(329 days)
Not Found
No
The description focuses on data management, storage, and display, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as an "Obstetrical Information Management System" and "data management system" that records, stores, and displays data from other monitors. It acts as a "decision support tool" and "electronic medical record," but it does not directly treat or diagnose any medical condition.
No
Explanation: The device is described as an "Obstetrical Information Management System" that records, stores, and displays data from fetal and maternal monitors, and manages patient information. It serves as a "decision support tool as well as an electronic medical record." While it organizes clinical data and supports decision-making, it does not explicitly state that it performs a diagnostic function or provides a diagnosis. Its primary role appears to be data management and information organization.
No
The device description explicitly states that the system is comprised of software in addition to hardware components such as an IBM RISC System/6000, redundant disk drives, X-terminal graphics workstation, optical disk drive, and laser printer.
Based on the provided information, the WatchChild™ System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- WatchChild's Function: The WatchChild™ System is described as an Obstetrical Information Management System. Its primary function is to record, store, and display data from fetal monitors and maternal vital signs monitors. It also manages patient information and serves as a decision support tool and electronic medical record.
- Lack of Sample Analysis: The description does not mention the system analyzing any biological samples from the patient. It interfaces with monitoring equipment that collects physiological data directly from the patient.
Therefore, the WatchChild™ System falls under the category of a medical device that manages and displays patient data, rather than an in vitro diagnostic device that analyzes biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HGM
Device Description
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. 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical testing: The software was tested to verify and validate the software.
Clinical testing: None required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K893981, Unknown, K970456, K870692, K960109, K903992
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
1/3
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.
1
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
2
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.
3
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 (301) 594-4613. Additionally, for question 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" (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 (800) 638-2041 or (301) 443-6597 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
4
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
==============================================================================================================================================================================
510(k) Number K974248/S
November 11, 1997
WatchChild
TM Obstetrical Patient Data Management System