(203 days)
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 concepts in the provided text. The focus is on data organization and access.
No.
The system is described as a clinical data management system and decision support tool, not a device that directly treats or prevents disease.
No
The QS System is described as a "clinical data management system" and "clinical information system." Its primary function is the "management of clinical data" for "providing integrated, ready and organized access to patient and/or clinical data." It serves as a "decision support tool as well as an electronic medical record." It does not directly acquire or analyze data to diagnose a condition, but rather manages and presents existing clinical data.
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 In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is a "clinical data management system" and a "clinical information system." Its primary function is the management and organization of clinical data, serving as a decision support tool and electronic medical record.
- Device Description: The description reinforces its role as a software application for managing clinical data.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The QS System does not perform any such analysis on biological specimens. It manages and presents data that may have been generated by IVD devices or other clinical sources, but it is not an IVD itself.
- Predicate Devices: The listed predicate devices (K833395 and K931133) are described as a "Quantitative Sentinel System" and a "Clinical Information System (CIS) with Fetal Monitor Remote Display." These are consistent with clinical data management systems, not IVDs.
In summary, the QS System is a software tool for managing and presenting clinical data, not a device that performs diagnostic tests on biological samples.
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 QS System serves as a decision support tool as well as an electronic medical record.
Product codes
Not Found
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is intended for use in a hospital/clinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
1 1996
Quantitative Sentinel System 510(k) Summarv
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
203-949-2538 Phone: 203-284-9465 Fax:
[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 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 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(x)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.
1
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.