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510(k) Data Aggregation
(29 days)
SORIN FLEXTHERM
The Sorin FlexTherm Heater-Cooler System is used with a Stöckert S3 heart-lung machine and / or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Sorin FlexTherm is designed to provide temperature control during extracorporeal procedures. The device can be used in conjunction with heat exchangers tubing sets and heating/cooling blankets present on the market with an intended use in ECC (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers) and able to withstand a pressure of at least 2 bar. The device is used to warm or cool a patient during cardiopulmonary bypass procedures lasting up to six (6) hours.
As the unmodified device, the Sorin FlexTherm is a software-controlled device provided with hardware elements.
The main components for both devices are the housing provided with wheels, compressor, condenser unit, evaporator, expansion valves, water tanks, heaters, pumps, valves, sensors and a user interface/display.
Here's a breakdown of the acceptance criteria and study information for the Sorin FlexTherm device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| TEST CLASSIFICATION | TEST TYPE | ACCEPTANCE CRITERIA | REPORTED DEVICE PERFORMANCE |
|---|---|---|---|
| Functional/Performance | Functional performances without patient simulator | ||
| in terms of system capacity to reach the target | |||
| temperature, precision of the temperature control | |||
| and pump capacity. | Not explicitly stated, but implied to be defined by internal methods and specifications, ensuring the device can reach target temperatures with precision and adequate pump capacity. | "The Sorin FlexTherm successfully met all acceptance criteria for each test." | |
| Functional/Performance | Functional performances with patient simulator in | ||
| terms of cooling/warming a patient and | |||
| administration of cold/warm cardioplegia. | Not explicitly stated, but implied to be defined by internal methods to demonstrate effective cooling/warming of a simulated patient and delivery of cardioplegia. | "The Sorin FlexTherm successfully met all acceptance criteria for each test." | |
| Electrical Safety | Assessment against IEC 60601-1 electrical safety standard. | Compliance with IEC 60601-1. | "The electrical safety of Sorin FlexTherm was verified by testing the unit against the IEC 60601-1 electrical safety standard." |
| Electromagnetic Compatibility | Assessment against IEC 60601-1-2 safety standard. | Compliance with IEC 60601-1-2. | "The electromagnetic compatibility was also verified by testing the device against the applicable electromagnetic compatibility IEC 60601-1-2 safety standard." |
| Software Validation | Functional validation of the entire system software. | Compliance with internal procedures, recognized standards for software life cycle processes and quality assurance, and FDA Guidance for software in medical devices. | "The SW provided with Sorin FlexTherm was also fully validated." and "The software documentation was developed according to the requirements of the FDA Guidance..." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify a numerical sample size for the in-vitro performance tests. It only states that "Comparative tests were performed according to internal methods developed by the manufacturer."
- Data Provenance: The document does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. It only mentions in vitro testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not Applicable: This information is not provided. The study conducted was in vitro testing, not a clinical study involving expert assessment of patient data for ground truth establishment. The ground truth for these tests would likely be the known physical properties and expected performance of the device and simulators.
4. Adjudication Method for the Test Set:
- Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of data (e.g., image readings). Since this was an in vitro performance study, such adjudication methods would not be relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was NOT done. The document primarily describes in vitro testing and compliance with safety standards, and software validation. There is no mention of human readers, comparative effectiveness with or without AI assistance, or any effect sizes related to human performance improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes (implicitly). The in vitro tests described ("Functional performances without patient simulator" and "Functional performances with patient simulator") are solely focused on the device's inherent performance. The software validation also indicates an assessment of the algorithm's functionality independently. There is no human intervention in the device's operational performance being evaluated in these tests, making them standalone assessments of the device's capabilities.
7. Type of Ground Truth Used:
- The ground truth for the in vitro tests would be based on known physical parameters, engineering specifications, and established performance benchmarks for temperature control, precision, and pump capacity. For example, if a target temperature is 37°C, the ground truth is simply 37°C, and the device's output is measured against that. For electrical safety and EMC, the ground truth is compliance with the specified IEC standards.
8. Sample Size for the Training Set:
- Not Applicable / Not Provided: This device is a hardware heater-cooler system with embedded software. While the software was developed and validated, the document does not indicate that it uses machine learning or AI models that require a "training set" in the conventional sense (i.e., a large dataset for model training). The software development followed standard life cycle processes, which involves design, coding, and validation, rather than data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Provided: As noted above, the concept of a "training set" and associated ground truth establishment for machine learning models does not appear to apply to this device's software development as described in the document. The software validation relied on established software engineering principles and FDA guidance.
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