(219 days)
Hemodialysis with an ELISIO™-H hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
The device is for prescription use only. This product is intended for single use only. The performance properties of reused dialyzers have not been established.
The ELISIO-H hemodialyzers are medical devices used as an artificial kidney system for the treatment of patients with renal failure. 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 ELISIO-H dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.
ELISIO™-H Hemodialyzer Acceptance Criteria and Study Details
The provided document describes the ELISIO™-H Hemodialyzer, which is an artificial kidney system for treating patients with renal failure. The submission (K131381) focuses on the inclusion of two additional family members (-90H and -250H) to the existing ELISIO-H product line. The primary method of demonstrating substantial equivalence to predicate devices (K122347, K002761, K926005, K082414) was through non-clinical bench studies.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table format with pass/fail thresholds. Instead, it refers to performance "as well as" or "substantially equivalent" to legally marketed predicate devices. The "reported device performance" is a qualitative summary of non-clinical testing results.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analyte Clearance | Substantially equivalent to predicate hemodialyzers | Testing indicates comparable performance for urea, creatinine, phosphate, Vitamin B12, inulin clearance. |
| Ultrafiltration Coefficient | Substantially equivalent to predicate hemodialyzers | Testing indicates comparable performance. |
| Pressure Drop | Substantially equivalent to predicate hemodialyzers | Testing indicates comparable performance. |
| Safety | Safe for intended use | Testing indicates the device is safe. |
| Effectiveness | Effective for intended use | Testing indicates the device is effective. |
Note: The acceptance criteria are inferred from the statement "Results of bench studies establish substantial equivalence to Fresenius hemodialyzer performance" and "Testing performed on the ELISIO-H dialyzers indicates that they are safe, effective and perform as well as the legally marketed device models." No specific numerical thresholds are provided for "substantially equivalent" or "as well as."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the non-clinical bench tests (e.g., number of dialyzer units tested for each parameter). It broadly states "non-clinical studies included those for analyte clearance...".
- Data Provenance: The studies were non-clinical bench tests, meaning they were conducted in a laboratory setting, not on human subjects. The country of origin for the data is not specified, but the submitter (Nipro Medical Corporation) is located in Miami, FL, USA. The studies are prospective in nature, as they were conducted to evaluate the performance of the ELISIO™-H hemodialyzer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. For non-clinical bench studies of this nature, "ground truth" is established through standardized laboratory measurement techniques and scientific principles, not through expert consensus on interpretation of data. The performance metrics are objectively measured.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters where there can be inter-observer variability in establishing ground truth (e.g., image interpretation). For non-clinical, objective bench tests, adjudication is not performed in this manner.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study was a non-clinical bench study, not a clinical study involving human readers or interpretation of cases. Therefore, no effect size for human readers improving with AI assistance is applicable or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the studies conducted were standalone "device only" performance tests. The performance of the ELISIO™-H hemodialyzer itself (e.g., its ability to clear analytes, ultrafiltration coefficient) was measured directly. This is implicitly a "standalone" assessment of the device's physical and functional properties.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established through objective laboratory measurements of physical and chemical parameters based on established scientific methods. For example:
- Analyte Clearance: Measured concentrations of urea, creatinine, etc., before and after passage through the dialyzer, under controlled conditions.
- Ultrafiltration Coefficient: Direct measurement of fluid removal under a given transmembrane pressure.
- Pressure Drop: Direct measurement of pressure difference across the dialyzer.
These are not pathology, expert consensus, or outcomes data, but rather direct measurements of the device's functional performance.
8. The Sample Size for the Training Set
This question is not applicable. There is no mention of machine learning or AI algorithms being developed or "trained" for this device. The ELISIO™-H hemodialyzer is a physical medical device, not a software algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as no training set was used for an AI/ML algorithm.
§ 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.”