(205 days)
Remote Care is a patient management web based application device for use with the Analogic FETALGARD Lite™ to record and graphically display maternal abdominal contractions and the fetal heart rate by means of a display in the format of a graphic or PDF strip file. The data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.
Remote Care is intended to be used only with the Analogic Fetalgard Lite to assist in the transmission and graphical display of maternal abdominal contractions and fetal heart rate. Remote Care receives the strip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the Remote Care web site for viewing by the health care provider.
Remote Care does not provide real-time capabilities or alerts. The device is intended for use to communicate strip data which can be used to aid in assessing the well being of the fetus in the final trimester of pregnancy. Healthcare professionals must apply clinical judgment and experience to assess the data transmitted. The device is not intended as a replacement for professional medical care. It should not be used for patients requiring emergency intervention.
Remote Care is an internet database application and repository for the storage and archival of patient information with their physiological data that relates to the Remote Care OB customers' prenatal experience. "Remote Care" receives data from the Analogic FETALGARD Lite™ and makes the data available to the medical professional through the World Wide Web.
The "Remote Care" device is an internet database application for storing, archiving, and displaying patient information with physiological data related to prenatal experience, specifically maternal abdominal contractions and fetal heart rate. It receives data from the Analogic FETALGARD Lite™ device and makes it available to medical professionals via the World Wide Web.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K050234 510(k) Summary) does not explicitly state formal acceptance criteria or quantifiable performance metrics for the "Remote Care" device. Instead, the "Discussion of functional testing" section generally states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional compliance to specifications | Tests have been conducted and successfully completed |
| Performance comparison to the predicate device | Tests have been conducted and successfully completed |
The primary "performance" discussed is the comparison of features between "Remote Care" and its predicate device, Analogic FETALGARD Lite™. This comparison indicates that "Remote Care" offers more advanced features like increased security, a scalable patient database solution, and World Wide Web accessibility.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size used for a test set. There is no mention of patient data (e.g., number of cases, geographical origin) being used for formal testing of the "Remote Care" system's accuracy or efficacy. The "functional testing" appears to refer to internal verification that the system operates as designed and functions similarly to the predicate device in terms of displaying data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a "ground truth" for a test set. Since the functional testing focuses on the system's ability to receive and display data from the monitoring device, rather than diagnostic accuracy, this type of expert assessment is not described.
4. Adjudication Method:
No adjudication method is mentioned, as there is no description of a clinical study involving interpretation or evaluation of data by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The submission focuses on the "Remote Care" system as an accessory for data transmission and display, not as a diagnostic aid that would involve human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document does not describe a standalone performance study. The device is explicitly stated to "aid in assessing the well being of the fetus" and that "Healthcare professionals must apply clinical judgment and experience to assess the data transmitted." This indicates it's designed as a tool for human professionals, not for independent diagnostic decisions.
7. Type of Ground Truth Used:
No specific "ground truth" (e.g., pathology, outcomes data) is mentioned in relation to the functional testing of the "Remote Care" system. The testing likely focused on the technical fidelity of data transmission and graphical representation in comparison to the predicate device.
8. Sample Size for the Training Set:
The document does not refer to a "training set." The "Remote Care" device is an internet database application and display system, not a device that employs machine learning or AI that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set or machine learning components are described in the provided information.
§ 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).