(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.
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July 15, 2020
LifeSignals, Inc. Saravanan Balasubramanian Vice President - Medical Systems & Regulatory Affairs 39355 California Street, Suite 305 Fremont, California 94538
Re: K200690
Trade/Device Name: Life Signal ECG Remote Monitoring Patch Platform Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, MWJ Dated: June 11, 2020 Received: June 17, 2020
Dear Saravanan Balasubramanian:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200690
Device Name
LifeSignals ECG Remote Monitoring Patch Platform
Indications for Use (Describe)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for LifeSignals. The logo consists of a blue square with white wave-like lines inside, followed by the word "LifeSignals" in blue. The word "LifeSignals" is written in a modern, sans-serif font.
510(k) Summary for LifeSignals ECG Remote Monitoring Patch Platform
| 5.1 Company name | :LifeSignals, Inc. |
|---|---|
| Address | :39355 California Street, Suite 305Fremont, CA 94538.USA |
| Contact | :Saravanan BalasubramanianVice President – Medical Systems & Regulatory AffairsEmail: saravanan@lifesignals.comTel: 510.770.6412 Ext. 4 |
- 5.2 Date prepared: July 15, 2020
5.3 Device
| Trade Name | : | LifeSignals ECG Remote Monitoring Patch Platform |
|---|---|---|
| Model Name | : | ECG Remote Monitoring Patch Platform |
| Common Name | : | Wireless ECG Remote Monitoring System |
5.4 Classification Product code
| RegulationClassification | ProductCode | Description | |
|---|---|---|---|
| Cardiovascular | 21 CFR 870.2910Class II | DRG | Transmitters and Receivers,Physiological Signal, Radiofrequency |
5.5 Subsequent Product codes
| Device Panel | RegulationClassification | ProductCode | Description |
|---|---|---|---|
| Cardiovascular | 21 CFR 870.200Class II | MWJ | Medical Magnetic TapeRecorder |
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Image /page/4/Picture/1 description: The image shows the logo for LifeSignals. The logo consists of a blue square with a waveform inside, followed by the word "LifeSignals" in blue, sans-serif font. The waveform graphic is on the left side of the logo, and the text is on the right.
5.6 Predicate & Reference Devices
Predicate Device :
| 510(k) Number | : K152139 |
|---|---|
| Model | : Vital Connect Platform |
| Manufacturer | : Vital Connect, Inc., USA |
Reference Device - I (for technology comparison of Biosensor Patch) :
| 510(k) Number | : K172011 |
|---|---|
| Model | : LifeSignals' WiPoint Biosensor iOS Receiver App System |
| Manufacturer | : LifeSignals, Inc., USA |
Reference Device - II (for ECG data acquisition - Secondary product code MWJ:
| 510(k) Number | : K152626 |
|---|---|
| Model | : H3+ Holter Recorder |
| Manufacturer | : Mortara Instrument, Inc. |
5.7 Device description
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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Image /page/5/Picture/1 description: The image shows the logo for LifeSignals. The logo consists of a blue square with white sound wave-like lines inside, followed by the word "LifeSignals" in a stylized blue font. The font is modern and slightly rounded, giving the logo a clean and professional look.
- 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.
- 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.
- 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.
5.8 Indications for Use
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 server 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.
| Comparison | Predicate (K152139) | Subject Device (K200690) |
|---|---|---|
| Manufacturer | Vital Connect, Inc. USA | LifeSignals, Inc., USA |
| Product Codes | DRG (Primary) , DSI , MHX | DRG (Primary), MWJ |
| Regulation Classification | 21 CFR 870.1025 | 21 CFR 870.1025 |
| (Primary) | Class II | Class II |
| Intended use /Indications for use | The Vital Connect Platform is a wirelessremote monitoring system intended for useby healthcare professionals for continuouscollection of physiological data in home andhealthcare settings. This can include heartrate, electrocardiography (ECG), heart ratevariability, R-R interval, respiratory rate,skin temperature, activity (including stepcount), and posture (body position relative togravity including fall). Data are transmittedwirelessly from the Vital Connect Sensor forstorage and analysis. The Vital ConnectPlatform can include the ability to notifyhealthcare professionals when physiologicaldata fall outside selected parameters. Thedata from the Vital Connect Platform areintended for use by healthcare professionalsas an aid to diagnosis and treatment. | The LifeSignals ECG RemoteMonitoring Patch Platform is awireless remote monitoring systemintended for use by healthcareprofessionals for continuouscollection of Electrocardiography(ECG) & Heart Rate monitoring inhome and healthcare settings. Data istransmitted wirelessly fromLifeSignals Biosensor to Remotesecure server for storage andanalysis. The LifeSignals ECGRemote Monitoring Patch Platformincludes an ability to notifyhealthcare professionals when HeartRate falls outside the set limits. |
| Comparison | Predicate (K152139) | Subject Device (K200690) |
| Intended Population | General care patients who are 18 years or older | Non-critical, adult population, 18 years or older |
| Intended Use Environment | Home & Healthcare settings | Home & Healthcare settings |
| Monitored Parameters | ||
| ECG | ✓ (Single channel) | ✓ (Two channels) |
| Heart Rate | ✓ | ✓ |
| Heart Rate Variability | ✓ | x |
| Respiration | ✓ | x |
| Skin Temperature | ✓ | x |
| Activity & posture | ✓ | x |
| Continuous Physiologicaldata monitoring | ✓ | ✓ |
| Heart Rate Range &accuracy (Stationary andAmbulatory) | 30 – 200 BPM (Range)± 5 or 10% whichever is greater | 30 – 250 BPM (Range)± 3 or 10% whichever isgreater |
| Programmable AlertNotification & Setting | ✓ | ✓ |
| "Alarm" Function(to assist clinician forimmediate intervention ) | x | x |
| Sensor | ||
| Single Use | ✓ | ✓ |
| Wear Life | 72 hours | 72 hours |
| Data can be transferred &Stored | ✓ | ✓ |
| Battery | Coin cell – Zinc Air (1 no) | Coin cell – Zinc Air ( 2 no) |
| Applied part category | Type BF | Type CF |
| Communication protocol | Bluetooth (BT4.1) | WLAN (802.11b) |
| Wireless Radio Frequency | 2.4 – 2.5 GHz | 2.4 – 2.4835 GHz |
| Communication Security | AES-CCM 128 | WPA2-PSK (AES 128) |
| Relay Device | ||
| Authentication from Server | ✓ | ✓ |
| Data transferred to Server | ✓ | ✓ |
| Data buffered if there is noconnection with Server | ✓ | ✓ |
| Data accessible from Relaydevice by 3rd party via API | ✓ | ✓ |
| Secure Server | Data is stored for access by any3rd party software | Data is stored for access byany 3rd party software |
| Comparison | Predicate (K152139) | Subject Device (K200690) |
| ECG analysis | No in-built arrhythmia analysis function and is intended to be used by any 3rd party arrhythmia analysis software | No in-built arrhythmia analysis function and is intended to be used by any 3rd party arrhythmia analysis software |
5.9 Substantial Equivalence comparison (Subject device & Predicate Device)
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Differences and Risks associated with that :
- Predicate device has only one channel of ECG, whereas the proposed device has two channels of ECG. Additional ECG channel does not add any risk to the device.
- The Predicate device has additional monitoring parameters (Respiration rate, temperature, HR variability) compared to the proposed device. However, these parameters are not required for the claimed intended use of the proposed device.
- The Predicate device has single Zinc-Air battery, whereas the Proposed device has two Zin-● Air battery. Additional Battery does not add any risk to the device.
- . The Predicate device uses BLE for wireless communication, whereas the Proposed device uses WLAN for wireless communication. The use of WLAN for wireless communication does not add any risk to the device.
- The Applied Part classification of the Predicate device is "BF", whereas the Proposed device ● Applied Part classification is "CF". Devices with CF classified Applied Part has a lower risk with lower leakage current as it is intended for direct Cardiac Application.
5.10 Technological Characteristics of Biosensor Patch (Subject Device & Reference Device - I )
The LifeSignals Biosensor Patch used in LifeSignals ECG Remote Monitoring Patch Platform is identical to the Biosensor Patch that is used in LifeSignals WiPoint Biosensor iOS Receiver App System, which is 510(k) cleared under K172011, except for firmware change to support different intended use and for additional memory to buffer the data in the Biosensor Patch, as explained in the following table :
| Comparison | Reference Device - I (K172011) | Subject Device (K200690) |
|---|---|---|
| Manufacturer | LifeSignals, Inc. | LifeSignals, Inc. |
| Product Code | DRG (Primary), DRT, DRX | DRG (Primary), MWJ |
| General | ||
| Number of ECG Electrodes | Four Electrodes | Identical |
| Dimension (L x W x T) | 112 x 79 x 6 mm | Identical |
| Weight | 18 grams | Identical |
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| Comparison | Reference Device – I (K172011) | Subject Device (K200690) |
|---|---|---|
| Sensor & wireless Chip | Life Signal LC1110 (custom chip) | Identical |
| Battery | Zinc Air – 2 no – DC 2.8V | Identical |
| PCBA | Rigid - Flex | Minor changeNote1 |
| Top cover | Thermoformed Foam | Identical |
| User inputs | Switch & LED | Identical |
| Body Contact Material | ||
| Adhesive | Hydrocolloid | Identical |
| Electrode design | Ag/AgCl Eyelet | Identical |
| Electrolyte | Hydrogel | IdenticalNote2 |
| Wear Life | 72 hours | Identical |
| Electrical (Applied Part) | Type CF – Defibrillation proof | Identical |
| Wireless Communication | ||
| Protocol | WLAN-802.11b | Identical |
| Security | WPA2-PSK (AES 128) | Identical |
Note 1 : The Firmware & Memory chip are different from the Reference device-I to support the new intended use. Note 2 : Hydrogel part number is different. It is of same family & manufacturer. (Biocompatibility test is repeated)
| 5.11 Substantial Equivalence comparison ECG data acquisition performance – Secondary |
|---|
| product code (Subject device & Reference Device – II ) |
| Comparison | Reference Device - II(K152626) | Subject Device(K200690) |
|---|---|---|
| Manufacturer | Mortara Instrument, Inc., USA | LifeSignals, Inc., USA |
| Product Codes | MWJ | DRG (Primary), MWJ |
| Regulation Classification(All product codes) | 21 CFR 870.2800Class II | 21 CFR 870.102521 CFR 870.2800Class II |
| Intended use /Indications for use | The H3+ Holter recorder is intended toacquire, record and store continuous ECGdata as directed by a clinician from adult,adolescent, pediatric, infant and neonatepatient populations for a maximumrecording time of 14 days in a hospital,clinic or home environment. The H3+ isintended to be used with a compatibleambulatory ECG (Holter) analysis systemwhich will analyze the recorded data. TheH3+ data and the data analysis are thenreviewed by trained medical personnel forthe purpose of forming a clinicaldiagnosis. The H3+ Holter Recorder is nota life-supporting device. | LifeSignalsECGTheRemoteMonitoring Patch Platform is a wirelessremote monitoring system intended foruse by healthcare professionals forcontinuouscollectionofElectrocardiography (ECG) & HeartRate monitoring in home and healthcaresettings. Data is transmitted wirelesslyfrom LifeSignals Biosensor to Remotesecure server for storage and analysis.LifeSignalsTheRemoteMonitoring Patch Platform includes anability to notify healthcare professionalswhen Heart Rate falls outside the setlimits. |
| Intended Population | Adult, adolescent, pediatric,Infant & Neonate Patientpopulation | Non-critical, adult population,18 years or older |
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| Comparison | Reference Device – II(K152626) | Subject Device(K200690) |
|---|---|---|
| Intended Use | Home & Healthcare settings | Home & Healthcare settings |
| Environment | ||
| Data type | Digital | Digital |
| Record Duration | Up to 14 days | Up to 72 hours in Biosensor patch,when Relay device is not availablein wireless range & in Secure Serverwhen Relay device is available. |
| Record Medium | Internal Flash Memory | Internal Flash Memory (Biosensor)or Hard disk (Secure Server) |
| Data Transfer Method | Via USB Port | Wireless |
| ECG Channels | 3 | 2 |
| Frequency Response | Meets the requirement of IEC60601-2-47 | Meets the requirements ofIEC 60601-2-47 |
| Sampling Rate | 180 sps | 244.14 sps |
| Dynamic Range | 12-bit | 16-bit / ± 300 mV |
| Amplitude Resolution | 6.25 uV | 5.3 uV |
| Cable | 5-wires | Integrated Patch design |
| Impedance measurement | No | No |
| Pacemaker Detection | Yes | No |
| Time displayed | Yes | Yes (In Relay device) |
| Dimension | 64 x 25 x 19 mm | 112 x 79 x 6 mm |
| Weight | 28 grams | 18 grams |
| ECG analysis | No in-built arrhythmia analysisfunction and is intended to beused with a compatibleanalysis software | No in-built arrhythmiaanalysis function and isintended to be used with acompatible analysis software |
Differences and Risks associated with that :
- Reference device has three channels of ECG, whereas the proposed device has two channels . of ECG.
- Reference device uses 5-wires electrodes, while the proposed device has integrated patch ● design with four electrodes.
- . Reference device is intended for 14 days of recording, while the proposed device is intended for 72 hours. The recording period of more than 48 hours shall be considered to be extended cardiac monitoring. However, if there is a clinical requirement, multiple biosensor Patch can be worn by the patient to extend the monitoring period up to 14 days and the secure sever has ability to record more than 14 days of data simultaneously.
- . Reference device has a pacemaker detection capability, while the proposed device does not have pacemaker detection capability. The proposed device is contraindicated for use with active implantable medical devices including pacemakers.
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5.12 Summary of Performance Testing
Verification & Validation activities were performed on LifeSignals ECG Remote Monitoring Patch Platform to demonstrate substantial equivalence to the predicate device:
- Biocompatibility testing of In-vitro cytotoxicity, skin irritation and skin sensitization . were conducted on the LifeSignals Biosensor Patch, according to ISO 10993-1: 2009 Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing within a Risk Management Process.
- Electrical Safety and electromagnetic compatibility testing were conducted on the Biosensor Patch for compliance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11.
- Performance testing were conducted on the LifeSignals ECG Remote Monitoring Platform for compliance with IEC 60601-2-47 and IEC 60601-2-27.
- Usability study was conducted on the LifeSignals ECG Remote Monitoring Platform for compliance with IEC 60601-1-6 and "USFDA Guidance- Applying Human Factors and Usability Engineering to Medical Devices "
- 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. The adhesion (Wear-life) of LifeSignals Biosensor Patch was also verified in accordance to AAMI ANSI EC12.
- Wireless performance & coexistence testing was conducted as per ANSI/IEEE . C63.27:2017 : American National Standard for Evaluation of Wireless coexistence. Also tested for compliance to FCC CFR47 Part 15 subpart C & ETSI EN 300 328
- Software in the ECG Remote Monitoring Platform was designed, documented, verified . & validated as per the IEC 62304: Medical device Software - Software Life Cycle Process and USFDA Guidance for the content of premarket submissions for Software contained in Medical device. The Software for this device is determined as Class B, "Moderate" level of concern.
- . Shelf-life and packaging transportation testing were conducted and verified as per the acceptance criteria
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5.13 Conclusion
The LifeSignals ECG Remote Monitoring Patch Platform is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device for its intended use. Minor differences between the LifeSignals ECG Remote Monitoring Patch Platform and the predicate device have no effect on safety or effectiveness, as established through various performance tests. Further, LifeSignals Biosensor Patch used in LifeSignals ECG Remote Monitoring Patch Platform is substantially equivalent with respect to technology & design to the legally marketed referenced 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).