(292 days)
The Terumo® Advanced Perfusion System 1 is indicated for use for up to six 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 Terumo® Advanced Perfusion System 1 (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 system O components (100/120V or 220/240V)
- Central Control Monitor (CCM) A display used for configuration and control of o system components
- Two roller pump hand cranks and hand crank bracket O
- Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, ● including the following:
- 0 6" Roller Pump
- 0 4" Roller Pump
- O Centrifugal Control Unit with Centrifugal Drive Motor (up to 2)
- Pods
- Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal circuit, in O conjunction with the air sensor
- Level Detection Pod Used to monitor liquid levels within a hard shell reservoir. O
- O Pressure Pod - Used to monitor the pressure in the extracorporeal circuit
- Temperature Pod Used to monitor the temperature in the extracorporeal circuit and / O or the patient
- Flowmeter Pod Used to monitor flow volume and generate an alarm if backflow is O detected
- Venous Line Occluder Pod Used with the Occluder Head to provide a computer O controlled tube clamping mechanism to regulate flow in the venous line
- Interface Pods to enable data transfer between cardiac monitoring and data display o systems (i.e., Terumo CDI™ 500 Monitor, and TLink™ Data Management System)
- Electronic Patient Gas System (EPGS) 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 refers to the Terumo® Advanced Perfusion System 1, a cardiopulmonary bypass heart-lung machine console (K221895). The submission is a 510(k) for a modified device, claiming substantial equivalence to a predicate device (K172220). The modifications primarily involve updating the Central Control Monitor (CCM) hardware and associated software due to component obsolescence. As such, the study does not involve evaluating the primary clinical performance of the heart-lung machine in a traditional sense, but rather the performance of the updated components to ensure they meet the existing safety and effectiveness standards.
Given the nature of the device (a heart-lung machine console) and the modifications being for component obsolescence, the "device performance" in relation to acceptance criteria primarily revolves around technical and functional verification rather than clinical metrics like sensitivity or specificity.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance | Comments |
|---|---|---|---|
| Software Validation | All software system requirements successfully met. | All requirements identified as software system requirements were successfully met. | Verified by system-level testing of CCMD, LAN I/F, Power Manager Pod, code reviews, integration testing, and other verification methods. Includes boundary tests and message generation. |
| Hardware Verification (Mounting Arm) | Performance requirements met. | Requirements for mounting arm performance were met through internal testing and analysis. | |
| Hardware Verification (Mounting Arm Environmental) | Environmental conditions met. | Requirements for mounting arm environmental conditions were met through internal testing and analysis. | |
| Hardware Verification (CCMD) | Gloved hand response. | CCMD gloved hand response requirement was met through internal testing. | |
| Hardware Verification (Power Consumption) | Power consumption met. | Power consumption requirement was met through internal testing and analysis. | |
| Hardware Verification (Electrical Safety) | Compliance with IEC 60601-1. | Successfully passed external electrical safety testing per IEC 60601-1. | |
| Hardware Verification (Electromagnetic Compatibility) | Compliance with IEC 60601-1-2. | Successfully passed external Electromagnetic Compatibility testing per IEC 60601-1-2. | |
| Hardware Verification (Shipping & Vibration) | Compliance with ISTA-3A and MIL-STD-810G, Method 514.6 (10Hz-100Hz). | Successfully passed shipping and vibration testing per ISTA-3A and MIL-STD-810G. | |
| Hardware Verification (Physical Characteristics/Documentation) | Requirements related to physical characteristics and documentation met. | Verified through inspection. | |
| Hardware Verification (Action-Oriented Features/Basic Operations) | Basic operations and deterministic behaviors of the design met. | Verified through system-level demonstration. | |
| Reliability (Cleaning & Label Adhesion) | Applicable materials requiring cleaning and label adhesion successfully passed established acceptance criteria. | Successfully passed established acceptance criteria. | Verified through testing, analysis, and similarity. |
| Reliability (CCMD Reliability Targets & Life) | CCMD meets all reliability targets and 12-year life. | CCMD meets all reliability targets and 12-year life. | Verified through testing, analysis, and similarity. |
| Hardware Validation (Usability) | Verification of requirements, user needs, and risk mitigations within project scope. | Validation testing successfully completed verification. | Executed by external perfusionists to ensure real-world usability. |
2. Sample Size for the Test Set and Data Provenance
Due to the nature of the device modification (component obsolescence and software updates for an existing heart-lung machine console), the "tests" described are primarily engineering verification and validation activities rather than clinical trials with patient data.
- Test Set Sample Size: Not explicitly stated in terms of patient data or typical "test set" in an AI/imaging context. The testing involved various units of the device (or components thereof) for hardware and software verification. For usability validation, it involved "external perfusionists" as "usability testers," but the number of such testers is not specified.
- Data Provenance: Not applicable in the context of patient data for clinical performance. The data provenance described is from internal and external engineering testing, demonstration, inspection, and analysis by the manufacturer (Terumo Cardiovascular Systems Corporation) and external testing facilities for specific standards (e.g., electrical safety, EMC).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: For the hardware validation (usability testing), "external perfusionists" were used as "usability testers." The specific number of these experts is not defined.
- Qualifications of Experts: They are described as "external perfusionists," implying they are qualified medical professionals experienced in operating such equipment, as per the device's indications for use.
4. Adjudication Method for the Test Set
Not applicable. The reported tests are primarily engineering and functional verification, and usability testing by qualified professionals, rather than diagnostic interpretation requiring adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic performance of an AI-powered system, often in comparison to human readers, and the current submission is for a hardware/software update of an existing mechanical device, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a heart-lung machine console, which by its nature requires human operators (qualified medical professionals). Therefore, "standalone" performance in the context of an AI algorithm is not directly applicable. The device's software performance was validated through various engineering tests (system-level testing, boundary tests, code reviews, integration testing), but always in the context of its function within the complete system operated by a human.
7. The Type of Ground Truth Used
The "ground truth" here is defined by:
- Engineering Specifications and Requirements: For all hardware and software verification tests.
- Industry Standards: For electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), shipping and vibration (ISTA-3A, MIL-STD-810G).
- User Needs and Risk Mitigations: For the hardware validation/usability testing.
8. The Sample Size for the Training Set
Not applicable. This submission is for a hardware/software update to an existing medical device, not an AI/machine learning algorithm requiring a "training set" of data in the conventional sense. The "software updates" mentioned are traditional programming changes to address component obsolescence and improve existing functionalities.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI algorithm.
§ 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).