(73 days)
The FX CorAL hemodialyzers are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency.
The FX CorAL hemodiafilters are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency.
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.
This document is an FDA 510(k) clearance letter for a medical device called FX CorAL hemodialyzers. It primarily discusses the substantial equivalence of the new device to a previously cleared predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical or algorithmic performance study often seen with AI/ML devices.
Therefore, the information required to answer your questions regarding acceptance criteria and study details (especially for AI/ML performance, experts, ground truth, and sample sizes for training/test sets) is not present in the provided text. The document explicitly states:
- "No clinical studies were performed." (Page 8, Section 1.8.6)
- "Not applicable. The FX CorAL dialyzers do not contain software." (Page 8, Section 1.8.4 - implying no software verification/validation testing as would be done for an AI/ML device)
- "No animal studies were performed." (Page 8, Section 1.8.5)
The clearance is based on the new devices being identical to the predicate devices in manufacturing, design, sterilization method, and materials, with only labeling changes. The performance data for the predicate device (K220721) is deemed applicable.
However, I can extract the general type of performance metric mentioned: Urea clearance.
Here's a breakdown of what can be inferred from the document and what cannot:
Acceptance Criteria & Device Performance:
The document doesn't explicitly state "acceptance criteria" in the format of a clinical trial endpoint or AI/ML performance metric. Instead, it refers to "Key Performance Specifications/Characteristics" for urea clearance (Table 2, Page 6). It also states that "FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across the membrane."
Table of Performance (Inferred from "Typical Urea Clearance"):
| Trade Name | Flow Rate Conditions (mL/min) Qb | Flow Rate Conditions (mL/min) Qd | Flow Rate Conditions (mL/min) Qf | Typical Urea Clearance (mL/min) |
|---|---|---|---|---|
| FX CorAL 60 D. | 300 | 500 | 0 | 270 |
| FX CorAL 80 D. | 300 | 500 | 0 | 277 |
| FX CorAL 100 D. | 300 | 500 | 0 | 282 |
| FX CorAL 120 D. | 300 | 500 | 0 | 285 |
| FX CorAL 600 D. | 300 | 500 | 75 | 285 |
| FX CorAL 800 D. | 300 | 500 | 75 | 288 |
| FX CorAL 1000 D. | 300 | 500 | 75 | 292 |
Regarding the Study Details for AI/ML Performance:
Based on the provided text, the device is a physical medical device (hemodialyzer), not an AI/ML software device. As such, answers to most of your specific questions related to AI/ML study design are not applicable or the information is not provided.
- Sample size for the test set and data provenance: Not applicable in the context of an AI/ML test set. The performance data mentioned (Table 2) is in vitro (bench testing), not from a patient test set, and its specific provenance (country, retrospective/prospective) is not detailed.
- Number of experts used to establish ground truth: Not applicable. This refers to the ground truth for an AI/ML device, which is not what this document is about.
- Adjudication method: Not applicable for this type of device and study.
- MRMC comparative effectiveness study: Not applicable. The device does not involve human readers or AI assistance in diagnostic interpretation.
- Standalone (algorithm only) performance: Not applicable. The device is a physical hemodialyzer, not an algorithm.
- Type of ground truth used: For urea clearance, the ground truth would be based on in vitro laboratory measurements, likely chemical assays measuring concentrations before and after filtration, rather than expert consensus, pathology, or outcomes data.
- Sample size for the training set: Not applicable. There is no AI/ML model for which a training set would be required.
- How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.
Summary of what is available in the text:
- Device Type: Hemodialyzers (physical medical devices).
- Performance Metrics: In vitro urea clearance (sodium clearance typically used as a marker).
- Study Type: Substantial equivalence a new device to a predicate device, noting that the new device is "identical" to the predicate, and hence the previous predicate's data applies.
- Clinical Studies: None performed for this 510(k) submission.
- Software/AI Component: None. The device "does not contain software."
- Animal Studies: None performed.
§ 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.”