AEROTEE, MODEL # 1001

K982408 · Piper Medical Products · CAF · Sep 14, 1998 · Anesthesiology

Device Facts

• Record ID: K982408
• Device Name: AEROTEE, MODEL # 1001
• Applicant: Piper Medical Products
• Product Code: CAF · Anesthesiology
• Decision Date: Sep 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use with pneumatic small volume nebulizers to deliver aerosolized medication.

Device Story

AeroTee is a respiratory accessory used with pneumatic small volume nebulizers. It functions as an interface to deliver aerosolized medication to the patient. The device is intended for use in clinical or home settings under the direction of a healthcare provider. It facilitates the transport of nebulized drug particles from the nebulizer cup to the patient's airway. By providing a consistent pathway for aerosol delivery, it assists in the administration of prescribed respiratory medications, potentially improving therapeutic efficacy for patients with respiratory conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a pneumatic nebulizer accessory. It is designed for integration with standard small volume nebulizers to facilitate aerosol delivery. No specific materials, software, or electronic components are described.

Indications for Use

Indicated for use with pneumatic small volume nebulizers to deliver aerosolized medication to patients requiring respiratory therapy.

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

SEP 1 4 1998

Mr. S. David Piper Piper Medical Products 3929 Arderly Court Sacramento, Ca 95826

Re : K982408 AeroTee Regulatory Class: II (two) Product Code: 73 CAF September 4, 1998 Dated: Received: September 8, 1998

Dear Mr. Piper:

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 leqally 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 aqainst 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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## Page 2 - Mr. S. David Piper

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

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

Enclosure

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| 510(k) Number (if known): | K982408 |
|---------------------------|----------|
| Device Name: | AeroTee™ |
| Indication for Use: | |

For use with pneumatic small volume nebulizers to deliver aerosolized medication.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

ﺮ. Prescription Use : (Per 21 CFR 810.109)

ﮩﺮﺳ ﺳﺮ

Over-the-Counter Use ___________________

Marta Kramer

Division Sign. Division of Cardiov

(Optional Format 1-2-96)

INTNDUSE.DOC