(287 days)
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
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.
Here's a breakdown of the acceptance criteria and study information for the CIV-ob Obstetrical Monitoring Software Application based on the provided K051175 document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests (as described) | Reported Device Performance (as described) |
|---|---|---|
| Voluntary Standard Compliance | IEC 60601-1-4 Computer Controlled Medical Devices | Complies with IEC 60601-1-4 standard. |
| Software Risk Analysis | Addressing risks related to: | Checked as part of CIVnet's Software Test Procedure for validation. Results not numerically reported in this document. |
| - Communication | ||
| - Loss of power conditions | ||
| - Out of limit conditions | ||
| - Server communication | ||
| - Installation | ||
| - Memory capacity | ||
| Hardware Risk Analysis | Risks associated with off-the-shelf devices and their possible failure. | Not explicitly detailed as a separate test result, but implied to be addressed. |
| User Interface Risk Analysis | Addressing: | Not explicitly detailed as a separate test result, but implied to be addressed. |
| - Patient Data Security | ||
| - Patient Data Accuracy |
Important Note: The provided document is a 510(k) Summary, not a full study report. It states that the acceptance criteria are detailed in CIVnet's IEC 60601-1-4 report and Risk Analysis, and that software risks are "checked as part of CIVnet's Software Test Procedure for validation." However, the document does not provide numerical results, performance metrics, or specific pass/fail rates for any of the criteria in this 510(k) Summary. The performance is broadly stated as "compliance" or "addressed."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not provided in the document. The submission focuses on software and system validation rather than a clinical efficacy study requiring expert-established ground truth for a specific diagnostic outcome.
4. Adjudication Method for the Test Set
- This information is not provided in the document. As no clinical ground truth establishment or reader study is described, adjudication methods are not applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No MRMC comparative effectiveness study is described or implied in the provided document. The device is a "clinical data management system" and an "Obstetrical Monitoring Software Application," focusing on data management, display, and archiving, rather than an AI diagnostic tool designed to directly improve human reader performance on a diagnostic task.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- The document describes the device as a "software application" that performs functions like displaying data, providing control, archiving, and interfacing. The validation mentioned ("Software Test Procedure for validation of the software") implies testing of the algorithm/software's functionality and adherence to specifications. While not explicitly termed a "standalone performance study," the software validation would assess the algorithm's ability to precisely execute its programmed functions (e.g., accurately display data, archive data correctly, provide visual notifications when heart rates exceed limits). However, no specific performance metrics for this standalone functionality (e.g., accuracy of visual notifications, data fidelity during archiving) are reported in this summary beyond general compliance.
7. The Type of Ground Truth Used
- For the software testing described, the "ground truth" would be the expected functional behavior and output of the software based on its design specifications and the standards it aims to comply with (e.g., IEC 60601-1-4). For example, if the software is supposed to display a fetal heart rate value from a monitor, the ground truth would be that the displayed value matches the input value received from the monitor. If it's supposed to trigger a visual alert for a heart rate exceeding a threshold, the ground truth would be that the alert triggers precisely when that threshold is met by the input data. This is more akin to systematic verification and validation against specifications rather than traditional clinical ground truth methods like pathology or expert consensus.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The CIV-ob is described as a "clinical data management system" and software application, not a machine learning or AI algorithm that typically requires a training set. Its functionality appears to be rule-based and deterministic, focused on data handling, display, and alerts according to predefined criteria.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable/not provided for the same reasons as in point 8.
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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: 972-3-6962240 / Ext 218 Mobile: 972-524-640089 Fax: 972-3-9607842 E-mail: rudi.lokits@ness.com
Contact Person:
Rudi Lokits Tel: 972-524-640089 E-mail: rudi.lokits@ness.com
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 (800) 638-2041 or (301) 443-6597 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):
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
§ 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).