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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 < 6.4 mm for patients 20-40 kg. Machine alarm for incorrect segment ID. Ultrafiltration Rate: 0-1000 mL/hr. Blood Flow Rate: 6-465 mL/min (depending on segment ID). Venous Pressure Monitor: -60 to +300 mmHg (± 40, 60, 80 mmHg fixed window). Arterial Pressure Monitor: -260 to +100 mmHg or -60 to +300 mmHg (± 40, 60, 80 mmHg auto-set). | Implemented and functionally identical to the predicate device. |
| Conductivity Testing Method | Independent Conductivity. Automatically set alarm windows ± 0.5 mS/cm around calculated conductivity (adjustable by user an additional ± 0.5 mS/cm within range). Average Accuracy: ± 1.5%. | Verified (considered substantially equivalent to manual testing). |
| Reinfusion Method | Assisted Reinfusion. | New mechanism of returning blood introduced (considered substantially equivalent to unassisted reinfusion). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes (number of devices or test cases) used for each specific test mentioned (Biocompatibility, Electrical Safety, Software V&V, Mechanical, Environmental, Ship, Human Factors).
The data provenance (country of origin, retrospective/prospective) is not specified. The testing was conducted "according to existing FMCRTG procedures, protocols, declared performance standards, and guidelines of the quality system regulation (21 CFR §820)."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes the performance testing of a physical medical device (hemodialysis machine) based on engineering specifications and regulatory standards, not the performance of an AI/ML algorithm that requires expert-established ground truth for a test set. Experts would be involved in the design, testing, and regulatory review processes, but their role isn't in establishing a "ground truth" for an AI model's output in the typical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for evaluating subjective interpretations, often in the context of AI models. The testing described here is focused on objective engineering performance verification.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The document describes a hemodialysis machine, which is not an AI-assisted diagnostic or interpretive device that would typically be evaluated with a multi-reader, multi-case study comparing human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a hemodialysis machine, a physical piece of medical equipment, not an AI algorithm. Its performance is inherent to its mechanical and software functions, which inherently involve human operation as "human-in-the-loop."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like a hemodialysis machine, "ground truth" refers to established engineering specifications, physical laws, and regulatory standards. The performance characteristics (e.g., flow rates, temperatures, pressures, accuracy) are evaluated against these predefined, objective criteria. For instance, the accuracy of blood flow rates is verified against a known, precise measurement reference. The "ground truth" is therefore:
- Established engineering specifications and design requirements.
- International standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1-2:2014 for EMC, IEC 60601-2-16 for dialysate temperature).
- Quality system regulations (21 CFR §820).
8. The sample size for the training set
This is not applicable. The device is a hemodialysis machine, not an AI/ML model that is 'trained' on data.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" for this type of medical device.
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