(249 days)
The HemoCare® Hemodialysis System is indicated for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare Hemodialysis System is indicated for use in chronic dialysis facilities, self-care dialysis facilities, and the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed with the assistance or observation of an individual who has been trained and is considered competent in the use of the device. The HemoCare Hemodialysis System is not indicated for solo hemodialysis in the home setting.
The HemoCare® Hemodialysis System is a self-contained, software-controlled device that provides hemodialysis treatments, including short daily and nocturnal hemodialysis, for patients with renal failure. The device is intended for use by a single patient in chronic dialysis facilities, self-care dialysis facilities, and the home setting. The HemoCare® Hemodialysis System is composed of the following components:
- The HemoCare® Treatment Device is a hemodialysis delivery system. When provided a source of water for dialysis, it produces infusion grade dialysate using liquid acid and powder bicarbonate concentrates. The Treatment Device provides secure, 2-way communication with the cloud for transmitting patient registration, physician-prescribed dialysis treatments, patient monitoring, and device status information.
- The HemoCare® Water Device is a water purification system that produces water for dialysis through distillation of EPA drinking water. The Water Device interfaces with the Treatment Device.
- The Blood Treatment Set connects to the patient access site and interfaces with the Treatment Device to provide extracorporeal blood flow through a dialyzer for dialysis treatment. The Blood Treatment Set is terminally sterilized and includes displacement blood pumps, a heparin delivery system, and an access disconnect sensor. The Blood Treatment set can be used for up to 16 treatments.
The provided text describes the HemoCare® Hemodialysis System, a medical device. However, it does not contain the specific information required to complete the detailed table about acceptance criteria and device performance results as requested, nor does it detail a study proving the device meets acceptance criteria in the context of an AI/ML algorithm.
The document is a 510(k) summary for a hemodialysis system, focusing on its substantial equivalence to predicate devices. It outlines performance data categories like Biocompatibility, Electrical Safety, Software Verification and Validation, Bench Performance Testing, Sterilization and Shelf Life, Human Factors, and Clinical Testing.
Importantly, the document does not describe an AI/ML algorithm that would have "acceptance criteria," "test sets," "ground truth," "expert readers," or "MRMC studies" in the context typically associated with an AI/ML medical device submission. The "Software Verification and Validation Testing" section states that "Testing results demonstrate that the device meets all software performance requirements," but it does not specify what those requirements are, nor does it indicate these requirements relate to an AI/ML diagnostic or predictive function.
Therefore, I cannot fulfill the request as the type of information sought (related to AI/ML algorithm performance) is not present in the provided text. The document is about a physical medical device (hemodialysis system) and its regulatory clearance as substantially equivalent to existing devices, not about a software-as-medical-device (SaMD) or AI-enabled medical device performance study with the detailed metrics requested.
§ 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.”