(23 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.
- · 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
- · 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
- Pods
- Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor
- Level Detection Pod Used to monitor liquid levels within a hard shell o reservoir.
- Pressure Pod Used to monitor the pressure in the extracorporeal circuit O
- 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 (e.g., Terumo CDI™ 100 Monitor, 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 pertains to the resubmission of the Terumo Advanced Perfusion System 1 (K153376) due to a hardware modification. As such, the information provided focuses on the substantial equivalence to a previously cleared device (K151349) rather than a full de novo acceptance criteria study for a new device. Therefore, many of the typical study details for an AI/algorithm-based device are not applicable or not provided in this regulatory document.
However, based on the provided text, I can infer and extract the following:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from modification goal) | Reported Device Performance (From Conclusion) |
|---|---|
| Prevent inadvertent shut off and/or failure of the On/Off Switch leading to loss of system power. | "Hardware verification and validation testing has confirmed that the modification satisfies the design input requirements and prevents inadvertent loss of system power." |
Explanation: The primary goal of the hardware modification was to address a potential issue with the On/Off switch that could lead to power loss. The "acceptance criteria" here is implicitly that the modification successfully resolves this issue. The "reported device performance" directly states that the modification achieves this.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified. The document states "successful design verification and validation testing," but does not provide details on the number of units or test scenarios used.
- Data Provenance: Not specified. Given this is a hardware modification for an existing device, it's likely testing was conducted internally by the manufacturer, Terumo Cardiovascular Systems Corporation, based in Ann Arbor, Michigan, USA. The nature of testing points to prospective testing of the modified hardware.
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):
- Number of Experts: Not applicable. This is a hardware modification of a medical device, not an AI/algorithm-based diagnostic or prognostic tool that relies on expert interpretation for ground truth. The "ground truth" here is the functional performance of the hardware.
- Qualifications of Experts: Not applicable in the context of expert review for ground truth as described for AI/algorithm studies. The testing would have been performed by engineers and quality assurance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This is not a study requiring adjudication of interpretations from multiple experts. The "ground truth" is determined by successful functional testing of the hardware.
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:
- MRMC Study: No. This document describes a hardware modification to an existing heart-lung machine console, not an AI-assisted diagnostic or therapeutic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: Not applicable. This device is a console that requires human operation ("when used by a qualified medical professional who is experienced in the operation of this or similar equipment"). It is not an algorithm that performs a function independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for this hardware modification is the demonstrable stable and reliable operation of the On/Off switch and the prevention of inadvertent power loss, as confirmed by design verification and validation testing. This would involve functional tests, electrical safety tests, and potentially stress tests to ensure the new component meets its intended performance specifications.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is a hardware system, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this hardware device.
§ 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).