FUNHALER, MODEL V-201E

K072822 · Infamed , Ltd. · CAF · Nov 26, 2007 · Anesthesiology

Device Facts

• Record ID: K072822
• Device Name: FUNHALER, MODEL V-201E
• Applicant: Infamed , Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Funhaler® is primarily intended for use in the pediatric population in conjunction with prescribed Metered Dose Inhalers for their respective approved uses in accordance with physician instructions. Funhaler® is only indicated for use with Metered Dose Inhalers. Other products such as Nebulizers and Actuators are not suitable for use with Funhaler®. Funhaler® is intended to improve compliance with pediatric patients in the use of MDI's, by providing audible and visual feedback to the patient indicating the proper use of the MDI and resultant medication delivery to the patient.

Device Story

Funhaler V201 is a spacer device for pediatric MDI use; consists of mouthpiece, cylindrical spacer, and incentive module. Device provides audible and visual feedback to encourage proper inhalation technique and improve patient compliance. Used in clinical or home settings by pediatric patients under physician instruction. Operates mechanically; incentive module triggers feedback upon correct airflow/inhalation. Healthcare providers use device to facilitate medication delivery; feedback mechanism helps ensure patient receives prescribed dose. Benefits include increased adherence to respiratory treatment regimens in children.

Clinical Evidence

Limited clinical testing demonstrated improved compliance in children using the Funhaler compared to the predicate device. Bench testing confirmed particle size distribution and drug delivery performance met or exceeded the predicate device and FDA guidance requirements.

Technological Characteristics

Spacer device with mouthpiece, cylindrical spacer, and incentive module. Materials comply with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). Mechanical feedback mechanism (audible/visual). Compatible with standard Metered Dose Inhalers. Manufactured under ISO 13485 quality systems. Complies with 21CFR820, 16CFR 1500:1501, and FDA guidance for spacers/actuators.

Indications for Use

Indicated for pediatric patients aged 18 months and older requiring respiratory drug delivery via Metered Dose Inhaler (MDI). Contraindicated for newborns and infants younger than 18 months.

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

• Funhaler (K042546)

Submission Summary (Full Text)

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K072822

NOV 2 6 2007

#### 5.0 510K Summary

# 510(k) Summary

September 27, 2007

Submitter: InfaMed Ltd 45 Stirling Highway Nedlands, Western Australia 6009

Contact: Lorraine Glover

#### 510(k) Numbers and Product Codes of equivalent devices:

Infamed Ltd. - Funhaler K042546; SE: 3 January 2005

#### Indications for Use and Intended Population

Funhaler® is intended for use primarily in the pediatric population. Pediatric subgroups may vary, however Funhaler® is suitable to all subgroups with the exception of newborns and infants younger than 18 months. Funhaler® is used in combination with a Metered Dose Inhaler for respiratory drug delivery.

"Funhaler® is primarily intended for use in the pediatric population in conjunction with prescribed Metered Dose Inhalers for their respective approved uses in accordance with physician instructions."

Funhaler® is only indicated for use with Metered Dose Inhalers. Other products such as Nebulizers and Actuators are not suitable for use with Funhaler®.

Funhaler® is intended to improve compliance with pediatric patients in the use of MDI's, by providing audible and visual feedback to the patient indicating the proper use of the MDI and resultant medication delivery to the patient.

This document contains company confidential and or proprietary information. Do not copy, distribute, or otherwise of this document without prior written express consert from Generic Devices Corsulting, Inc. and/or InfaMed Ltd.

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### Device Description

The Funhaler® V201 is basically a Spacer, similar in function and construction to commonly used Spacers. It is nearly identical and functionally equivalent to the predicate device (Funhaler®, Infamed Ltd; K042546) the device consists of a Mouthpiece, cylindrical Spacer. tapered on each end, incentive module and a molded connector compatible with approved Metered Dose Inhalers.

The Funhaler® V201 differs from predicate device in a number of ways;

- 1. Funhaler® V201 is provided with a breathing Mask or in an SKU which includes the mouthpiece, but not the mask. The mask is also available as a separately ordered accessory.
- 2. The packaging has been changed from a thick plastic film box, to a softpack bag.
- 3. The contract manufacturing sites have changed.

The Funhaler® works in conjunction with virtually all standards, approved, Metered Dose Inhalers and has been tested for particle size, distribution and drug delivery with a variety of MDI's and drugs in accordance with FDA Guidance for these devices.

Performance of Funhaler® with respect to particle size distribution has been confirmed to be better than or equal to the predicate device. Limited clinical testing has demonstrated improved compliance with children using the Funhaler® when compared to the predicate device.

#### Performance Standards

The Funhaler® meets or exceeds the following Performance Standards:

- 21CFR820 Quality System Requlation .
- . ISO 10993-10; Biological Evaluation of Medical Devices; Tests for irritation and sensitization
- . ISO 10993-5; Biological Evaluation of Medical Devices; Tests for Cytotoxicity (MEM)
- . ISO 13485 - Quality Systems, Medical Devices
- . EN 14971 - Risk Analysis
- . FDA Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers, and Actuators; October 1, 1993
- 16CFR 1500:1501- Consumer Product Safety, as applicable for products intended . for use with children.
- . 21CFR801 - Labeling
- FDA division of Bioequivalence Guidance for the In-Vitro Portion of Bioequivalence . requirements for Metaproterenol Sulfate and Albuterol Inhalation Aerosols (Metered Dose Inhalers)
- . Guidance for Industry and FDA Staff-Premarket Assessment of Pediatric Medical Devices: May 2004

This document contains company confidential and or proprietary information. Do not copy, distribute, or otherwise of this document without prior written express consent from Generic Devices Corsulting, Inc. and/or InfaMed Ltd.

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## Conclusion

The Funhaler V201 and the predicate device, Funhaler® is nearly identical. Both the Funhaler® The Tunnaler V201 and the production intended use, theory of operation, materials and V20 Fand predicate device have laontion riftendous asso, wis sy and and effective, as indicated, for its intended use.

This document contains company confidential and/or proprietary information. Do not copy, distribute, or therevise of this I his doominent without prior written express consert from Generic Devices Corsulting, Inc. and/or InfaMed Ltd.

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NOY 2 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Infamed Limited C/O Mr. John Greenbaum President Generic Devices Consulting, Incorporated 20310 SW 48th Street Southwest Ranches, Florida 33332

Re: K072822

Trade/Device Name: Funhaler V201 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: September 27, 2007 Received: October 2, 2007

Dear Mr. Greenbaum:

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. Greenbaum

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 (QS) 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 vours.

Sujata Y. Mokhine Davis

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

510(k) Number (if known): _ K__ 072 & 22

Device Name: Funhaler V201

Indications for Use:

Funhaler is intended for use primarily in the pediatric population. Funhaler is used in combination with a Metered Dose Inhaler for respiratory drug delivery.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

E. Walle fa MH

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

510(k) Number: ! 0674822

This document contains company confidential and/or proprietary information. Do not copy, distribute, or otherwise of this document without prior written express consent from Generic Devices Corsulting, Inc. and/or InfaMed Ltd.

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