(202 days)
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.
The ULTRAMIST 2000 is an aerosol therapy apparatus.
The provided text is a 510(k) premarket notification letter from the FDA regarding the Ultramist 2000 device. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information about acceptance criteria, device performance metrics, study details (like sample size, data provenance, expert qualifications, adjudication methods), or any comparative effectiveness studies (MRMC, standalone performance). It also does not mention how the ground truth was established for training or testing sets.
Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on the regulatory approval process and the intended use of the device as an aerosol therapy apparatus for respiratory disorders.
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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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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) |
§ 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).