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The Bernoulli Management System (MS) Software is a software application intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital-type environment. It is used to provide a secondary display of multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs), lung ventilator, respiratory gas monitor, IV infusion.(including PCA) pump, feeding pump and related ancillary devices, and to provide remote monitoring and alarm surveillance. This application is also intended to provide primary alarm surveillance for devices where no alarm notification capability is enabled or available in low acuity MedSurg, Cardiac, General ward care areas to monitor patients who are currently not monitored. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring procedures.

The Bernoulli Management System (MS) Software is to be used under license by or on the order of a physician or licensed healthcare professional in the course of his/her professional practice.

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The provided FDA 510(k) summary (K130208) for the Bernoulli® Enterprise Software is a clearance letter and an "Indications for Use" statement. It affirms the device's substantial equivalence to a predicate device but does not contain the detailed study information or acceptance criteria requested.

Therefore, I cannot extract the specific details about the acceptance criteria or a study proving the device meets them from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on performance studies with specific statistical metrics.

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The Bernoulli MS software is intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital type environment. It is used to provide a secondary display of ventilator, respiratory monitor, IV infusion (including PCA) pump, feeding pump, and/or multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs) to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring procedures.

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This appears to be a 510(k) clearance letter from the FDA for the Bernoulli™ Management System, and not a study describing acceptance criteria and device performance. The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

Therefore, the requested information about acceptance criteria, device performance, study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone study results is not present in the provided document.

The document specifically states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates a regulatory review based on equivalence to existing devices, not a detailed performance study where specific acceptance criteria and their fulfillment are described.

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The Bernoulli MS software is intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital type environment. It is used to provide a secondary display of ventilator, respiratory monitor, and/or multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs) to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring. procedures.

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This appears to be a 510(k) clearance letter from the FDA for the Bernoulli™ Management System. This document does not contain the specific acceptance criteria and detailed study results that you are asking for.

FDA 510(k) clearance letters primarily state that the device has been found substantially equivalent to a predicate device, meaning it's as safe and effective as a device already on the market. They typically do not include the detailed performance study results or acceptance criteria used by the manufacturer during their development and validation process. Those details would normally be found in the 510(k) submission itself, which is a confidential document submitted to the FDA by the manufacturer.

Therefore, I cannot provide the information you requested based on the provided text.

To answer your questions, I would need to analyze the actual 510(k) summary, often referred to as the "510(k) Premarket Notification." Sometimes, manufacturers publish these summaries publicly.

If you can provide the 510(k) Summary document for K061932, I could potentially extract the requested information.

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The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator and respiratory gas monitor data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.

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This document is a 510(k) premarket notification FDA clearance letter for the Bernoulli™ Ventilator Management System. It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.

The letter confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as a legally marketed device, but the letter does not include details of performance studies or acceptance criteria themselves.

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a different document, such as the full 510(k) submission or a detailed performance study report for the Bernoulli™ Ventilator Management System.

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The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator and blood gas monitor data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.

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I'm sorry, but without the actual study or a detailed summary of its contents, I cannot provide the requested information about acceptance criteria and device performance. The provided text is a letter from the FDA regarding a 510(k) premarket notification for the Bernoulli™ Ventilator Management System, which acknowledges receipt and substantial equivalence to legally marketed predicate devices. It does not contain details about specific acceptance criteria, study methodologies, results, or the other specific points you've requested.

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The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.

Bernoulli™ Ventilator Management System

The provided text describes a 510(k) clearance for the Bernoulli™ Ventilator Management System but does not contain information about the acceptance criteria, reported device performance, or details of a study demonstrating such performance. It is a regulatory clearance letter and an "Indications for Use Statement".

Therefore, I cannot provide the requested information.

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The Venturi® ventilator is intended to mechanically control or assist the breathing of adult and pediatric patients. The Venturi® is designed for use in hospital intensive care units (ICU).

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I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance data for the Venturi® Ventilator. The document is an FDA 510(k) clearance letter from 1999, which primarily states that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them.

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The Venturi Ventilator is intended to mechanically control and assist the breathing of adult and pediatric patients under the direction of a physician.

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I am able to extract the requested information about the device and its indications for use. However, the provided document is a 510(k) clearance letter from the FDA, which confirms the substantial equivalence of the "Venturi Ventilator" to a legally marketed predicate device.

This document does not contain the detailed study information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, or training set size and ground truth establishment) that you are requesting.

Regulatory clearance letters like this one often refer to studies and data submitted by the manufacturer, but they do not typically reproduce those study details in the letter itself. The FDA's determination of substantial equivalence is based on the applicant demonstrating that their device is as safe and effective as a predicate device, often by showing that it has the same technological characteristics and indications for use, or that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot fulfill your request using only the provided text. You would need access to the actual 510(k) submission or supporting documentation from Cardiopulmonary Corp. to find the information you're looking for.

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