ULTRAMIST 2000

K972657 · Texas Medical Industries, Inc. · CAF · Feb 2, 1998 · Anesthesiology

Device Facts

• Record ID: K972657
• Device Name: ULTRAMIST 2000
• Applicant: Texas Medical Industries, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Feb 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Ultramist 2000 is an aerosol therapy apparatus for home use; delivers prescribed medication via nebulizer as inhaled mist to bronchial tree. Device produces microscopic particles for deep penetration; treatment duration 3-3.5 ml in <10 minutes. Operated by patients (toddlers to geriatric) per physician order; used 3-4 times daily. Benefits include simplified medication delivery for respiratory conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Aerosol therapy apparatus; nebulizer-based mist delivery system. Designed for home use; dimensions/materials not specified.

Indications for Use

Indicated for treatment of respiratory disorders in patients ranging from toddlers to geriatric. Requires prescription by a licensed physician for home use.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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) | | |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | <div>(Division Sign-Off)</div> <div>Division of Cardiovascular, Respiratory,</div> <div>and Neurological Devices</div> | |
| 510(k) Number | K972657 | |
| Prescription Use | OR | Over the Counter Use |
| (per 21 CFR 801.109) | | (Optional Format 1-2-96) |