ATLANTEAN TRIGGER NEBULIZER

K102719 · Atlantean Corporation · CAF · Jul 1, 2011 · Anesthesiology

Device Facts

• Record ID: K102719
• Device Name: ATLANTEAN TRIGGER NEBULIZER
• Applicant: Atlantean Corporation
• Product Code: CAF · Anesthesiology
• Decision Date: Jul 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

Device Story

The Atlantean Trigger Nebulizer is a small volume nebulizer used in home and hospital settings to deliver aerosolized medication. It features a manual trigger mechanism allowing patients or clinicians to activate aerosol generation on demand, conserving medication and reducing environmental contamination. Alternatively, it can operate in a continuous mode when the trigger is locked. The device draws inhaled air directly through the nebulizer, differing from traditional designs that use a nebulizer tee as a reservoir. An optional BFE/VFE filter can be attached to the exhalation port. The device is operated by patients or healthcare professionals to deliver prescribed aerosolized drugs. It benefits patients by improving respirable mass delivery and optimizing treatment times compared to standard nebulizers.

Clinical Evidence

Bench testing only. The device was evaluated for respirable mass and treatment times at 5LPM, demonstrating improved performance compared to the predicate device. No clinical data was provided.

Technological Characteristics

Small volume nebulizer; manual trigger mechanism for on-demand or continuous aerosol generation; includes optional BFE/VFE exhalation filter. Operates by drawing inhaled air through the nebulizer unit. No electronic or software components described.

Indications for Use

Indicated for patients requiring medical aerosol treatments administered via a Small Volume Nebulizer, as prescribed by a physician or healthcare professional. For use in homecare and hospital settings with FDA-approved drugs.

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

• Hudson RCI Micro Mist (K930525)

Submission Summary (Full Text)

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JUL - 1 2011

### 510(k) Summary - Date 09/10/2010 8.

In accordance with 21 CFR section 807.92 Atlantean is submitting the following 510(k) summary.

### Submitter Information 8.1.

Atlantean Corporation 1F, No. 789, Bo-ai St., Chubay City Hsinchu County 302, Taiwan

Tel. [phone]

Owner/Operator No .: 10033507

### 8.2. Preparer of Submission and Contact for Information

MDVentures

Tom Shanks* - Principal 29201 Via Norte Temecula, CA 92591

[phone] Phone: [phone] FAX: E-mail: [e-mail]

### 8.3. Name of Device

Proprietary Name: Trigger Nebulizer Common Name: Nebulizer Classification Name: Nebulizer (direct patient interface) Product Code: CAF Regulation Number: 868.5630 Device Class 2

#### 8.4. Substantially equivalent to:

- l Hudson RCI Micro Mist (K930525)
#### 8.5. Description of the device

The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used with a specific drug nor is it distributed with such drugs.

The nebulizer has a trigger that allows the patient or clinician to activate the nebulizer which then generates respiratory size aerosolized liquids into gasses that are delivered directly to the patient This trigger function conserves medication and reduced environmental for breathing. contamination by medication. This nebulizer is also available with an attachable BFE/VFE filter that connects to the exhalation port of the nebulizer.

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### Atlantean Corporation Trigger Nebulizer 510(k) Submission

# 8.6. Intended Use of the Device

The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

### Comparison to Predicate Devices 8.7.

# Similarities:

- · The Atlantean Trigger Nebulizer (see Figure 1) utilizes equivalent, materials, principles of aerosol generation, and intended use are identical.
- · With the trigger in the locked position the Atlantean Trigger Nebulizer operates as a continuous mode.

# Differences:

- · The Atlantean Trigger Nebulizer incorporates a trigger mechanism that allows the patient or clinician to activate the nebulizer which then sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient for breathing. This trigger function conserves medication and reduced environmental contamination of medication.
- · The Atlantean Trigger Nebulizer enhances the performance by drawing inhaled air through the nebulizer as opposed to the Hudson RCI Micro Mist in which inhaled air passes through a Nebulizer Tee and aerosol tubing which acts as an aerosol reservoir.
- · The Atlantean Trigger Nebulizer also is available with an attachable BFE/VFE filter that connects to the exhalation port of the nebulizer.

### Performance testing:

Atlantean Trigger Nebulizer was found to have improved respirable mass overall and treatment times at 5LPM and than the predicate device. All other attributes were not found to be significantly different than the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL - 1 2011

Atlantean Corporation C/O Mr. Tom Shanks Principal MDVentures 29201 Via Norte Temecula, California 92591

Re: K102719

Trade/Device Name: Atlantean Trigger Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 21, 2011 Received: June 23, 2011

Dear Mr. Shanks:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Shanks

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Miller

Anthony D. Watson, B.S., M.S., M.B.A. 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

510(k) Number (if known):

Atlantean Trigger Nebulizer Device Name:

### Indications for Use:

The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concu

Dune Collins Lee Schullis, MD, PhD

(Division Sign-Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510ik) Number:

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