(168 days)
The zensor monitoring device is a small, lightweight, wearable battery operated system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient's body.
The device is to be used in the home environment to provide clinicians with patient physiological data.
The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients.
The zensor monitoring system displays ECG and respiration waveforms from the reserver. The system monitors the following configurable physiological parameters: Heart Rate, as well as key cardiac arrhythmias, and a patient activated recording.
The zensor monitoring system has the option to store full disclosure ECG. Respiration and accelerometer data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronine system for review by healthcare practitioners. All physiological data stored on the device can be imported for viewing on Intelesens zensor+ (Ambulatory Full Disclosure ECG and Event Viewer) for later analysis by a clinician.
The zensor system includes the following components:
- zensor device a wireless (Wi-Fi) monitoring device .
- . Adherent electrode array
Software
- . zensor App for configuration of device settings
- . zensoronline web based monitoring application identical to Canberra cleared in K110015 and K131000 except for name change and support of zensor functionality.
- zensor+, full disclosure and event data viewing PC software .
The zensor also includes a standalone battery charger. Charging does not / cannot occur when the zensor device is connected to a patient.
The zensor device monitors physiological parameters and is a wireless, wearable ECG and respiratory monitor. It is a small, battery-operated system comprised of the zensor monitoring unit (a body worn transmitter device), the zensor electrode array, and zensor battery pack. The zensor device is connected to the electrode array via magnetic studs, and the array is positioned as appropriate on the patient's body. The electrode array consists of three patch electrodes containing conductive gel and is self-adhesive and will adhere to the patient's skin. The zensor device communicates to a remote data base using Wi-Fi or mobile hotspot. The rechargeable battery pack contains a rechargeable 3.7V lithium ion battery to power the zensor device. The battery pack is charged using the zensor single bay charging dock. When fully charged the life of the battery pack can be up to three days (dependent on device configuration).
The physiological parameters monitored include ECG and respiration waveforms, heart rate and respiration rate, activity, detection of cardiac arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation) and recording of patient-activated events.
The zensor monitoring device has the option to store full disclosure ECG and respiration data and/or wirelessly transmit pre-defined event alerts or patient-activated recordings to the Intelesens zensor online system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory Full Disclosure ECG and Event Viewer) for later analysis by a clinician.
The device also contains on-board ECG arrhythmia detection algorithms to automatically record and send ECG data on detection of one or more of the following arrhythmias:
- asystole, ●
- . ventricular fibrillation, (VF)
- bradycardia
- atrial fibrillation (AF) ●
- tachycardia ●
Accelerometer: The zensor device incorporates a digital accelerometer MEMS (Micro Electro Mechanical System). This is used to monitor 3-axis acceleration, providing information on patient activity.
Electrode Array
- The zensor electrode array is a patient worn adhesive sensor that facilitates the ● acquisition of ECG (3 lead) and respiration signals.
- The array is placed onto the patient following the instructions detailed in the user manual.
- . The array consists of three electrodes and 5 magnetic studs for connecting to the device.
zensor electrode array has the same patient contact materials as the V-Patch electrode (K131000)
The provided text describes the "zensor System," which is a wearable ECG and respiratory monitor. It monitors physiological parameters including ECG and respiration waveforms, heart rate and respiration rate, activity, and detects cardiac arrhythmias.
Here's an analysis of the acceptance criteria and study information:
1. Table of acceptance criteria and reported device performance:
The document explicitly states that the device was tested for "Compliance with AAMI EC 57." AAMI EC57:1998/(R) 2008, "Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms," sets performance standards for arrhythmia detection. Although the specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds) from AAMI EC57 are not detailed in this submission, the statement of compliance implies that the device met these established standards.
The document lists the following cardiac arrhythmias that the device's algorithms are designed to detect:
- Asystole
- Ventricular Fibrillation (VF)
- Bradycardia
- Atrial Fibrillation (AF)
- Tachycardia
However, the specific reported performance metrics (e.g., sensitivity, specificity, accuracy) for each of these arrhythmia detections are not provided in this summary. The summary only states "Compliance with AAMI EC 57."
| Function/Characteristic | Acceptance Criteria (Implied by AAMI EC 57 Compliance) | Reported Device Performance |
|---|---|---|
| Arrhythmia Detection | Meets AAMI EC 57 standards for sensitivity and specificity of specified arrhythmias. | "Compliance with AAMI EC 57" (Specific performance metrics not detailed in this summary). |
| ECG/Heart Rate | 3 leads, 360 Hz sample rate, 0.67-40 Hz bandwidth, 12-bit resolution | 3 leads, 360 Hz sample rate, 0.67-40 Hz bandwidth, 12-bit resolution |
| Respiration | 120 Hz sample rate, 12-bit resolution | 120 Hz sample rate, 12-bit resolution |
2. Sample size used for the test set and the data provenance:
The document mentions "Compliance with AAMI EC 57" for testing arrhythmia detection algorithms. AAMI EC57 typically requires testing on standardized ECG arrhythmia databases (such as MIT-BIH Arrhythmia Database, AHA Database, European ST-T Database, etc.) which are collections of retrospective physiological data. However, the specific size of the test set (number of patients, duration of recordings) and the country of origin of the data are not explicitly stated in this document. It's implied that a retrospective dataset was used given the standard practice for AAMI EC57 testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
AAMI EC57 compliance often involves comparing algorithm output against expert-annotated ground truth. However, the exact number of experts, their qualifications, and the specific method of ground truth establishment for the test set used for this device are not detailed in the provided text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The adjudication method used to establish the ground truth for the test set is not specified in the document. For AAMI EC57 compliance, ground truth is typically established by expert cardiologists reviewing and annotating the ECG data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The document does not mention an MRMC comparative effectiveness study involving human readers or the effect size of human improvement with AI assistance. The focus of the performance data section is on the device's algorithmic performance and compliance with technical standards.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was done. The document states that "The zensor System has been tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market." It specifically references "Compliance with AAMI EC 57," which is a standard for evaluating the performance of cardiac rhythm and ST-segment measurement algorithms in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For "Compliance with AAMI EC 57," the ground truth typically involves expert-annotated ECG recordings from established arrhythmia databases. However, the specific method for establishing ground truth is not explicitly stated in this summary.
8. The sample size for the training set:
The sample size used for training the device's algorithms is not specified in this document.
9. How the ground truth for the training set was established:
The method for establishing ground truth for the training set is not specified in this document.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.