(134 days)
No
The description focuses on data management, display, archiving, and basic alerts based on predefined limits. There is no mention of algorithms that learn or adapt from data.
No
The device is a data management and monitoring software application that displays and archives data from bedside monitors; it does not directly provide therapy.
No
The device is a clinical data managing software application intended to manage and display perinatal monitoring data. It does not perform diagnostic functions, but rather organizes and presents data acquired from other bedside monitors or manual inputs. Its purpose is data management and display, not to determine the presence or absence of a disease or condition.
Yes
The device is described as a "software application" and its function is data management, display, and archiving. While it interfaces with bedside monitors, the description focuses solely on the software's role in processing and presenting this data, without mentioning any hardware components included as part of the device itself. The testing mentioned is software verification and validation, and compliance with software and electronic record standards.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the CIVNET CIV-ob™ (plus) is a software application for managing and displaying clinical data acquired from bedside monitors or manual inputs related to pregnant women. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The data it manages comes from external monitoring devices and manual entry. The data sources are bedside monitors (measuring things like FHR and Uterine Activity) and manual inputs (like provider notes, head decent, and cervix dilation). These are not in vitro tests.
- Its function is data management and display. The core purpose of the software is to collect, organize, display, and archive data from other sources. It does not perform any diagnostic tests itself.
The device falls under the category of a clinical data management and monitoring system, which is distinct from an IVD.
N/A
Intended Use / Indications for Use
The CIVNET CIV-ob™ (plus) is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting
The CIVNET CIV-ob™ (plus) is indented to manage perinatal monitoring data acquired from bedside monitors or manual inputs for viewing at the central nursing station. The system also produces an electronic medical record.
The CIVNET CIV-obTM (plus) has display fields for the following obstetric data:
- Monitoring site details
- Patient demographics
- Provider notes
- FHR
- Uterine Activity (via tocodynamometry IUP)
- Head Decent
- Cervix Dilation
Product codes
HGM
Device Description
The CIVNET CIV-ob™ (plus) Obstetrical Data Management and Monitoring software application is for remote display, archiving and data management of fetal/maternal bedside monitor and/or Birth Tracking monitors. The CIVNET CIV-ob™ (plus) is intended for use as a clinical data management and monitoring system for multiple bedsides with the added ability to connect multiple monitors to a single bed side. The CIVNET CIV-ob™ (plus) is indicated for maternal/fetal vital signs data management and is suitable for the hospital and clinical environment.
The CIVNET CIV-ob™ (plus) Data Management and Monitoring software application is intended for automatic fetal/maternal monitoring and patient data management. The application does this by:
- a) Providing Obstetrical Data Management and remote display of information and graphs from Obstetrical monitors.
- b) Displaying real time fetal heart rate and TOCO data HS and CD data received from the patient bed-side in a one-to-one representation as it is displayed on the fetal/maternal monitor.
- c) Providing the means to display multiple beds simultaneously.
- d) Providing automatic Archiving of the data.
- e) Providing Administrative Control to ensure that the system performs without technical failure.
- Providing easy interfacing with any IT patient record system for data acquisition, viewing and storage of electronic patient record.
- g) Providing visual notification of fetal/maternal monitor alerts such as out of limit heart rate or poor signal quality.
- h) Providing the ability to record as part of the patient record, fluid input and output information that is defined by the user.
- i) Providing the user the ability to enter comments and specific data.
- j) Providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).
- k) Providing the ability to print (locally or remotely) patient records and CIV-obTM (plus) data base definition (e.g. item names).
- l) Providing the ability to connect multiple monitors to a single bed side.
The role of the CIV-ob™ (plus) software remains the same as the CIV-ob™ in that the CIV-ob™ (plus) system is designed to archive electronic data provided by the fetal/maternal monitor, and to display real-time graphical data received from the monitor via the hospital network.
The CIV-OBTM (plus) system is comprised of five modules:
-
- Main Server (with an option of multiple servers per site)
-
- Mid Server for every Birth Tracking monitor
-
- Monitoring Station
-
- Central monitor module
-
- Site Sniffer control and revision module
The CIVNET CIV-ob™ (plus) is a modification of the CIVNET CIV-ob™. It contains the same functions, with the following additions:
- . The development environment tool used is Microsoft ".Net" developing environment.
- Display of Cervix dilation birth tracking parameter
- Display Fetal head decent birth tracking parameter
- Display of all birth tracking alert messages present on the birth tracking monitor . is part of the remote monitoring.
CIVNET CIV-OB™ (plus) is intended to be marketed in three configurations.
- Configuration 1 CIV-OB™ (plus) for Data Management and Monitoring of . both obstetrics and birth tracking
- Configuration 2 CIV-OB™ (plus) for Data Management and Monitoring of ● obstetrics only
- Configuration 3 CIV-OB™ (plus) for Data Management and Monitoring of fetal . birth tacking only
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
Pregnant women
Intended User / Care Setting
healthcare setting
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 CIV-ob™ (plus) has been thoroughly tested through verification of its specifications and validation of its software. Verification of compliance with the following standards has also been made to support the safety of the device in its intended environment.
- IEC 60601-1-4 Programmable Electrical Medical Systems
- IEC 62304 Software Life Cycle for Medical Devices
- Compliance with 21 CFR Part 11 Rule on electronic records and signatures.
The modifications made to the CIV-ob™ (plus) did not require clinical testing.
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
ATTACHMENT 5
K103172 page 1 of 4
CIV-ob (plus)
MAR 1 1 2011
Civnet Communication Ltd. Traditional 510(k)
Section 5
510(k) Summary
CIV-ob (plus) Obstetrical Data Management and Monitoring Software Application
510(k) Number K
Applicant's Name: CIVNET Communication Ltd. Hatamar St. 58, Moshav Hemed, Israel 50295 Tel: 972-3-7568824 Fax: 972-3-9607842 E-mail: Nathy@civnet.co.il
- Contact Person: Nathan Ben-nathan Tel: 972-504331000 E-mail: Nathy@civnet.co.il
Date: June 10, 2010
Trade Name: CIV-ob™ (plus) Obstetrical Data Management and Monitoring Software Application
- Common Name: Perinatal monitoring system
Classification:
HGM, 21 CFR & 884.2740, for Perinatal Monitoring System and accessories, Class II
Identification of Legally Marketed Predicate Devices:
CIVNET believes that the CIV-ob™ (plus) Obstetrical Data Management and Monitoring Software Application used to monitor Obstetrical fetal/maternal monitors and their related EMR (Electronic Medical Record) data is substantially equivalent to:
1
K103172 page 2 of 4
CIV-ob (plus)
- CIVNET CIV-ob Obstetrical Software Application, cleared under K051175.
- Barnev Inc. BIRTHTRACK (A.K.A. CLM) Computerized Labor Monitoring System cleared under K082704.
without raising new safety and/or effectiveness issues.
A discussion of substantial equivalence is provided in Section 12 of this submission.
Device Description:
The CIVNET CIV-ob™ (plus) Obstetrical Data Management and Monitoring software application is for remote display, archiving and data management of fetal/maternal bedside monitor and/or Birth Tracking monitors. The CIVNET CIV-obTM (plus) is intended for use as a clinical data management and monitoring system for multiple bedsides with the added ability to connect multiple monitors to a single bed side. The CIVNET CIV-ob™ (plus) is indicated for maternal/fetal vital signs data management and is suitable for the hospital and clinical environment.
The CIVNET CIV-ob™ (plus) Data Management and Monitoring software application is intended for automatic fetal/maternal monitoring and patient data management. The application does this by:
- a) Providing Obstetrical Data Management and remote display of information and graphs from Obstetrical monitors.
- b) Displaying real time fetal heart rate and TOCO data HS and CD data received from the patient bed-side in a one-to-one representation as it is displayed on the fetal/maternal monitor.
- c) Providing the means to display multiple beds simultaneously.
- d) Providing automatic Archiving of the data.
- e) Providing Administrative Control to ensure that the system performs without technical failure.
- Providing easy interfacing with any IT patient record system for data ದಿ acquisition, viewing and storage of electronic patient record.
- g) Providing visual notification of fetal/maternal monitor alerts such as out of limit heart rate or poor signal quality.
- h) Providing the ability to record as part of the patient record, fluid input and output information that is defined by the user.
- i) Providing the user the ability to enter comments and specific data.
- j) Providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).
- k) Providing the ability to print (locally or remotely) patient records and CIV-obTM (plus) data base definition (e.g. item names).
- l) Providing the ability to connect multiple monitors to a single bed side.
2
K103172 Page 3 of 4
CIV-ob (plus)
The role of the CIV-ob™ (plus) software remains the same as the CIV-ob™ in that the CIV-ob™ (plus) system is designed to archive electronic data provided by the fetal/maternal monitor, and to display real-time graphical data received from the monitor via the hospital network.
The CIV-OBTM (plus) system is comprised of five modules:
-
- Main Server (with an option of multiple servers per site)
-
- Mid Server for every Birth Tracking monitor
-
- Monitoring Station
-
- Central monitor module
-
- Site Sniffer control and revision module
The CIVNET CIV-ob™ (plus) is a modification of the CIVNET CIV-ob™. It contains the same functions, with the following additions:
- . The development environment tool used is Microsoft ".Net" developing environment.
- Display of Cervix dilation birth tracking parameter �
- Display Fetal head decent birth tracking parameter ●
- Display of all birth tracking alert messages present on the birth tracking monitor . is part of the remote monitoring.
CIVNET CIV-OB™ (plus) is intended to be marketed in three configurations.
- Configuration 1 CIV-OB™ (plus) for Data Management and Monitoring of . both obstetrics and birth tracking
- Configuration 2 CIV-OB™ (plus) for Data Management and Monitoring of ● obstetrics only
- Configuration 3 CIV-OB™ (plus) for Data Management and Monitoring of fetal . birth tacking only
Intended Use
The CIVNET CIV-ob™ (plus) is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting
The CIVNET CIV-ob™ (plus) is indented to manage perinatal monitoring data acquired from bedside monitors or manual inputs for viewing at the central nursing station. The system also produces an electronic medical record.
The CIVNET CIV-obTM (plus) has display fields for the following obstetric data:
- Monitoring site details ●
- Patient demographics ●
- Provider notes .
- FHR .
3
K103172 page 4 of 4
CIV-ob (plus)
- Uterine Activity (via tocodynamometry IUP) .
- Head Decent
- Cervix Dilation .
Summary of Technological Characteristics of device compared to predicate devices
The CIV-ob™ (plus) has been updated from the predicate version (K051175). There have been no changes to the intended use or fundamental scientific technology.
The software of the CIV-ob™ (plus) has been updated to introduce several new features. The changes to the software include the addition of the birth tracking parameters as part of the fetal monitoring application.
Summary of Non-Clinical testing for the device and conclusions
The CIV-ob™ (plus) has been thoroughly tested through verification of its specifications and validation of its software. Verification of compliance with the following standards has also been made to support the safety of the device in its intended environment.
- IEC 60601-1-4 Programmable Electrical Medical Systems
- IEC 62304 Software Life Cycle for Medical Devices
- Compliance with 21 CFR Part 11 Rule on electronic records and signatures.
Summary of clinical testing for the device and conclusions
The modifications made to the CIV-ob™ (plus) did not require clinical testing.
Conclusion:
The summary above shows that there are no new questions or safety and effectiveness issues for the CIV-ob™ (plus) when compared to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60! Silver Spring, MD 20993-0002
MAR 1 1 2011
Mr. Nathan Ben-nathan Chairman CIVNET Communication Ltd. Hatamar St. 58 Moshav Hemed ISRAEL 50295
Re: K103172
Trade/Device Name: CIV-ob" (plus) Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: March 8. 2011 Received: March 11, 2011
Dear Mr. Ben-nathan:
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 individions for use stated in the enclosure) to legally marketed predicate devices marketed in intestant 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, Orig. 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, lintern of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related
5
Page 2
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Hubert Heman MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
ATTACHMENT 2
CIV-ob (plus)
Section 4
Indications for Use Statement
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
CIV-ob™ (plus)
Indications for Use:
The CIVNET CIV-ob™ (plus) is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting
The CIVNET CIV-ob™ (plus) is indented to manage perinatal monitoring data acquired from bedside monitors or manual inputs for viewing at the central nursing station. The system also produces an electronic medical record.
The CIVNET CIV-ob™ (plus) has display fields for the following obstetric data:
- Monitoring site details
- Patient demographics .
- Provider notes �
- . FFR
- Uterine Activity (via tocodynamometry IUP) .
- Head Decemt ●
- Cervix Dilation
Prescription Use X (Per 21 CFR 801.109 subpart D) Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
| Concurrence of CDRH/Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Section 4 | (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) NumberK103172 | 510(k) Number | K103172 |
| 510(k) Number | K103172 |
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