(203 days)
The Omron NE-U22 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings. It is not intended for use with Pentamidine.
Micro Air Vibrating Mesh Nebulizer (NE-U22) uses low frequency vibration to create aerosol and provide fine particles to the patient's lungs. The mesh plate has more than 6,000 holes to create low velocity aerosol. The VMT nebulizer is portable and quiet. This nebulizer is battery powered, 2 "AA" and it is lightweight. The batteries last approximately 40 treatments. This nebulizer provides precise drug delivery in a very short time. The metal alloy mesh cap is durable and resistant to corrosion.
This is a premarket notification for a medical device (a nebulizer), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement is not applicable in the context of an AI/ML device submission.
The document describes the Omron Micro Air Vibrating Mesh Nebulizer (Model NE-U22) and asserts its substantial equivalence to a previously cleared predicate device (Omron NE-U04 - K923024).
Here's why the AI/ML specific questions cannot be answered from the provided text:
- No AI/ML Components: The device description explicitly states "Software driven: No". This confirms that the NE-U22 is a physical medical device and does not utilize artificial intelligence or machine learning.
- Substantial Equivalence: The 510(k) submission process for non-AI devices primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is done by comparing technical characteristics, indications for use, and performance claims, rather than through extensive clinical trials with ground truth established by experts or comparative effectiveness studies of AI assistance.
However, I can extract the relevant "acceptance criteria" and "reported device performance" in the context of this device's submission, based on the comparison with its predicate:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are implied by the performance characteristics of the predicate device, and "reported device performance" are the corresponding characteristics of the new device. The document explicitly states "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices," implying that the NE-U22 meets or exceeds the performance of the NE-U04 in all relevant aspects.
| Feature / Acceptance Criteria (from Predicate NE-U04) | Reported Device Performance (NE-U22) |
|---|---|
| Indications for Use: aerosolize liquid medications for inhalation; not for Pentamidine; Pediatric and adult patient population; Home, Hospital, Sub-acute Institutions environment of use. | Same (Explicitly stated "Same" for Indications for Use). |
| Power source: Battery - 2 “AA” / AC Adapter AC 120V (60Hz/ DC 3 V | Same (Explicitly stated "Same"). |
| Nebulizing method: Vibrating mesh | Same (Explicitly stated "Same"). |
| Software driven: No | No (Explicitly stated "No"). |
| Materials in patient contact: Polypropylene | Identical (Explicitly stated "Identical"). |
| Standards met: IEC 60601-1, IEC 60601-1-2, UL 60601-1, FCC Part 15 Subpart B Class B, ISO 14971 | Same (Explicitly stated "Same"). This indicates meeting relevant electrical safety, electromagnetic compatibility, and risk management standards. |
| Drug delivery rate: |
§ 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).