WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM

K974248 · Air-Shields, Inc. · HGM · Oct 7, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K974248
• Device Name: WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
• Applicant: Air-Shields, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Oct 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The WatchChild™ System is a complete Obstetrical Information Management 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. WatchChild 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™ is an obstetrical patient data management system used in hospital/clinical settings. It interfaces with fetal monitors and maternal vital signs monitors to record, display, and archive clinical data, including fetal monitor waveforms, maternal NIBP, SaO2, heart rate, patient charting, lab results, and medication records. The system automatically polls NIBP, SaO2, and heart rate at hospital-defined intervals. Hardware includes an IBM RISC System/6000, redundant disk drives, X-terminal graphics workstation, optical disk drive, and laser printer. The system functions as an electronic medical record and decision support tool, organizing data for clinician review to assist in patient management from fetal stress testing through discharge.

Clinical Evidence

No clinical data provided. Software verification and validation were performed via bench testing.

Technological Characteristics

Computer-based system utilizing IBM RISC System/6000 hardware, redundant disk drives, X-terminal graphics workstation, optical disk drive, and laser printer. Interfaces with fetal and maternal monitors to archive waveforms and vital signs. Software-based data management and decision support.

Indications for Use

Indicated for use in hospital/clinical environments to manage obstetrical patient data, including fetal monitor data and maternal vital signs, from initial fetal stress tests through 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

• Original WatchChild System (K893981)
• AMS DASTAR (Unknown)
• OB Trac Vue (K970456)
• Peritronics 9000C (K870692)
• Quantitative Sentinel (K960109)
• Cygnet Central (K903992)

Submission Summary (Full Text)

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510(k) Submission

| Submitter: | Air-Shields Information Systems |
|------------|-------------------------------------------------------------------------|
| | Marci L. Goldfinger, Director, Quality Assurance and Regulatory Affairs |
| | 330 Jacksonville Road |
| | Hatboro, PA 19040 |
| Phone: | 215-675-5200 |
| Fax: | 215-675-1859 |

Date summary was prepared: November 11, 1997

Name(s) of the device: WatchChild™ Obstetrical Patient Data Management System

Six predicate devices are identified in the Identification of predicate device(s) submission. They include:

| K893981 | Original WatchChild System |
|---------|----------------------------|
| Unknown | AMS DASTAR |
| K970456 | OB Trac Vue |
| K870692 | Peritronics 9000C |
| K960109 | Quantitative Sentinel |
| K903992 | Cygnet Central |

## Description of the device:

The WatchChild™ Obstetrical Patient Data Management System is a data management system that interfaces with patient monitoring equipment to record, display and/or archive the data. The system is a computer based system that contains software for easy data storage and retrieval of fetal/maternal data. The system is comprised of, in addition to the software, an IBM RISC System/6000, redundant disk drives to assure reproducibility of information, X-terminal graphics workstation, optical disk drive, and laser printer.

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WatchChild archives all fetal monitor data, maternal hemodynamic and waveform data (NIBP and SaO2), patient charting, admission forms, examinations, flowsheets, medications, lab results, discharge information, and notes. WatchChild automatically reads NIBP, SaO,, and heart rate at hospital defined intervals.

## Intended Use

The WatchChild™ System is a complete Obstetrical Information Management 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. WatchChild 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.

## Comparison of device characteristics to predicate

The WatchChild™ Obstetrical Patient Data Management System is equivalent to the predicate devices identified above. The system has the same capabilities to record, display, archive data collected from fetal monitors and maternal monitors. The features that are common to all of the predicates are features that are contained in the WatchChild system.

## Non clinical testing:

The software was tested to verify and validate the software.

## Clinical testing:

None required

November 11, 1997 WatchChild™ Obstetrical Patient Data Managment System 长974248

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# Conclusion:

Based on the information contained in this notification, it is concluded that the WatchChild™ Obstetrical Patient Data Management System is substantially equivalent to the legally market systems.

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Image /page/3/Picture/0 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HUMAN" in a circular arrangement on the left side. On the right side, the letters "USA" are written vertically. In the center of the logo is a stylized image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### OCT 7 1998

Ms. Marci L. Goldfinger Director, Quality Assurance and Regulatory Affairs Hill:Rom® Air-Shields, Inc. 330 Jacksonville Road Hatboro, PA 19040

Re: K974248

WatchChild™ Obstetrical Patient Data Management System Dated: July 15, 1998 Received: July 17, 1998 Regulatory Class: II 21 CFR 884.2740/Procode: 85 HGM

Dear Ms. Goldfinger:

We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fectiver on , Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at [phone]. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### K974248 510(k) Number

To be assigned by FDA

Device Name: WatchChild™Obstetrical Patient Data Management System

## Indications for Use:

The WatchChild™ System is a complete Obstetrical Information Management 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. WatchChild 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

O Over-the Counter Use

\|lau Yn
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

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510(k) Number K974248/S

November 11, 1997

WatchChild
TM Obstetrical Patient Data Management System