(90 days)
Not Found
No
The description focuses on data management, calculations from user-defined formulas, and basic alerts based on thresholds, none of which inherently require AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
No
The device is described as a clinical data management system and a decision support tool, focused on managing and organizing patient data, not directly treating or diagnosing conditions.
No
The device is described as a "clinical data management system" and a "decision support tool as well as an electronic medical record." While it processes patient data and provides notifications (e.g., for fetal heart rate limits), its primary function is data management and organization, not directly diagnosing medical conditions. It assists in providing information to aid clinical decisions rather than making a diagnosis itself.
Yes
The device description explicitly states that the Quantitative Sentinel (QS) System is a "software application" and a "clinical data management system." While it interfaces with other medical devices and operates on off-the-shelf hardware, the device itself, as described, is the software application for data management and decision support.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Quantitative Sentinel (QS) System is described as a clinical data management system (CIS). Its primary function is to manage and organize patient data, whether entered manually or acquired from other medical devices. It acts as an electronic medical record and a decision support tool.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The data it manages comes from electronic forms, interfaces with other systems and devices, and user input.
- Focus on Data Management: The intended uses and device description clearly focus on data management, storage, retrieval, and presentation, not on performing diagnostic tests on biological specimens.
While the system may process data that originates from diagnostic tests performed by other devices (like fetal monitor heart rate values), the QS System itself is not performing the diagnostic test on a biological sample. It is managing and presenting the results of those tests or other clinical data.
N/A
Intended Use / Indications for Use
The Quantitative Sentinel (QS) System's is intended for automatic patient data management. It does this by:
- (a) providing the user the ability to create and use electronic forms for entering, viewing and storing patient and facility related data (e.g. charts, forms, graphs, chalkboards, care plans, user reference manual).
- (b) interfacing with other hospital information systems and medical devices for automatic data acquisition, viewing and storage with the electronic patient record.
- (c) providing visual notification of when acquired fetal monitor heart rate values exceed the user defined limits for high and low fetal heart rate and poor signal quality.
- (d) providing Spectra Alerts capabilities for fetal monitoring (surveillance).
- (e) providing automatic computations of physiologic indexes (e.g. nutrition).
- (f) providing calculations from user defined formulas (i.e. index calculator).
- (g) providing the ability to record, with the patient record, fluid input and oulput information that is defined by the user.
- (h) providing the ability to export patient data to relational databases for research and Quality Assurance purposes.
- (i) providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).
- (j) providing the ability to print (locally or remotely) patient records and QS database definition (e.g. item names)
- (k) providing the ability to review fetal monitor data (OB-Link) remotely over the internet.
Product codes (comma separated list FDA assigned to the subject device)
85 HGM
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
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 have been extensively tested to meet its 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
QUANTITATIVE SENTINEL SYSTEM 7.0 510(k) SUMMARY
Prepared 04 September 1999
[807.92(a)1] Contact Information
Maria Vitug Fouts Sr. Regulatory Compliance Specialist
| Address: | GE Marquette Medical Systems, Inc. | |
|---|---|---|
| 200 Harry S. Truman Parkway, Suite 220 | ||
| Annapolis, MD 21401 | ||
| Phone: | 410-573-6294 | |
| Fax: | 410-897-0349 |
[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-5. QS System. QS Perinatal, QS-ICU, and QS-Surveillance, Surveillance & Archive, QS Unit Manager, QS Lab Access
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 | GE Marquette Medical | |
| Systems, (formerly Quantitative | ||
| Medicine, Inc.) | ||
| 200 Harry S. Truman Pkwy. | ||
| Annapolis, MD 21401 | K973608 | |
| Corometrics Spectra-Tel | ||
| Telecommunications and | ||
| Display System | Corometrics Medical Systems, | |
| Inc. | ||
| 61 Barnes Park Road North | ||
| Wallingford, CT 06492 | K852608, K894958 |
1
[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.
| Parameter | QMI's QS System
Version 5.04.1 | QMI's Predicate QS
System
(K960109) | Corometrics
Spectra-Tel
(K852608) |
|---------------------------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Interface HIS,
physiologic monitors | Yes | Yes | Yes |
| Network architecture | Ethernet, Token Ring,
or IBM Wireless LAN | Off-the-shelf
computers and
accessories | No network; modem
connection |
| Hardware platform | Off-the-shelf
computers and
accessories | Off-the-shelf
computers and
accessories | Off-the-shelf
computers and
accessories |
| Spectra Alerts | Yes | No | Yes |
| Remote Access to
fetal monitor patient
data | Yes
(via web-browser) | Yes
(via WAN or modem
connection) | Yes
(via modem
connection) |
[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 have been extensively tested to meet its requirements and design. No clinical testing was necessary to demonstrate conformity to performance requirements.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of an eagle or bird with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 1999
Ms. Maria Vitug Fouts Senior Regulatory Compliance Specialist GE Marquette Medical Systems, Inc. 200 Harry S. Truman Parkway, Suite 220 Annapolis, MD 21401
Re: K993008 Quantitative Sentinel (QS) System, Version 5.04.1 Dated: September 7, 1999 Received: September 7, 1999 Requlatory Class: 11 21 CFR§ 884.2740/Procode: 85 HGM
Dear Ms. Fouts:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act, You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP reqult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiiance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Quantitative Sentine! (QS) System
Indications for Use:
The Quantitative Sentinel (QS) System's is intended for automatic patient data management. It does this by:
-
(a) providing the user the ability to create and use electronic forms for entering, viewing and
storing patient and facility related data (e.g. charts, forms, graphs, chalkboards, care plans, user reference manual). -
(b) interfacing with other hospital information systems and medical devices for automatic data acquisition, viewing and storage with the electronic patient record.
-
(c) providing visual notification of when acquired fetal monitor heart rate values exceed the user defined limits for high and low fetal heart rate and poor signal quality.
-
(d) providing Spectra Alerts capabilities for fetal monitoring (surveillance).
-
(e) providing automatic computations of physiologic indexes (e.g. nutrition).
-
(f) providing calculations from user defined formulas (i.e. index calculator).
-
(g) providing the ability to record, with the patient record, fluid input and oulput information that is defined by the user.
-
(h) providing the ability to export patient data to relational databases for research and Quality Assurance purposes.
-
(i) providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).
-
(i) providing the ability to print (locally or remotely) patient records and QS database definition (e.g. item names)
-
(k) providing the ability to review fetal monitor data (OB-Link) remotely over the internet.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence if CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.19) | |
|---|---|
| ----------------------------------------- | ---------------------------------------------------- |
OR
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K993008 |
|---|---|
| --------------- | --------- |
| Over the Counter Use | |
|---|---|
| ---------------------- | -- |