(27 days)
The CLIRANS® E-series Hollow Fiber Dialyzers are indicated for use whenever a patient is found to be in acute or chronic renal failure and hemodialysis is prescribed by a physician. The device should be used only at the direction of a physician who has evaluated all of the pertinent features of the patient's illness. This device is indicated for single use only.
The 2.0 m2 CLIRANS® E and EE Series dialyzers that are the subject of this 510(k) are a larger size (larger fiber surface area) of the currently cleared dialyzers (K003425).
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance
The document describes the submission of Terumo Medical Corporation's CLIRANS® E-Series Dialyzers (specifically a larger 2.0 m² size) for substantial equivalence to existing predicate devices (CLIRANS® E-Series cleared under K003425 and Althin AF-220 cleared under K992573). The acceptance criteria are implicitly defined by demonstrating that the new device's performance is comparable to or better than the predicate devices across a set of physical and functional characteristics.
| Acceptance Criterion (Category) | Reported Device Performance |
|---|---|
| In Vitro Clearance | Performed, no new issues. |
| Coefficient of Ultrafiltration, Kuf | Performed, no new issues. |
| In Vitro Kuf | Performed, no new issues. |
| Pressure Drop (Blood & Dialysate Compartments) | Performed, no new issues. |
| Priming Volume | Performed, no new issues. |
| Structural Integrity (Fiber Leak Test) | Performed, no new issues. |
| Biocompatibility (Blood Contacting Materials) | Tested in accordance with FDA G95-1 (ISO-10993). Results demonstrate biocompatibility. |
| Sterilization Assurance Level (SAL) | Validated to a SAL of 10⁻⁶ in accordance with ANSI/AAMI/ISO 11134 and EN 554. |
Note: The document explicitly states, "None of the data raises any new issues of safety and effectiveness." and "Differences between the devices do not raise any significant or new issues of safety or effectiveness." This implies the performance fell within acceptable limits relative to the predicate devices. Specific quantitative ranges or thresholds for the acceptance criteria are not provided in this document, as the submission focuses on demonstrating substantial equivalence rather than meeting pre-defined specific numerical targets for a novel device.
Study Details
The provided text describes a submission for substantial equivalence for a medical device (dialyzer) and primarily focuses on verification testing to demonstrate equivalence to predicate devices, rather than a clinical trial or algorithm performance study. Therefore, several of the requested sections are not applicable in the context of this document.
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Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test but alluded to as "tests were performed." In-vitro verification tests typically use a batch or statistically significant number of units.
- Data Provenance: The tests were "performed to demonstrate the substantial equivalence," suggesting a controlled, laboratory-based study, likely performed by the manufacturer (Terumo Medical Corporation). The country of origin of the data is implicitly the USA, where Terumo Medical Corporation is located. The study is prospective in the sense that these tests were conducted specifically for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert-established ground truth. The "ground truth" here is the established performance characteristics of the predicate devices.
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Adjudication method for the test set:
- Not applicable. This is not a study requiring expert adjudication.
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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 not a study involving human readers or AI assistance. It concerns the performance of a physical medical device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference standard for comparison is the known performance characteristics of the predicate devices. These characteristics would have been established through a combination of their own verification testing, clinical use data, and regulatory clearances. For biocompatibility, it's adherence to international standards (ISO-10993) and for sterilization, it's adherence to specific standards (ANSI/AAMI/ISO 11134 and EN 554).
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The sample size for the training set:
- Not applicable. This report does not describe a machine learning or AI-based device that would require a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is described.
§ 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.”