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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 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.

Device Description

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.

AI/ML Overview

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.

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K Number

K173972

Device Name

2008T BlueStar Hemodialysis Machine

Manufacturer

Fresenius Medical Care Renal Therapies Group, LLC

Date Cleared

2018-05-10

(132 days)

Product Code

KDI

Regulation Number

876.5860

Type

Traditional

Panel

Gastroenterology-Urology (GU)

Reference & Predicate Devices

K150708,K153449

Intended Use

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.

Device Description

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.

AI/ML Overview

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

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