QUANTITATIVE SENTINEL SYSTEM
Device Facts
| Record ID | K963608 |
|---|---|
| Device Name | QUANTITATIVE SENTINEL SYSTEM |
| Applicant | Quantitative Medicine, Inc. |
| Product Code | HGM · Obstetrics/Gynecology |
| Decision Date | Mar 11, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2740 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Intended Use
The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The QS System serves as a decision support tool as well as an electronic medical record. The QS System operates on off-the-shelf software and hardware. The device is intended for use in a hospital/clinical environment.
Device Story
QS System is a software-based clinical information system (CIS) for hospital/clinical environments. It integrates clinical data from manual entry or automated acquisition (HIS, physiologic monitors). It functions as an electronic medical record and decision support tool, organizing data typically found in paper records or disparate systems. It operates on off-the-shelf hardware and network architectures (Ethernet, Token Ring, or IBM Wireless LAN). Clinicians access integrated patient data to support clinical decision-making. The system includes alert capabilities (Spectra Alerts) to notify providers of clinical events.
Clinical Evidence
No clinical data. Bench testing only; software and environment extensively tested to meet design requirements.
Technological Characteristics
Software-based clinical information system; operates on off-the-shelf computer hardware; supports Ethernet, Token Ring, and IBM Wireless LAN network architectures; interfaces with Hospital Information Systems (HIS) and physiologic monitors; provides clinical data management and decision support alerts.
Indications for Use
Indicated for use in hospital/clinical environments for the management of patient and clinical data, serving as an electronic medical record and clinical decision support tool.
Regulatory Classification
Identification
A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.
Predicate Devices
- Quantitative Sentinel System (K960109)
- Corometrics Model 400 Extended Surveillance and Alerts (Spectra 400) (K852608)
Related Devices
- K960109 — QUANTITATIVE SENTINEL SYSTEM · Quantitative Medicine, Inc. · Aug 1, 1996
- K993008 — QUANTITATIVE SENTINEL SYSTEM · Marquette Medical Systems, Inc. · Dec 6, 1999
- K213335 — Capsule Surveillance System · Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. · Jan 14, 2022
- K161767 — Philips IntelliVue GuardianSoftware · Philips Medizin Systeme Boeblingen GmbH · Jan 27, 2017
- K151736 — Philips IntelliVue GuardianSoftware · Philips Medizin Systeme Boblingen GmbH · Oct 21, 2015
