QUANTITATIVE SENTINEL SYSTEM

K960109 · Quantitative Medicine, Inc. · HGM · Aug 1, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K960109
• Device Name: QUANTITATIVE SENTINEL SYSTEM
• Applicant: Quantitative Medicine, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Aug 1, 1996
• 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 clinical data management/information system (CIS) for hospital/clinical environments; manages manually or automatically acquired patient data; integrates data from disparate paper records and clinical systems/devices; functions as an electronic medical record and decision support tool; operates on off-the-shelf hardware and software; provides clinicians with organized access to patient information to facilitate clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data was necessary to demonstrate conformity to performance requirements.

Technological Characteristics

Software-based clinical information system; operates on off-the-shelf computer hardware; supports Ethernet, Token Ring, or IBM Wireless LAN network architectures; interfaces with Hospital Information Systems (HIS) and physiologic monitors.

Indications for Use

Indicated for use in hospital/clinical environments for the management of patient 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 (K833395)
• Clinical Information System (CIS) with Fetal Monitor Remote Display (FMRD) (K931133)

Submission Summary (Full Text)

{0}

510(k): Quantitative Sentinel (QS) System
K960109

AUG 1 1996

# Quantitative Sentinel System
## 510(k) Summary

Prepared: 29 December 1995

## [807.92(a)1] Contact Information

Maria Vitug Fouts
Regulatory Affairs/Compliance Specialist

Address: Corometrics Medical Systems, Inc.
61 Barnes Park Road North
Wallingford, CT. 06492

Phone: [phone]
Fax: [phone]

## [807.92(a)2] Device Name and Classification

The proprietary name of the modified device to be introduced into interstate commerce is the Quantitative Sentinel System.

Common names include: QS, QS-2, QS System, QS/Perinatal System, QS-FirstStep, and QS-Surveillance.

As indicated in the original premarket notification submission, the Quantitative Sentinel System is a class II device. To date no formal classification name has been issued for software based clinical information systems.

## [807.92(a)3] Identification of Legally Marketed Equivalent Devices (Predicate Systems)

| Predicate System | Manufacturer | k Number |
| --- | --- | --- |
| Quantitative Sentinel System | Quantitative Medicine, Inc. (QMI)
200 Harry S. Truman Pkwy.
Annapolis, MD 21401 | k833395 |
| Clinical Information System (CIS) with Fetal Monitor Remote Display (FMRD) | CliniComp, Intl.
4510 Executive Drive
San Diego, CA 92121 | k931133 |

*SE - Substantial Equivalence decision

## [807.92(a)4 & 807.92(a)5] Device Description & 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.

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{1}

510(k): Quantitative Sentinel (QS) System

# Quantitative Sentinel System
## 510(k) Summary

Continued

[807.92(a)6] Predicate Device Comparison of Technological Characteristics

| Parameter | QMI's QS System, Version 4.02.3 | QMI's Predicate QS System (k833395) | CliniComp's CIS w/ FMRD (k931133) |
| --- | --- | --- | --- |
| Interface HIS, physiologic monitors | Yes | Yes | Yes |
| Network architecture | Ethernet, Token Ring, or IBM Wireless LAN | DECnet | Ethernet |
| Hardware platform | Off-the-shelf computers and accessories | Off-the shelf computers and accessories | Off-the-shelf computers and accessories |

[807.92(b)1, 807.92(b)2 & 807.92(b)3] Performance Standards per the Food, Drug and Cosmetic Act

To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration.

[807.92(d)] Additional Information

The QS software and its environment has been extensively tested to meet it requirements and design. No clinical testing was necessary to demonstrate conformity to performance requirements.

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