(121 days)
The LifeSignals ECG Remote Monitoring Patch Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and Heart Rate monitoring in home and healthcare settings. Data is transmitted wirelessly from LifeSignals Biosensor Patch to Remote Secure for storage and analysis.
The LifeSignals ECG Remote Monitoring Patch Platform is intended for non-critical, adult population, who are 18 years of age or older.
The LifeSignals ECG Remote Monitoring Patch Platform includes an ability to notify healthcare professionals when Heart Rate falls outside the set limits.
LifeSignals ECG Remote Monitoring Patch Platform consists of three main components: (1) LifeSignals Biosensor Patch. (2) LifeSignals Relay device. (3) LifeSignals Remote Secure Server.
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LifeSignals Biosensor Patch acquires ECG signals from the body, pre-processes as two channels of ECG data and are wirelessly transmitted to the Relay device. Under normal operation, when the Relay Device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If the Relay device is not available or if there is any interruption in the communication between the Relay device and the Biosensor Patch, data shall be buffered (stored) locally in the Biosensor Patch until the wireless connection is re-established.
Biosensor Patch uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device. -
Relay Device manages wireless communication between LifeSignals Biosensor and LifeSignals Remote Secure Server. Relay device is a LifeSignals Relay Application Software-installed compatible commercial hardware platform, like a mobile phone or a tablet.
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LifeSignals Relay Application's functions:
- Manage secured wireless communication (WLAN 802.11b) between Relay device and Biosensor Patch and encrypts communication between the Relay device and the LifeSignals Remote Secure Server.
- Receive ECG signals from the Biosensor Patch and transmit them after encryption to Secure Server as quickly as possible. They manage the database in Relay device, for buffering/storing the data securely if there is any disruption in communication with the Secure Server.
- Provide user interface for selecting, pairing and establishing connection with Biosensor Patch.
- Display alert notifications received from the Secure Server when the Heart Rate of its associated Biosensor or of some other Biosensor in its network falls outside the configured range, when it is configured by the Secure Server to receive such notification.
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LifeSignals Secure Server consists of a hardware platform that is a Linux-compatible Secure server, LifeSignals Secure Server Application software that is installed in the hardware platform along with a Web UI, a browser-based application that interfaces with LifeSignals Secure Server Application.
LifeSignals Secure Server Application manages the decryption, uploading and storage of Biosensor data received from multiple authenticated Relay devices. The Signal Processing and Heart Rate Library in the LifeSignals Secure Server Application processes and filters the received ECG signals before storing them in a secured location. It also derives the Heart Rate from the ECG data and the Heart Rate value is appended to the filtered ECG Signals.
LifeSignals Secure Server Application can include the ability to send alert notifications to any configured Relay Device connected in its network, when Heart Rate value of any Biosensor falls outside the set range of values.
Web UI provides user interface for user (login) management, Relay management & Heart Rate Alert setting. It interfaces with Secure Server Application.
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The Secure Sever Application does not carry out any arrhythmia analysis of ECG data by itself. However, the ECG data received and stored by the LifeSignals Secure server is intended to be used with an approved third-party ECG analysis software. Based on the type of ECG analysis software, the LifeSignals ECG Remote Monitoring Platform can be used for a suitable clinical workflow such as a Remote Patient Monitoring, Mobile Cardiac Telemetry, Cardiac Event Monitor or Holter Monitoring system.
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The ECG data may be accessible by a Third-Party Application installed in the Relay device using the Application Programming Interface (API) layer of the Relay Application Software, after suitable configuration and verification. In this configuration, LifeSignals Secure Server is optional and the data from Relay device shall be transmitted to a server location configured by the third-party application. Also, in this configuration, Signal processing and Heart Rate processing Library shall be integrated in third-party secure server application or in third-party relay application.
The provided text describes the acceptance criteria and study proving the device meets those criteria, specifically for the LifeSignals ECG Remote Monitoring Patch Platform (K200690).
Here's an organized breakdown of the information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative targets for each performance metric, nor does it provide detailed quantitative results for all reported device performance. Instead, it describes general compliance with standards and the methods used to verify performance against requirements, implicitly stating that acceptance criteria were met by passing these tests.
However, based on the comparison section, we can infer some key performance aspects:
| Feature/Metric | Predicate (K152139) (For comparison) | Acceptance Criteria (Inferred from regulatory standards and predicate comparison) | Reported Device Performance (K200690) |
|---|---|---|---|
| Heart Rate Range | 30 – 200 BPM | 30 – 250 BPM | 30 – 250 BPM |
| Heart Rate Accuracy | ± 5% or 10% whichever is greater | ± 3% or 10% whichever is greater (Improved accuracy compared to predicate) | ± 3% or 10% whichever is greater (Improved accuracy) |
| ECG Channels | Single channel | At least single channel; Device offers two for enhanced data | Two channels |
| Wear Life | 72 hours | 72 hours (Tested for adhesion according to AAMI ANSI EC12) | 72 hours |
| Electrical Safety | Not explicitly stated (Predicate Type BF) | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11; Applied Part: Type CF (lower risk) | Complies (Type CF) |
| EMC | Not explicitly stated | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Complies |
| ECG Waveform Quality | Implicitly meets standards | Performance testing for IEC 60601-2-47 and IEC 60601-2-27 compliance; Demonstrated good quality | Verified through comparative on-body performance study and compliance with IEC 60601-2-47/2-27 |
| Wireless Performance | Bluetooth (BT4.1) | Compliance with ANSI/IEEE C63.27:2017, FCC CFR47 Part 15 subpart C & ETSI EN 300 328 | Complies (WLAN 802.11b) |
| Biocompatibility | Not explicitly stated | Compliance with ISO 10993-1:2009 (In-vitro cytotoxicity, skin irritation, skin sensitization) | Complies |
| Usability | Not explicitly stated | Compliance with IEC 60601-1-6 and USFDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" | Complies |
| Software Validation | Not explicitly stated | Compliance with IEC 62304 and USFDA Guidance for software in medical devices (Class B, "Moderate" concern level) | Complies |
| Shelf-life & Packaging | Not explicitly stated | Verified as per acceptance criteria | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Ambulatory performance of Heart Rate algorithm and ECG waveform quality of LifeSignals ECG Remote Monitoring Patch Platform was verified using nonrandomized, self-control comparative on-body comparative performance study."
- Sample Size: The specific number of subjects for this "on-body comparative performance study" is not explicitly stated in the provided text.
- Data Provenance: The location where the study was conducted (country of origin of the data) is not explicitly stated. Given the manufacturer is based in Fremont, California, USA, and the FDA submission, it's highly probable the study was conducted in the USA, but this is an inference.
- Retrospective or Prospective: The study is described as a "comparative on-body comparative performance study," which suggests a prospective design where the device was used on subjects/patients.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts or a specific process for establishing ground truth for the test set data, particularly in the context of human readers reviewing ECGs. This suggests the primary "ground truth" for the device's performance metrics (like heart rate accuracy and ECG quality) was likely derived from:
- Comparison against established medical devices or gold-standard measurements concurrently obtained during the "on-body comparative performance study."
- Compliance with recognized international standards for ECG devices (IEC 60601-2-47 and IEC 60601-2-27).
4. Adjudication Method for the Test Set
Since the document does not describe a process involving human expert adjudication for the test set, there is no adjudication method (e.g., 2+1, 3+1) mentioned or implied. The performance validation seems to rely on technical measurement and comparison to established standards and potentially concurrently recorded data from reference devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a data acquisition and monitoring platform, not an AI-driven diagnostic algorithm that assists human readers in interpretation.
- Effect Size: N/A, as no such study was conducted or described.
6. Standalone (Algorithm Only) Performance
The device itself is a data acquisition and monitoring platform. While it includes "Signal Processing and Heart Rate Library" to process and filter ECG signals and derive Heart Rate, it is explicitly stated that:
- "The Secure Sever Application does not carry out any arrhythmia analysis of ECG data by itself."
- "No in-built arrhythmia analysis function and is intended to be used by any 3rd party arrhythmia analysis software."
Therefore, the concept of a "standalone (i.e. algorithm only without human-in-the-loop performance)" study in the context of diagnostic AI does not directly apply to this device. Its "performance" is in accurate data capture and heart rate calculation, which was verified through the "on-body comparative performance study" and compliance with electrical/performance standards.
7. Type of Ground Truth Used
The ground truth for validating the device's performance (heart rate accuracy, ECG waveform quality) appears to be derived from:
- Comparative Measurements: Likely against established, validated reference devices or methods during the "nonrandomized, self-control comparative on-body comparative performance study." This typically involves comparing the device's output to a known, accurate physiological measurement.
- Compliance with Industry Standards: Meeting the requirements specified in international standards like IEC 60601-2-47 and IEC 60601-2-27 for ECG devices. This implies that the standards themselves define acceptable ground truth performance levels.
There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth for this device's validation.
8. Sample Size for the Training Set
The document focuses on the performance verification of the device as a monitoring platform. It does not mention a "training set" or "training" process, indicating that this device is not an AI/Machine Learning model that would require such data for its development. The device performs signal acquisition and basic heart rate derivation, likely based on established signal processing algorithms rather than learned models.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set or an AI/ML model that requires training, the concept of "how the ground truth for the training set was established" is not applicable to the information provided for this device.
§ 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).