(252 days)
FX CorAL HD dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients, including pediatric patients, with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
The FX CorAL dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzers are 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 FX CorAL dialyzers are high-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzers contain semipermeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.
The document describes the FX CorAL 40 and FX CorAL 50 dialyzers and their substantial equivalence to predicate devices, focusing on performance, materials, and intended use. There is no information provided in the document regarding acceptance criteria or performance of an AI/ML device.
The provided text describes a medical device clearance (K242053) for FX CorAL 40 and FX CorAL 50 dialyzers, which are high permeability hemodialysis systems. While the request asks about acceptance criteria and study details for an AI/ML device, the document focuses on the performance data of these physical medical devices. Therefore, much of the requested information regarding AI/ML specifics (like effect size of AI assistance, standalone algorithm performance, training set details, expert qualifications for ground truth) is not applicable to this submission.
However, I can extract the relevant information pertaining to the tests conducted for these dialyzers, which function as "acceptance criteria" for a physical device.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document lists performance tests conducted and states that "All testing met predetermined acceptance criteria." It does not explicitly list numerical acceptance criteria values for each test but provides typical performance results for urea clearance.
| Test Conducted | Acceptance Criteria (Stated as met predetermined criteria) | Reported Device Performance (Typical Values) |
|---|---|---|
| Blood Compartment Volume | Results were compared with the acceptance criteria. | Not numerically specified, but stated to have met criteria. |
| Clearance – Sodium (marker for urea), Creatinine, Phosphate, Vitamin B12 | Analyzed test samples over a specified range of flow rates. | FX CorAL 40 Dialyzer: Typical Urea Clearance: 178 mL/min (Qb=200, Qd=500, Qf=0) |
| FX CorAL 50 Dialyzer: Typical Urea Clearance: 192 mL/min (Qb=200, Qd=500, Qf=0) | ||
| Protein Sieving Coefficient | Calculated in accordance with ISO 8637-1 First Edition 2017-11. | Not numerically specified, but stated to have met criteria. |
| Ultrafiltration (Blood Kuf) | Calculated as the slope from a plot of UFR over applied TMP range. | Not numerically specified, but stated to have met criteria. |
| Pressure Drop | Measured inlet and outlet pressures across flow rates. | Not numerically specified, but stated to have met criteria. |
| Blood Compartment Integrity | Evaluate the integrity of the blood compartment. | Not numerically specified, but stated to have met criteria. |
| Biocompatibility Testing | Update to toxicological risk assessment and specific tests met acceptance. | Specific tests (Chemical Analysis, Subchronic Toxicity, Genotoxicity, Hemocompatibility) were performed and met criteria. |
| Human Factors Validation Testing | Demonstrated safe and effective use in accordance with FDA guidance. | Not numerically specified, but stated to have met criteria. |
| Clinical Studies (spKt/V) | Adequacy of clearance with mean spKt/V values. | FX CorAL 40 Dialyzer: Mean spKt/V of 2.42 |
| FX CorAL 50 Dialyzer: Mean spKt/V of 2.08 (all tolerated) |
2. Sample size used for the test set and the data provenance:
- Performance Testing (in vitro): Sample size for each specific in vitro test (e.g., clearance, integrity) is not explicitly stated, but it's implied that multiple samples were tested to generate the "typical" values and ensure criteria were met.
- Clinical Studies (retrospective):
- Sample Size: Fourteen (14) pediatric ESRD patients
- Data Provenance: Retrospective clinical data analysis. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the document describes a physical medical device (dialyzer), not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for the dialyzer's performance is established through well-defined physical and chemical measurements following international standards (e.g., ISO 8637-1).
4. Adjudication method for the test set:
Not applicable. For physical device performance, the results are typically quantitative measurements against defined specifications, not subjective interpretations requiring adjudication.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used:
- In vitro Performance Tests: Ground truth is based on established physical and chemical measurement standards (e.g., ISO 8637-1 First Edition 2017-11) and direct laboratory measurements of parameters like clearances, sieving coefficients, ultrafiltration rates, and pressure drops.
- Biocompatibility Testing: Ground truth is established through standardized biological evaluation tests as per FDA guidance and ISO 10993-1.
- Clinical Studies: "Adequate clearance" (demonstrated by spKt/V values) and patient tolerance serve as clinical outcomes demonstrating the device's effectiveness in a real-world setting.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device and thus does not have a "training set" in that context.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.”