HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100

K122857 · Pegasus Research Corp. · CAF · Nov 7, 2012 · Anesthesiology

Device Facts

• Record ID: K122857
• Device Name: HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
• Applicant: Pegasus Research Corp.
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Res-Q Continuous Nebulizer is a device to used under the medical supervision in hospital, nursing homes, extended care facilities and outpatient clinics. The Res-Q Continuous Nebulizer is a high output nebulizer to be used to deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions for patients whom extended therapy is required. Patient population: Asthma, pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, or other appropriate medications would be nebulized. The Res-Q Continuous Nebulizer requires 50 psig source gas. HE air or oxygen may be added via Multi-gas inlet.

Device Story

Res-Q Continuous Nebulizer is a high-output nebulizer for delivery of aerosolized medications and diagnostic formulations; provides hydration to loosen secretions. Operates via 50 psig source gas; includes multi-gas inlet for air or oxygen. Used in clinical settings (hospitals, nursing homes, outpatient clinics) under medical supervision. Device facilitates extended therapy for respiratory conditions. Benefits include improved medication delivery and airway hydration for patients with asthma, COPD, or pneumonia.

Technological Characteristics

High-output nebulizer; requires 50 psig source gas; multi-gas inlet for air or oxygen; intended for clinical use.

Indications for Use

Indicated for patients with asthma, pneumonia, COPD, or conditions requiring nebulized sympathomimetic amines, parasympathetic amines, or other medications. Used for delivery of aerosolized medications/diagnostic formulations and hydration to loosen secretions in hospital, nursing home, extended care, and outpatient 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 7, 2012

Mr. Kenneth Miller President Pegasus Research Corporation 3303 Harbo Boulevard, Suite F3 Costa Mesa, California 92626

Re: K122857

Trade/Device Name: Res-Q Continuous Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: October 11, 2012 Received: October 17, 2012

Dear Mr. Miller:

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 Eederal Register.

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#### Page 2 - Mr. Miller

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kwame O.
Ulmer

Digitally signed by Kwame O. Ulmer
DN: c=US, o=U.S. Govemment, ou=HHS,
ou=FDA, ou People, cn Kwame O.
Ulmer,
0.9.2342.19200300.100.1.1-1300183618
Date: 2012.11.07 15:53:48-05'00

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

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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122857

510 (k) Number (if known) Pending

# Device Name: RES-Q CONTINUOUS NEBULIZER

### INDICATIONS FOR USE:

The Res-Q Continuous Nebulizer is a device to used under the medical supervision in hospital, nursing homes, extended care facilities and outpatient clinics. The Res-Q Continuous Nebulizer is a high output nebulizer to be used to deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions for patients whom extended therapy is required. Patient population: Asthma, pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, or other appropriate medications would be nebulized. The Res-Q Continuous Nebulizer requires 50 psig source gas. HE air or oxygen may be added via Multi-gas inlet.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schult

Division Sign-Off Division of cardiovascular, Respiratory, and Neurological Devices 85 K 510 (K) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter

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