PRIMEAIRE

K992722 · Thayer Medical Corp. · CAF · Nov 10, 1999 · Anesthesiology

Device Facts

• Record ID: K992722
• Device Name: PRIMEAIRE
• Applicant: Thayer Medical Corp.
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PrimeAire is an accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use,

Device Story

PrimeAire is a dual-valved holding chamber accessory for metered dose inhalers (MDIs). Device attaches to MDI nozzle/mouthpiece; functions as spacer to facilitate medication delivery from MDI canister. Used by patients to improve inhalation of aerosolized medication. Non-sterile; single-patient use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-valved holding chamber; non-sterile; single-patient use; compatible with standard MDI nozzles/mouthpieces.

Indications for Use

Indicated for use as a holding chamber accessory for metered dose inhaler (MDI) canisters and nozzles/mouthpieces to assist in medication delivery. Intended for single-patient 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

NOV 1 0 1999

Mr. David T. Sladek Thayer Medical Corporation 4575 South Palo Verde Road, Suite 337 Tucson, AZ 85714-1961

Re: K992722 PrimeAire Regulatory Class: II (two) Product Code: 73 CAF August 12, 1999 Dated: Received: August 13, 1999

Dear Mr. Sladek:

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.

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Paqe 2 - Mr. David T. Sladek

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 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/dsma/dsmamain.html".

Sincerely yours,

Joanne A Weitshausen fen

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Thaver Medical Corporation Page 3 510(k) Notification - PrimeAire

## 1.8 Indications for Use Statement

Page I of I

510(k) Number (if known): K992722

Device Name: PrimeAire

Indications For Use:

The PrimeAire is an accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use,

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K992722 |

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)