(202 days)
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Not Found
No
The summary describes a standard aerosol therapy apparatus with no mention of AI or ML capabilities.
Yes
The device is described as "an aerosol therapy apparatus which is designed for the treatment of respiratory disorders" and "delivering medication in a mist form which is inhaled into the bronchial tree for therapeutic reasons."
No
The device is described as an "aerosol therapy apparatus" designed for the treatment of respiratory disorders by delivering medication in mist form. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is an "aerosol therapy apparatus" and produces a mist, indicating it is a hardware device that delivers medication.
Based on the provided information, the ULTRAMIST 2000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for delivering medication in a mist form to the bronchial tree for therapeutic reasons. This is a direct treatment of a patient's respiratory system.
- Device Description: It's described as an "aerosol therapy apparatus."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. The ULTRAMIST 2000 is a therapeutic device used to administer medication directly to the patient.
N/A
Intended Use / Indications for Use
The ULTRAMIST 2000 is an aerosol therapy apparatus which is designed for the treatment of respiratory disorders. It is designed for home use by patients ranging in age from toddlers to adult to geriatric. Normal usage is based on prescribed medication and is typically used three to four times a day.
Through the use of a separate nebulizer, it produces a simple means for delivering medication in a mist form which is inhaled into the bronchial tree for therapeutic reasons. A treatment of 3 - 3.5 ml can be completed in less than 10 minutes and produces microscopic particles which allow for deeper penetration.
The device is to be used only on the order of a licensed physician.
Product codes
73 CAF
Device Description
The ULTRAMIST 2000 is an aerosol therapy apparatus which is designed for the treatment of respiratory disorders. It produces a simple means for delivering medication in a mist form which is inhaled into the bronchial tree for therapeutic reasons, through the use of a separate nebulizer.
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
bronchial tree
Indicated Patient Age Range
toddlers to adult to geriatric
Intended User / Care Setting
Home use, on the order of a licensed physician.
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).
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Image /page/0/Picture/10 description: The image shows a partial view of the Department of Health & Human Services logo. The logo includes the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 1998
Mr. Ted Whitworth President Texas Medical Industries, Inc. Dallas Metroplex 1409 Industrial Park Royse City, Texas 75189
Re: K972657 Ultramist 2000 Regulatory Class: II (two) Product Code: 73 CAF Dated: October 30, 1997 Received: November 6, 1997
Dear Mr. Whitworth:
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 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, Druq, 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.
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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 requlation (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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Respiratory
Enclosure
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| Page | 1 of | |
|---|---|---|
| OI |
510(k) Number (if Known) K972657
Indications for use:
The ULTRAMIST 2000 is an aerosol therapy apparatus which is designed for the treatment of respiratory disorders. It is designed for home use by patients ranging in age from toddlers to adult to geriatric. Normal usage is based on prescribed medication and is typically used three to four times a day.
Through the use of a separate nebulizer, it produces a simple means for delivering medication in a mist form which is inhaled into the bronchial tree for therapeutic reasons. A treatment of 3 - 3.5 ml can be completed in less than 10 minutes and produces microscopic particles which allow for deeper penetration.
The device is to be used only on the order of a licensed physician.
ATTACHMENT: Patient instructions and product labels are included for your files.
(PLEASE DO NOT WRITE BELOW THIS LINE _ CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices | ||
| 510(k) Number | K972657 | |
| Prescription Use | OR | Over the Counter Use |
| (per 21 CFR 801.109) | (Optional Format 1-2-96) |