Search Results

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.

• 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.

Ask a specific question about this device

The Novalung System is indicated for long-term (> 6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) 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. These may include:

• · Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
• · ECMO-assisted cardiopulmonary resuscitation in adults

The Novalung ultimate kit (US) is a single use, ethylene oxide (EO) sterilized device comprised of a disposable tubing set and accessories. The Novalung ultimate kit (US) contains a disposable tubing set, pump head, oxygenator with heat exchanger, and accessories (gas line, priming line, stopcocks, luer caps, Christmas tree connector, tubing clamps, cable ties). The tubing set is pre-connected to a hollow fiber membrane oxygenator and blood pump head (Deltastream DP3 3/8"), which forms an extracorporeal circuit. All blood-contacting surfaces of the tubing set, except for the blood pump head, are coated with x.ellence coating. The Novalung ultimate kit (US) tubing set has three (3) integrated pressure sensors (IPS) that connect to the Novalung System sensor box. The flow sensor detects air bubbles in the extracorporeal circuit and measures blood flow. The Novalung ultimate kit (US) provides treatment for a blood flow range of 1-6.5 L/min and has a total extracorporeal priming volume of 670 mL ± 10%. In the Novalung ultimate kit (US), blood flows from the patient through the tubing set with IPSs, through the pump head and the oxygenator, and back to the patient. Blood flow is driven through the oxygenator by the pump head that is powered by the Novalung System console's pump drive.

The provided document is a 510(k) premarket notification for a medical device called the "Novalung ultimate kit (US)". This device is an extracorporeal circuit and accessories used for long-term respiratory/cardiopulmonary support. There is no mention of Artificial Intelligence (AI) or machine learning (ML) in this document, so it does not contain the information needed to answer your questions about AI device acceptance criteria or performance studies.

The document primarily focuses on demonstrating the substantial equivalence of the Novalung ultimate kit (US) to a legally marketed predicate device (Novalung System XLung kit, K191407) through non-clinical performance testing and biocompatibility assessments.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance related to an AI/ML device.
2. Sample sizes used for a test set, data provenance, or details about training sets for an AI/ML device.
3. Number of experts, qualifications, or adjudication methods for establishing ground truth for an AI/ML device.
4. MRMC studies or effect sizes for human readers with and without AI assistance.
5. Standalone performance of an algorithm.
6. Type of ground truth used for an AI/ML device.

Ask a specific question about this device

The Novalung System is indicated for long-term (> 6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) 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. These may include:

• · Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
• · ECMO-assisted cardiopulmonary resuscitation in adults

The Novalung System is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support. The following therapies are available with the Novalung System:

• Extracorporeal CO2 removal (ECCO2R)
• Extracorporeal membrane oxygenation (ECMO) ●
  The Novalung System consists of the Novalung console and XLung kit. The Novalung console is composed of the following components:
• Control panel ●
• Power supply ●
• Sensor box ●
• . Pump drive
  The Novalung console powers and monitors the operation of the blood pump head in the extracorporeal circuit. The control panel has a touchscreen display on which all data, parameters, and values are displayed. Parameters can be selected and adjusted by pressing the touchscreen as well as by using the control panel function keys and the center knob. The control panel is attached to the power supply, which provides power to the console. The console also provides two (2) battery packs that supply power to the console if there is a power failure.
  The sensor box allows data to be transferred to the console and displayed on the control panel. It has connectors for pressure sensors that connect to the XLung kit tubing set and a flow sensor.
  The XLung kit contains a disposable tubing set and accessories (gas line, priming line, stopcocks, luer caps, Christmas tree connector, tubing clamps, cable ties). The tubing set is pre-connected to a hollow fiber membrane oxygenator (XLung oxygenator) and blood pump head (Deltastream DP3 3/8"), which forms an extracorporeal circuit. All blood-contacting surfaces of the tubing set, except for the blood pump head, are coated with x.ellence coating.
  The XLung kit tubing has 3 integrated pressure sensors (IPS) that connect to the sensor box. The flow sensor detects air bubbles in the extracorporeal circuit and measures blood flow. The XLung kit provides treatment for a blood flow range of 1-7 L/min and has a total extracorporeal priming volume of 605 mL ± 10%.
  The blood pump head is pre-connected to the XLung kit tubing set, which is provided sterile. Blood flow in the XLung kit tubing set is driven by the pump drive when it is connected to the blood pump head.
  The following accessories are available with the Novalung System:
• Bracket and rail connector
• Flow sensor ●
• Pressure sensor connecting cables
• System cart ●
• Compact holder spike and bracket
• Pump drive holders ●
• . Infusion holder

The provided text describes the Novalung System, an extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. It outlines the device's indications for use, its components, and various tests conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not present a table of specific acceptance criteria alongside reported device performance for these tests. Instead, it generally states that "All testing met predetermined acceptance criteria" and provides summaries of the types of tests performed and their overall conclusions.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert qualifications, and ground truth establishment cannot be extracted directly from this document.

Here's a summary of the information that can be extracted or inferred from the provided text, and an explanation for what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "All testing met predetermined acceptance criteria." However, it does not provide a specific table with numerical or qualitative acceptance criteria for each test (e.g., "Oxygen transfer rate > X mL/min," "Pressure drop

Ask a specific question about this device