QUANTITATIVE SENTINEL SYSTEM

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

Intended 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.

Predicate Devices

• Quantitative Sentinel System (K973608)
• 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 |

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## [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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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> |
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OR

| (Division Sign-Off) | <div> <img alt="Signature" src="signature.png"/> </div> |
|--------------------------------------------------------------------|---------------------------------------------------------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |

| 510(k) Number | K993008 |
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| Over the Counter Use | |
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