(105 days)
No
The device description focuses on mechanical components (spacer, mask, whistle, spinner disk) providing audible and visual feedback. There is no mention of AI, ML, or any computational analysis of data to inform the device's function.
Yes
The device is a spacer used in conjunction with Metered Dose Inhalers for respiratory drug delivery. It is intended to deliver medication to patients, fulfilling the function of a therapeutic device.
No
The device is a medical accessory (inhaler spacer) that facilitates drug delivery and compliance, not one that identifies or characterizes a disease or condition.
No
The device description clearly outlines physical components like a mouthpiece, cylindrical spacer, connector, breathing mask, whistle, and spinner disk. These are hardware components, not software.
Based on the provided text, the Funhaler® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Funhaler® Function: The Funhaler® is a medical device designed to facilitate the delivery of medication from a Metered Dose Inhaler (MDI) to a patient's lungs. It acts as a spacer to improve drug delivery and incorporates features to encourage compliance in pediatric patients.
- No Specimen Analysis: The description of the Funhaler® clearly indicates it is used in conjunction with an MDI for drug delivery to the patient, not for analyzing samples from the patient.
Therefore, the Funhaler® falls under the category of a drug delivery device, not an In Vitro Diagnostic device.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
73 CAF
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;
-
- 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.
-
- Funhaler® incorporates a Whistle to provide audible feedback when the Spacer is used properly with the MDI, aiding in compliance with children.
-
- 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.
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
Primarily in the pediatric population. Suitable to all pediatric subgroups 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 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;
-
- 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.
-
- 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.
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