NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912

K080226 · Hill-Rom Manufacturing, Inc. · HGM · Apr 9, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K080226
• Device Name: NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
• Applicant: Hill-Rom Manufacturing, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Apr 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

NaviCare® WatchChild™ is indicated for use in a hospital/clinical environment. NaviCare® WatchChild™ is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. NaviCare® WatchChild™ organizes clinical data that would normally be provided on paper records or other clinical systems and devices. This system also serves as a decision support tool and electronic medical record.

Device Story

NaviCare® WatchChild™ is an obstetrical data management system used in hospital/clinical settings. It interfaces with fetal and maternal vital signs monitors to record, store, and display patient data throughout the pregnancy and delivery continuum. The system aggregates clinical data, replacing traditional paper records, and functions as an electronic medical record and decision support tool. Clinicians use the system to organize patient information and facilitate clinical decision-making by providing a centralized view of maternal and fetal status. The device benefits patients by ensuring comprehensive, accessible, and organized clinical documentation throughout the obstetrical care process.

Technological Characteristics

Obstetrical data management system; software-based; integrates with fetal and maternal vital signs monitors; functions as an electronic medical record and decision support tool.

Indications for Use

Indicated for use in hospital/clinical environments for managing obstetrical patient data from prenatal care through post-delivery discharge. Intended for recording, storing, and displaying fetal and maternal vital signs.

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)

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Dawn M. Reilly, RAC Official Correspondent Manager, Regulatory Affairs & Quality Assurance Hill-Rom Manufacturing, Inc. 1225 Crescent Green, Suite 200 CARY NORTH CAROLINA 27518

APR - 9 2008

Re: K080226

Trade Name: NaviCare® WatchChild™ Obstetrical Data Management System Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: March 7, 2008 Received: March 10, 2008

Dear Ms. Reilly:

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 ass suited in also increations 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, the of tee, market the device, subject to the general controls provisions of the Act. The general thorolors, namies are CDTS 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 (Premarket 11 your al), it may be subject to such additional controls. Existing major regulations affecting your Apploval), it the 7 to sally of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Protecting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Nancy C Brogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Hill-Rom Manufacturing 1225 Crescent Green, Suite 200 Carv. North Carolina 27518

## Attachment A: Indications for Use Statement

510(k) Number: (if known)

K080224

Device Name:

NaviCare® WatchChild™

Indications for Use:

NaviCare® WatchChild™ is indicated for use in a hospital/clinical environment. NaviCare® WatchChild™ is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. NaviCare® WatchChild™ organizes clinical data that would normally be provided on paper records or other clinical systems and devices. This system also serves as a decision support tool and electronic medical record.

Prescription Use X (Per 21 CFR 801. 109) AND/OR

Over-The-Counter Use

(Per 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)

Tomitohry

Division Sign-Off) Division of Reproductive. Abdominal. and Radiological Devices 510(k) Number

HILL-ROM CONFIDENTIAL

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