(168 days)
No
The device description focuses on mechanical components and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is a holding chamber that administers aerosolized medication; it does not directly provide therapy but rather facilitates the delivery of therapeutic agents.
No
Explanation: The device description states it is "intended to administer aerosolized medication" and is a "spacer primarily used ... for the inhalation of approved MDIs for the therapy of the upper and lower respiratory system." This describes a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components like a balloon, translucent housing, and a mechanical valve, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The Watchhaler is intended to administer aerosolized medication. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on how the device helps deliver medication to the respiratory system. It doesn't mention any analysis of biological samples or diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases
The Watchhaler is a medical device used for drug delivery, specifically a valved holding chamber (VHC) or spacer for use with metered dose inhalers (MDIs).
N/A
Intended Use / Indications for Use
The Watchhaler is a holding chamber intended to administer aerosolized medication with a Metered Dose Inhaler. For pediatric patients (3 years and older). The environment of use includes home care, nursing homes, sub-acute institutions, and hospitals
Product codes
NVP
Device Description
The Watchhaler is a spacer primarily used in the pediatric population for the inhalation of approved MDIs for the therapy of the upper and lower respiratory system. The design of the device is held in the shape of a colored toy animal to address its users, the children. The device consists of a balloon which is enclosed by a translucent housing. During inhalation the balloon collapses with the speed of deflation controlled by a mechanical valve. The fixed volume of the balloon and the low inhalation flow provided by the valve help to ensure a constant drug delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower respiratory system
Indicated Patient Age Range
Pediatric -- 3 years and older
Intended User / Care Setting
Home care, nursing home, sub-acute institution, or hospital
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)
Not Found
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
Kotoiou
Activaero
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 10-Jan-08
JUN 3 0 2008
| Activaero America, Inc.
P.O. Box 351
Dublin, OH 43017-9684 | | Tel - (614) 761-3555
Fax - (614) 761-3505 |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Official Contact: | | William Zimlich - CEO |
| Proprietary or Trade Name: | | Watchhaler |
| Common/Usual Name: | | Spacer / Holding chamber |
| Classification Name: | | Nebulizer (Direct Patient Interface)
CAF - 868.5630 |
| Predicate Devices: | Trudell AeroChamber Plus Valved Holding Chamber K992917
Trudell AeroChamber Plus aVHC with Flow-Vu IFI K070674
InfaMed Funhaler K042546 | |
Device Description
The Watchhaler is a spacer primarily used in the pediatric population for the inhalation of approved MDIs for the therapy of the upper and lower respiratory system. The design of the device is held in the shape of a colored toy animal to address its users, the children. The device consists of a balloon which is enclosed by a translucent housing. During inhalation the balloon collapses with the speed of deflation controlled by a mechanical valve. The fixed volume of the balloon and the low inhalation flow provided by the valve help to ensure a constant drug delivery.
| Indications for Use -- | The Watchhaler is a holding chamber intended to administer
aerosolized medication with a Metered Dose Inhaler. | |
|------------------------|-------------------------------------------------------------------------------------------------------------------|--|
| Patient Population -- | Pediatric -- 3 years and older | |
| Environment of Use -- | Home care, nursing home, sub-acute institution, or hospital | |
| Contraindications -- | None | |
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2
10-Jan-08
Attributc
Proposed Watchhaler
| Indications for Use
(all have except pentamidine) | The Watchhaler is a holding chamber intended to
administer aerosolized medication with a Metered
Dose Inhaler. |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Environments of use | Home care, nursing home, sub-acute institutions or
hospitals |
| Patient population | Pediatric (3 years and older) |
| Single patient, multi-use | Yes |
| Used with mouthpiece | Yes |
| Used with most pressurized Metered
Dose Inhalers | Yes |
| Feedback | Visual |
| Flow control / maximum flow rate | Yes / 15 Lpm |
| Materials | ISO 10993 tested |
| Inhalation volume | Maximum 300 ml |
Differences Between Other Legally Marketed Predicate Devices
The Watchhaler is viewed as substantially equivalent to the following predicate devices -Trudell AeroChamber Plus Valved Holding Chamber K992917, Trudell AeroChamber Plus aVHC with Flow-Vu IFI K070674, and InfaMed Funhaler K042546
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2008
Activaero America, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
Re: K080100
Trade/Device Name: Watchhaler Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVP Dated: June 25, 2008 Received: June 26, 2008
Dear Mr. Dryden:
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. Dryden
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 (OS) 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 yours,
C
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
4
Indications for Use Statement
Page 1 of 1
510(k) Number:
KO80100 (To be assigned)
Device Name:
Watchhaler
Indications for Use:
The Watchhaler is a holding chamber intended to administer aerosolized medication with a Metered Dose Inhaler. For pediatric patients (3 years and older). The environment of use includes home care, nursing homes, sub-acute institutions, and hospitals
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
QRS
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080100