# K080461: Star ST and Arrhythmia Software, Release J.0

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Mar 13, 2008 after 22 days
- Product code: MLD (Monitor, St Segment With Alarm)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K941811 (1994). 101 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964122: HP Star ST and Arrhhythmia Software, Hewlett-Packard Co. (1997) Summary page 1.
- K991773: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable P, Hewlett-Packard GmbH (1999) Summary page 1.
- K001348: ST/AR ST and Arrhythmia Software, Agilent Technologies, Inc. (2000) Summary page 1.
- K003621: ST/AR ST and Arrhythmia Software, Model Release D.0, Agilent Technologies, Inc. (2000) Summary page 1.
- K014261: ST/AR ST and Arrhythmia Software, Model Release E.0, Philips Medical Systems, Inc. (2002) Summary page 1.
- K021251: ST/AR ST and Arrhythmia Software, Release E.I., Philips Medical Systems (2002) Summary page 1.
- K033513: Easi Ecg Algorithm, Philips Medical Systems (2004) Summary page 1.
- K040357: M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System II, Philips Medical Systems, Inc. (2004) Summary page 1.
- K070260: Star ST and Arrhythmia Software, Release H.0, Philips Medical Systems (2007) Summary page 1.
- K073462: Modification to Dash 3000, 4000, 5000 Monitor and Accessories, Ge Medical Systems Information Technologies (2008) Summary page 1.
- K031320: EK-Pro Arrhythmia Detection Algorithm, Ge Medical Systems Information Technologies (2003) Summary page 1.

## Most influential descendants
- K101521: ST/AR ST and Arrhythmia Software Model: Release K.O (2010), 4 descendants of its own
- K150352: V Series Monitoring System (including V12 and V21 Monitors) (2015), 1 descendant of its own
- K152305: Nihon Kohden Afib Detection Program QP-039P (2016), 0 descendants of its own
- K153448: Passport Series Patient Monitors (Including Passport 8, Passport 12) (2016), 0 descendants of its own
- K151812: Patient Monitors Various Models (2016), 0 descendants of its own

## Indications for use
Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients. The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias, and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients. The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients. Note: The ST algorithm does not analyze ventricularly paced or ventricular ectopic beats. The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.

Source page: https://510kreport.com/device/K080461
Methodology: https://510kreport.com/methodology