(173 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 heart-lung 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.
- · 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
- o Two roller pump hand cranks and hand crank bracket
- Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following:
- 6'' Roller Pump O
- o 4" Roller Pump
- Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O
- Pods
- Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor
- o Level Detection Pod Used to monitor liquid levels within a hard shell reservoir.
- O Pressure Pod - Used to monitor the pressure in the extracorporeal circuit
- Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient
- Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected
- 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 (i.e., Terumo CDI™ 500 Monitor, and TLink™ Data Management System)
- · Electronic Gas Blender Provides control and monitoring of the gas output to the oxygenator
- Flexible Lamps (15 inch or 33 inch) for local illumination
- · Mounting hardware (e.g., center poles, crossbars, and brackets)
This document describes a 510(k) premarket notification for the Terumo® Advanced Perfusion System 1, focusing on modifications to the device. Please note that this submission primarily addresses engineering modifications (hardware and software) to an existing device and therefore does not include information typically found in studies for a novel AI device, such as training sets, ground truth establishment for AI, expert adjudication methods, or MRMC studies.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a detailed table format within the document. However, the performance data section indicates that the device was evaluated against existing safety and performance standards for medical devices. The reported device performance is that it complies with these standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1) | Complies |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Complies |
| Software Verification & Validation (FDA Guidance for Software in Medical Devices – "major" level of concern) | Testing conducted and documentation provided as recommended by FDA guidance. |
| Design Input Requirements for Modifications (e.g., Battery Backup supply voltage, Health signal, Capacity, AC to Battery switching, Function status diagnostic, Simulated use) | Testing conducted and resulted in data demonstrating the System 1 performs within defined design input requirements for the proposed modifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/ML model for which a sample size or data provenance would be relevant. The testing performed was on the modified System 1 device itself.
- Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The entire modified device was subjected to testing.
- Data Provenance: Not applicable. The testing relates to the function of hardware and software modifications of the device, not analysis of external data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is for engineering modifications to a medical device, not an AI/ML model that requires human expert annotation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method is mentioned as the testing performed was focused on device functionality and compliance with engineering standards.
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
No. An MRMC study was not conducted or mentioned, as this submission is not for an AI-assisted diagnostic or therapeutic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is not an algorithm-only product. It is a cardio-pulmonary bypass machine. Software verification and validation were performed on the embedded software within the device, which is an integral part of its function, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the defined engineering specifications and regulatory standards that the device performance was measured against.
- Type of Ground Truth: Engineering specifications for hardware and software functionality, and compliance with recognized Consensus Standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance for software in medical devices.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" in the context of an AI/ML model. The software modifications were developed and verified, but this is distinct from training an AI model on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML training set, the establishment of ground truth for such a set is not relevant to this submission.
§ 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).