Search Results
Found 1 results
510(k) Data Aggregation
K Number
K230823Device Name
AusculThing ACC
Manufacturer
AusculThing Oy
Date Cleared
2023-07-12
(110 days)
Product Code
DQD, DQC
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
AusculThing Oy
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AusculThing ACC software is a decision-support SW for the healthcare provider (the user) in the evaluation of patient heart sounds. The ACC is used to record, display, and analyze acoustic signals of the heart recorded by means of an electronic stethoscope. It is intended for use on adult and pediatric patients. The automated analysis will categorize heart sounds as either "abnormal" if any heart murmur of any intensity is identified in any position across the precordium, or "normal" if either no murmurs or benign murmurs are identified. ACC is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretation offered by the software is only significant when used in conjunction with physician over-read and including all other relevant patient data. The device is intended for Rx use only. The AusculThing ACC shall be used together with Thinklabs One electronic stethoscope.
Device Description
AusculThing ACC is a decision support SW that collects heart sounds from adult and pediatric patients. The ACC software receives the data using a Thinklabs One electronic stethoscope. The SW is running on a mobile device, where the electronic stethoscope is connected to. The SW guides the user how relevant heart sound recordings should be obtained from different parts of the body. After recording, the ACC analyzes the recordings in conjunction automatically using an AI -based algorithm, which is trained using a proprietary echocardiogram validated high-quality data database. The basic functionality of the ACC SW is to give a user an instant, automated, analysis of the patient under evaluation and differentiate between normal and pathological sounds. For the abnormal heart sounds, the ACC delivers information on suspected murmurs. The ACC software is a SW that allows a user to upload heart sounds/phonocardiogram (PCG) data to the device for analysis and visualization. The AusculThing ACC Mobile App runs on a mobile device. The app permits the electronic recording of heart sound signals via a compatible electronic stethoscope (Thinklabs One). The app also permits visual and acoustic playback of heart sounds in the mobile device. After analysis, results are returned to the user in the App. The Murmur detection algorithm is based on a neural network model that uses heart sounds to detect the presence of pathological heart sounds. The user can utilize the heart sound analysis results and the acoustic and visual representation of the heart sound recordings as decision support data in their decision-making process regarding the presence and type of a heart murmur.
Ask a Question
Page 1 of 1