CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION

K051175 · Civent Communications, Ltd. · HGM · Feb 17, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K051175
• Device Name: CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
• Applicant: Civent Communications, Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The CIVNET CIV-ob is a software application that is intended for use as a clinical data management system (also referred to as a clinical information system - CIS). The function of the system is the management of fetal and maternal vital heart rate and uterine vital signs clinical data automatically acquired from a bedside fetal monitor, for the purpose of providing, 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 CIV-ob serves as an electronic medical record. The CIV-ob operates with off-the-shelf software and hardware. The device is intended for use in a hospital/clinical environment.

Device Story

CIV-ob is a clinical information system (CIS) for obstetrical monitoring; manages fetal/maternal heart rate and uterine vital signs. Inputs: real-time data from bedside fetal monitors via interface protocols. Transformation: software processes, archives, and displays data; provides visual notifications for out-of-limit heart rates or poor signal quality; enables multi-bed monitoring. Output: electronic patient record, remote data review via TCP/IP, and printed reports. Used in hospital/clinical settings by healthcare providers. Benefits: replaces paper records with organized electronic access; facilitates remote monitoring and data storage; improves clinical workflow efficiency.

Clinical Evidence

Bench testing only. Validation performed via software test procedures addressing communication, power loss, out-of-limit conditions, server communication, installation, memory capacity, and user interface risks (data security/accuracy).

Technological Characteristics

Software application operating on off-the-shelf hardware. Connectivity via TCP/IP for remote review and IT system interfacing. Complies with IEC 60601-1-4 (Computer Controlled Medical Devices).

Indications for Use

Indicated for automatic fetal monitor patient data management in hospital/clinical environments. Facilitates display, archiving, and remote review of fetal heart rate and uterine (TOCO) vital signs. Provides visual alerts for high/low heart rate and poor signal quality. Intended for prescription use.

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

• GE Marquette Medical Quantitative Sentinel System (K993008)
• ClinComp. Intl CIS w/ FMRD (K931133)

Submission Summary (Full Text)

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K051175 page

# FEB 1 7 2006

### 510(k) Summary

CIV-ob Obstetrical Monitoring Software Application

510(k) Number K_

## Submitter's Name:

CIVNET Communication Ltd. Meshk 58, Ben Natan Moshav Hemed, Israel 50295 Tel: [phone] / Ext 218 Mobile: [phone] Fax: [phone] E-mail: [e-mail]

#### Contact Person:

Rudi Lokits Tel: [phone] E-mail: [e-mail]

Trade Name:

CIV-ob Obstetrical Monitoring Software Application

#### Classification Name:

System, Monitoring, Perinatal

### Classification:

The FDA has classified these devices as a class II device (product code HGM) and are reviewed by the Obstetrics and Gynecology Devices Group.

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### Predicate Devices:

The CIV-ob Obstetrical Monitoring Software Application is substantially equivalent to:

· GE Marquette Medical Quantitative Sentinel System, cleared under K993008, Dec 6, 1999.

- · ClinComp. Intl CIS w/ FMRD, cleared under K931133.
#### Performance Standards:

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, to the best of our knowledge, the CIV-ob Obstetrical Monitoring Software Application complies with the following voluntary standard:

IEC 60601-1-4 Computer Controlled Medical Devices i

#### Acceptance Criteria and Risk Analysis:

Acceptance criteria for compliance with the standards is detailed in CIVnet's IEC 60601-1-4 report and Risk Analysis.

The software risks addressed are communication, loss of power conditions, out of limit conditions, server communication, installation, memory capacity. These are checked as part of CIVnet's Software Test Procedure for validation of the software.

The hardware risks are those associated with the off-the-shelf devices and their possible failure.

The User Interface risks addressed are Patient Data Security and accuracy.

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#### Device Description and Intended Use:

The CIVNET CIV-ob is a software application that is intended for use as a clinical data management system (also referred to as a clinical information system - CIS). The function of the system is the management of fetal and maternal vital heart rate and uterine vital signs clinical data automatically acquired from a bedside fetal monitor, for the purpose of providing, 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 CIV-ob serves as an electronic medical record. The CIV-ob operates with off-the-shelf software and hardware. The device is intended for use in a hospital/clinical environment.

#### Substantial Equivalence:

The CIV-ob Obstetrical Monitoring Software Application is substantially equivalent to its predicate devices:

· GE Marquette Medical Quantitative Sentinel System, cleared under K993008, Dec 6, 1999.

- · ClinComp. Intl CIS w/ FMRD, cleared under K931133.
without raising new safety and/or effectiveness issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rudi Lokits General Manager CIVNET Communication Ltd. Meshk 58, Ben Natan Moshav Hemed, 50295 ISRAEL

Re: K051175 Trade/Device Name: CIV-ob Monitoring Software Application Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: December 29, 2005 Received: January 4, 2006

Dear Mr. Lokits:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements. including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

FEB 1 7 2006

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This letter will allow you to begin marketing your device as described in your Section 5 0(k) This letter will anow you to begin manxemig your antial equivalence of your device to a legally premarket notification. The FDA Inding of Sacsantial of Success of Survilles of Sermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parl 801), please If you desire spective advice for your device on our labeling numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation chance, "rinsonalisms of your responsibilities under the Act from the 807.97). You may obtain other general mornation your copyright its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known):

K051175

Device Name:

CIV-ob Monitoring Software Application

Indications for Use:

The CIVNET CIV-ob software application is intended for automatic fetal monitor patient data management. The application does this by:

- a) Displaying on-line fetal heart rate and TOCO data received from the patient Displaying on mic recar near representation as it is displayed on the fetal monitor paper printout.
- b) Providing the means to control and display multiple beds simultaneously.
- c) Providing automatic Archiving of the data.
- c) Frovide the ability to interface with different fetal monitors operating with the same interface protocol.
- e) Easy interfacing with any IT patient record system for data acquisition, viewing and storage of electronic patient record.
- f) Provide visual notification of when acquired fetal monitor heart rate exceed I to ride visual nothlous for high and low fetal heart rate and poor signal quality.
- g) Providing the ability to record, with patient record, fluid input and output information that is defined by the user.
- h) Providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).
- Providing the ability to print (locally or remote) patient records. i)
- i) I roviding the ability to review fetal monitor data remotely over the TCP/IP

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of Obstetrics and Gynecology Devices

510(k) Number

Prescription Use V (Per 21 CFR 801.109) OR

Over the Counter Use

(Per 21 CFR 801.109)

PREMARKET NOTIFICATION

David A. Hegy

ivicion Sion-Off Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number