(93 days)
The NIVO Nebuliser System is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance.
The NIVO Nebuliser System is suitable for use in adult and pediatric 7 years or older (>20kg) patients whilst using a facemask.
The Aeroneb® Pro X control module, cables, adaptor and bracket components of the NIVO Nebuliser system are intended for multiple patient use as described in the instruction manual.
The NIVO Nebuliser unit, EE and SE elbow components of the NIVO Nebuliser system are intended for single use as described in the instruction manual.
The NIVO Nebuliser System is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance. The system includes the Aeroneb® Pro X control module, cables, adaptor and bracket components (intended for multiple patient use) and the NIVO Nebuliser unit, EE and SE elbow components (intended for single use).
The provided text is a medical device approval letter from the FDA for the VIVO Nebulizer System, dated November 10, 2010. It focuses on the device's substantial equivalence to previously marketed devices and its regulatory classification. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. Therefore, I cannot provide an answer based on the given text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Martha Folan Quality Assurance/ Regulatory Affairs Aerogen, Limited Galway Business Park Dangan Galway Ireland
NOV 1 0 2010
Re: K102240
Trade/Device Name: VIVO Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: October 7, 2010 Received: October 12, 2010
Dear Ms. Conneelv:
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- Ms. Conneely
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/Reporta.Problem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Russo
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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KI02240
Indications for Use Form
Indications for Use
NOV 1 0 2010
510(k) Number (if known):
Device Name:
Indications for Use:
The NIVO Nebuliser System is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance.
The NIVO Nebuliser System is suitable for use in adult and pediatric 7 years or older (>20kg) patients whilst using a facemask.
The Aeroneb® Pro X control module, cables, adaptor and bracket components of the NIVO Nebuliser system are intended for multiple patient use as described in the instruction manual.
The NIVO Nebuliser unit, EE and SE elbow components of the NIVO Nebuliser system are intended for single use as described in the instruction manual.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schulte
(Division Sign-Off) Division of Anesthesiology, General Hosphal Infection Control, Dental Devices
4102240 510(k) Number:
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§ 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).