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

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.

AI/ML Overview

The provided document describes the Funhaler V201, a spacer device intended for use with Metered Dose Inhalers (MDIs) primarily in the pediatric population. The submission focuses on demonstrating substantial equivalence to a predicate device (Funhaler®, K042546) and compliance with various performance standards.

Here's an analysis of the acceptance criteria and the study information as requested:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance
Quality Systems	21CFR820 Quality System Regulation	Meets/Exceeds
	ISO 13485 - Quality Systems, Medical Devices	Meets/Exceeds
Biocompatibility	ISO 10993-10; Biological Evaluation of Medical Devices; Tests for irritation and sensitization	Meets/Exceeds
	ISO 10993-5; Biological Evaluation of Medical Devices; Tests for Cytotoxicity (MEM)	Meets/Exceeds
Risk Management	EN 14971 - Risk Analysis	Meets/Exceeds
Device Performance (In vitro)	FDA Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers, and Actuators; October 1, 1993	"Performance of Funhaler® with respect to particle size distribution has been confirmed to be better than or equal to the predicate device."
	FDA division of Bioequivalence Guidance for the In-Vitro Portion of Bioequivalence requirements for Metaproterenol Sulfate and Albuterol Inhalation Aerosols (Metered Dose Inhalers)	Tested for particle size, distribution, and drug delivery with a variety of MDIs and drugs in accordance with FDA Guidance. Performance confirmed to be better than or equal to the predicate device.
Pediatric Considerations	Guidance for Industry and FDA Staff-Premarket Assessment of Pediatric Medical Devices: May 2004	Meets/Exceeds
Consumer Product Safety	16CFR 1500:1501- Consumer Product Safety, as applicable for products intended for use with children.	Meets/Exceeds
Labeling	21CFR801 - Labeling	Meets/Exceeds
Clinical Performance (Compliance - specifically stated for "pediatric patients")	Improved compliance with pediatric patients using the Funhaler® when compared to the predicate device.	"Limited clinical testing has demonstrated improved compliance with children using the Funhaler® when compared to the predicate device."

Study Information

The document provides limited details regarding specific studies, primarily relying on demonstrating substantial equivalence to the predicate device and compliance with general standards.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated for either the particle size distribution/drug delivery testing or the "limited clinical testing."
- Data Provenance: Not specified. The submitter (InfaMed Ltd) is based in Western Australia.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies mentioned (particle size, drug delivery, and compliance) would likely rely on objective measurements or the assessment of healthcare professionals, but the specific number or qualifications of "experts" for ground truth establishment are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not described in the provided text.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device (Funhaler V201) is a medical device spacer, not an AI-powered diagnostic or interpretive tool that would involve human readers. Its primary reported benefits are improved compliance and proper medication delivery, not diagnostic accuracy.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The Funhaler V201 is a physical medical device, not an algorithm. Therefore, a "standalone" algorithm-only performance study is not applicable. The device's performance relates to its mechanical and functional characteristics, such as particle size distribution and drug delivery when used with an MDI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For particle size distribution and drug delivery, the ground truth would typically be established through in-vitro analytical measurements using standardized laboratory equipment (e.g., cascade impactors for particle size, chemical analysis for drug delivered).
- For improved compliance, the ground truth would likely be based on observational data gathered during the "limited clinical testing," potentially through direct observation by clinicians or objective measures of engagement with the device's feedback mechanisms. The document doesn't specify the exact method.
The sample size for the training set:
- Not applicable as this is a physical medical device, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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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 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.
1. The packaging has been changed from a thick plastic film box, to a softpack bag.
1. 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, arranged in a staggered formation. The profiles are connected by a flowing line that forms the lower part of the design. Encircling the profiles is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

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 (240) 276-0115. 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/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.

Page 10 of 61

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).