OBIX PERINATAL DATA SYSTEM 7.0 by CLINICAL COMPUTER SYSTEMS, INC.

For obstetrical patients, the OBIX Perinatal Data System 7.0 provides health care professionals a method to display and archive electronic fetal monitor data and manage demographic information and documentation.

The intended use of the OBIX system is displaying and recording fetal and maternal physiological data obtained from electronic fetal monitors. The OBIX system also has these capabilities:

Monitors fetal and maternal physiological data obtained from standard electronic fetal monitors and accompanying accessories and captures it on permanent storage media.
Displays the monitored data for one or more patients in the patient rooms and at other locations as required by the hospital.
Supports patient management activities, including note entry onto the electronic fetal monitor tracings and into the medical record.
Provides tools that assist clinicians in evaluating fetal heart rate patterns.
Generates flowsheets and graphs based on the notes recorded for the patient.
The optional Registration Interface registers patients in the OBIX system directly from the hospital's admissions system. Patients can also be registered in the OBIX system manually, when necessary.
Displays the Status Board (chalkboard), which shows patient rooms and key data elements in real-time format. The Status Board is typically displayed at one or more central locations, usually at the central nurses' station.
Provides optional remote access to patient monitoring and management activities through off-site workstations connected by a virtual private network (VPN) connection or a secure hospital Web page.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for the OBIX Perinatal Data System 7.0. It confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

However, the document does not contain the detailed information necessary to fully answer the questions about acceptance criteria, study design, and performance. The letter is a regulatory approval, not a scientific study report. It mentions that the FDA reviewed the information provided by the applicant, but the specifics of that information (like detailed study results, ground truth establishment, sample sizes, etc.) are not present in this document.

Therefore, I can only provide general information based on what is typically required for such submissions, and note where the specific data is missing.

Here's an attempt to answer based on the provided text and typical FDA submission requirements, with caveats where information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria or reported device performance. The FDA letter confirms the device is substantially equivalent for its intended use, but does not detail the specific performance metrics or the thresholds it met.

The "Indications for Use" section describes the functionalities of the OBIX Perinatal Data System 7.0, which include:

Monitoring and capturing fetal and maternal physiological data from electronic fetal monitors.
Displaying monitored data for multiple patients.
Supporting patient management activities (note entry).
Providing tools to assist clinicians in evaluating fetal heart rate patterns.
Generating flowsheets and graphs.
Optional Registration Interface for patient registration.
Displaying a real-time Status Board.
Optional remote access.

To infer acceptance criteria, one would expect the submission to have demonstrated that these functionalities perform as intended, are accurate in their data display and capture, and do not introduce errors that could harm patients. However, the specific quantitative criteria are not in this document.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in the performance studies submitted to the FDA, not in the regulatory approval letter itself.

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

The provided document does not specify the number of experts used to establish ground truth or their qualifications. This information would be part of the clinical or performance validation study details, which are not included here.

4. Adjudication Method for the Test Set

The provided document does not specify the adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The provided document does not indicate if a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor does it provide an effect size of how much human readers improve with AI vs. without AI assistance. The OBIX Perinatal Data System 7.0 is described as a "perinatal monitoring system" that "provides tools that assist clinicians in evaluating fetal heart rate patterns." While it assists clinicians, it is not explicitly stated as an AI-powered diagnostic tool that directly improves human reader performance in a quantifiable MRMC study context.

6. If a Standalone Study Was Done

The provided document does not explicitly state if a standalone (algorithm-only without human-in-the-loop performance) study was done. Given the description of the device as a "data system" that displays and records data and "provides tools that assist clinicians," it is likely that the performance assessment focused on the accuracy of data acquisition, display, and archiving, rather than a standalone diagnostic performance of an algorithm.

7. Type of Ground Truth Used

The provided document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data, etc.) for any studies.

8. Sample Size for the Training Set

The provided document does not specify the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established

The provided document does not explain how the ground truth for the training set was established.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Clinical Computer System, Inc. % Mr. William Sammons Sr. Project Engineer, Sr. Reviewer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087

JUN 1 4 2012

Re: K121208

Trade/Device Name: OBIX Perinatal Data System 7.0 Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: May 30, 2012 Received: May 31, 2012

Dear Mr. Sammons:

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. 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 (reporting of medical

{1}------------------------------------------------

device-related 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/Resourcesfor You/Industry/default.htm.

. Sincerely yours,

Benjamin K. Evanko

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a black and white logo. The logo is a black circle with a white letter "C" inside. Within the "C", there is a white figure that appears to be a mother holding a baby. The logo is simple and conveys a sense of care and nurturing.

anuter ns incorporated

Indications for Use

510(k) Number (if known): K | 2 | 2 | 2 0 8

Device Name: OBIX Perinatal Data System 7.0

Indications for Use:

The intended use of the OBIX system is displaying and recording fetal and maternal physiological data obtained from electronic fetal monitors. The OBIX system also has these capabilities:

Monitors fetal and maternal physiological data obtained from standard electronic fetal monitors ● and accompanying accessories and captures it on permanent storage media.
. Displays the monitored data for one or more patients in the patient rooms and at other locations as required by the hospital.
. Supports patient management activities, including note entry onto the electronic fetal monitor tracings and into the medical record.
Provides tools that assist clinicians in evaluating fetal heart rate patterns. .
Generates flowsheets and graphs based on the notes recorded for the patient. ●
. The optional Registration Interface registers patients in the OBIX system directly from the hospital's admissions system. Patients can also be registered in the OBIX system manually, when necessary.
Displays the Status Board (chalkboard), which shows patient rooms and key data elements in . real-time format. The Status Board is typically displayed at one or more central locations, usually at the central nurses' station.
Provides optional remote access to patient monitoring and management activities through off-. site workstations connected by a virtual private network (VPN) connection or a secure hospital Web page. -

Prescription Use Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Carolyn Y Newland
	(Division Sign-Off)
	for Division of Reproductive, Gastro-Renal, and Urological Devices
510(k) Number	K121208

715 Tollgate Road	Tel: 847-622-0847
Elgin, IL 60123-9331	Tel: 888-871-0963
	Fax: 847-622-0880

Page_1_of_1510(k) Summary14

OBIX

perinatal data system

Regulation Number and Section

§ 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).