(99 days)
The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.
The Advanced Perfusion System 1) is a configurable heartlung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements.
The System 1 components are listed below.
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· System 1 Base:
- Chassis platform Provides operating power and back up battery power for all o system components (100/120V or 220/240V)
- Central Control Monitor (CCM) A touch screen display used for o configuration and control of system components
- Two roller pump hand cranks and hand crank bracket o
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· Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following:
- 6" Roller Pump o
- 4" Roller Pump o
- Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O
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Pods
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Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor
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Level Detection Pod Used to monitor liquid levels within a hard shell o reservoir.
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Pressure Pod Used to monitor the pressure in the extracorporeal circuit O
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Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient
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Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected
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Venous Line Occluder Pod Used with the Occluder Head to provide a O computer controlled tube clamping mechanism to regulate flow in the venous line
- Interface Pods to enable data transfer between cardiac monitoring and data o display systems (e.g., Terumo CDI™ 100 Monitor, CDI™ 500 Monitor, and TLink™ Data Management System)
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· Electronic Gas Blender Provides control and monitoring of the gas output to the oxygenator
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· Flexible Lamps (15 inch or 33 inch) for local illumination
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· Mounting hardware (e.g., center poles, crossbars, and brackets)
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria using metrics such as sensitivity, specificity, or AUC.
The document is a 510(k) summary for a software modification to the Terumo® Advanced Perfusion System 1. It states that "The device software has been revised to improve system performance" and that "Software verification and validation has confirmed that the modifications improve system performance." However, it does not provide details on:
- Specific performance metrics (e.g., accuracy, precision, recall)
- Quantitative acceptance criteria for these metrics
- The results of any performance study against those criteria
- Details about the test set, ground truth, or expert involvement
The document focuses on demonstrating substantial equivalence to a previously cleared device (K131041) based on identical intended use, indications for use, operating principles, and technical specifications, where the primary change is software modification "to improve system performance." The "Performance Testing" section only broadly mentions "software verification and validation testing at the unit, integration, system, and regression levels" but does not elaborate on the specific performance results against pre-defined acceptance criteria for medical device efficacy or safety.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).