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. The WatchChild™ 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 Description

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 ●
. Physician's notes
Fetal Strip faxing .
Obstetrical statistical trend reports, e.g., patient enrollments and discharges over ● time
The WatchChild™ System has the ability to simultaneously display graphic and text data on the same screen permitting the clinician to view a patient's fetal strip along with her medical data. Interaction with The WatchChild™ System is accomplished through a graphical user interface (GUI). The user activates buttons on the screen utilizing either a light pen or a mouse. The WatchChild™ System is offered with an optional optical disk archiving system (WORM technology) that replaces conventional paper storage. In addition, an optional physician's remote access is also available. Using a personal computer, 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.

AI/ML Overview

The provided text is a 510(k) summary for the WatchChild™ Obstetrical Patient Data Management System. It explicitly states that clinical testing is not applicable for this device. As such, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in a clinical context.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not applicable/not provided for clinical performance as clinical testing was deemed unnecessary. The submission focuses on substantial equivalence to a predicate device and software verification/validation.
Reported Device Performance: Not applicable for clinical performance. The device's performance is described in terms of its features and capabilities (recording, storing, displaying data, organizing clinical information, decision support, EMR functionality).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as no clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no clinical test set was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is an information management system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable for clinical performance. The "standalone" mentioned refers to its ability to be installed as a standalone system or integrated with hospital information systems, not its performance as an algorithm without human interaction for clinical decision-making.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical performance. The "ground truth" for this device would relate to the accuracy of data acquisition, storage, and display, which would be verified through software testing and functional validation, not clinical ground truth like pathology.

8. The sample size for the training set

Not applicable as no machine learning/AI training set is mentioned for this device.

9. How the ground truth for the training set was established

Not applicable as no machine learning/AI training set is mentioned for this device.

Summary of what is present:

Nonclinical Testing: "Testing was conducted to verify and validate the software." This is the only type of "testing" mentioned.
Predicate Device: The system is compared to "The WatchChild™ System Obstetrical Patient Data Management System cleared for marketing by FDA in 510(k) K014094 on January 11, 2002." The submission claims substantial equivalence based on having "the same capabilities to record, display, and archive data collected from fetal and maternal monitors, nurse's and doctor's notes and annotations."
Conclusion: The manufacturer concluded that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device."

In essence, this is a re-submission or update of an existing device, and the regulatory pathway chosen (510(k)) and the nature of the device (data management system) meant that clinical effectiveness studies were not required to demonstrate substantial equivalence. The focus was on software validation and functional equivalence to the predicate device.

Summary

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OCT - 8 2003

Appendix 14a

510(k) SUMMARY

Hill-Rom Manufacturing, Inc.The WatchChild™ System
NAME	Hill-Rom Manufacturing
ADDRESS	1225 Crescent GreenSuite 200Cary, NC 27511
TELEPHONE:	919/854-3600
FAX	919/854-3217
CONTACT	Ms. Cindy L. Crosby
DATE SUMMARY PREPARED:	September 3, 2003
DEVICE NAME
Proprietary Name:	The WatchChild™ Obstetrical Patient DataManagement System
Trade Name:	The WatchChild™ System
Classification Name:	Perinatal Monitoring System and Accessories

PREDICATE DEVICE

The device to which Hill-Rom is claiming substantial equivalence is The WatchChild™ System Obstetrical Patient Data Management System cleared for marketing by FDA in 510(k) K014094 on January 11, 2002.

DESCRIPTION OF DEVICE

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

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Appendix 14a

. Physician's notes
Fetal Strip faxing .
Obstetrical statistical trend reports, e.g., patient enrollments and discharges over ● time

The WatchChild™ System has the ability to simultaneously display graphic and text data on the same screen permitting the clinician to view a patient's fetal strip along with her medical data. Interaction with The WatchChild™ System is accomplished through a graphical user interface (GUI). The user activates buttons on the screen utilizing either a light pen or a mouse. The WatchChild™ System is offered with an optional optical disk archiving system (WORM technology) that replaces conventional paper storage. In addition, an optional physician's remote access is also available. Using a personal computer, 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, 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. The WatchChild™ 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.

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.

NONCLINICAL TESTING

Testing was conducted to verify and validate the software.

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K032772, page 3 of 3

Appendix 14a

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 shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted as three curved lines forming a shape resembling a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

Public Health Service

OCT - 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cindy L. Crosby Executive Director, Quality Assurance and Regulatory Affairs Hill-Rom Company, Inc. 1225 Crescent Green, Suite 200 CARY NC 27511

Re: K032772

Trade/Device Name: The WatchChildTM Obstetrical Patient Data Management System Version 7.2.0 Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: 85 HGM

Dated: September 5, 2003 Received: September 8, 2003

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 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 (800) 638-2041 or (301) 443-6597 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

Enclosure

Page 2

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Page 1 of 1

510(k) Number (if known) K062277

Device Name: The WatchChild™ Obstetrical Patient Data Management System

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)		OR	Over-The-Counter Use
------------------------------------------	-----------------------------------------------	----	----------------------	--------------

Signature
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

Radiological Devices
510(k) Number K032772

Regulation Number and Section

§ 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).