(182 days)
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 OS System serves as a decision support tool as well as an electronic medical record.
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 OS 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.
This document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.
Instead, the provided text is a 510(k) summary for the Quantitative Sentinel System 7.0, describing its intended use, comparison to predicate devices, and asserting that no clinical testing was necessary to demonstrate conformity to performance requirements.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment.
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QUANTITATIVE SENTINEL SYSTEM 7.0 510(k) SUMMARY
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Prepared 06 September 1996
[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: | 203-949-2538 |
|---|---|
| Fax: | 203-284-9465 |
[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, OS-2, OS System, OS/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 | K960109 |
| Corometrics Model 400Extended Surveillance andAlerts (Spectra 400) | Corometrics Medical Systems, Inc.61 Barnes Park Road NorthWallingford, CT 06492 |
[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 -
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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 OS 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.
| Parameter | QMI's QS SystemVersion 4.04.0 | QMI's Predicate QSSystem(K960109) | CorometricsSpectra 400(K852608) |
|---|---|---|---|
| Interface HIS,physiologic monitors | Yes | Yes | Fetal MonitorsOnly |
| Network architecture | Ethernet, TokenRing, or IBMWireless LAN | Off-the-shelfcomputers andaccessories | Proprietary |
| Hardware platform | Off-the-shelfcomputers andaccessories | Off-the-shelfcomputers andaccessories | Proprietary |
| Spectra Alerts | Yes | No | Yes |
[807.92(a)6] Predicate Device Comparison of Technological Characteristics
[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 its requirements and design. No clinical testing was necessary to demonstrate conformity to performance requirements.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
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.(b)
Classification. Class II (performance standards).