(240 days)
The VitalConnect Platform is a wireless monitoring system intended for use by healthcare professionals for unattended surveillance of physiological data within healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters.
The device is not intended to be used on critical care patients and is intended to supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older. It is not intended for home use.
The VitalConnect Platform is a wireless data collection system that monitors physiological data and consists of the following sub systems:
• VitalConnect Sensor (includes adhesive Patch and Sensor Module)
• Relay Software Library
• Server Software Library
VitalConnect Platform sub-system includes: VitalConnect Sensor . a) Patch The Patch is designed as a disposable self-adhesive interface to the body. b) Sensor Module Residing within the patch, the sensor module performs processing functions related to capture of physiological data and also performs bi-directional communication with the relay device. VitalConnect Relay Software Library ● The Relay Software Library manages bi-directional communication between the Sensor Module and the Server Software Library and is installed on a relay device. VitalConnect Secure Server Software Library . The Server Software Library is installed on a central server, manages the upload, processing and storage of sensor data, as well as real-time configuration of and notifications from the VitalConnect Platform. The VitalConnect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via a bi-directional relay to the central server. The VitalConnect Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver module, worn on the torso to record heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall) for in-patient use.
The VitalConnect Platform (K132447) is a wireless monitoring system intended for use by healthcare professionals for unattended surveillance of physiological data within healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria for each physiological parameter. Instead, it states that "The results of the non-clinical and clinical studies demonstrate that the VitalConnect Platform is safe and effective for its intended use" and that the device is "substantially equivalent to the currently marketed predicate devices" based on intended use and product performance.
However, the non-clinical testing section lists the parameters for which testing was conducted, implying that the device's performance for these parameters was evaluated for accuracy and safety. For the purpose of this analysis, we will infer the "reported device performance" as the successful completion of these tests, leading to the substantial equivalence determination.
| Physiological Parameter / Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing: | ||
| Electrocardiograph (ECG) | Met industry standards for ECG monitoring and safety. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. |
| Heart rate | Met industry standards for heart rate measurement accuracy. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. |
| Heart rate variability | Met industry standards for heart rate variability measurement. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. |
| Respiration rate | Met industry standards for respiration rate measurement accuracy. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. |
| Body impedance | Met industry standards, if applicable, for measurement. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. |
| Activity (step count) | Met industry standards for activity tracking accuracy. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. (The predicate device K083287, Corventis, Mobile Patient Management System, is specifically mentioned for Activity and Posture comparison, implying similar performance expectations.) |
| Posture (body position, fall) | Met industry standards for posture detection and fall alerts. | Bench testing conducted; deemed safe and effective and substantially equivalent to predicate devices. (The predicate device K083287, Corventis, Mobile Patient Management System, is specifically mentioned for Activity and Posture comparison, implying similar performance expectations.) |
| Bluetooth verification | Successful communication and data transfer. | Bench testing conducted. |
| Notification | Timely and accurate alerts when parameters are outside limits. | Bench testing conducted. |
| Measurement accuracy | As defined by relevant standards for each parameter. | Bench testing conducted. (This is a general category covering the accuracy of the physiological measurements listed above). |
| Communication, data transmission and storage | Reliable and secure data flow and storage. | Bench testing conducted. |
| Reliability | Consistent and dependable operation. | Bench testing conducted. |
| Electromagnetic compatibility | Compliance with EMC standards. | Bench testing conducted. |
| Electrical safety testing | Compliance with IEC 60601-1 and related standards. | Bench testing conducted. |
| Co-existence testing | No adverse interference with other medical devices. | Bench testing conducted. |
| Software verification and validation | Software functions as intended, safely and effectively. | Bench testing conducted. |
| Biocompatibility verification and testing | No adverse biological reactions from device contact. | Bench testing conducted. |
| Clinical Testing: | Safe and effective for intended use in human subjects. | Clinical study performed on human subjects; results demonstrate safety and effectiveness, supporting substantial equivalence. The summary doesn't detail specific metrics (e.g., sensitivity, specificity, accuracy) from the clinical study, but concludes it demonstrated the device is safe and effective for its intended use. |
2. Sample Size Used for the Test Set and the Data Provenance
The 510(k) summary states that "Clinical study was performed on human subjects" but does not provide any details regarding the sample size used for the test set.
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided document. It only indicates that the study was "performed on human subjects."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The 510(k) summary does not provide information on the number of experts used, their qualifications, or how ground truth was established for the clinical study. Given the nature of physiological monitoring, ground truth would likely be established by simultaneously using validated, reference-standard monitoring equipment.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not mentioned or implied. The device is a physiological monitoring system, not an imaging diagnostic device that typically involves human readers interpreting cases. Therefore, the concept of human readers improving with AI assistance is not directly applicable in the context of this device as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physiological monitoring system that captures and processes data. The non-clinical "bench testing" of parameters like heart rate, ECG, respiratory rate, etc., represents a standalone performance evaluation of the device's algorithms and sensors without direct human intervention in the continuous data capture and processing (though humans would be setting up the test and evaluating the output). The clinical study, while involving human subjects, evaluates the device's performance in a real-world setting, also largely as a "standalone" system in terms of its ability to collect and transmit physiological data. The system is designed to provide unattended surveillance and notify healthcare professionals, implying its algorithms operate independently to detect deviations.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the type of ground truth used. However, for physiological monitoring devices, ground truth for parameters like heart rate, ECG, respiration rate, and temperature would typically be established using:
- Reference standard medical devices: e.g., a calibrated ECG machine for heart rate and ECG, a capnograph or spirometer for respiration, a precision thermometer for skin temperature.
- Direct observation/manual counting: for respiration rate.
- Known physical movements/positions: for activity and posture.
While not stated, it is highly probable that validated, higher-accuracy reference devices were used in parallel during the clinical study to establish ground truth for comparison.
8. The Sample Size for the Training Set
The 510(k) summary does not mention a separate training set or its sample size. This device is primarily a physiological sensor and data transmission platform, not a machine learning-based diagnostic algorithm that typically requires a distinct training phase on a large dataset. While its internal algorithms (e.g., for heart rate variability, or detecting fall) would have been developed and tested, the document focuses on the validation studies rather than the development phase data.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned (see point 8), the method for establishing its ground truth is not provided. If internal algorithm development involved data, it would logically follow similar ground truth establishment methods as for the clinical validation, likely using reference standard devices.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).