Search Results

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

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 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:

• 1. Main Server (with an option of multiple servers per site)
• 2. Mid Server for every Birth Tracking monitor
• 3. Monitoring Station
• 4. Central monitor module
• 5. 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

The acceptance criteria and study proving the device meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria for the "CIV-ob (plus)" device, nor does it provide specific numerical performance metrics. Instead, the focus of the submission is on demonstrating substantial equivalence to predicate devices and verifying compliance with relevant standards through verification and validation. The "performance" is implicitly tied to the proper functioning of the software as a data management and monitoring system.

• Developed in Microsoft ".Net"
• Display of Cervix dilation birth tracking parameter
• Display of Fetal head decent birth tracking parameter
• Display of all birth tracking alert messages present on the birth tracking monitor as part of remote monitoring. |
  | (a) Obstetrical Data Management & remote display | Provides Obstetrical Data Management and remote display of information and graphs from Obstetrical monitors. |
  | (b) Display real-time FHR and TOCO data | Displays 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) Display multiple beds simultaneously | Provides the means to display multiple beds simultaneously. |
  | (d) Automatic Archiving of data | Provides automatic Archiving of the data. |
  | (e) Administrative Control for technical failure prevention | Provides Administrative Control to ensure that the system performs without technical failure. |
  | (f) Easy interfacing with IT patient record system | Provides easy interfacing with any IT patient record system for data acquisition, viewing and storage of electronic patient record. |
  | (g) Visual notification of alerts | Provides visual notification of fetal/maternal monitor alerts such as out of limit heart rate or poor signal quality. |
  | (h) Record user-defined fluid input/output | Provides the ability to record as part of the patient record, fluid input and output information that is defined by the user. |
  | (i) User input for comments and specific data | Provides the user the ability to enter comments and specific data. |
  | (j) Archive files to secondary/tertiary storage | Provides the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk). |
  | (k) Print patient records and database definition | Provides the ability to print (locally or remotely) patient records and CIV-ob™ (plus) database definition (e.g. item names). |
  | (l) Connect multiple monitors to a single bedside | Provides the ability to connect multiple monitors to a single bed side. |
  | Compliance with Standards: | Verified compliance with:
• IEC 60601-1-4 Programmable Electrical Medical Systems
• IEC 62304 Software Life Cycle for Medical Devices
• 21 CFR Part 11 Rule on electronic records and signatures. |
  | No New Safety/Effectiveness Issues compared to predicates | The submission concludes there are "no new questions or safety and effectiveness issues for the CIV-ob™ (plus) when compared to the predicate devices." This is the overarching "acceptance criteria" for 510(k) equivalence. The modifications did not require clinical testing, implying no new safety or effectiveness concerns were raised that would necessitate such testing. |

2. Sample Size for Test Set and Data Provenance:

The document explicitly states: "The modifications made to the CIV-ob™ (plus) did not require clinical testing." This implies there was no specific "test set" of patient data used for performance evaluation in a clinical setting for this particular 510(k) submission. The evaluation was primarily based on non-clinical testing (software verification and validation) and comparison to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since no clinical testing was performed for this 510(k) submission, and thus no "test set" with clinical ground truth, this information is not applicable.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device is a data management and monitoring software, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The submission explicitly states "The modifications made to the CIV-ob™ (plus) did not require clinical testing."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The "CIV-ob (plus)" is described as an "Obstetrical Data Management and Monitoring Software Application." Its function is to display, archive, and manage data from other devices (fetal/maternal monitors) and manual inputs for review by clinical staff at a central nursing station. It also generates electronic medical records.

While the software itself operates in an "algorithm-only" fashion by processing and displaying data, it is inherently designed to be human-in-the-loop for interpretation, decision-making, and often, input (e.g., patient demographics, provider notes, fluid input/output, comments). Therefore, a "standalone performance" in the sense of an algorithm making a diagnostic decision or prediction independently is not the primary function of this device, nor was such a study described. Its "performance" revolves around data accuracy, reliable display, and adherence to functional specifications, which were assessed through non-clinical verification and validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical testing (verification and validation), the "ground truth" would be established by the device's functional specifications, design requirements, and compliance with industry standards. For example, displaying FHR data would be verified against the actual data stream received from the monitor to ensure accuracy of representation. Archiving would be verified by successfully retrieving stored data. No clinical ground truth (like expert consensus on diagnoses, pathology, or patient outcomes) was established or used for this 510(k) submission for the device's performance.

8. The Sample Size for the Training Set:

Not applicable. This device is a data management and monitoring software application, not a machine learning or AI algorithm that typically requires a "training set" of data for model development. Its functionality is based on established programming logic and data handling protocols.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there was no training set for this device.

Ask a specific question about this device