MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM

K014094 · Hill-Rom Manufacturing, Inc. · HGM · Jan 11, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K014094
• Device Name: MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
• Applicant: Hill-Rom Manufacturing, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jan 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The intended use of the WatchChild™ Obstetrical Patient Data Management System is a complete Obstetrical Information System which has the ability to record, store, and display data from fetal monitors and maternal vital signs monitors, and manages patient information from the initial Fetal Stress Tests through post delivery discharge. Information from the system organizes clinical data, which would normally be provided on paper records or other clinical systems and devices. This system serves as a decision support tool as well as an electronic medical record. This device is intended for use in a hospital/clinical environment.

Device Story

WatchChild™ System is an obstetrical information management system; records, stores, and displays fetal and maternal data from fetal monitors and vital signs monitors. Inputs include fetal monitoring signals, maternal vital signs, and manual entries (nursing/physician notes, ADT data). System features GUI with light pen or mouse interaction; utilizes WORM technology for data storage, replacing paper records. Used in hospital/clinical settings by clinicians. Provides real-time and trended data display; supports remote physician access for viewing and annotating fetal strips. Acts as electronic medical record and decision support tool; facilitates clinical workflow by centralizing patient data from admission through discharge.

Clinical Evidence

No clinical data. Bench testing only for software verification and validation.

Technological Characteristics

Obstetrical information management system; utilizes WORM (Write Once Read Many) technology for data storage. Interfaces with fetal and maternal vital signs monitors. Supports standalone installation or integration with Hospital Information Systems. GUI-based interface with light pen or mouse input. Prescription use device.

Indications for Use

Indicated for use in hospital/clinical environments for the management of obstetrical patient data, including fetal and maternal vital signs, from initial fetal stress tests through labor, delivery, and post-delivery discharge.

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

• WatchChild™ Obstetrical Patient Data Management System (K974248)

Submission Summary (Full Text)

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Hill-Rom Manufacturing, Inc. The WatchChild™ System

K014094
Page 1 of 3

JAN 1 1 2002

| NAME | Hill-Rom Manufacturing |
|------------------------|------------------------------------------------------------------|
| ADDRESS | 11000 Regency Parkway<br>West Tower, Suite 205<br>Cary, NC 27511 |
| TELEPHONE: | 919/468-2300 |
| FAX | 919/468-2335 |
| CONTACT | Ms. Cindy L. Crosby |
| DATE SUMMARY PREPARED: | December 7, 2001 |

DEVICE NAME

| Proprietary Name: | The WatchChild ^TM Obstetrical Patient Data<br>Management System |
|----------------------|----------------------------------------------------------------------------|
| Trade Name: | The WatchChild ^TM System |
| Classification Name: | Perinatal Monitoring System and Accessories |

### PREDICATE DEVICE

The device to which Hill-Rom is claiming substantial equivalence is the WatchChild™ Obstetrical Patient Data Management System cleared for marketing by FDA in 510(k) K974248 on October 7, 1998.

# DESCRIPTION OF DEVICE

The WatchChild™ Obstetrical Patient Data Management System (The WatchChild™ System) is a complete Obstetrical Information Management System that has the capability to record, store, and display fetal and maternal data from initial fetal stress tests through labor, delivery and discharge. Specifically, data from fetal monitoring and maternal vital signs monitoring equipment can be recorded, stored, and displayed on the WatchChild System via automation of the following areas:

- . Admission/Discharge/Transfer (ADT)
- Labor and Delivery notes ●
- Nursing notes ●

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K014094
Page 2 of 3

### Hill-Rom Manufacturing, Inc. The WatchChild™ System

- Physician's notes .
- Fetal Strip faxing ●
- r etail Obstetrical trend reports (e.g., patient enrollments and discharges over . time)

The WatchChild™ System has the ability to simultaneously display graphic and text The Viatenonilia - Oystem has the clinician to view a patient's fetal strip along with her medical data. Interaction with the WatchChild™ System is accomplished with her modiour data. Interface (GUI). The user activates buttons on the screen through a graphiodi ason internationse. The WatchChild™ System is offered with an utilizing entrer a light pon of a modeo. WORM technology) that replaces conventional paper storage. In addition, an optional physician's remote access is also available. paper storage. In addition, a physician can call from outside the hospital and display real time and/or trended data for any patient connected to the system, as well as perform annotations to the patient's fetal strip.

The WatchChild™ System can be installed as a stand-alone system or connected to the Hospital's Information System.

#### INTENDED USE

The intended use of the WatchChild™ Obstetrical Patient Data Management System is a complete Obstetrical Information System which has the ability to record, store, lo a complete one from fetal monitors and maternal vital signs monitors, and manages and display data from the initial Fetal Stress Tests through post delivery discharge. pation. Information from the manizes clinical data, which would normally be provided on over records or other clinical systems and devices. This system serves as a on paper roomas or carell as an electronic medical record. This device is intended for use in a hospital/clinical environment.

Consistent with 21 CFR §801.109, the WatchChild ™ System is considered a prescription use device.

# COMPARISON OF DEVICE TECHNOLOGICAL CHARACTERISTICS TO PREDICATE DEVICE

The WatchChild™ System that is subject of this submission is equivalent to the predicate device indicated above. The system has the same capabilities to record, display, and archive data collected from fetal and maternal monitors, nurse's and doctor's notes and annotations.

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# Hill-Rom Manufacturing, Inc. The WatchChild™ System

K014094
Page 3 of 3

# NONCLINICAL TESTING

Testing was conducted to verify and validate the software.

# CLINICAL TESTING

Clinical testing is not applicable for this device.

# CONCLUSIONS

It is our conclusion that the data presented in this submission demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three overlapping human profiles.

ood and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850

JAN 1 1 2002

Ms. Cindy L. Crosby Executive Director Quality Assurance and Regulatory Affairs Hill-Rom® Company, Inc. 11000 Regency Parkway West Tower, Suite 205 CARY NC 27511

Re: K014094 Trade/Device Name: The WatchChild™ Obstetrical Patient Data Management System Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: 85 HGM Dated: December 7, 2001 Received: December 12, 2001

Dear Ms. Crosby:

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); 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.

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This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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510(k) Number (if known) K0114094

Device Name: The WatchChild™ Obstetrical Patient Data Management System

#### Indications For Use:

The intended use of the WatchChild™ Obstetrical Patient Data Management System is a The intendou ado of the mation system which has the ability to record, store, and complete obsternear information of consisted with signs monitors, and manages patient information from the initial fetal stress tests through post delivery discharge. Information from the inklarical data, which would normally be provided on paper Viaturemia - organizes olimour adde, this system serves as a decision support records of other official ofetened cal record. This device is intended for use in a hospital/clinical environment.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _

Sauce W. Sherrel for N.Bogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices