(24 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 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)
The provided text describes a 510(k) premarket notification for the Terumo Advanced Perfusion System 1, which involves software modifications to an existing device. It discusses software verification and validation, and design validation testing, but does not provide explicit acceptance criteria or detailed study results in the format requested.
Here's an analysis based on the information provided and what is missing:
The document states: "Software verification and validation testing were conducted and discussion of the these activities (i.e. protocols, acceptance criteria, and test results) at the unit, integration, and system level are included as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."". However, the actual acceptance criteria and test results are not included in the provided text.
Similarly, for design validation: "Design validation testing was conducted and demonstrates that the System 1 performs within the defined design input requirements for the proposed modifications. The following testing was performed on the subject device: . Simulated use case testing . Validation of the Instructions For Use changes". Again, the specific acceptance criteria and detailed results are not provided.
Therefore, I cannot populate the table and answer all questions directly from the given text.
Based on the available information, here's what can be extracted and what remains unknown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated/Inferred) | Reported Device Performance (Stated/Inferred) |
|---|---|
| Software Verification & Validation: The document states that protocols, acceptance criteria, and test results were included in the full submission, as recommended by FDA guidance. | Software Verification & Validation: "Software verification and validation testing... confirmed that the modifications do not adversely impact system performance." (Specific data not provided) |
| Design Validation: The document states design validation demonstrates the system performs within defined design input requirements. This would imply criteria for successful simulated use and validation of Instructions For Use changes. | Design Validation: "design validation testing ... demonstrates that the System 1 performs within the defined design input requirements for the proposed modifications." (Specific data not provided for simulated use cases or IFU validation) |
| Biocompatibility: Device does not come into patient contact. | Not applicable - no biocompatibility testing performed or required. |
| Electrical Safety and EMC: Software modifications do not impact these aspects. | Not applicable - no testing performed. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not specified in the provided text.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are internal manufacturer testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified. The document mentions "qualified medical professional who is experienced in the operation of this or similar equipment" for the device's use, which might imply involvement in validating the simulated use cases, but this is an inference, not a direct statement about ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not specified.
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 device is a heart-lung machine console, not an AI diagnostic tool involving human readers.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm only" device in this submission. The software modifications are for a console that operates a heart-lung machine; its performance is intrinsically linked to the machine's function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the software verification and validation, and design validation, the "ground truth" would likely be adherence to defined software requirements, design input requirements, and successful operation during simulated use testing. Specific "ground truth" types like pathology or outcomes data are not relevant for this type of device modification.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI model that requires a training set in the conventional sense. The "training" here would refer to the software development and testing cycles.
9. How the ground truth for the training set was established
- Not applicable for the reasons stated in point 8.
§ 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).