(117 days)
The VitalFlow Console controls the speed of the VitalFlow Centrifugal blood pump during extracorporeal cardiopulmonary life support for adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The VitalFlow Centrifugal pump is driven by the VitalFlow Motor Drive or the VitalFlow Emergency Handcrank.
The VitalFlow Console provides control of blood pumping through an extracorporeal circuit during extracorporeal membrane oxygenation (ECMO) procedures. The console powers the VitalFlow motor drive unit which provides rotation of the VitalFlow Centrifugal pump. Pump motor speed (RPM) can be adjusted by the user and flow and bubble detection is provided by an ultrasonic flow probe and displayed on the touchscreen. The touchscreen display allows users to set alarm limits for all measured parameters. The device will alarm visually and audibly when limits are exceeded. Status indicators, power/battery life and secondary RPM indicator are provided. Data download and data streaming from the console is available for ECMO circuit data only; no patient data is stored for output.
The provided FDA 510(k) clearance letter for the VitalFlow Console (K250199) generally describes the device and its indications for use, and makes a case for substantial equivalence to a predicate device. However, it does not provide specific details about acceptance criteria or the study that proves the device meets those criteria, particularly regarding AI or algorithm performance.
The core of this submission is about a software upgrade to an existing hardware device (VitalFlow Console) which enables software upgrades via USB. The FDA clearance is based on demonstrating that this change does not raise new questions of safety or effectiveness and maintains the existing performance characteristics. Therefore, the information typically requested in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, AI effect size, etc.) would primarily be relevant if the upgrade introduced a new AI/algorithmic component or significantly altered a measurement or diagnostic function that required such validation.
Based on the document, here's what can be extracted and what cannot:
Analysis of the Provided Document Regarding Acceptance Criteria and Performance Study:
The document explicitly states:
"Software verification (which included Cybersecurity) was used to verify the performance characteristics of the subject device with the upgrade over USB change."
And:
"Substantial equivalence of the performance characteristics is demonstrated through regression testing. The VitalFlow Console (Upgrade Over USB) continues to meet international standards for safety and has demonstrated effectiveness at maintaining the device performance."
This indicates that the performance study focused on regression testing to ensure the new software upgrade feature (upgrade over USB) did not negatively impact the existing performance of the device or introduce new risks, especially related to cybersecurity. It was not a de novo study to establish new performance metrics for an AI or algorithmic component, as the device's fundamental function (controlling a blood pump) remains unchanged, and the cleared modification is about the method of software updating.
Therefore, most of the specific questions about AI/algorithm performance studies (e.g., number of experts, ground truth type, MRMC study) are not applicable to the scope of this particular 510(k) submission.
Extracted Information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Submission) | Reported Device Performance (from Submission) |
|---|---|
| Maintain Predicate Device's Performance Characteristics | "Continues to meet international standards for safety and has demonstrated effectiveness at maintaining the device performance." |
| No New Questions of Safety or Effectiveness Raised by Upgrade Over USB Feature | "The modified VitalFlow Console (Upgrade Over USB)... does not raise new or different questions of safety or effectiveness." |
| Compliance with Special Controls (21 CFR 870.4100) | "The VitalFlow Console (Upgrade Over USB) device meets all special controls identified in 21 CFR 870.4100." (e.g., technological characteristics, non-clinical performance via regression testing) |
| Cybersecurity Compliant | "Software verification (which included Cybersecurity) was used to verify the performance characteristics..." |
| Labeling Remains Adequate | "The Instructions for Use remain unchanged from the predicate submission K230364." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The testing mentioned is "Software verification" and "regression testing." For software changes, the "test set" would typically refer to the test cases used in the verification and validation (V&V) activities. The document does not provide the number of test cases run or the duration/number of runs for regression testing.
- Data Provenance: Not explicitly stated. Given that it's regression testing for a software update on an existing device, it would likely involve internal testing data and potentially real-world data from the existing predicate device's operational environment. It's implicitly a combination of retrospective (based on existing device performance) and prospective (new tests for the updated software) testing, but the document doesn't specify. Country of origin not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Stated. This type of information is typically required for studies establishing diagnostic accuracy or clinical effectiveness, often involving human readers/interpreters. This submission focuses on a software update for a control console, where "ground truth" would relate to the correct functioning of the software and hardware rather than clinical interpretation by experts. "Software verification" and "regression testing" would involve engineering and software quality assurance expertise to establish whether the device performed as specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Stated. Adjudication methods are relevant for subjective interpretations (e.g., medical images). For software verification and regression testing, failures are objective (e.g., a test case passes or fails, a function behaves as expected or not).
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 as this submission is not about a diagnostic AI/CAD device or a device that assists human interpretation in a new way. It's about a software update for a control console.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Stated in this context. The "algorithm" here is the control software for the blood pump. Its "standalone" performance would be measured by its ability to precisely control the pump's RPM, detect flow, and manage alarms, which is what "software verification" and "regression testing" would assess. The document confirms these existing performance characteristics are maintained.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the traditional sense. For software verification and regression testing, the "ground truth" is the established functional and performance requirements of the device. This is confirmed through testing against design specifications, system requirements, and pre-existing performance benchmarks of the predicate device.
8. The sample size for the training set:
- Not Applicable. This is not an AI/Machine Learning device where a "training set" is relevant. The "software update" refers to a traditional software engineering change, not an AI model retraining.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI model.
Summary of Device and Changes:
- Device: VitalFlow Console, controls a centrifugal blood pump for extracorporeal cardiopulmonary life support.
- Predicate: VitalFlow Console (K230364).
- Change in K250199: Enables software upgrades to be uploaded through the USB port (previously required Medtronic service personnel to open the console and connect laptops to individual boards).
- Regulatory Focus: Ensuring the new USB update feature does not compromise the safety or effectiveness of the device, particularly regarding cybersecurity and maintaining existing performance.
- Performance Study Type: Software verification and regression testing, indicating an engineering-focused validation rather than a clinical outcome or AI performance study.
§ 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
(a)
Identification. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).(b)
Classification —Class II (special controls). The special controls for this device are:(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible;
(2) The devices and accessories in the circuit must be demonstrated to be biocompatible;
(3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories;
(4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability;
(5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and
(6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.