(15 days)
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Not Found
No
The document describes a simple medical device (valved holding chamber) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended to administer aerosolized medication from Metered Dose Inhalers, indicating a therapeutic purpose to deliver medication to patients.
No
Explanation: The device is intended to administer medication, not to diagnose a medical condition.
No
The provided text describes a physical medical device (Valved Holding Chamber) used to administer medication, not a software-only device.
Based on the provided information, the "AeroChamber® Plus Valved Holding Chamber" is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for administering aerosolized medication from inhalers to patients. This is a therapeutic or drug delivery function, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical device used for drug delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The "AeroChamber® Plus Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device is intended to by 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
73 CAF
Device Description
AeroChamber® Plus Valved Holding Chamber
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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
patients who are under the care or treatment of a licensed health care professional or physician. The intended environments for use include the 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.)
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Predicate Device(s)
Not Found
Reference Device(s)
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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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or abstract human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1999
Mr. Darryl J. Fischer Trudell Medical International 725 Third Street London, Ontario, Canada N5V 5G4
Re: K992917 AeroChamber Plus™ Valved Holding Chamber Regulatory Class: II (two) Product Code: 73 CAF Dated: August 25, 1999 Received: August 30, 1999
Dear Mr. Fischer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Darryl J. Fischer
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 8
Page 35 of 35
1992917 510(k) Number (if known):
Device Name: AeroChamber® Plus Valved Holding Chamber
Indications for Use:
The "AeroChamber® Plus Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device is intended to by 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)
Prescription Use
(per 21 CFR 801.109)
✓
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
M. Ryk
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Dev 510(k) Number _