LITEAIRE

K993101 · Thayer Medical Corp. · CAF · Oct 26, 2000 · Anesthesiology

Device Facts

• Record ID: K993101
• Device Name: LITEAIRE
• Applicant: Thayer Medical Corp.
• Product Code: CAF · Anesthesiology
• Decision Date: Oct 26, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LiteAire is a collapsible, disposable 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 LiteAire is a dual-valved holding chamber designed to serve three major functions: - To reduce the amount of MDI medication deposited in the patient's mouth and throat, thus reducing the potential for unwanted local or systemic side effects. - To ease the problems that many patients have in synchronizing actuation of the MDI canister with the start of inhalation. - To retain a significant portion of the MDI drug plume until the patient's next inhalation, in cases where actuation and inhalation are asynchronous. The LiteAire is a non-sterile device for single-patient use.

Device Story

LiteAire is a collapsible, disposable, dual-valved holding chamber used as an accessory to MDI canisters. It functions as a spacer to improve medication delivery efficiency; it retains the drug plume to assist patients unable to synchronize MDI actuation with inhalation; it reduces oropharyngeal deposition of medication. The device is intended for single-patient use. It is operated by the patient or caregiver in a clinical or home setting. By facilitating better inhalation timing and reducing local medication deposition, it helps minimize potential side effects and improves therapeutic outcomes for patients using MDI-delivered drugs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Collapsible, dual-valved holding chamber; disposable; non-sterile; designed for universal compatibility with MDI nozzles/mouthpieces.

Indications for Use

Indicated for patients requiring MDI medication delivery who have difficulty synchronizing MDI actuation with inhalation or who require reduced oropharyngeal medication deposition.

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

OCT 2 6 2000

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

Re: K993101 LiteAire Regulatory Class: II (two) Product Code: 73 CAF October 2, 2000 Dated: October 4, 2000 Received:

Dear Mr. Sladek:

We have reviewed your Section 510 (X) notification of intent .to market we nave reviewed your section on the determined the device is the device relerenced above and we indications for use stated in the substantially equivalence (some marketed predicate devices marketed in enclosure) to regally marketed productions the enactment date of the interstate commerce provices that have been eeelessified Medical Device Amendments) of or actitie Federal Food, Drug, and in accordance with the provisions of the market the device, subject to
Cosmetic Act (Act). You may, therefore, market the development The general controls the general controls provisions of the Act. the general Controls provisions of the montal registration, provisions of the nee increase soquing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device Is crassiriou (boo asoroval), it may be subject to such Controls) of Crass III (Frencessor of regulations affecting your device 800 additional Concrolor. Thiroling and Regulations, Title 21, Parts 800 und in the ood equivalent determination assumes compliatie to 895. co 655. If babbeansed Banufacturing Practice requirements, as set with the Current Cood Hanarian (QS) for Medical Devices: rorth in the gaarry by Just 820) and that, through periodic QS General regulation (Er Origing Administration (FDA) will verify such no rood and broy with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements regulatory action. regulatory accron. In and the Federal Register. Please note: this concerning your device in the ification submission does not affect any obligation you might have under sections 531 through 542 of the act obligation you might have andor becoded Radiation Control provisions, or other Federal laws or regulations.

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## Page 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,

A James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Thayer Medical Corporation Page 5 510(k) Notification - LiteAire

## 1.8 Indications for Use Statement

Page 1 of 1

510(k) Number (if known):

Device Name: LiteAire

Indications For Use:

The LiteAire is a collapsible, disposable 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 LiteAire is a dual-valved holding chamber designed to serve three major functions:

- To reduce the amount of MDI medication deposited in the patient's mouth and . throat, thus reducing the potential for unwanted local or systemic side effects.
- To ease the problems that many patients have in synchronizing actuation of the . MDI canister with the start of inhalation.
- To retain a significant portion of the MDI drug plume until the patient's next . inhalation, in cases where actuation and inhalation are asynchronous. The LiteAire is a non-sterile device for single-patient use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory
and Neurological Devices
510(k) Number K993/01

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)