(127 days)
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.
Not Found
This document is a 510(k) clearance letter for a medical device called "AG PLUS", a nebulizer. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, this letter does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a detailed study proving performance against defined acceptance criteria in the manner typically seen for AI/ML device clearances.
Therefore, based only on the provided text, I cannot extract the requested information.
Here's why and what kind of document would typically contain this information:
- Acceptance Criteria & Device Performance: This information is usually found in the performance testing sections of the 510(k) submission, specifically detailing studies conducted to characterize the device's technical specifications (e.g., aerosol particle size, drug delivery rate, compressor flow/pressure). These studies would compare the new device's performance to the predicate or to established standards.
- Study Details (Sample Size, Data Provenance, Ground Truth, Experts, MRMC, Standalone): These are details specific to the design and execution of clinical or performance studies. If this were an AI/ML device, these points would be critical. However, for a nebulizer, the "studies" typically focus on engineering performance (e.g., aerosol characterization, compressor output) rather than diagnostic accuracy studies with human readers or pathology.
- Training Set Information: This is entirely relevant to AI/ML devices. A nebulizer is a mechanical device, so it doesn't have a "training set" in the context of machine learning.
What to look for if this were an AI/ML device (which it isn't):
If this document were for an AI/ML device, I would expect to find the requested information in sections detailing:
- Clinical Performance Study: This is where the results of the device's diagnostic accuracy, sensitivity, specificity, etc., would be presented, often against a ground truth.
- Reader Study / Multi-Reader Multi-Case (MRMC) Study: If human-in-the-loop performance or comparison to human readers was evaluated.
- Validation Study: Detailing the test set characteristics, ground truth establishment, and standalone performance metrics.
- Algorithm Development / Training Details: Describing the training data and how its ground truth was established.
In summary, the provided document is a regulatory clearance letter, not a technical report or clinical study summary. It confirms market authorization based on substantial equivalence but does not contain the detailed performance study information requested.
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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
§ 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).