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AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.

AllNEB is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.

This document is a 510(k) clearance letter for a medical device called "AllNEB Breath Actuated Nebulizer." It demonstrates the device's substantial equivalence to a legally marketed predicate device, the AeroEclipse II Breath Actuated Nebulizer (K053605).

The core of the acceptance criteria and proof revolves around comparative performance testing, showing that the AllNEB device performs similarly to the predicate device across various aerosolization metrics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly derived from the performance of the predicate device. The goal is to demonstrate "substantial equivalence," meaning the new device performs similarly to the predicate. The performance of the predicate device, AeroEclipse II Breath Actuated Nebulizer (K053605), serves as the "acceptance criteria," and the "Reported Device Performance" is that of the AllNEB device.

The tables provided in the 510(k) summary (pages 7-16) present a direct comparison of various aerosolization parameters for both the AllNEB (Subject Device) and the AeroEclipse II (Predicate Device) under different conditions (Breath Actuated Mode, Constant-Output Mode, Adult settings, Pediatric settings, and Simulated Breathing).

Key Performance Metrics (Acceptance Criteria are inferred to be "similar to predicate"):

• MMAD (Mass Median Aerodynamic Diameter): A measure of the central tendency of the particle size distribution.
• GSD (Geometric Standard Deviation): A measure of the spread or variability of the particle size distribution.
• Total Dose Delivered: The total amount of medication delivered by the nebulizer.
• Total Respirable Dose (0.5-5 µm): The amount of medication delivered as particles within the respirable range (able to reach the lower respiratory tract).
• Coarse Particle Dose (>4.7 µm): The amount of medication delivered as larger particles.
• Fine Particle Dose (4.7 um) | 350 | 218 | Similar |
  | **Fine Particle Dose (

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The Enchant AllPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients aged 18 years and older. Patients must be capable of generating an exhalation flow of 10 lpm for 3-4 seconds to promote secretion clearance. This device may be used to prevent or reverse atelectasis and as an inspiratory, deep breathing positive exerciser. It may be used in hospital and clinical settings.

AllPEP provides PEEP during user exhalation and features a mechanism which provides oscillations during exhalation as well.

Principle of Operation: The oscillating positive exhalation pressure device, AllPEP, includes a housing, a top cover, and an oscillating mechanism. The patient inhales room air through a one-way valve and when exhaling the exhaled gas is directed through the upper portion of the device which contains a swinger mechanism to oscillate the air, causing the air to vibrate.

The provided text is a 510(k) premarket notification FDA review letter for the "AllPEP" device, classified as an Incentive Spirometer. It addresses the substantial equivalence of the AllPEP device to a predicate device, DHD Acapella K991561.

The document details the device's indications for use, patient population, environment of use, and a comparison of its features and performance to the predicate device. Crucially, it highlights non-clinical bench testing as the primary method to demonstrate substantial equivalence, rather than clinical studies involving human participants or MRMC studies.

Therefore, the following is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria based only on the information provided in the document.

Acceptance Criteria and Device Performance for AllPEP

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