CERNER FETALINK (VERSION 1.0)

K091251 · Cerner Corp. · HGM · Aug 25, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K091251
• Device Name: CERNER FETALINK (VERSION 1.0)
• Applicant: Cerner Corp.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Aug 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Cerner FetaLink is a software application for obstetrical monitoring. It receives fetal heart rate and uterine contraction data from fetal monitoring devices. The software displays this data graphically, allowing clinicians to visualize the relationship between contractions and fetal heart rate. It provides alerts for data trends falling outside of pre-defined reference ranges. Used in hospitals and clinics at the bedside, central nursing stations, or remote locations by obstetrical healthcare professionals. The output assists clinicians in monitoring labor progress and making clinical decisions regarding patient care.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Software application for perinatal monitoring. Functions as a display and alerting system for fetal heart rate and uterine contraction data. Operates via integration with existing fetal monitoring hardware. Connectivity includes bedside, central station, and remote access.

Indications for Use

Indicated for pregnant women in antepartum and/or intrapartum phases of pregnancy, monitored by obstetrical healthcare professionals in hospital or clinic settings.

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.

Submission Summary (Full Text)

{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 [phone] or [phone] 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