(133 days)
The Aeroneb® Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria. The text is a letter from the FDA regarding a 510(k) premarket notification for the Aeroneb® Go Nebulizer, confirming its substantial equivalence to a legally marketed predicate device.
The document includes:
- Trade/Device Name: Aeroneb® Go Nebulizer
- Regulation Number and Name: 21 CFR 868.5630, Nebulizer
- Regulatory Class: II
- Product Code: CAF
- Indications for Use: The Aeroneb® Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
However, it does not provide any specific details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any tests.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory clearance letter, not a detailed study report.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Enright Quality Assurance and Regulatory Affairs Manager Aerogen (Ireland), Limited Galway Business Park Dangan, Galway IRELAND
OCT 2 3 2008
Re: K081650
Trade/Device Name: Aeroneb® Go Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: October 3, 2008 Received: October 6, 2008
Dear Mr. Enright:
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. Enright
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Witmuele-Lerdinng fry
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
510(K) Number (if known): K081650
Device Name: Aeroneb® Go Nebulizer
Indications for Use:
The Aeroneb® Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over the Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
L.A.
Division Sign-Off) 'Jivision of Anesthesiology, General Hospital Infection Control, Dental Devices
K 081650 710(k) Number:
§ 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).