OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22

K062263 · Omron Healthcare, Inc. · CAF · Feb 23, 2007 · Anesthesiology

Device Facts

• Record ID: K062263
• Device Name: OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
• Applicant: Omron Healthcare, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Feb 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Micro Air Vibrating Mesh Nebulizer (NE-U22) aerosolizes liquid medications for inhalation. Device utilizes low-frequency vibration applied to a mesh plate containing >6,000 holes to generate low-velocity aerosol. Portable, battery-powered (2 AA) unit; lightweight; designed for home, hospital, and sub-acute care settings. Patient self-administers or uses under clinical supervision. Provides precise drug delivery in short treatment times. Metal alloy mesh cap is corrosion-resistant. Output is aerosolized medication for patient inhalation; intended to facilitate respiratory drug delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vibrating mesh nebulization; battery (2 AA) or AC adapter powered. Materials: Polypropylene (patient contact), metal alloy mesh cap. Dimensions: 38x51x104 mm; Weight: 97g. Standards: IEC 60601-1, IEC 60601-1-2, UL 60601-1, FCC Part 15 Subpart B Class B, ISO 14971. Non-software driven.

Indications for Use

Indicated for pediatric and adult patients requiring aerosolized liquid medication inhalation. Contraindications: None; not for use with Pentamidine.

Regulatory Classification

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.

Predicate Devices

• Omron NE-U04 (K923024)

Submission Summary (Full Text)

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Premarket Notification 510(k) Section 5 – 510(k) Summary

K062263

# 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<br>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<br>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)<br>nebulizer system designed to aerosolize liquid medications for<br>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 |

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## 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”<br>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 | <0/3 ml/min |
| Reservoir size | 7 ml | 7 ml |
| Nebulizer components cleanable | Yes | Yes |
| Operating conditions | 0°C to 45°C 30% to 85% RH | Same |
| Storage conditions | -25°C to 70°C 10% to 90% RH | Same |
| Dimensions (mm) | 38(W) x 51(D) x 104(H) | 68(W) x 60(D) x 172(H) |
| Weight (kg) without battery | 97 grams without battery | 148 gm without battery |

#### Differences Between Other Legally Marketed Predicate Devices

The Model Micro Air Vibrating Mesh Nebulizer (NE-U22) is viewed as substantially equivalent to the following predicate device - Omron NE-U04 - K923024.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2007

Mr. Ranndy Kellogg VP Marketing and Product Development Omron Healthcare, Incorporated 1200 Lakeside Drive Bannockburn, Illinois 60015-1243

Re: K062263

Trade/Device Name: Micro Air Vibrating Mesh Nebulizer Model - NE-U22 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 4, 2007 Received: February 6, 2007

Dear Mr. Kellogg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Kellogg

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chris Lins Pi-R

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

Page 1 of 1

| 510(k) Number: | K062263 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Micro Air Vibrating Mesh nebulizer Model - NE-U22 |
| Indications for Use: | The Omron NE-U22 is an ultrasonic (vibrating mesh)<br>nebulizer system designed to aerosolize liquid medications<br>for inhalation by the patient.<br><br>The device may be used with pediatric and adult patients in<br>the home, hospital, and sub-acute care settings.<br><br>It is not intended for use with Pentamidine. |

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mird Vele

Thickens, etc.

Bentonite, etc.

210000 K And