(116 days)
Not Found
No
The summary describes a software application for viewing and displaying physiological waveforms and patient data, with no mention of AI or ML algorithms for analysis, interpretation, or prediction.
No
The device is a software application for viewing fetal heart rate and uterine contractions, which is for monitoring and information display rather than direct treatment or therapy.
Yes
The device displays various patient clinical data (e.g., maternal heart rates, oxygen saturation, blood pressure, uterine contractions) to assist obstetrical healthcare clinicians in monitoring and understanding the physiological state of pregnant women. This is a function typical of diagnostic devices, which gather and present data for the purpose of diagnosis or monitoring.
Yes
The device description explicitly states "Cerner FetaLink+ is the software application that runs on the user's iPhone or iPad." and the intended use states it is a "software-only application". The summary does not mention any accompanying hardware components that are part of the regulated device.
Based on the provided information, Cerner FetaLink+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze samples from the human body. IVDs are designed to examine specimens like blood, urine, tissue, etc., to provide information about a person's health.
- Cerner FetaLink+ displays real-time physiological data. The device's intended use and description clearly state that it displays real-time measurements of fetal heart rate, uterine contractions, maternal heart rates, oxygen saturation, and blood pressure. This is direct physiological monitoring, not the analysis of a biological sample.
Therefore, Cerner FetaLink+ falls under the category of a medical device that monitors physiological parameters, not an IVD.
N/A
Intended Use / Indications for Use
Cerner FetaLink+ is a software-only application intended for use on iOS mobile devices by obstetrical healthcare clinicians to view near real time the simultaneous measurement of fetal heart rate(s) and uterine contractions waveforms in one view. FetaLink+transforms the ongoing measurements into a visual wave display which conveys the frequency, duration and relative strength of uterine contractions combined with the patient data of pregnant women in the antepartum and/or intrapartum phases of pregnancy.
Product codes
HGM
Device Description
Cerner FetaLink+ is the software application that runs on the user's iPhone or iPad. The application displays patient clinical waveform data including maternal heart rates, maternal oxygen saturation, maternal blood pressure, and uterine contractions. Within the application, the user can view annotations associated to waveform data.
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
obstetrical healthcare clinicians in a clinical setting
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)
The testing performed was intended to ensure the functional requirements have been implemented and that hazards identified in the Device Hazard Analysis have been mitigated.
Cerner's validation demonstrated that all functional requirements and hazard analysis software mitigations for Cerner FetaLink+ were executed and the expected results achieved. Based on the results of the testing performed, Cerner FetaLink+ was evaluated to be a safe and effective device for use in a live patient environment.
Functional testing, which validated that all functional requirements for the software have been met, were completed prior to formative and summative usability with no outstanding issues identified.
Formative and summative usability, which involved task-based walkthroughs and post-test questionnaire, evaluated possible use errors in the user interface. Based on the results, changes were implemented to mitigate identified use errors.
The results of summative usability and the mitigations applied based on those results show that residual risk has been reduced as low as reasonably practicable.
Interference testing was completed in order to identify and mitigate any risks of interference from clinical or non-clinical devices used in close proximity to the mobile device on which the software resides.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Cerner Corporation
Cerner FetaLink+ ™
K 121758
510(k) Summary
510(k) Summary
Submitter's Name: Submitter's Address:
Submitter's Telephone:
Submitter's Contact:
Cerner Corporation 10234 Marion Park Drive Kansas City, MO 64137
816-221-1024
Shelley S. Looby, Director Regulatory Affairs 816-201-1368 (office) 816-885-3069 (mobile) slooby@cerner.com
Date 510(k) Summary Prepared:
September 10, 2012
Trade/Proprietary Name: Cerner FetaLink+™ (Version 1.0) FetaLink+™ Common/Usual Name: Classification Name: Obstetrical and Gynecological Monitoring Devices Classification Regulation: 884.2740 Regulation Description: Perinatal Monitoring System and AccessoriesProduct Code: HGM Classification: Class II
Predicate Device:
Manufacturer:
AirStrip OB®
AirStrip Technologies 335 E Sonterra Blvd Suite 200 San Antonio, TX 78258
510(k) Number:
OCT 9 2012
1
510(k) Summary
Description of the Device
Cerner FetaLink+ is the software application that runs on the user's iPhone or iPad. The application displays patient clinical waveform data including maternal heart rates, maternal oxygen saturation, maternal blood pressure, and uterine contractions. Within the application, the user can view annotations associated to waveform data. .
Statement of Intended Use
Cerner FetaLink+ is a software-only application intended for use on iOS mobile devices by obstetrical healthcare clinicians to view near real time the simultaneous measurement of fetal heart rate(s) and uterine contractions waveforms in one view. FetaLink+transforms the ongoing measurements into a visual wave display which conveys the frequency, duration and relative strength of uterine contractions combined with the patient data of pregnant women in the antepartum and/or intrapartum phases of pregnancy.
Summary of the technological characteristics of the device compared to the predicate device
| Company | Cerner Corporation | AirStrip Technologies |
|---|---|---|
| Model | FetaLink+ | Airstrip OB |
| System Characteristics | ||
| Operating | ||
| System | IOS 5.1 | IOS 5.0, Android, Blackberry, |
| Windows Mobile | ||
| Operator | ||
| Interfaces | Mobile hand-held device with | |
| touch screen and virtual | ||
| keyboard | Mobile hand-held device with | |
| touch screen or keypad |
Information to support substantial equivalence claims is summarized below.
2
`
.
.
.
| Company | Cerner Corporation | AirStrip Technologies |
|---|---|---|
| Model | FetaLink+ | Airstrip OB |
| Network | ||
| Validation | ||
| Required? | Yes. It is the customer's | |
| responsibility to perform network | ||
| validation. | Yes. It is the customer's | |
| responsibility to perform network | ||
| validation. | ||
| Patient List | View census (all laboring | |
| patients), grouped by location. | ||
| Displays the following | ||
| demographic information on the | ||
| patient list: | ||
| Patient First Name Patient Middle Name Patient Last Name Patient Age Physician Name Patient Photo | View census (all laboring | |
| patients), grouped by location. | ||
| Displays the following | ||
| demographic information on the | ||
| patient list: | ||
| Patient First Name Patient Middle Name Patient Last Name Patient Age Physician Name | ||
| Target | ||
| Population | Pregnant patients monitored on | |
| various fetal monitoring medical | ||
| devices | Pregnant patients monitored on | |
| various fetal monitoring medical | ||
| devices | ||
| Company | Cerner Corporation | AirStrip Technologies |
| Model | FetaLink+ | Airstrip OB |
| Clinical Data | Displays the following clinical | |
| information relevant to | ||
| pregnancy: | ||
| • Gravida | ||
| • Para | ||
| • Maternal Temperature | ||
| • Maternal Pulse | ||
| • Maternal Systolic BP | ||
| • Maternal Diastolic BP | ||
| • Maternal SPO2 | ||
| • Cervical Dilation | ||
| • Cervical Effacement | ||
| • Fetal Station | ||
| • Fetal Count | ||
| • Membrane Status | ||
| • Epidural Status | ||
| • EDD | ||
| • EGA | Displays the following clinical | |
| information relevant to | ||
| pregnancy: | ||
| • Gravida | ||
| • Para | ||
| • Maternal Temperature | ||
| • Maternal Pulse | ||
| • Maternal Systolic BP | ||
| • Maternal Diastolic BP | ||
| • Maternal SPO2 | ||
| • Cervical Dilation | ||
| • Cervical Effacement | ||
| • Fetal Station | ||
| • Fetal Count | ||
| • Membrane Status | ||
| • Epidural Status | ||
| • EDD | ||
| Live waveform | ||
| data | Graphical display of fetal heart | |
| rates and contraction data in | ||
| near real time. Specifically: Will | ||
| display the following read-only | ||
| waveform elements: | ||
| • Baby 1 Heart Rate | ||
| Waveform Data | ||
| • Baby 2 Heart Rate | ||
| Waveform Data | ||
| • Baby 3 Heart Rate | ||
| Waveform Data | ||
| • Baby 4 Heart Rate | ||
| Waveform Data | ||
| • Maternal Uterine Activity | ||
| Waveform Data | ||
| • Annotations | Graphical display of fetal heart | |
| rates and contraction data in | ||
| near real time. Specifically: Will | ||
| display the following read-only | ||
| waveform data elements: | ||
| • Baby 1 Heart Rate | ||
| Waveform Data | ||
| • Baby 2 Heart Rate | ||
| Waveform Data | ||
| • Maternal Uterine Activity | ||
| Waveform Data | ||
| • Annotations | ||
| Company | Cerner Corporation | AirStrip Technologies |
| Model | FetaLink+ | Airstrip OB |
| Historical view | ||
| of waveform | ||
| data | Ability to navigate to view | |
| historical waveform data of the | ||
| current monitored episode. | ||
| Specifically: Will display the | ||
| following read-only historical | ||
| waveform data elements: | ||
| Baby 1 Heart Rate | ||
| Waveform Data Baby 2 Heart Rate | ||
| Waveform Data Baby 3 Heart Rate | ||
| Waveform Data Baby 4 Heart Rate | ||
| Waveform Data Maternal Uterine Activity | ||
| Waveform Data Annotations | Ability to navigate to view | |
| historical waveform data of the | ||
| current monitored episode. | ||
| Specifically: Will display the | ||
| following read-only historical | ||
| waveform data elements: | ||
| Baby 1 Heart Rate | ||
| Waveform Data Baby 2 Heart Rate | ||
| Waveform Data Maternal Uterine Activity | ||
| Waveform Data Annotations |
.
.
· . ·
:
.
.
3
·
·
・
.
.
.
: :
.
・
·
:
.
.
・
:
:
:
:
・
·
4
Like Airstrip OB, Cerner FetaLink+ is designed to be used by obstetrical health providers in a clinical setting. Both systems share the capabilities listed below:
- · Provide a dynamic near real time view of the graphical display of the relationship between fetal heart rates and contraction data which can be accessed remotely using a hand held device
Summary of Performance Testing
The testing performed was intended to ensure the functional requirements have been implemented and that hazards identified in the Device Hazard Analysis have been mitigated.
Cerner's validation demonstrated that all functional requirements and hazard analysis software mitigations for Cerner FetaLink+ were executed and the expected results achieved. Based on the results of the testing performed, Cerner FetaLink+ was evaluated to be a safe and effective device for use in a live patient environment.
5
Cerner Corporation
As part of the development and release process, the software goes through internal testing, which includes the following:
- . Unit Testing (Verification)
- . Functional Testing (Validation)
- Regression Testing .
- Exploratory Testing .
- Assembly Testing ●
Conclusions
Functional testing, which validated that all functional requirements for the software have been met, were completed prior to formative and summative usability with no outstanding issues identified.
Formative and summative usability, which involved task-based walkthroughs and post-test questionnaire, evaluated possible use errors in the user interface. Based on the results, changes were implemented to mitigate identified use errors.
The results of summative usability and the mitigations applied based on those results show that residual risk has been reduced as low as reasonably practicable.
Interference testing was completed in order to identify and mitigate any risks of interference from clinical or non-clinical devices used in close proximity to the mobile device on which the software resides.
FetaLink+has been found to be adequately safe and effective for the intended users, its intended uses, and use environments.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
OCT
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
9 2012
Ms. Shelley S. Looby. MT(ASCP)BB Director, Regulatory Affairs/Quality Assurance Cerner Corporation 10234 Marion Park Drive KANSAS CITY MO 64137
Re: K121758
Trade/Device Name: Cerner FetaLink+TM Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: September 17, 2012 Received: September 19, 2012
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. 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
7
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,
Sincerely yours,
Benjamin K. Evans
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
8
Indications for Use
510(k) Number (if known): K121758 Device Name: Cerner FetaLink+ ™
Indications for Use:
Cerner FetaLink+ is a software-only application intended for use on iOS mobile devices by obstetrical healthcare clinicians to view near real time the simultaneous measurement of fetal heart rate(s) and uterine contractions waveforms in one view. FetaLink+transforms the ongoing measurements into a visual wave display which conveys the frequency, duration and relative strength of uterine contractions combined with the patient data of pregnant women in the antepartum and/or intrapartum phases of pregnancy.
Prescription Use X ._ (Part 21 CFR 801 Subpart D) Over-The-Counter Use n.a. (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Denjar.
(Division Sign-Of
Concurrence of CDRH, Office of Device Evaluation (ODE)
090 2012
AND/OR
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121758