(90 days)
The intended use of the AG EDGE is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication.
The AG EDGE is indicated only for use with nebulizer provided and viceversa.
The AG EDGE is transportable equipment intended for home health care use. The AG EDGE is not intended as a life sustaining or life support device.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the "AG EDGE" nebulizer, determining its substantial equivalence to legally marketed predicate devices.
The text focuses on regulatory aspects such as:
- The FDA's review and determination of substantial equivalence.
- The device's classification (Class II).
- General controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
- Contact information for further guidance.
- Indications for Use.
It does not contain details about:
- Specific acceptance criteria for performance.
- Any study design, methodology, or results related to device performance against such criteria.
- Sample sizes for test or training sets.
- Ground truth establishment, number or qualifications of experts, or adjudication methods.
- MRMC comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot provide the requested table or details about a study from the given input.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medel S.P.A. C/O Mr. Terrence M. O'Brien Official Correspondent Medel USA 112 Caviston Way Cary, North Carolina 27519
JAN - 8 2007
Re: K063103
Trade/Device Name: AG EDGE Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: October 9, 2006 Received: October 10, 2006
Dear Mr. O'Brien:
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. O'Brien
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
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
510(k) Number (if known): Device Name: AG EDGE
Indications for Use:
The intended use of the AG EDGE is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication.
The AG EDGE is indicated only for use with nebulizer provided and viceversa.
The AG EDGE is transportable equipment intended for home health care use. The AG EDGE is not intended as a life sustaining or life support device.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/O R
Over-The-Counter Use __ (21 CFR 801 Subpart C)
Marlon Jackson
(Division Sign-Out)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
§ 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).