(182 days)
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No
The summary describes a clinical data management system and electronic medical record with decision support capabilities, but there is no mention of AI, ML, or related technologies. The description focuses on data organization and access.
No
The device is described as a "software application" and "clinical data management system" that serves as a "decision support tool as well as an electronic medical record." Its function is to manage and organize clinical data, not to directly treat or provide therapy.
No
The device is described as a clinical data management system that organizes and provides access to patient data, serving as a decision support tool and electronic medical record. It does not perform diagnostic functions but manages data that might be used for diagnosis.
Yes
The device description explicitly states that the Quantitative Sentinel (QS) System is a "software application" and operates on "off-the-shelf software and hardware," indicating that the device itself is the software component, not a dedicated hardware device.
Based on the provided information, the Quantitative Sentinel (QS) System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "clinical data management system" and "clinical information system." Its primary function is managing and organizing clinical data, not performing diagnostic tests on biological samples.
- Device Description: The description reinforces its role as a software application for data management and access, not a device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on software testing and meeting requirements, not on the accuracy or performance of a diagnostic test.
While it serves as a "decision support tool," this is based on the organization and presentation of existing clinical data, not on the results of a diagnostic test performed by the device itself.
N/A
Intended Use / Indications for 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 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.
Product codes
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Device Description
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. The device is intended for use in a hospital/clinical environment.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
hospital/clinical environment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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QUANTITATIVE SENTINEL SYSTEM 7.0 510(k) SUMMARY
া :
1/2
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 400 | ||
| Extended Surveillance and | ||
| Alerts (Spectra 400) | Corometrics Medical Systems, Inc. | |
| 61 Barnes Park Road North | ||
| Wallingford, 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 -
1
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 System
Version 4.04.0 | QMI's Predicate QS
System
(K960109) | Corometrics
Spectra 400
(K852608) |
|----------------------------------------|-------------------------------------------------|-----------------------------------------------|-----------------------------------------|
| Interface HIS,
physiologic monitors | Yes | Yes | Fetal Monitors
Only |
| Network architecture | Ethernet, Token
Ring, or IBM
Wireless LAN | Off-the-shelf
computers and
accessories | Proprietary |
| Hardware platform | Off-the-shelf
computers and
accessories | Off-the-shelf
computers and
accessories | 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.