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510(k) Data Aggregation
K Number
K223367Device Name
Ochsner Connected Inhaler Sensor
Manufacturer
Date Cleared
2023-08-30
(299 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
Ochsner Clinic Foundation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage.
The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review information collected from the Sensors and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physicians, and health care providers.
When used with a prescribed MDL, the System can report on information captured during the normal course of use, such as the time between actuations, that can be helpful in assessing MDI technique.
When used under the care of a physician with a prescribed MDI, the System can assist in the management of respiratory health symptoms and exacerbations by providing feedback through reminders, notifications, and self-management education.
The System is intended to be used in populations from Child (>2 years) to adult.
The System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.
The System may also be used in clinical trials where researchers need to know information about the use of MDI medications by a participant.
The output of the System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The System is not intended for use as an MDI or inhaled medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI or inhaled medication.
Device Description
The Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor. The Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage. The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review information collected from the Sensors and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physicians, and health care providers. When used with a prescribed MDI, the System can report on information captured during the normal course of use, such as the time between actuations, that can be helpful in assessing MDI technique. When used under the care of a physician with a prescribed MDI, the System can assist in the management of respiratory health symptoms and exacerbations by providing feedback through reminders, notifications, and self-management education.
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