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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:

1. 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.
2. 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.
3. Number and Qualifications of Experts (Ground Truth - Test Set): Not applicable.
4. Adjudication Method (Test Set): Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done. The document explicitly states "No clinical studies were performed."
6. 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."
7. Type of Ground Truth Used: Not applicable, as no new performance study is described. The in vitro urea clearance data is laboratory performance data.
8. Training Set Sample Size: Not applicable. The device is not an AI/ML algorithm that requires training data.
9. 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.

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