K993008 · Marquette Medical Systems, Inc. · HGM · Dec 6, 1999 · Obstetrics/Gynecology
Device Facts
Record ID
K993008
Device Name
QUANTITATIVE SENTINEL SYSTEM
Applicant
Marquette Medical Systems, Inc.
Product Code
HGM · Obstetrics/Gynecology
Decision Date
Dec 6, 1999
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.2740
Device Class
Class 2
Attributes
Software as a Medical Device
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.
Device Story
Software-based clinical information system (CIS) for hospital/clinical environments; manages manually or automatically acquired patient data. Inputs: data from hospital information systems (HIS) and physiologic monitors (e.g., fetal heart rate). Transforms inputs into integrated electronic medical records; performs automatic computations of physiologic indexes (e.g., nutrition) and user-defined formulas. Outputs: visual alerts for fetal heart rate/signal quality, electronic charts, graphs, and care plans. Accessed by clinicians via local network or remote web-browser. Facilitates decision support and research/QA via database export. Benefits: provides organized, ready access to patient data, replacing paper records; enables remote fetal monitoring surveillance.
Clinical Evidence
Bench testing only. No clinical data was necessary to demonstrate conformity to performance requirements.
Technological Characteristics
Software application operating on off-the-shelf hardware/computers. Connectivity via Ethernet, Token Ring, or IBM Wireless LAN. Supports remote access via web-browser. Features include automated data acquisition, physiologic index computation, and alert generation. No specific materials or sterilization methods applicable as it is a software-only system.
Indications for Use
Indicated for automatic patient data management in hospital/clinical environments. Supports fetal monitoring surveillance and physiologic data management for patients requiring clinical information system integration.
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.
Corometrics Spectra-Tel Telecommunications and Display System (K852608, K894958)
Submission Summary (Full Text)
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K993008
#### 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<br>System | GE Marquette Medical<br>Systems, (formerly Quantitative<br>Medicine, Inc.)<br>200 Harry S. Truman Pkwy.<br>Annapolis, MD 21401 | K973608 |
| Corometrics Spectra-Tel<br>Telecommunications and<br>Display System | Corometrics Medical Systems,<br>Inc.<br>61 Barnes Park Road North<br>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<br>Version 5.04.1 | QMI's Predicate QS<br>System<br>(k960109) | Corometrics<br>Spectra-Tel<br>(k852608) |
|---------------------------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Interface HIS,<br>physiologic monitors | Yes | Yes | Yes |
| Network architecture | Ethernet, Token Ring,<br>or IBM Wireless LAN | Off-the-shelf<br>computers and<br>accessories | No network; modem<br>connection |
| Hardware platform | Off-the-shelf<br>computers and<br>accessories | Off-the-shelf<br>computers and<br>accessories | Off-the-shelf<br>computers and<br>accessories |
| Spectra Alerts | Yes | No | Yes |
| Remote Access to<br>fetal monitor patient<br>data | Yes<br>(via web-browser) | Yes<br>(via WAN or modem<br>connection) | Yes<br>(via modem<br>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.
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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
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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<br>(Per 21 CFR 801.19) | <div> <img alt="Checkmark" src="tick.png"/> </div> |
|-----------------------------------------|----------------------------------------------------|
|-----------------------------------------|----------------------------------------------------|
OR
| (Division Sign-Off) | <div> <img alt="Signature" src="signature.png"/> </div> |
|--------------------------------------------------------------------|---------------------------------------------------------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K993008 |
|---------------|---------|
|---------------|---------|
| Over the Counter Use | |
|----------------------|--|
|----------------------|--|
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
