(360 days)
Optiflux Dialyzers are intended for patients with acute kidney disease when conservative therapy is judged to be inadequate.
The Optiflux F180NR dialyzer is a high-flux, single-use, ethylene oxide (EO) sterilized hemodialyzer. The dialyzer is provided blood pathway sterile and non-pyrogenic. The membrane surface area is 1.7 m2.
This document is a 510(k) summary for the Fresenius Medical Care Optiflux F180NR Dialyzer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML medical device.
Therefore, many of the requested points are not applicable to this type of submission.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" against "reported device performance" similar to what might be found for a new AI/ML device where specific metrics (e.g., sensitivity, specificity, AUC) are presented against predefined thresholds.
Instead, the document states:
- "All testing met predetermined acceptance criteria. Results of the proposed device design verification tests met the requirements and demonstrated that, like the predicate device, the Optiflux F180NR dialyzer is safe and effective for its intended use." (Page 6)
The "key performance characteristic" explicitly mentioned is Urea clearance, with Sodium clearance being used as a marker.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Urea Clearance (as measured by Sodium clearance) | 278 (Typical Urea Clearance for Optiflux F180NR, from Table 1, page 5) |
| Blood Compartment Volume | Met requirements (details not quantified in this summary) |
| Clearance (Sodium, Vitamin B12, Creatinine, Phosphate, Lysozyme) | Met requirements (details not quantified in this summary) |
| Protein Sieving Coefficient | Met requirements (details not quantified in this summary) |
| Ultrafiltration | Met requirements (details not quantified in this summary) |
| Pressure Drop | Met requirements (details not quantified in this summary) |
| Structural Integrity | Met requirements (details not quantified in this summary) |
| Blood Compartment Integrity | Met requirements (details not quantified in this summary) |
| Simulated Shipping and Distribution | Met requirements, maintaining product and package integrity and sterility (details not quantified in this summary) |
| Biocompatibility (various tests listed on pages 6-7) | Met requirements |
| Human Factors Validation Testing | Leveraged to demonstrate safe and effective use |
Note: The document states that performance testing was conducted in accordance with ISO 8637:2010 and FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. The specific numerical acceptance criteria for each test are not provided in this summary.
2. Sample size used for the test set and the data provenance
The document provides a summary of tests performed, but does not specify the sample sizes (number of devices, or specific data points) used for each test. It also does not mention data provenance (e.g., country of origin, retrospective/prospective) for these engineering and performance tests, as these are typically bench-top or in vitro tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical hemodialyzer, not an AI/ML device that relies on expert interpretation for ground truth. The "ground truth" for its performance is established through standardized engineering and in vitro testing methods.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert ground truth establishment for AI/ML devices. For this physical device, performance is evaluated against engineering specifications and standards.
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 a physical medical device (dialyzer), not an AI/ML software. Therefore, MRMC studies and AI assistance for human readers are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is established through standardized in vitro bench testing following recognized international standards (ISO 8637:2010) and FDA guidance documents. This includes:
- Calculated measurements (e.g., blood compartment volume, ultrafiltration, pressure drop).
- Analytical testing of samples (e.g., clearance of various substances, protein sieving coefficient).
- Physical integrity tests (e.g., structural and blood compartment integrity).
- Biocompatibility tests (e.g., cytotoxicity, sensitization, hemolysis).
- Simulated shipping and distribution tests.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" for a physical dialyzer.
§ 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.”