WATCHHALER

K080100 · Activaero America, Inc. · NVP · Jun 30, 2008 · Anesthesiology

Device Facts

• Record ID: K080100
• Device Name: WATCHHALER
• Applicant: Activaero America, Inc.
• Product Code: NVP · Anesthesiology
• Decision Date: Jun 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Watchhaler is a holding chamber intended to administer aerosolized medication with a Metered Dose Inhaler. For pediatric patients (3 years and older). The environment of use includes home care, nursing homes, sub-acute institutions, and hospitals

Device Story

Watchhaler is a spacer/holding chamber for pediatric patients (3+ years) to facilitate MDI medication delivery. Device features toy-animal-shaped translucent housing enclosing a balloon. During inhalation, balloon collapses; mechanical valve controls deflation speed and limits inhalation flow to 15 Lpm. Fixed balloon volume (max 300 ml) and flow control ensure constant drug delivery. Provides visual feedback to user. Used in home, nursing home, sub-acute, or hospital settings. Device helps children comply with respiratory therapy by using child-friendly design.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: ISO 10993 tested. Principle: Mechanical valved holding chamber with balloon-based flow control. Max inhalation volume: 300 ml. Max flow rate: 15 Lpm. Form factor: Toy-shaped housing. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for pediatric patients 3 years and older for the administration of aerosolized medication via Metered Dose Inhaler in home, nursing home, sub-acute, or hospital settings.

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.

Predicate Devices

• Trudell AeroChamber Plus Valved Holding Chamber (K992917)
• Trudell AeroChamber Plus aVHC with Flow-Vu IFI (K070674)
• InfaMed Funhaler (K042546)

Submission Summary (Full Text)

{0}------------------------------------------------

Kotoiou

Activaero

### Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 10-Jan-08

JUN 3 0 2008

| Activaero America, Inc.<br>P.O. Box 351<br>Dublin, OH 43017-9684 | | Tel - [phone]<br>Fax - [phone] |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Official Contact: | | William Zimlich - CEO |
| Proprietary or Trade Name: | | Watchhaler |
| Common/Usual Name: | | Spacer / Holding chamber |
| Classification Name: | | Nebulizer (Direct Patient Interface)<br>CAF - 868.5630 |
| Predicate Devices: | Trudell AeroChamber Plus Valved Holding Chamber K992917<br>Trudell AeroChamber Plus aVHC with Flow-Vu IFI K070674<br>InfaMed Funhaler K042546 | |

#### Device Description

The Watchhaler is a spacer primarily used in the pediatric population for the inhalation of approved MDIs for the therapy of the upper and lower respiratory system. The design of the device is held in the shape of a colored toy animal to address its users, the children. The device consists of a balloon which is enclosed by a translucent housing. During inhalation the balloon collapses with the speed of deflation controlled by a mechanical valve. The fixed volume of the balloon and the low inhalation flow provided by the valve help to ensure a constant drug delivery.

| Indications for Use -- | The Watchhaler is a holding chamber intended to administer<br>aerosolized medication with a Metered Dose Inhaler. | |
|------------------------|-------------------------------------------------------------------------------------------------------------------|--|
| Patient Population -- | Pediatric -- 3 years and older | |
| Environment of Use -- | Home care, nursing home, sub-acute institution, or hospital | |
| Contraindications -- | None | |

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# Non-Confidential Summary of Safety and Effectiveness Page 2 of 2

10-Jan-08

## Attributc

#### Proposed Watchhaler

| Indications for Use<br>(all have except pentamidine) | The Watchhaler is a holding chamber intended to<br>administer aerosolized medication with a Metered<br>Dose Inhaler. |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Environments of use | Home care, nursing home, sub-acute institutions or<br>hospitals |
| Patient population | Pediatric (3 years and older) |
| Single patient, multi-use | Yes |
| Used with mouthpiece | Yes |
| Used with most pressurized Metered<br>Dose Inhalers | Yes |
| Feedback | Visual |
| Flow control / maximum flow rate | Yes / 15 Lpm |
| Materials | ISO 10993 tested |
| Inhalation volume | Maximum 300 ml |

## Differences Between Other Legally Marketed Predicate Devices

The Watchhaler is viewed as substantially equivalent to the following predicate devices -Trudell AeroChamber Plus Valved Holding Chamber K992917, Trudell AeroChamber Plus aVHC with Flow-Vu IFI K070674, and InfaMed Funhaler K042546

-

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 3 0 2008

Activaero America, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K080100

Trade/Device Name: Watchhaler Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVP Dated: June 25, 2008 Received: June 26, 2008

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

Page 1 of 1

510(k) Number:

KO80100 (To be assigned)

Device Name:

Watchhaler

Indications for Use:

The Watchhaler is a holding chamber intended to administer aerosolized medication with a Metered Dose Inhaler. For pediatric patients (3 years and older). The environment of use includes home care, nursing homes, sub-acute institutions, and hospitals

Prescription Use XX (Part 21 CFR 801 Subpart D)

or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

QRS

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080100