(87 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is for a simple nebulizer.
Yes
The device is used to administer aerosolized medication prescribed by a physician or healthcare professional to patients for their care or treatment, which aligns with the definition of a therapeutic device.
No
The provided text describes the "TruMist™ Air Entrained Disposable nebulizer" as a device used to administer aerosolized medication. Its intended use is for treatment, not for diagnosing a condition or disease.
No
The device description explicitly states "AIR ENTRAINED DISPOSABLE NEBULIZER," which is a hardware device used for administering medication.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer aerosolized medication to patients. This is a therapeutic function, not a diagnostic one.
- Device Description: The description is "AIR ENTRAINED DISPOSABLE NEBULIZER," which is consistent with a device used for drug delivery, not for testing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays
IVDs are devices used to perform tests on samples taken from the human body to help diagnose, monitor, or screen for diseases or conditions. This device's function is to deliver medication, which is a treatment, not a diagnostic activity.
N/A
Intended Use / Indications for Use
Intended / Indications for Use: The "TruMist™ Air Entrained Disposable nitendou / intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device troumbled to by used by these patients to administer aerosolized medication 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
Not Found
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 professional or physician / home, hospitals and clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three stripes across its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1998
Mr. Darryl Fischer Trudell Medical International 725 Third Street London, Ontario, CANADA N5V 5G4
Re : K982179 TruMist Air Entrained Disposable Nebulizer Regulatory Class: II (two) Product Code: 73 CAF June 17, 1998 Dated: Received: June 22, 1998
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 regulatory 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 Fischer
This letter will allow you to beqin 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 diaqnostic 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 requlation 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
2
| 1 |
|---|
| 510(k) Number (if known): | K 982179 |
|---|---|
| Device Name: | AIR ENTRAINED DISPOSABLE NEBULIZER |
Indications For Use:
Intended / Indications for Use: The "TruMist™ Air Entrained Disposable nitendou / intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device troumbled to by used by these patients to administer aerosolized medication 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)
Zank
9-15-98.
Prescription Use i (Per 21 CFR 801.109) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
510(k) Number _
(Optional Format 1-2-96)