(132 days)
The AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device, intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
The device may be used with a compressor capable of delivering a flow of 2.75 to 8 lpm under an operating pressure of 15 to 50 psi.
AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device.
The provided text is a 510(k) summary for the AeroEclipse® Durable Breath Actuated Nebulizer. This document is a regulatory submission for a medical device and does not contain information about acceptance criteria, performance studies, or clinical validations in the way a scientific paper or a more detailed regulatory submission (like a PMA) would.
Therefore, based solely on the provided text, I cannot extract the information required to populate a table of acceptance criteria and reported device performance, or answer questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, which is a regulatory pathway for lower-risk devices. This means the manufacturer demonstrated that their device is as safe and effective as another device already on the market, rather than conducting extensive clinical trials to establish its efficacy against predefined acceptance criteria for a novel technology.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2008
Mr. Darryl Fischer Associate Director, Quality & Regulatory Affairs Trudell Medical International 725 Third Street London, Ontario, CANADA N5V 5G4
Re: K080926
Trade/Device Name: AeroEclipse® Durable Breath Actuated Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 7, 2008 Received: July 8, 2008
Dear Mr. Fischer:
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. Fischer
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 (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.
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) 276-0120. 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.
Thommels-Leidner Bell
Chiu S. 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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510(k) Number: K080926
Device Name: AeroEclipse® Durable Breath Actuated Nebulizer
Indications for Use:
The AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device, intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
The device may be used with a compressor capable of delivering a flow of 2.75 to 8 lpm under an operating pressure of 15 to 50 psi.
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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
or
h. Mch for m. Husband
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080926
Prescription Use: (per 21CFR 801.109) Over the Counter Use: _
§ 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).