(230 days)
2008T BlueStar Hemodialysis Machine: The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis 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 ≤ 40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.
bibag System (Optional):
The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
Crit-Line Clip Monitor (CLiC) (Optional):
The Crit-Line Clip Monitor is used with the 2008T BlueStar Hemodialysis Machine to noninvasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
The 2008T BlueStar Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, and alarms. The 2008T BlueStar Hemodialysis Machine provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the blood into the dialysate circuit. In this separate 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. During hemodialysis, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood.
I am sorry, but based on the provided text, there is no information about a study that proves the device meets the acceptance criteria with specific details such as:
- A table of acceptance criteria and the reported device performance: While Table 3 lists "Key Performance Characteristics," it provides specifications for features like Blood Flow Rates, Maximum Dialysate Flow Rate, Net Fluid Removal, Dialysis Time, Dialysis Fluid Composition, Dialysis Fluid Temperature, and Heparin Delivery Rate. However, it does not present these as "acceptance criteria" alongside "reported device performance" from a specific study.
- Sample size used for the test set and the data provenance: This information is not explicitly provided for any performance study mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a hemodialysis machine, not an AI-assisted diagnostic or interpretive device, so an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical device, not an algorithm being evaluated in isolation.
- The type of ground truth used: Not applicable for performance characteristics of a hemodialysis machine. The "clinical accuracy study" for the blood pressure module would have a ground truth, likely a reference blood pressure measurement method, but details are not provided beyond "in accordance with ISO 81060-2."
- The sample size for the training set: Not applicable for a hemodialysis machine's performance characteristics. This is relevant for AI/ML models.
- How the ground truth for the training set was established: Not applicable.
The document discusses various types of testing to support substantial equivalence, safety, and efficacy:
- Biocompatibility Testing: Performed on the hydraulics assembly and new blood pressure cuffs according to ISO 10993-1. Specific endpoints like cytotoxicity, sensitization, and irritation were evaluated.
- Human Factors Validation Testing: Performed on device modifications impacting usability, concluding they are safe and effective.
- Electrical Safety and Electromagnetic Compatibility (EMC): Tested according to IEC 60601-1-2:2020.
- Software Verification and Validation Testing: Performed to ensure software conforms to user needs, is implemented correctly, does not introduce unintended issues, and is traceable to requirements.
- Clinical Studies: A clinical accuracy study was performed for the replacement blood pressure module and cuff combination in accordance with IEC 80601-2-30: Edition 2.0 2018-03 and ISO 81060-2 Third edition 2018-11. This study concluded that the blood pressure module used in conjunction with the extension tube and blood pressure cuffs is accurate in accordance with ISO 81060-2.
However, none of these sections provide the detailed "acceptance criteria" and "reported device performance" in a comparative table, nor do they offer the specific sample sizes, expert qualifications, or ground truth establishment methods requested for typical AI/ML device evaluations. The document focuses on showing compliance with established standards and regulatory guidance for a hemodialysis machine and its components.
§ 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.”