(127 days)
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No
The summary describes a compressor for a nebulizer, a mechanical device for delivering medication. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as treating respiratory conditions by converting liquid medication into a fine mist for inhalation, which is a therapeutic action.
No
The device, AG PLUS, is intended to deliver medication for treating respiratory conditions, not to diagnose them.
No
The device description explicitly states it is a "compressor" which is a hardware component used to convert liquid medication into a mist. This is not a software-only device.
Based on the provided information, the AG PLUS device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to convert liquid medication into a mist for inhalation to treat respiratory conditions. This is a therapeutic application, not a diagnostic one.
- Mechanism of Action: The device is a compressor that works with a nebulizer to deliver medication. This is a physical process for drug delivery, not a test performed on biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting biomarkers, or providing diagnostic information about a patient's condition.
Therefore, the AG PLUS falls under the category of a therapeutic medical device, specifically a drug delivery device for respiratory conditions.
N/A
Intended Use / Indications for Use
The intended use of the AG PLUS 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 PLUS compressor is to be used only with specific 510(k) cleared nebulizer whose input specifications may be met by the pressure and flow characteristics of the AG PLUS compressor. The initial nebulizer distributed with the AG PLUS compressor will be the Medel Jet Pro, the performance of which is contained in this 510(k) notification.
The AG PLUS is transportable equipment intended for home health care use. The AG PLUS is not intended as a life sustaining or life support device.
Product codes
CAF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lungs
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
home health care
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2006
Medel S.P.A. C/O Mr. Terrence O' Brien Official Correspondent Medel USA 112 Caviston Way Cary, North Carolina 27519
Re: K060404 Trade/Device Name: AG PLUS Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: May 19, 2006 Received: May 30, 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) 276-0115. 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): K060404 Device Name: AG PLUS
Indications for Use:
The intended use of the AG PLUS 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 PLUS compressor is to be used only with specific 510(k) cleared nebulizer whose input specifications may be met by the pressure and flow characteristics of the AG PLUS compressor. The initial nebulizer distributed with the AG PLUS compressor will be the Medel Jet Pro, the performance of which is contained in this 510(k) notification.
The AG PLUS is transportable equipment intended for home health care use. The AG PLUS 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)
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Number: K0604