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510(k) Data Aggregation
K Number
K200884Device Name
B-Secur HeartKey Software Library
Manufacturer
B-Secur Ltd.
Date Cleared
2020-12-07
(249 days)
Product Code
DPS, DOK
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
B-Secur Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The B-Secur HeartKey Software Library is intended to be used by medical device manufacturers in medical devices to assess a single lead ECG spot checks from adult patients. The product allows the processing and extraction of beats from an ECG signal to provide a heart rate reading and ECG rhythm analysis. The library will classify a 30 second ECG spot check recording as normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia, unreadable or inconclusive.
The library is intended to be integrated into other device software. All interpretations must be reviewed by a medical professional for clinical decision making, and the user of the device should not make changes to their medication without consulting a physician.
The library is not intended for use in life supporting or sustaining systems, or cardiac alarm systems.
Device Description
The B-Secur HeartKey Software Library is an "object library". An object library is a collection of callable functions that have been compiled into native machine code of the computer on which they will execute. The HeartKey Software Library includes a basic application for viewing and analyzing electrocardiogram (ECG) data. The source code for the library is not available and cannot be modified by the end user.
The B-Secur HeartKey Software Library provides ECG signal processing and QRS detection for a single lead ECG 30s spot check. System input lead is configurable based on the application, but the typical application is arrhythmia screening from a Lead I stainless steel dry electrode device capable of carrying out periodic spot checks.
The software library is designed to accept a digital ECG stream and produce several metrics.
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