Besmed Reusable Jet Nebulizer

K150591 · Besmed Health Business Corp · CAF · Jun 30, 2015 · Anesthesiology

Device Facts

• Record ID: K150591
• Device Name: Besmed Reusable Jet Nebulizer
• Applicant: Besmed Health Business Corp
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. The Besmed Reusable Jet Nebulizer is intended for use with pediatric (2 years and older) and as defined by the prescribed medication and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.

Device Story

Besmed Reusable Jet Nebulizer is a handheld, pneumatic device; functions as a small volume nebulizer to aerosolize liquid prescription medications for patient inhalation. Operates via connection to an external pneumatic air source; airflow through the nebulizer creates aerosolized particles for delivery to the patient's respiratory tract. Used in clinical, home, school, and long-term care environments; operated by patients or healthcare providers. Output is an aerosol mist; assists in the administration of respiratory therapies. Benefits include effective delivery of prescribed medications to the lungs.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence to existing predicate devices.

Technological Characteristics

Handheld, pneumatic small volume nebulizer. Operates via external pneumatic air source. Designed for reusable use. No electronic components, software, or algorithms.

Indications for Use

Indicated for pediatric patients (2 years and older) and adult patients requiring aerosolized prescription medication via a small volume nebulizer in hospital, home, school, or long-term care settings.

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.

Submission Summary (Full Text)

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

June 30, 2015

Besmed Health Business Corp. C/O Paul Dryden Regulatory Consultant President, ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134

Re: K150591

Trade/Device Name: Besmed Reusable Jet Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: Mav 28, 2015 Received: June 1, 2015

Dear Mr. Dryden:

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 - Paul Dryden

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

## K150591

Device Name

## Besmed Reusable Jet Nebulizer

Indications for Use (Describe)

The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer.

The Besmed Reusable Jet Nebulizer is intended for use with pediatric (2 years and older) and as defined by the prescribed medication and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| | XX Prescription Use (Part 21 CFR 801 Subpart D) |
|--|-------------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

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