(357 days)
Hemodialysis with the FB-U 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 Nipro FB-U hemodialyzer is a medical device intended for use as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient, through the extracorporeal system, into 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.
Device: Nipro FB-U Hemodialyzer
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Predicate) | Reported Device Performance (Nipro FB-U Hemodialyzer) |
|---|---|---|
| Clearances | Not explicitly stated, implied to be equivalent to predicate. | Demonstrated to be equivalent to predicate in non-clinical tests. |
| Ultrafiltration coefficient | Not explicitly stated, implied to be equivalent to predicate. | Demonstrated to be equivalent to predicate in non-clinical tests. |
| Volume of blood compartment | Not explicitly stated, implied to be equivalent to predicate. | Demonstrated to be equivalent to predicate in non-clinical tests. |
| Pressure drop | Not explicitly stated, implied to be equivalent to predicate. | Demonstrated to be equivalent to predicate in non-clinical tests. |
| Positive and negative pressure tests | Not explicitly stated, implied to be equivalent to predicate. | Passed (included in non-clinical tests). |
| Blood compartment integrity | Not explicitly stated, implied to be equivalent to predicate. | Passed (included in non-clinical tests). |
| Transportation tests | Not explicitly stated, implied to be equivalent to predicate. | Performed and results included in submission. |
| Biocompatibility | Not explicitly stated, implied to be equivalent to predicate. | Performed and results included in submission. |
| Shelf-life testing | Not explicitly stated, implied to be equivalent to predicate. | Performed and results included in submission. |
| Materials - Housing | Polypropylene/polycarbonate (for predicate and/or similar devices) | Polypropylene |
| Materials - Membrane | Polyether sulfone/Cellulose Triacetate (for predicate and/or similar devices) | Cellulose Triacetate |
| Design | Mechanical device consisting of a cylindrical rigid housing enclosing hollow fibers | Same |
| Intended Use | As part of an artificial kidney system for removal of toxins and excess water from blood | Same |
| Energy Source | To be used with dialysis machines equipped with an ultrafiltration controller or accurate fluid balancing system | Same |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "Non-clinical tests submitted," which include "dimensional and performance to include: positive and negative pressure tests, blood compartment integrity, clearances, Ultrafiltration coefficient, volume of blood compartment, and pressure drop." It also mentions "Other test items include: Transportation tests, biocompatibility, and shelf-life testing."
- Sample Size: The document does not explicitly state the specific sample sizes used for each of these non-clinical tests.
- Data Provenance: The tests are described as "non-clinical tests submitted," implying they were conducted by Nipro Medical Corporation as part of their submission. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective, though non-clinical tests are generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The study relies on objective physical and chemical measurements (e.g., clearances, pressure tests) rather than expert interpretation of data for establishing ground truth in non-clinical testing.
4. Adjudication Method for the Test Set:
Not applicable. As the study primarily concerns non-clinical, objective measurements, an adjudication method for a "test set" (in the sense of human interpretation) is not relevant.
5. 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. No MRMC study was conducted. This device is a hemodialyzer, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical hemodialyzer, and therefore the concept of a standalone algorithm or human-in-the-loop performance is not relevant. The performance evaluation is of the device's physical and functional characteristics.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical tests was established through objective physical and chemical measurements and engineering standards. For example:
- Clearances were measured against established methods for filtration efficiency.
- Pressure tests confirmed resistance to specified pressures.
- Integrity tests confirmed the physical structural soundness.
- Biocompatibility tests likely adhered to ISO standards (e.g., ISO 10993).
- Shelf-life tests involved stability and performance over time.
The "ground truth" for showing substantial equivalence was the performance characteristics of the legally marketed predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set. The performance data is derived from testing of the physical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.”