Who is the manufacturer of CERNER FETALINK+(VERSION1.0)?

Cerner Corp. filed the 510(k) submission for CERNER FETALINK+(VERSION1.0) (K121758).

What is the FDA product code for CERNER FETALINK+(VERSION1.0)?

HGM. It is classified under 21 CFR 884.2740 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for CERNER FETALINK+(VERSION1.0)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CERNER FETALINK+(VERSION1.0)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CERNER FETALINK+(VERSION1.0)

K121758 · Cerner Corp. · HGM · Oct 9, 2012 · Obstetrics/Gynecology

Device Facts

Record ID	K121758
Device Name	CERNER FETALINK+(VERSION1.0)
Applicant	Cerner Corp.
Product Code	HGM · Obstetrics/Gynecology
Decision Date	Oct 9, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.2740
Device Class	Class 2
Attributes	Software as a Medical Device

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.

Device Story

Cerner FetaLink+ is a software application for iOS devices (iPhone/iPad) used by obstetrical clinicians to remotely view near-real-time fetal and maternal monitoring data. The device receives waveform data (fetal heart rates, uterine contractions) and clinical patient information (e.g., maternal vitals, cervical status) from existing hospital fetal monitoring systems. It transforms these inputs into a visual waveform display and patient census list. Clinicians use the mobile interface to monitor laboring patients, view historical waveform data, and check annotations. The device facilitates clinical decision-making by providing remote access to patient status, allowing clinicians to assess the frequency, duration, and strength of contractions alongside fetal heart rate patterns. It is intended for use in clinical environments where network validation has been performed by the customer.

Clinical Evidence

Bench testing only. Validation included unit, functional, regression, exploratory, and assembly testing to ensure functional requirements and hazard mitigations were met. Formative and summative usability testing with task-based walkthroughs and questionnaires evaluated user interface errors, leading to design refinements. Interference testing confirmed no adverse impact from proximity to other clinical devices.

Technological Characteristics

Software-only application for iOS 5.1. Operates on mobile handheld devices with touchscreen/virtual keyboard. Displays read-only waveform data and patient clinical information. Connectivity requires customer-performed network validation. No specific hardware materials or energy sources; relies on host mobile device hardware.

Indications for Use

Indicated for obstetrical healthcare clinicians to monitor pregnant patients in antepartum and/or intrapartum phases. Displays fetal heart rate(s) and uterine contraction waveforms, plus maternal clinical data.

Regulatory Classification

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.

Predicate Devices

AirStrip OB® (K090269)

Submission Summary (Full Text)

{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: K090269 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

CERNER FETALINK+(VERSION1.0)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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CERNER FETALINK+(VERSION1.0)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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