(30 days)
Not Found
No
The description focuses on data management, display, and storage, with no mention of AI/ML algorithms for analysis or decision support beyond basic data organization and trend reporting. The "decision support tool" aspect appears to refer to providing organized data for human interpretation, not automated analysis.
No.
The device is described as an "Obstetrical Patient Data Management System" which records, stores, and displays data, and acts as a "decision support tool" and "electronic medical record." It does not directly treat or diagnose conditions.
No
The device is described as an "obstetrical information management system" that records, stores, and displays data. It serves as a "decision support tool" and "electronic medical record," but it does not directly perform diagnostic functions by interpreting data or identifying conditions. It manages data from other monitors, which might be diagnostic, but it is not diagnostic itself.
No
The device description explicitly mentions optional hardware components like an optical disk archiving system (WORM technology) and the need for interaction through a graphical user interface (GUI) utilizing a light pen or a mouse, indicating it is not solely software.
Based on the provided information, the WatchChild™ Obstetrical Patient Data Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for managing patient data, specifically from fetal and maternal monitors. It organizes clinical data and serves as a decision support tool and electronic medical record. This does not involve testing samples taken from the human body to provide diagnostic information.
- Device Description: The description details a system for recording, storing, and displaying data from external monitoring devices. It focuses on data management, user interface, and archiving. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of these specimens
- Reagents or assays
The WatchChild™ System is clearly described as a data management system for obstetrical care, integrating information from other medical devices. It does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
85 HGM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital/clinical environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical Testing: Testing was conducted to verify and validate the software.
Clinical Testing: Clinical testing is not applicable for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
OCT - 8 2003
Appendix 14a
510(k) SUMMARY
| Hill-Rom Manufacturing, Inc.
| The WatchChild™ System | |
|---|---|
| NAME | Hill-Rom Manufacturing |
| ADDRESS | 1225 Crescent Green |
| Suite 200 | |
| Cary, 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 Data |
| Management 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
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 ●
1
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.
2
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.
3
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.
4
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
5
Page 1 of 1
510(k) Number (if known) K062277
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 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.
(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 | ||
|---|---|---|---|---|
| ------------------------------------------ | ----------------------------------------------- | ---- | ---------------------- | -------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
Radiological Devices
510(k) Number K032772