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510(k) Data Aggregation
(86 days)
The Dual Spray MINISPACER® MDI adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit, as prescribed by a physician or other licensed health care practitioner.
The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short term and long term critical care environments.
The device is intended for sale by or on the order of a physician.
MiniSpacer® Dual Spray MDI Adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit.
This looks like a 510(k) clearance letter from the FDA for a medical device called "MiniSpacer® Dual Spray MDI Adapter."
Based on the provided text, it's a clearance letter, not a study report. Therefore, none of the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies can be extracted from this document.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory framework. It does not contain any details about performance criteria or the studies used to demonstrate those criteria.
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(406 days)
The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber designed to serve three major functions:
- To reduce the amount of MDI medication deposited in the patient's mouth and . throat, thus reducing the potential for unwanted local or systemic side effects.
- To ease the problems that many patients have in synchronizing actuation of the . MDI canister with the start of inhalation.
- To retain a significant portion of the MDI drug plume until the patient's next . inhalation, in cases where actuation and inhalation are asynchronous. The LiteAire is a non-sterile device for single-patient use.
The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber.
This document is a 510(k) premarket notification approval letter from the FDA to Thayer Medical Corporation for a device called "LiteAire," which is a collapsible, disposable accessory device for use with metered dose inhalers (MDIs). The document does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details.
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(89 days)
The PrimeAire is an accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use,
The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use.
This document is a 510(k) premarket notification from the FDA regarding the "PrimeAire" device. It is a letter confirming that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is a regulatory approval letter, not a performance study report.
Therefore, I cannot provide the requested information based on the input.
To answer your request, I would need a document that describes the design verification and validation testing for the PrimeAire device, including its performance characteristics and the studies conducted to demonstrate its safety and effectiveness.
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(91 days)
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(90 days)
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