(27 days)
Not Found
No
The summary describes a system for collecting, transmitting, and displaying physiological data (ECG and heart rate) with basic alarming based on set limits. There is no mention of AI, ML, or any advanced analytical capabilities that would suggest the use of these technologies for interpretation, prediction, or complex pattern recognition. The software is described as performing processing functions related to capturing and transmitting data, and the application manages upload, processing, and display, along with simple threshold-based alarms.
No.
The device is described as a "wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data," and it "does not detect or diagnose medical conditions." Its function is solely for monitoring, not for treating or alleviating a condition.
No
The "Intended Use / Indications for Use" section explicitly states, "The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions."
No
The device description explicitly includes hardware components: the Life Sensor Electrode (comprising the Life Sensor Patch and Life Sensor Module), which contains battery-powered electronics and sensing apparatus. While there is software (Firmware and Application), the system is not solely software.
Based on the provided information, the Life Sensor Cardiac Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Life Sensor Cardiac Monitor Function: The Life Sensor Cardiac Monitor directly monitors physiological data (heart rate and ECG) from the patient's body in vivo (within the living organism) using electrodes attached to the skin. It does not examine specimens derived from the body.
- Intended Use: The intended use is for monitoring physiological data within healthcare settings for review by healthcare professionals. It explicitly states that the device "does not detect or diagnose medical conditions."
Therefore, the Life Sensor Cardiac Monitor falls under the category of a medical device that monitors physiological parameters directly from the patient, rather than an IVD device that analyzes specimens.
N/A
Intended Use / 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.
Product codes
DRG, DRT, DRX
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's upper torso region just above the heart.
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
Healthcare professionals within healthcare settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
- . 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.
Key Metrics
Accuracy: ±10 or ±5/min, whichever is greater.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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.
11 Perimeter Road
Nashua, NH 03063 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Balaji Sudabattula
VP, Quality and Regulatory Affairs
Phone: 385-988-0625
Email: balaji.sudabattula@braveheart.life |
April 10, 2019
II. Device Identification and Classification
| Device Trade Name:
Model Name:
Common Name: | Life Sensor Platform
Life Sensor Cardiac Monitor
Wireless Remote Monitoring System |
|---------------------------------------------------|------------------------------------------------------------------------------------------|
| Classification Name: | Transmitters and Receivers, Physiological Signal,
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.
5
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
(subject) | WiPatch & WiApp System |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | BraveHeart Wireless, Inc.
Nashua, NH | LifeSignals
Fremont, CA |
| Intended use | The Life Sensor Platform is a
wireless monitoring system
intended for use by healthcare
professionals for surveillance of
physiological data within
healthcare settings. This includes
heart rate and
electrocardiography (ECG). Data
is transmitted wirelessly from Life
Sensor Patch to an application on
iOS device where it is displayed
for review by healthcare
professionals. The device is
intended for use on general care | The LifeSignals WiPatch &
WiApp system is intended for
spot check and short-term
monitoring of ECG & heart
rate of patients at rest or
patients who can be
transported within the range
of the antenna network. The
WiPatch & WiApp system has
visual and audio alarms to
alert clinical personnel when
heart rate falls outside the set
limits. The device is intended
for use on general care
patients of 18 years or older.
The device is not intended for |
VI. Summary Table of Substantial Equivalence
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| Comparison | Life Sensor Platform
(subject) | WiPatch & WiApp System |
|-----------------------------|---------------------------------------------------------|----------------------------------|
| | patients 18 years or older and by
prescription only. | use on critical care patients. |
| Intended
Population | Adults ≥ 18 | Adults ≥ 18 |
| Intended Use
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.
7
- . 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.