(203 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of the nebulizer and does not mention any AI or ML components or functionalities.
Yes
The device is designed to aerosolize liquid medications for inhalation by patients, which indicates it is used for therapeutic purposes (administering medication for treatment).
No
This device is a nebulizer system designed to aerosolize liquid medications for inhalation, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a "nebulizer system" and describes physical components like a mesh plate, batteries, and a metal alloy mesh cap, indicating it is a hardware device.
Based on the provided information, the Omron NE-U22 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "aerosolize liquid medications for inhalation by the patient." This describes a device used for drug delivery directly to the patient's body, not for testing samples taken from the body (which is the core function of an IVD).
- Device Description: The description focuses on the mechanism of creating an aerosol for inhalation and the physical characteristics of the device. It does not mention any components or processes related to analyzing biological samples.
- Anatomical Site: The anatomical site is the lungs, which is where the medication is delivered, not where a sample is taken for analysis.
- Lack of IVD-related information: The document lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnostic purposes
- Reagents or assays
- Performance metrics typically associated with diagnostic tests (sensitivity, specificity, etc.)
In summary, the Omron NE-U22 is a medical device used for drug delivery via inhalation, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
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.
Product codes
CAF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
Pediatric and adult
Intended User / Care Setting
Home, hospital, and sub-acute care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Omron -- NE-U04 -- K923024
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Premarket Notification 510(k) Section 5 – 510(k) Summary
Non-Confidential Summary of Safety and EffectivenessFEB 2 3 2007
Page 1 of 2 15-Feb-07
| Omron Healthcare, Inc. | |
|---|---|
| 1200 Lakeside Dr. | |
| Bannockburn, IL 60015 | |
| Official Contact: | Ranndy Kellogg -- VP Marketing and Product |
| Development | |
| Proprietary or Trade Name: | Omron Micro Air Vibrating mesh nebulizer |
| Common/Usual Name: | Nebulizer |
| Classification Name: | Nebulizer (Direct Patient Interface) |
| Device: | Model NE-U22 |
| Predicate Devices: | Omron -- NE-U04 -- K923024 |
| Tel - 847-247-5609 | |
| Fax - 847-680-6269 |
Device Description:
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.
| Indications for Use: | |
|---|---|
| Indicated Use -- | The Omron NE-U22 is an ultrasonic (vibrating mesh) |
| nebulizer system designed to aerosolize liquid medications for | |
| inhalation by the patient. | |
| It is not intended for use with Pentamidine. | |
| Patient Population -- | Pediatric and adult |
| Environment of Use -- | Home, hospital, and sub-acute care settings. |
| Contraindications -- | None |
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 15-Feb-07
Device Attributes:
| Features | NE-U22 | NE-U04 |
|---|---|---|
| Indications for use | The Omron NE-U22 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medications for inhalation by the patient. It is not intended for use with Pentamidine. | Same |
| Environment of Use | Home, Hospital, Sub-acute Institutions | Same |
| Patient Population | Pediatric and adult | Same |
| Contraindications | None | Same |
| Power source | Battery - 2 “AA” | |
| AC Adapter AC 120V (60Hz/ DC 3 V | Same | |
| Nebulizing method | Vibrating mesh | Same |
| Software driven | No | No |
| Materials in patient contact | Polypropylene | Identical |
| Standard met | IEC 60601-1, IEC 60601-1-2, UL 60601-1, FCC Part 15 Subpart B Class B, ISO 14971 | Same |
| Drug delivery rate | 0.25 ml/min to 0.9 ml/min |