(132 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 2008 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 is 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 non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation 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, heating, 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.
The provided text describes specific acceptance criteria and the studies conducted to verify the performance of the 2008T BlueStar Hemodialysis Machine.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (Verification Method) |
|---|---|---|
| Blood Flow Rates | 8 mm line: 20–600 mL/min (not available with Low Volume feature enabled). Accuracy: ± 10% tested at -200 mmHg. | |
| 6.35 mm line: 20–465 mL/min. | ||
| 4.8 mm line: 10–274 mL/min. | ||
| 2.6 mm line: 6–86 mL/min. | Verified through functional and performance verification testing, and regression testing. (Implied to meet specification as no deviations are reported). | |
| Dialysate Flow Rates | Selectable increments: (0)/100 /150/200/300/400/500/600/700/800 mL/min. | |
| Auto Flow based on Blood Pump rate (Qb) for 1.5x and 2.0x Qd. (Specific Qb-Qd ranges detailed in the table). Adjusts at least 15–20 mL/min Qb. Accuracy: ± 5%. | Verified through functional and performance verification testing, and regression testing. (Implied to meet specification). | |
| Net Fluid Removal | 0–4000 mL/hr. Accuracy (on total vol. removed): ± (1% UF rate + 18 mL/hr) for 100 mL/min Qd; ± (1% UF rate + 30 mL/hr) for 500 mL/min Qd; ± (1% UF rate + 48 mL/hr) for 800 mL/min Qd. | Verified through functional and performance verification testing. (Implied to meet specification). |
| Dialysis Time | 0-9:59 hours (adjustable). SLED fixed at 12 hours. Accuracy: ± 1 second per hour. | Verified through functional and performance verification testing. (Implied to meet specification). |
| Dialysis Fluid Composition | Volumetric, selectable: Acid 130–155 mEq/L Na+, Bicarbonate 20-40 mEq/L. Monitoring conductivity average accuracy: ± 1.5%. | Verified through functional and performance verification testing. (Implied to meet specification). |
| Dialysis Fluid Temperature | Range 35°C–39°C (alarm window auto-adjusted to 2°C above/below set point, not below 34°C (or 30°C for BTM recirculation) or above 41 °C). Accuracy: ± 0.3°C. | Verified through functional and performance verification testing. (Implied to meet specification). Lower Dialysate Temperature Limit adjusted to 34°C to comply with IEC 60601-2-16:2012. |
| Heparin Delivery Rate | 0 – 9.9 mL/hr. Accuracy: ± 5%. | Verified through functional and performance verification testing. (Implied to meet specification). |
| Electrical Safety & EMC | In accordance with IEC 60601-1-2:2014. | Evaluated and verified through electrical testing. |
| Biocompatibility | ISO 10993 requirements for hydraulic components. | Tested via Chemical analysis Simulated-Use Leachable Extraction, Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Hemocompatibility (Indirect Contact), Subchronic toxicity, and Risk assessment. |
| Software | Effectiveness of software modifications, confirmation of machine operation, essential performance, and safe operation. (Specific unit, integration, and system level verification, regression testing, and code reviews for changes meeting design inputs and good coding practices). | Unit, integration, and system level software verification testing. Functional and performance verification testing. Regression testing. Code reviews. |
| Mechanical Components | Functional verification for new paint, tubing organizer, Patient Card housing, keyboard, Monitor EMI ground assembly, hook for extended lines, ratio valves, UF pumps, acid and bicarbonate pumps. | Functional verification of mechanical components. |
| Environmental & Ship | Performs normally in temperature- and humidity-controlled environments. Withstands typical shipping and distribution hazards. | Environmental testing and ship testing. |
| Human Factors | New features are safe and effective for intended users, uses, and environments (for device modifications impacting usability). | Human Factors testing. |
| SLED Functionality | Dialysate flow rates: 100, 150, 200, 300 mL/min. Ultrafiltration Rate: 0-1000 mL/hr (10 mL/hr increments). Blood Flow Rates: 0-300 mL/min. Treatment Time: 0-12:00 (hours:minutes). Contraindicated for patients ≤ 40 kg. | Implemented and functionally identical to the predicate device. |
| Low Volume Hemodialysis | Restricts blood pump segment sizes to |
§ 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.”