(148 days)
The 2008K2 Hemodialysis Machine is indicated for acute and chronic hemodialysis therapy in a healthcare facility.
Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg and ≤ 40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing
The 2008K2 Hemodialysis machines is used for dialysis therapy. The machine pumps blood from the patient through an extracorporeal circuit containing a semi-permeable membrane (dialyzer). This membrane acts as an artificial kidney to transport toxins (diffusion) and excess water (ultrafiltration) from the blood into a separate fluid (dialysate) circuit. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood. In the dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer. Balancing chambers control the incoming flow and outgoing flow of the dialysate fluid during ultrafiltration.
This looks like a 510(k) Pre-Market Notification for a medical device, specifically a hemodialysis machine. Based on the provided text, the document describes modifications to an existing device (the 2008K2 Hemodialysis Machine) and argues for its substantial equivalence to a predicate device.
The document does not contain the detailed information required to fill out your request about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device.
Here's why and what information is missing:
- This is not an AI/ML device: The document describes a physical medical device (hemodialysis machine) with software controls. It is not an AI/ML system that makes diagnostic or treatment decisions. Therefore, the concepts of "test set," "ground truth," "experts," "adjudication," "MRMC study," "standalone performance," or "training set" as they relate to AI/ML model validation are not applicable here.
- Focus is on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and technological characteristics, or that any differences do not raise new questions of safety or effectiveness.
- Performance Data is for Mechanical/Electrical/Software Functionality: The "Performance Data" section (5.8) outlines various tests conducted, such as Biocompatibility, Electrical Safety, Software Verification and Validation, Mechanical and Acoustic Testing, and Other Bench Testing (microbiological purity, risk-based analysis of software updates). These tests confirm the engineering and software functionality of the hemodialysis machine itself, not the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested table or answer the specific questions about AI/ML device validation.
If you were to adapt your request to the type of device described, the document would contain:
- Acceptance Criteria: These would be functional specifications for the hemodialysis machine (e.g., blood flow rates, fluid removal accuracy, dialysate flow rates, temperature control, alarm functionality, electrical safety standards compliance).
- Study Proving Acceptance: This would refer to the various verification and validation tests listed in section 5.8 (e.g., "Software Verification and Validation Testing," "Mechanical testing included net fluid removal accuracy evaluations," "Simulated dialysis testing at the full range of dialysate and blood flow rates").
Since your questions are specifically tailored for AI/ML devices, and this document does not describe one, I cannot fulfill the request as stated.
§ 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.”