(55 days)
No
The document describes a simple spacer device with an incentive module, and there is no mention of AI, ML, or any computational processing beyond basic device function.
No
The device, a spacer for metered dose inhalers, delivers medication. While it aids in drug delivery, it does not directly treat a disease or condition itself.
No
The device is described as a spacer to be used with a metered dose inhaler for respiratory drug delivery, primarily in the pediatric population. Its function is to facilitate drug delivery, not to diagnose a condition.
No
The device description explicitly states it is a "Spacer" and describes physical components like a "Mouthpiece, cylindrical Spacer, tapered on each end, incentive module and a molded connector," indicating it is a hardware device.
Based on the provided information, the Funhaler is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The Funhaler is intended for respiratory drug delivery in combination with a Metered Dose Inhaler. This is a therapeutic purpose, not a diagnostic one.
- Device Description: It is described as a Spacer, which is a device used to improve the delivery of inhaled medication. This is a medical device, but not an IVD.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose like detecting diseases or conditions.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Funhaler does not fit this description.
N/A
Intended Use / 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 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.
Product codes
CAF
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;
-
- 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.
-
- The packaging has been changed from a thick plastic film box, to a softpack bag.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatric population, with the exception of newborns and infants younger than 18 months.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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;
-
- 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.
-
- The packaging has been changed from a thick plastic film box, to a softpack bag.
-
- 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.
2
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.
.
3
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.
4
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
5
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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