# K013564: Modification to Heartwave Alternans Processing System, Model Aps

- Pathway: 510(k) (Special)
- Applicant: Cambridge Heart, Inc.
- Decided: Nov 21, 2001 after 26 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930806 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010758: Heartwave Alternans Processing System, Aps, Cambridge Heart, Inc. (2001) Summary page 1.
- K010756: CH 2000 Cardiac Diagnostic System, Cambridge Heart, Inc. (2001) Summary page 1.
- K012206: Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System, Cambridge Heart, Inc. (2001) Summary page 1.

## Most influential descendants
- K022152: Heartwave Alternans Processing System, Model Aps (2002), 0 descendants of its own

## Indications for use
The Heartwave™ Alternans Processing System is intended for the measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing. The presence of Microvolt T-wave Alternans as measured by the Analytic Spectral Method of the Heartwave™ Alternans Processing System in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death). The Heartwave™ Alternans Processing System should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests. The interpretive results of the Alternans Processing System should be reviewed by a qualified physician. The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia. *Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is present in leads X, Y, Z, VM or two adjacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, (d) is at least three standard deviations greater than the background noise level, (e) has an onset heart rate at or below 110 beats per minute, and (f) is sustained for all heart rates above the onset heart rate.

Source page: https://510kreport.com/device/K013564
Methodology: https://510kreport.com/methodology