(150 days)
The GaleMed Neb-Easy Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. It is for adult and pediatric patients.
The nebulizer is a device intended to spray liquids in aerosol form into gasses that are delivered directly to the patient for breathing. It is a Class II device, requlation number: 868.5630.
This device operates on the venturi principle and is refillable. The device is called the GaleMed Neb-Easy Nebulizer. It is made from acrylic and polypropylene plastics, is injection molded and is intended for single patient use for up to 28 days. These material types are used in other predicate devices, such as the Salter Labs and Allegiance Airlife product lines. The specific materials have been tested for biocompatibility to ISO 10993 and results showed them to be non-reactive. All testing requirements contained in the "Reviewer Guidance: Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93" have been completed and were submitted by GaleMed for FDA review in their premarket notification submission. Comparative testing data to the predicate device (Allegiance Airlife Misty-Neb, K883964) was also performed at a third party independent test laboratory to the requirements of the "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93."
The Neb-Easy Nebulizer has several attachments that are used with it during the nebulization process. These include a Tee Connector, which connects to the top of the nebulizer; a mouthpiece and a 6 inch corrugated tube, which connects to the side of the Tee connector opposite the mouthpiece. These are standard accessories to class 1 oxygen masks and breathing circuits as well as being considered standard accessories to a nebulizer devices.
A standard oxygen tube connects to the bottom of the Neb-Easy Nebulizer and serves to connect the nebulizer to a pressurized gas source. This gas source is used to create the venturi and high flow conditions inside of the Neb-Easy that are used to create respirable aerosols. Flow rates are determined by the physician, but are typically between 5 lpm and 9 lpm.
The accessories, attachments, principles of operation and materials are all essentially equivalent to predicate devices already cleared by FDA.
The provided text describes a 510(k) submission for the GaleMed Neb-Easy Nebulizer, focusing on its substantial equivalence to a predicate device. The information primarily covers device description, materials, accessories, and regulatory status, but does not include acceptance criteria for device performance or a study demonstrating those criteria are met.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document mentions "Comparative testing data to the predicate device (Allegiance Airlife Misty-Neb, K883964) was also performed at a third party independent test laboratory to the requirements of the ‘Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93.’" However, it does not provide the results of this testing, specific acceptance criteria, or details about the study design that would allow me to populate the requested table and answer the specific questions about sample size, ground truth, or MRMC studies.
The document is purely a 510(k) summary for regulatory clearance, not a detailed scientific study report.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).