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.
1. Funhaler® incorporates a Whistle to provide audible feedback when the Spacer is used properly with the MDI, aiding in compliance with children.
1. 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.

AI/ML Overview

The Funhaler® is a medical device designed to improve compliance in pediatric patients using Metered Dose Inhalers (MDIs) for respiratory drug delivery. It functions similarly to a standard spacer but includes a whistle for audible feedback and a spinner disk for visual feedback, both indicating proper MDI use.

Here's an analysis of its acceptance criteria and the study proving it meets these:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance	Study Type/Evidence
Device Performance (Particle Size Distribution & Drug Delivery)	Performance equal to or better than the predicate device (Optichamber®) regarding particle size, distribution, and drug delivery when used with various MDIs 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."	In-vitro testing
Compliance (Pediatric Patients)	Improved compliance in pediatric patients when using the Funhaler® compared to the predicate device.	"Limited clinical testing has demonstrated improved compliance with children using the Funhaler® when compared to the predicate device."	Limited Clinical Testing
Quality System	21 CFR 820 Quality System Regulation	Meets/Exceeds the standard.	Adherence to regulatory standards
Biocompatibility (Irritation & Sensitization)	ISO 10993-10: Biological Evaluation of Medical Devices; Tests for irritation and sensitization	Meets/Exceeds the standard.	Adherence to regulatory standards
Biocompatibility (Cytotoxicity)	ISO 10993-5; Biological Evaluation of Medical Devices; Tests for Cytotoxicity (MEM)	Meets/Exceeds the standard.	Adherence to regulatory standards
Quality Management	ISO 13485 Quality Systems, Medical Devices	Meets/Exceeds the standard.	Adherence to regulatory standards
Risk Management	EN 14971 Risk Analysis	Meets/Exceeds the standard.	Adherence to regulatory standards
FDA Guidance (Nebulizers, MDIs, Spacers, Actuators)	FDA Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers, and Actuators; October 1, 1993	Meets/Exceeds the standard.	Adherence to regulatory standards
Consumer Product Safety (for children's products)	16 CFR 1500:1501 - Consumer Product Safety, as applicable for products intended for use with children.	Meets/Exceeds the standard.	Adherence to regulatory standards
Labeling	21 CFR 801 Labeling	Meets/Exceeds the standard.	Adherence to regulatory standards
FDA Bioequivalence Guidance	FDA division of Bioequivalence Guidance for the In-Vitro Portion of Bioequivalence requirements for Metaproterenol Sulfate and Albuterol Inhalation Aerosols (Metered Dose Inhalers)	Meets/Exceeds the standard.	Adherence to regulatory standards
Pediatric Medical Devices Guidance	Guidance for Industry and FDA Staff - Premarket Assessment of Pediatric Medical Devices; May 2004	Meets/Exceeds the standard.	Adherence to regulatory standards

2. Sample Size Used for the Test Set and Data Provenance

Particle Size Distribution & Drug Delivery (In-vitro testing): The document doesn't specify the exact sample size (number of tests or MDIs/drugs used) but states it was tested "with a variety of MDI's and drugs." The provenance is not explicitly mentioned as retrospective or prospective, but in-vitro testing is typically prospective, performed in a controlled laboratory setting.
Improved Compliance (Limited Clinical Testing): The document does not specify the sample size (number of children) nor the provenance (country of origin, retrospective/prospective) for this "limited clinical testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text for either the in-vitro particle testing or the limited clinical testing. For the in-vitro testing, the "ground truth" would be objective measurements based on established analytical methods, not expert consensus. For the clinical testing, it's unclear how "improved compliance" was measured and if it involved expert assessment.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests mentioned (in-vitro measurements and unspecified clinical assessment of compliance), a formal adjudication method like "2+1" or "3+1" is unlikely to be applicable in the traditional sense of diagnostic imaging studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The text mentions "Limited clinical testing has demonstrated improved compliance with children using the Funhaler® when compared to the predicate device," which suggests some form of comparison, but it does not fit the typical format or description of an MRMC study comparing human readers with and without AI assistance. The Funhaler® is a physical device, not an AI or diagnostic tool.

Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to the Funhaler® device. The Funhaler® is a physical medical device (a spacer) that enhances the delivery and perceived compliance of an MDI, rather than an algorithm or AI system. Its performance is always in conjunction with a human (the patient using it).

7. The Type of Ground Truth Used

Particle Size Distribution & Drug Delivery: The ground truth used would be objective, analytical measurements obtained through standard, validated in-vitro testing methodologies specified by FDA guidance. This is not expert consensus, pathology, or outcomes data in the usual clinical sense.
Improved Compliance (Limited Clinical Testing): The type of ground truth for "improved compliance" is not specified. It could involve observational data, patient/parent self-reporting, or specific behavioral metrics, but the document does not elaborate.

8. The Sample Size for the Training Set

This information is not applicable as the Funhaler® is a physical medical device, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above; there is no training set for this type of device.

Summary

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

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: +61 (08) 9321 2712

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

Device Description

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.

{1}------------------------------------------------

1. Funhaler® incorporates a Whistle to provide audible feedback when the Spacer is used properly with the MDI, aiding in compliance with children.
1. 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.

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.

{2}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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.

{3}------------------------------------------------

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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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

{4}------------------------------------------------

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

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
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.(b)
Classification. Class II (performance standards).