(30 days)
The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis.
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The provided document is a 510(k) Premarket Notification for a medical device, the Fresenius Ultraflo HPX Single Use Hemodialyzer. This type of regulatory submission is specifically for demonstrating substantial equivalence to a previously cleared device, not for proving that a device meets particular acceptance criteria through clinical studies in the way a new drug or novel medical device would.
Therefore, the information you've requested regarding acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not applicable or available within this document for the following reasons:
- No Clinical Testing: The document explicitly states: "No clinical testing was performed." The evaluation was based solely on in vitro testing to demonstrate substantial equivalence to predicate devices.
- Substantial Equivalence: The purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparison of technological characteristics, materials, and in vitro performance, not by establishing specific clinical acceptance criteria met by a new study.
- Safety and Effectiveness Summary vs. Efficacy Study: The information provided is a "Summary of Safety and Effectiveness" which focuses on comparing the device to existing predicate devices and summarizing in vitro test results, not detailing a large-scale clinical efficacy study with acceptance criteria.
However, I can extract the in vitro performance reported and the general assessment of equivalence:
Acceptance Criteria and Reported Device Performance
Given that no clinical acceptance criteria were established or assessed in a human study, the "acceptance criteria" here refer to the in vitro performance benchmarks derived from the predicate devices. The reported device performance indicates that the Ultraflo HPX met these benchmarks, demonstrating substantial equivalence.
| Acceptance Criteria (Inferred from Predicate Devices / In Vitro Benchmarks) | Reported Device Performance (Fresenius Ultraflo HPX) |
|---|---|
| Equivalent Priming Volume | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Bloodside Pressure Drops | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Dialysate-side Pressure Drops | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Ultrafiltration Coefficient | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Urea Clearance | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Creatinine Clearance | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Vitamin B12 Clearance | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Phosphate Clearance | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Equivalent Lysozyme Clearance | Determined via in vitro testing. (Implied: Met equivalence to predicates.) |
| Substantially Equivalent in Construction, Design, Materials, and Intended Use | Confirmed through comparison with predicate devices. |
Study Details (Not Applicable/Available for Clinical Efficacy)
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set. In vitro testing was performed, but the sample sizes for these bench tests are not specified in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication.
- 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 hemodialyzer, not a diagnostic imaging device typically evaluated with MRMC studies. No AI component is mentioned.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. No algorithm or AI component is mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for showing substantial equivalence was the in vitro performance of the predicate devices. The new device's in vitro performance was compared against these established benchmarks.
- The sample size for the training set: Not applicable. No AI model or training set is mentioned for this device.
- How the ground truth for the training set was established: Not applicable.
In conclusion, this document describes a 510(k) submission based on in vitro testing and comparison to predicate devices to establish substantial equivalence, rather than a clinical study with detailed acceptance criteria and performance metrics as typically seen for novel devices requiring clinical efficacy data.
§ 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.”