(328 days)
The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.
VitalPatch is a wearable biosensor which may be used as part of the VitalConnect Platform. The device is a disposable, battery-powered, adhesive patch containing sensors used to gather patients' physiological data, which are transmitted wirelessly. The modification proposed in this 510(k) increases the wear duration for the VitalPatch wearable biosensor from 96 hours to 120 hours.
The provided text is a 510(k) summary for a modification to the VitalPatch® VitalConnect Platform. This submission focuses on extending the wear duration of the device from 96 hours to 120 hours. As such, the detailed information typically found in a comprehensive clinical study report, like specific acceptance criteria for diagnostic performance, sample sizes for test and training sets, expert qualifications, and adjudication methods, is not explicitly present for all physiological parameters. However, the document does list performance tests performed and the nature of the modification.
Based on the provided document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for each physiological parameter (heart rate, ECG, etc.) in the context of this specific 510(k) for extended wear duration. The focus of this submission is primarily on extending the wear duration and ensuring the device continues to function as intended without raising new questions of safety or effectiveness. The performance data mentioned relates to engineering and wear-duration aspects.
| Acceptance Criteria Category | Reported Device Performance (as stated in this 510(k) summary) |
|---|---|
| Wear Duration | Extended from 96 hours to 120 hours. |
| Electrical Safety | Passed IEC 60601-1, 3.1 Ed. |
| Electromagnetic Compatibility | Passed IEC 60601-1-2, 4th Ed. |
| Battery Performance | Internal performance testing passed. |
| Skin Adherence/Wear Duration | Internal performance testing passed for extended duration. |
| Wear Performance (Sensor Functionality) | Internal performance testing passed for extended duration. |
| Wireless Coexistence | Demonstrated compliance with FDA Radio Frequency Wireless Technology in Medical Devices guidance. |
| Firmware Verification and Validation | Complied with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. |
| Substantial Equivalence | Device remains substantially equivalent to the predicate device K152139, as the modifications do not raise different questions of safety and effectiveness. |
| Physiological Data Monitored | No change in the list of monitored vital signs: Heart rate, ECG, heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (including fall). Performance for these parameters is implicitly assumed to be maintained from the predicate device given the "no change to technological characteristics" statement. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "internal performance testing" was conducted for battery performance, skin adherence/wear duration, and wear performance (sensor functionality) in support of extending the wear duration to 120 hours. However, it does not specify the sample size for this testing.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given it was "internal performance testing" for a 510(k) for a modification (wear duration extension), it was likely prospective testing conducted by the manufacturer, Vital Connect, Inc., to validate the extended wear duration.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the use of experts or their qualifications for establishing ground truth related to the performance of physiological parameters or the extended wear duration. The performance tests mentioned (electrical safety, EMC, battery, adherence, sensor functionality, firmware) typically use objective measurements against established standards or internal benchmarks rather than expert-derived ground truth in the way a diagnostic AI algorithm might.
4. Adjudication Method for the Test Set
As no "ground truth" established by experts or human readers is explicitly mentioned for the performance tests conducted, no adjudication method is described in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted as described in this document. The submission is for a device modification (wear duration extension) of a physiological remote monitoring system, not for a diagnostic AI algorithm that typically necessitates such studies to compare human reader performance with and without AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
A standalone performance study in the context of an "algorithm only" for diagnostic purposes was not explicitly described in this 510(k) summary. The VitalConnect Platform transmits physiological data for healthcare professionals' use, and the performance tests mentioned are related to the hardware's safety, functionality, and wear duration, not a standalone diagnostic algorithm.
7. Type of Ground Truth Used
For the specific performance tests conducted in support of this 510(k) (battery performance, skin adherence/wear duration, wear performance (sensor functionality)), the ground truth would have been established through objective measurements and engineering criteria rather than expert consensus, pathology, or outcomes data. For example, battery performance would be measured against expected discharge curves, skin adherence against defined detachment thresholds, and sensor functionality against known physical or electrical standards.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This 510(k) is for a hardware modification (extended wear duration) and not for the development or modification of an AI/ML algorithm that typically requires a training set. The "firmware verification and validation" mentioned refers to ensuring the software components function correctly for the extended duration, not to the training of a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned as part of this 510(k) submission, this information is not applicable and not provided in the document.
§ 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).