(55 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, deep learning, or any related concepts. The description focuses on data display, archiving, and basic patient management tools.
No.
The device displays and records physiological data and supports patient management activities, but it does not directly treat or diagnose any medical condition.
No.
The primary purpose of the OBIX Perinatal Data System 7.0 is to display, record, and manage fetal and maternal physiological data, along with providing tools for patient management and evaluation of fetal heart rate patterns. While it assists clinicians in evaluating data, it does not explicitly state that it makes a diagnosis itself.
Unknown
The provided text describes the intended use and capabilities of the OBIX Perinatal Data System 7.0, which is clearly a software system for managing fetal monitor data. However, the "Device Description" section is explicitly marked as "Not Found". Without a description of the device itself, it's impossible to definitively determine if it is solely software or if it includes dedicated hardware components (beyond standard computing infrastructure) that are part of the medical device itself. The description of receiving data from "standard electronic fetal monitors and accompanying accessories" suggests interaction with hardware, but it doesn't clarify if the OBIX system includes any of that hardware as part of its medical device definition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The OBIX Perinatal Data System 7.0 is described as a system that displays and archives electronic fetal monitor data and manages patient information and documentation. It monitors physiological data obtained from electronic fetal monitors.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples taken from the patient. Its function is to process and display data from external monitoring equipment.
Therefore, the OBIX Perinatal Data System 7.0 falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
HGM
Device Description
Not Found
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
Not Found
Intended User / Care Setting
health care professionals / hospital
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
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:
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. -
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