(30 days)
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Not Found
No
The summary describes a mechanical device (a valved holding chamber for inhalers) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is used to administer medication, but it is not a therapeutic device itself as it does not directly treat a condition.
No
The device is described as administering aerosolized medication, not diagnosing conditions.
No
The device description and intended use clearly describe a physical medical device (AeroChamber Plus® aVHC with Flow-Vu® IFI) used to administer medication, not a software-only device.
Based on the provided information, the AeroChamber Plus® aVHC with Flow-Vu® IFI is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for administering aerosolized medication from Metered Dose Inhalers to patients. This is a therapeutic purpose, not a diagnostic one.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The AeroChamber Plus® does not perform any such tests.
- Lack of Diagnostic Information: The provided text does not mention any diagnostic function, analysis of biological samples, or the generation of diagnostic information.
Therefore, the AeroChamber Plus® aVHC with Flow-Vu® IFI is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AeroChamber Plus® aVHC with Flow-Vu® IFI is 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 from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
Product codes
NVP
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
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed health care provider or physician / home, hospitals and clinics
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2007
Mr. John Straatman Director, Ouality & Regulatory Affairs Trudell Medical International 725 Third Street London, Ontario, CANADA N5V 5G4
Re: K070674
Trade/Device Name: AeroChamber Plus® aVHC with Flow-Vu® IFI Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVP Dated: March 8, 2007 Received: March 12, 2007
Dear Mr. Straatman:
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.
1
Page 2 - Mr. Straatman
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Saugte Y. Michieums.
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
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Image /page/2/Picture/0 description: The image shows the logo for Trudell Medical International. The logo consists of a shield-like emblem on the left and the company name on the right. The emblem is black and white and features the letters "ELL" within the shield, surrounded by a leafy design. The text "Trudell Medical International" is written in a bold, sans-serif font.
510(k) Number :
076674
Device Name: AeroChamber Plus® aVHC with Flow-Vu® IFI
Indications for Use:
The AeroChamber Plus® aVHC with Flow-Vu® IFI is 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 from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| Chello | |
|---|---|
| nt of Anocineziology, General Hospal, | |
| Jon Control, Cental Devices | |
| 510(k) Number: | K070674 |
| Prescription Use:
| (per 21CFR 801.109) | or Over the Counter Use |
|---|---|
| ------------------------------------------ | ------------------------- |