FUNHALER, MODEL FH 101

K042546 · Infamed , Ltd. · CAF · Jan 3, 2005 · Anesthesiology

Device Facts

• Record ID: K042546
• Device Name: FUNHALER, MODEL FH 101
• Applicant: Infamed , Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Jan 3, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

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 for prescription use only. 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 is a spacer device for pediatric respiratory drug delivery via MDI. It consists of a mouthpiece, cylindrical spacer, and molded connector. It features a breathing mask for younger children and a mouthpiece for older patients. To improve patient compliance, the device incorporates a whistle (audible feedback) and a spinner disk with a Mylar sticker (visual feedback) that activate upon proper inhalation technique. The device is used in a clinical or home setting under physician instruction. By providing immediate feedback on inhalation quality, it encourages correct MDI usage, ensuring effective medication delivery and potentially improving therapeutic outcomes for pediatric patients.

Clinical Evidence

Limited clinical testing demonstrated improved compliance with children using the Funhaler when compared to the predicate device. Bench testing for particle size, distribution, and drug delivery was performed in accordance with FDA guidance.

Technological Characteristics

Spacer device consisting of mouthpiece, cylindrical spacer, and molded connector. Includes breathing mask and compliance-enhancing features (whistle and spinner disk). Materials and construction are similar to predicate spacers. Complies with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 13485. Mechanical operation; no electronic or software components.

Indications for Use

Indicated for pediatric patients aged 18 months and older for respiratory drug delivery in conjunction with a prescribed 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

• Optichamber® (K962822)

Reference Devices

• CT Spacer (K010680)

Submission Summary (Full Text)

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K042546

JAN - 3 2005

#### Attachment I

510(k) Summary

December 21, 2004

Submitter: InfaMed Ltd 173 Mounts Bay Road Level One Perth, WA Australia 6000 Phone: [phone]

# Contact: Dennis Thiele

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

Respironics, Inc; Optichamber®

510(k) Number: # K962822

Product Code: 73 CAF

CFR Section: 868.5630

# 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 for prescription use only.

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 Description

The Funhaler® is basically a Spacer, similar in function and construction to commonly used Spacers such as the predicate device (Optichamber®, Respironics, Inc; K962822) and others, such as CT Spacer (K010680). The device consists of a Mouthpiece, cylindrical Spacer, tapered on each end and a molded connector compatible with approved Metered Dose Inhalers.

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

- 1. Funhaler® is provided with a breathing Mask in addition to the Mouthpiece. The breathing mask fits over the face (mouth and nose) to assure the full inhalation of the drug from the MDI in pediatric patients. Older (larger) patients may use the Mouthpiece in lieu of the Mask.

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- 2. Funhaler® incorporates a Whistle to provide audible feedback when the Spacer is used properly with the MDI, aiding in compliance with children.
- 3. Funhaler® incorporates a Spinner Disk, having a Mylar sticker, which spins and provides visual feedback (by spinning) when the Spacer is used properly with the MDI, also aiding in compliance with children.

The Funhaler® works in conjunction with virtually all standard, 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 Regulation .
- 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 Albutero! Inhalation Aerosols (Metered Dose Inhalers)
- Guidance for Industry and FDA Staff-Premarket Assessment of Pediatric Medical Devices; . Mav 2004

# Conclusion

There are more similarities than differences between the predicate device and the Funhaler®. Both the Funhaler® and predicate device have a similar intended use, theory of operation, materials and construction. When used in accordance with the Directions For Use, Funhaler® is safe and effective, as indicated, for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 3 2005

InfaMed Limited C/O Mr. John Greenbaum Consultant Generic Devices Consulting, Incorporated 20310 SW 48th Street Ft. Lauderdale, Florida 33332

Re: K042546

Trade/Device Name: Funhaler Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: November 30, 2004 Received: December 1, 2004

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/dsma/dsmamain.html

Sincerely yours,

Suyita Michuuto m.D.

Chiu Lin. Ph.D. FOR DR. CHILL LIN 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): _K042546

Device Name: _Funhaler

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)

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)

esiology, General Hospital,

510(k) Number