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The NIVO Nebuliser System is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance.

The NIVO Nebuliser System is suitable for use in adult and pediatric 7 years or older (>20kg) patients whilst using a facemask.

The Aeroneb® Pro X control module, cables, adaptor and bracket components of the NIVO Nebuliser system are intended for multiple patient use as described in the instruction manual.

The NIVO Nebuliser unit, EE and SE elbow components of the NIVO Nebuliser system are intended for single use as described in the instruction manual.

The NIVO Nebuliser System is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance. The system includes the Aeroneb® Pro X control module, cables, adaptor and bracket components (intended for multiple patient use) and the NIVO Nebuliser unit, EE and SE elbow components (intended for single use).

The provided text is a medical device approval letter from the FDA for the VIVO Nebulizer System, dated November 10, 2010. It focuses on the device's substantial equivalence to previously marketed devices and its regulatory classification. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. Therefore, I cannot provide an answer based on the given text.

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The Aeroneb® Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria. The text is a letter from the FDA regarding a 510(k) premarket notification for the Aeroneb® Go Nebulizer, confirming its substantial equivalence to a legally marketed predicate device.

The document includes:

• Trade/Device Name: Aeroneb® Go Nebulizer
• Regulation Number and Name: 21 CFR 868.5630, Nebulizer
• Regulatory Class: II
• Product Code: CAF
• Indications for Use: The Aeroneb® Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

However, it does not provide any specific details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any tests.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory clearance letter, not a detailed study report.

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The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb® Professional Nebulizer System is suitable for use in adult and pediatric patients as described in the Instruction Manual.

The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance.

The provided text is a 510(k) premarket notification letter from the FDA regarding the Aeroneb® Professional Nebulizer System. This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such information would typically be found in the detailed technical documentation submitted as part of the 510(k) application, a summary of which might be included in the "510(k) Summary" document, but not in this specific letter.

Therefore, I cannot provide the requested information based on the given input.

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