(329 days)
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.
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.
The WatchChild™ Obstetrical Patient Data Management System is a data management system designed to interface with patient monitoring equipment to record, display, and archive fetal/maternal data. It functions as a complete Obstetrical Information Management System and a decision support tool, intended for use in a hospital/clinical environment.
Here's an analysis of its acceptance criteria and the study proving it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
As per the provided document, the device's acceptance criteria are primarily based on its substantial equivalence to six predicate devices. Therefore, the "performance" in this context refers to its ability to perform similar functions and produce comparable data to these established systems.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from "Comparison of device characteristics to predicate") |
|---|---|
| Ability to record data from fetal monitors | Has the same capabilities to record data from fetal monitors |
| Ability to record data from maternal vital signs monitors | Has the same capabilities to record data from maternal monitors |
| Ability to display data from fetal monitors | Has the same capabilities to display data from fetal monitors |
| Ability to display data from maternal vital signs monitors | Has the same capabilities to display data from maternal monitors |
| Ability to archive data from fetal monitors | Has the same capabilities to archive data from fetal monitors |
| Ability to archive data from maternal vital signs monitors | Has the same capabilities to archive data from maternal monitors |
| Manage patient information from initial Fetal Stress Tests through post-delivery discharge | Manages patient information from initial Fetal Stress Tests through post-delivery discharge |
| Organize clinical data similar to paper records or other clinical systems | Organizes clinical data which would normally be provided on paper records or other clinical systems and devices |
| Serve as a decision support tool | Serves as a decision support tool |
| Serve as an electronic medical record | Serves as an electronic medical record |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not mentioned. The document explicitly states "Clinical testing: None required."
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical testing or ground truth establishment by experts was performed for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The document states "Clinical testing: None required." The device is cleared based on substantial equivalence and non-clinical software verification and validation, not a comparative effectiveness study involving human readers.
- Effect Size of Human Readers Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: No. While the device is a "system" with software, the evaluation was not a standalone algorithm performance study in the sense of demonstrating diagnostic accuracy or efficacy. The "non clinical testing" refers to software verification and validation, not a performance study against a reference standard.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No specific ground truth (like expert consensus, pathology, or outcomes data) was established or used for performance evaluation, as no clinical testing was required in this submission. The "ground truth" for showing equivalence was the functionality and capabilities of the predicate devices.
8. Sample Size for the Training Set
- Sample Size: Not applicable/Not mentioned. No details on a "training set" are provided as this is a software system for data management and display, not an AI/ML diagnostic or predictive algorithm that typically requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable. There is no mention of a training set or ground truth for such a set.
§ 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).