafiltration rate, blood compatibility) is established through in vitro performance testing against validated standards and specifications, typically under laboratory conditions. There is no pathology, outcomes data, or expert consensus used as ground truth in the context of diagnostic accuracy for this type of device.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. There is no training set.
§ 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.”