(164 days)
The VitalFlow Set with Balance Biosurface is indicated for respiratory/cardiopulmonary support up to 48 hours that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation) of the patient's blood in adults 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.
VitalFlow Sets with Balance™ Biosurface contain components used to prepare an extracorporeal circuit for ECMO procedures. The components include the VitalFlow Tubing Sets packaged together with the legally marketed Nautilus VF Oxygenator and VitalFlow Centrifugal Pump as a standard kit. The components are connected together to prepare an extracorporeal circuit for ECMO procedures.
The VitalFlow Tubing Set contains a preassembled drainage and return loop "ECMO Circuit," tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The tubing assembly is provided pre-connected to the inlet of the VitalFlow Centrifugal Pump. The "Priming Circuit" contains components to supplement the basic extracorporeal circuit, as needed per hospital protocols for setting up the ECMO circuit. A venous reservoir and one-way valve are included in the priming circuit to facilitate ease of priming the ECMO circuit.
This product is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.
The Medtronic VitalFlow™ Set with Balance™ Biosurface is indicated for respiratory/cardiopulmonary support up to 48 hours for adults with acute respiratory or cardiopulmonary failure. The acceptance criteria and supporting study details are as follows:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the VitalFlow Set with Balance Biosurface primarily focus on demonstrating substantial equivalence to a predicate device and ensuring acceptable performance through pre-clinical bench testing and real-world clinical evidence. While explicit numerical acceptance criteria for many mechanical and biocompatibility tests are not provided in the summary, the overall conclusion is that the device "does not raise different questions of safety or effectiveness" compared to the predicate. The clinical summary provides comparative performance data for complications.
| Acceptance Criteria Category | Specific Criteria / Performance Target (Implied) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Consistent with intended use in extracorporeal support and compatible with other devices/accessories. | Geometry and design parameters are consistent with intended use and compatible with other devices/accessories in the extracorporeal circuit. |
| Biocompatibility | Must be biocompatible in accordance with ISO 10993-1. | Demonstrated to be biocompatible in accordance with ISO 10993-1. |
| Sterility and Shelf-Life | Maintain sterility, integrity, durability, and reliability over stated shelf-life. | Sterilization adoption evaluation and shelf-life assessment demonstrate maintenance of sterility, integrity, durability, and reliability over a 2-year shelf life. |
| Non-clinical Performance | Substantial equivalence of performance characteristics démontré on bench, mechanical integrity, durability, and reliability testing. | Pre-clinical bench studies were conducted, including simulated use durability, tensile strength, pressure tests, functional testing, kink testing, blood trauma testing, and coating coverage. The summary states "sufficient to demonstrate," implying these tests met internal criteria for equivalence. |
| Clinical Performance (Complications) | Comparable or favorable complication rates compared to "All other ECMO Systems" (a large cohort from the ELSO Registry). | Overall Complication Rate (≥ 1 of any): VitalFlow Set: 38.5% (75/195) vs. All other ECMO Systems: 35.1% (21501/61176). |
| Mechanical Complications: |
- Oxygenator Failure (Prevalence): VitalFlow Set: 4.6% (9/195) vs. All other ECMO Systems: 8.0% (4878/61176).
- Oxygenator Failure (Rate per 1000 Hrs): VitalFlow Set: 0.30 vs. All other ECMO Systems: 0.35.
- Pump Failure (Prevalence): VitalFlow Set: 2.6% (5/195) vs. All other ECMO Systems: 0.6% (368/61176).
- Pump Failure (Rate per 1000 Hrs): VitalFlow Set: 0.16 vs. All other ECMO Systems: 0.02.
- Thrombosis/Clots in Circuit Component: VitalFlow Set: 1.0% (2/195) vs. All other ECMO Systems: 2.1% (1272/61176).
Hemolysis: - Moderate or Severe Hemolysis: VitalFlow Set: 2.1% (4/195) vs. All other ECMO Systems: 5.2% (3197/61176).
(Other specific complication rates are listed in the table in the document and generally show comparable or lower rates for VitalFlow Sets, with the exception of pump failure prevalence and rate). |
| Labeling | Include detailed summary of non-clinical evaluations, instructions for anticoagulation, circuit setup, performance, and maintenance. | Instructions for Use include the required details. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Clinical "Test Set": 195 patients (VitalFlow Set group).
- Data Provenance: The data comes from a "summary of real-world evidence (195 reports) of the clinical experience with the VitalFlow Set from the ELSO Registry." This indicates the data is retrospective and derived from a registry, which typically collects data from multiple institutions/countries. The specific country of origin is not explicitly stated but the ELSO Registry is an international organization.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical complication data from the ELSO Registry. Registry data often involves reporting by treating clinicians, and data validation/adjudication processes vary by registry but are not detailed here.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical complication data from the ELSO Registry. It is implied that the reported complication rates are based on the data as collected and recorded within the registry.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study evaluates the device's performance in a real-world setting rather than comparing human readers with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable as the device is a medical device (extracorporeal circuit components) and not an AI algorithm. Its performance is inherent to its mechanical and biological functions, not an algorithm's output.
7. Type of Ground Truth Used
The ground truth for the clinical performance data (complication rates) is based on real-world outcomes data collected and reported to the ELSO Registry. For the pre-clinical tests, the ground truth would be established by validated test methods and engineering specifications.
8. Sample Size for the Training Set
This question is not applicable as the device is not an AI algorithm requiring a training set. The "training set" concept does not apply to the development and evaluation of this type of medical device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above.
§ 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.