Life Sensor Cardiac Monitor

K191331 · Braveheart Wireless, Inc. · DRG · Jun 12, 2019 · Cardiovascular

Device Facts

• Record ID: K191331
• Device Name: Life Sensor Cardiac Monitor
• Applicant: Braveheart Wireless, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jun 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The Life Sensor Cardiac Monitor (CM) is a wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data within healthcare settings. This includes heart rate and electrocardiography (ECG). Data is transmitted wirelessly from Life Sensor Electrode to an application on iOS device where it is displayed for review by healthcare professionals. The device is intended for use on general care patients 18 years or older and by prescription only.

Device Story

Wireless monitoring system for ECG and heart rate; consists of single-use adhesive Life Sensor Patch, battery-powered Life Sensor Module, and Life Sensor App on iOS device. Module captures physiological signals; transmits encrypted data via Bluetooth Low Energy (BLE) to iOS app. App displays data and provides visual alarms for heart rate limits, lead-off, asystole, tachycardia, bradycardia, low battery, or communication loss. Used in healthcare settings by healthcare professionals; provides real-time surveillance to assist clinical decision-making. Benefits include continuous patient monitoring without tethering to bedside equipment.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-1), electrical safety/EMC (IEC 60601-1, IEC 60601-2-27, IEC 60601-1-2), software verification/validation, shelf life, packaging integrity, and usability testing (IEC 62366).

Technological Characteristics

Wireless patch design; Bluetooth Low Energy (BLE) 2.4 GHz connectivity. Powered by non-rechargeable lithium-ion battery. Single-channel ECG sensing. Complies with IEC 60601-1, IEC 60601-2-27, IEC 60601-1-2, and IEC 62366. Software level of concern: moderate.

Indications for Use

Indicated for general care patients 18 years or older for monitoring heart rate and ECG in healthcare settings. Contraindicated for critical care patients, patients with active implantable medical devices (pacemakers, ICDs, LVADs), use in MR environments, or during surgical procedures with electro-surgical equipment.

Regulatory Classification

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.

Predicate Devices

• LifeSignals WiPatch & WiApp System (K172011)

Submission Summary (Full Text)

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June 12, 2019

BraveHeart Wireless, Inc. % Thomas Schorre Official Correspondent Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Ste. 444 Ludlum, Florida 33155-3708

Re: K191331

Trade/Device Name: Life Sensor Cardiac Monitor Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG, DRT, DRX Dated: May 14, 2019 Received: May 16, 2019

Dear Thomas Schorre:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Nicole Goodsell Assistant Director 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)

### K191331

Device Name Life Sensor Cardiac Monitor

## Indications for Use (Describe)

The Life Sensor Cardiac Monitor (CM) is a wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data within healthcare settings. This includes heart rate and electrocardiography (ECG). Data is transmitted wirelessly from Life Sensor Electrode to an application on iOS device where it is displayed for review by healthcare professionals. The device is intended for use on general care patients 18 years or older and by prescription only.

The device is contraindicated for use on critical care patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD), and left ventricular assist devices (LVAD); for use in magnetic resonance (MR) environments; for use during surgical procedures when electro-surgical equipment is optional. The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# Section 5

# 510(k) Summary for Life Sensor Platform

# (As required by 21 CFR 807.92)

### Submitter Information l.

Date Prepared:

| Submitter | BraveHeart Wireless, Inc.<br>11 Perimeter Road<br>Nashua, NH 03063 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Balaji Sudabattula<br>VP, Quality and Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |

April 10, 2019

### II. Device Identification and Classification

| Device Trade Name:<br>Model Name:<br>Common Name: | Life Sensor Platform<br>Life Sensor Cardiac Monitor<br>Wireless Remote Monitoring System |
|---------------------------------------------------|------------------------------------------------------------------------------------------|
| Classification Name: | Transmitters and Receivers, Physiological Signal,<br>Radiofrequency |
| Classification Panel: | Cardiovascular |
| CRF Section: | 870.2910, 870.2300, 870.2360 |
| Device Class: | |
| Product Code: | DRG, DRT, DRX |

### III. Predicate Device

| Manufacturer: | Life Signals, Inc |
|---------------|------------------------------------|
| Model Name: | LifeSignals WiPatch & WiApp System |
| 510(k) #: | K172011 |

This predicate has not been subject to a design-related recall.

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### IV. Device Description

Life Sensor Electrode

Bluetooth

iPad installed with Life Sensor App

The Life Sensor Cardiac Monitor (CM) Platform is a wireless data collection system that monitors physiological data (electrocardiograph and heart rate) and consists of the following sub-systems:

Life Sensor Electrode (includes Life Sensor Patch and Life Sensor Module) Life Sensor Firmware Life Sensor Application

# Life Sensor Electrode

- Life Sensor Patch: The Life Sensor Patch is the single-use, self-adhesive interface to a patient that is attached to the patient's upper torso region just above the heart.
- . Life Sensor Module: The Life Sensor Module attached to the Life Sensor Patch, contains the battery powered electronics and sensing apparatus necessary to operate the system. The Life Sensor Module automatically performs all the processing functions related to capturing the required physiological data from the body and performs encrypted, bi-directional communication to the Life Sensor Application, using Bluetooth Low Energy (BLE), when in range of the Life Sensor Application installed on a paired iOS device.
- Life Sensor Firmware:

The Life Sensor Firmware is the software installed on the Life Sensor Module. The Life Sensor Firmware manages bi-directional communication between the Life Sensor Module and the Life Sensor Application. Encrypted data is transmitted to and from the Life Sensor Module and the Life Sensor Application.

- . Life Sensor Application: The Life Sensor Application, installed on a paired iOS device, interacts with the Life Sensor Firmware and manages the upload, processing, and display of the physiological data transmitted by the Life Sensor Module.
When installed on a compatible hardware, the Life Sensor Application establishes connection to any of the Life Sensor Electrode through pairing process.

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Life Sensor Application has visual alarms to alert clinical personnel when heart rate of the person being monitored is outside the set limits, lead off, asystole, tachycardia and bradycardia, when the battery is low, or when there is loss of communication between the Life Sensor Application and the Life Sensor Electrode.

#### V. Indications for Use

The Life Sensor Cardiac Monitor (CM) is a wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data within healthcare settings. This includes heart rate and electrocardiography (ECG). Data is transmitted wirelessly from Life Sensor Electrode to an application on iOS device where it is displayed for review by healthcare professionals. The device is intended for use on general care patients 18 years or older and by prescription only.

The device is contraindicated for use on critical care patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD), and left ventricular assist devices (LVAD); for use in magnetic resonance (MR) environments; for use during surgical procedures when electro-surgical equipment is optional. The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions.

| Comparison | Life Sensor Platform<br>(subject) | WiPatch & WiApp System |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | BraveHeart Wireless, Inc.<br>Nashua, NH | LifeSignals<br>Fremont, CA |
| Intended use | The Life Sensor Platform is a<br>wireless monitoring system<br>intended for use by healthcare<br>professionals for surveillance of<br>physiological data within<br>healthcare settings. This includes<br>heart rate and<br>electrocardiography (ECG). Data<br>is transmitted wirelessly from Life<br>Sensor Patch to an application on<br>iOS device where it is displayed<br>for review by healthcare<br>professionals. The device is<br>intended for use on general care | The LifeSignals WiPatch &<br>WiApp system is intended for<br>spot check and short-term<br>monitoring of ECG & heart<br>rate of patients at rest or<br>patients who can be<br>transported within the range<br>of the antenna network. The<br>WiPatch & WiApp system has<br>visual and audio alarms to<br>alert clinical personnel when<br>heart rate falls outside the set<br>limits. The device is intended<br>for use on general care<br>patients of 18 years or older.<br>The device is not intended for |

### VI. Summary Table of Substantial Equivalence

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| Comparison | Life Sensor Platform<br>(subject) | WiPatch & WiApp System |
|-----------------------------|---------------------------------------------------------|----------------------------------|
| | patients 18 years or older and by<br>prescription only. | use on critical care patients. |
| Intended<br>Population | Adults ≥ 18 | Adults ≥ 18 |
| Intended Use<br>Environment | Healthcare facility | Healthcare facility |
| Heart Rate | Yes | Yes |
| ECG Display | Single channel | ECG-A and ECG-B |
| Sensor | Wireless patch design - | Wireless patch design RF/Wi-Fi |
| | RF/Bluetooth 2.4 GHz | 2.4 GHz 802.11b |
| Wear duration | 72 hours maximum | 72 hours maximum |
| Hardware | Standard commercial iOS tablet | Standard commercial iOS tablet |
| Platform | | |
| Technical Specifications | | |
| Display Range | 30 to 200 BPM | 30 to 250 BPM |
| Accuracy | ±10 or ±5/min, whichever is | ±3/min |
| | greater. | |
| Battery | Lithium ion (non-chargeable) | Two zinc air coin cell batteries |

Life Sensor CM Platform and the predicate device (LifeSignals WiPatch & WiApp System, 510(k) #: K172011) monitor and display ECG and heart rate. Healthcare professional can set limits for heart rate to alarm the healthcare provider if a patient's heart rate falls outside the set limits. Both transmit data to an iPad for review by healthcare professional.

Minor difference is that the predicate device uses Wi-Fi while the subject device uses Bluetooth Low Energy (BLE) to communicate with iPad.

### VII. Summary of Performance Testing

The following non-clinical testing has been completed to demonstrate safety and effectiveness of the Life Sensor Cardiac Monitor Platform.

- . Biocompatibility testing, including in-vitro cytotoxicity, irritation and sensitization, performed according to the recommendations of ISO 10993-1:2018, Biological evaluation of medical devices – Part: Evaluation and testing.
- . Electrical safety and EMC testing. The device complies with IEC 60601-1, IEC 60601-2-27, IEC 60601-1-2.

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- . Software verification and validation testing was conducted, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device is determined as "moderate" level of concern because a failure or latent flaw could lead to a minor injury to the patient through incorrect information or through the action of the care provider.
- . Bench testing, including shelf life, packaging integrity, operation and storage conditions.
- Usability testing. The device complies with IEC 62366.

# VIII. Conclusion

The Life Sensor Cardiac Monitor Platform is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device for its intended use.