(113 days)
The multiFlux 1000 dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury when conservative therapy is judged to be inadequate.
The multiFlux 1000 dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzer is provided blood pathway sterile and non-pyrogenic. The dialyzers allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.
The provided text describes the multiFlux 1000 dialyzers' substantial equivalence to a predicate device (FX CorAL dialyzers, K220721) and does not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, or most of the detailed information requested in your prompt.
Specifically:
- Acceptance Criteria Table: No table of acceptance criteria and reported device performance is provided. The document states that the performance specifications are substantially equivalent to the predicate device and that all performance testing from the predicate device's 510(k) (K220721) is being leveraged.
- Sample Size and Data Provenance (Test Set): Not applicable, as there is no new performance study described for the multiFlux 1000 dialyzer. The document mentions in vitro urea clearance data as an example from the Instructions for Use, but this is typical performance data, not acceptance criteria for a new study.
- Number and Qualifications of Experts (Ground Truth - Test Set): Not applicable.
- Adjudication Method (Test Set): Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done. The document explicitly states "No clinical studies were performed."
- Standalone (Algorithm Only) Performance: Not applicable. The multiFlux 1000 dialyzers are physical medical devices (dialyzers), not software or AI algorithms. The document explicitly states "The multiFlux 1000 dialyzers do not contain software."
- Type of Ground Truth Used: Not applicable, as no new performance study is described. The in vitro urea clearance data is laboratory performance data.
- Training Set Sample Size: Not applicable. The device is not an AI/ML algorithm that requires training data.
- Ground Truth for Training Set: Not applicable.
Summary of Relevant Information from the Provided Text:
- Acceptance Criteria and Proof of Meeting Criteria: The submission claims substantial equivalence to the predicate FX CorAL dialyzers (K220721). The changes (removal of blue colorant, extension of dialysate flange-port) are stated not to impact performance attributes. Therefore, all performance testing from the predicate device's 510(k) (K220721) is leveraged to support the multiFlux 1000 dialyzers. An example of in vitro Urea Clearance data is provided in Table 3 (page 5), but this is not presented as an acceptance criterion from a new study specific to the multiFlux 1000.
- Human Factors Validation Testing: "The multiFlux 1000 dialyzers were found to be safe and effective for their intended users, uses, and use environments." The details of this testing (acceptance criteria, sample size, outcome metrics) are not provided.
- Biocompatibility Testing: The multiFlux 1000 dialyzers are chemically equivalent to the predicate FX CorAL dialyzers per ANSI/AAMI/ISO 10993-18:2020, Annex C.4.d. The removal of blue colorant did not require additional biocompatibility testing. This implies that the previous biocompatibility testing for the predicate device is considered sufficient.
In essence, the document focuses on demonstrating substantial equivalence based on prior testing of a predicate device and states that no new clinical or animal studies, or software verification/validation, were performed for the multiFlux 1000 dialyzers.
§ 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.”