(87 days)
Unknown
872037/A, 926307
No
The device description lists only physical components (holding chamber, peak flow meter) and educational materials. There is no mention of software, algorithms, or any technology typically associated with AI/ML.
No
The device is a kit containing medical devices (AeroChamber and Peak Flow Meter) and educational materials for asthma management, but the kit itself is not a therapeutic device. The components within the kit have therapeutic functions.
Yes
Explanation: The kit includes a TruZone Peak Flow Meter, which is a diagnostic device used to measure lung function.
No
The device description explicitly lists hardware components: an AeroChamber Aerosol Holding Chamber and a TruZone Peak Flow Meter.
Based on the provided information, the AeroGear Asthma Action Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description states the kit is used in an "asthma management program" and contains a holding chamber and a peak flow meter. These are devices used for delivering medication and monitoring lung function, respectively. They do not perform tests on samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Device Description: The components listed (AeroChamber Aerosol Holding Chamber, TruZone Peak Flow Meter, and educational materials) are all devices and materials used directly by the patient or healthcare provider for managing asthma, not for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample collection, or laboratory analysis.
Therefore, the AeroGear Asthma Action Kit falls under the category of medical devices used for treatment and monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The AeroGear Asthma Action Kit is a product containing Chamber, Holding TruZone AeroChamber Aerosol the and educational Meter, a fanny pack Peak Flow materials used in an asthma management program. This intended to be marketed to hospitals, kit is outpatient clinics and physicians.
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
Not Found
Intended User / Care Setting
hospitals, outpatient clinics and physicians
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Unknown
Reference Device(s)
AeroChamber w/FLOWSIGnal, 510(k) #872037/A, TruZone Peak Flow Meter, 510(k) #926307
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).
0
JAN 1 0 1997
SECTION 2 - SUMMARY AND CERTIFICATION
510 (k) SUMMARY
Monaghan Medical Corporation 5 Latour Ave., Suite 1600 P.O. Box 2805 12901-0299 Plattsburgh, NY Phone: 518-561-7330 Fax: 518-561-5660 Contact: James A. Cochie QA/RA Manager
Date Prepared: October 1, 1996
Device Proprietary Name: AeroGear Asthma Action Kit Device Classification name: Unknown
Legally Marketed Device Identity:
AeroChamber w/FLOWSIGnal, 510(k) #872037/A TruZone Peak Flow Meter, 510(k) #926307
Device Description:
The AeroGear Asthma Action Kit is a product containing Chamber, Holding TruZone AeroChamber Aerosol the and educational Meter, a fanny pack Peak Flow materials used in an asthma management program. This intended to be marketed to hospitals, kit is outpatient clinics and physicians.
The two devices indicated above are currently marketed devices which have been cleared through the 510(k) process.