(118 days)
Not Found
Not Found
No
The description focuses on displaying data, providing graphical displays, and alerting based on out-of-reference-range data trends. There is no mention of AI, ML, or any related concepts like learning, prediction, or complex pattern recognition beyond simple thresholding.
No
The device is a software application for monitoring, displaying, and alerting on fetal monitoring data; it does not directly provide therapy.
No
The device is a software application that displays and alerts on data from fetal monitoring devices. It aids clinicians in monitoring labor but does not independently diagnose conditions.
Yes
The device description explicitly states "Cerner FetaLink is a software application". While it interacts with fetal monitoring devices (hardware), the device itself, as described, is the software application that receives, displays, and analyzes the data.
Based on the provided information, Cerner FetaLink is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is typically used for diagnosis, monitoring, or screening.
- Cerner FetaLink's Function: Cerner FetaLink's intended use and description clearly state that it is a software application that displays and analyzes data sent from fetal monitoring devices. It provides a graphical display of the relationship between uterine contractions and fetal heart rate and alerts clinicians to out-of-range data.
- No Specimen Analysis: The description does not mention any analysis of biological specimens. The data it processes comes directly from external monitoring devices applied to the patient.
Therefore, Cerner FetaLink falls under the category of a medical device used for monitoring and displaying physiological data, not an IVD device used for analyzing biological specimens.
N/A
Intended Use / Indications for Use
Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.
Product codes
HGM
Device Description
Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.
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 in the antepartum and/or intrapartum phases of pregnancy
Intended User / Care Setting
obstetrical healthcare professionals; hospital and clinic settings, bedside, central nursing station, or at remote locations
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, conveying the department's mission and purpose.
DEPARTMENT OF HEALTH & HUMAN SERVICES
. .
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 5 2009
Shelley S. Looby, MT (ASCP) BB Director, Regulatory Affairs/Quality Assurance Cerner® Corporation 2800 Rockcreek Parkway KANSAS CITY MO 64117
Re: K091251
Trade/Device Name: Cerner FetaLink™ Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: July 27, 2009 Received: July 29, 2009
Dear Ms. Looby:
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 (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 (OS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sammy M. Mourel
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K091251
Device Name: Cerner FetaLinkTM
Indications for Use:
Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Page 1 of 1
Lozza K. Nhay
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device
510(k) Number