CALG-STR Exercise ECG Analysis Algorithm
510(k) K112959
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112959 | Date26 Jan 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Active
- Expiring
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United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The CALG-STR Exercise ECG Analysis Algorithm is a software-based diagnostic tool designed to analyze multi-channel electrocardiogram (ECG) waveforms. It processes ECG data to derive key metrics, including heart rate, ventricular arrhythmia detection, representative beat formation, and ST segment deviation (elevation or depression) with ST slope analysis. These measurements assist trained physicians in assessing cardiac function during exercise testing. The algorithm operates within the classification of an electrocardiograph under FDA regulation 870.2340, falling under the Cardiovascular specialty and Device Class II.
This algorithm is supplied as part of a software system, intended for use in clinical settings where exercise ECG testing is performed. It is not described as single-use or reusable but functions as an integral component of a stress test system, such as the Philips ST80i. No sterility or MRI safety information is provided in the specifications. The device received FDA clearance under 510(k) number K112959, with a decision of Substantially Equivalent (SESE) by the Cardiovascular Review Panel in 2012.
Other devices from Philips Health Care
Questions
AI-generated answers, 20 Sep 2026
What specific cardiac metrics does the CALG-STR Exercise ECG Analysis Algorithm analyze during an exercise test?
The algorithm analyzes heart rate, detects ventricular arrhythmias, forms representative beats from the ECG data, and evaluates ST segment deviations (both elevation and depression) along with ST slope analysis. These metrics help physicians assess cardiac function during stress testing by providing detailed insights into the heart’s electrical activity under exertion.
Is this software designed for standalone use, or does it require integration with a specific system?
This algorithm is not standalone but is supplied as part of a broader software system, specifically intended for use within exercise ECG testing platforms like the Philips ST80i. It functions as an integral component of the stress test system to process and analyze ECG waveforms during testing.
How is the CALG-STR Exercise ECG Analysis Algorithm regulated, and what does that mean for its use in clinical settings?
The algorithm received FDA clearance under a 510(k) submission (K112959) and was deemed *Substantially Equivalent* to a predicate device by the Cardiovascular Review Panel in 2012. This means it meets FDA standards for safety and effectiveness as a Class II device under the Cardiovascular specialty (product code DPS), ensuring it can be legally used in clinical settings for its intended diagnostic purpose.
Does the algorithm include any special considerations for storage or maintenance, such as sterility or reusability?
Since the CALG-STR algorithm is a software-based component of an exercise ECG system (e.g., Philips ST80i), it does not require sterility or physical cleaning like disposable medical devices. However, the system it runs on may have its own maintenance guidelines—such as software updates or hardware calibration—to ensure accurate ECG analysis over time.