(346 days)
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 use on critical care patients.
The LifeSignals WiPatch & WiApp System is contraindicated for use on patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD) & left ventricular assist devices (LVAD); for use in a magnetic resonance (MR) environment; for use during surgical procedures when electro-surgical equipment is operational.
The LifeSignals WiPatch & WiApp System consists of the 1) LifeSignals WiPatch 2) LifeSignals WiApp System and 3) Access Point as described below.
The LifeSignals WiPatch:
- is a wireless ECG patch that--when attached to the upper left chest of a patient -continuously acquires physiological signals and transmits these signals wirelessly to any compatible receiver.
- is disposable and integrated with four adhesive electrodes for body interface.
- acquires two channels of electrocardiograph (ECG-A and ECG-B) signals
- transmits acquired signals after initial pre-processing to a compatible receiver wirelessly using the 802.11b communication protocol (2.4 GHz).
- is powered by two-coin cell batteries (zinc air) with an operating life up to 72 hours.
- has an integrated switch to power it on, and has bi-color LED indicators to indicate the communication status with the receiver.
The LifeSignals WiApp System:
- consists of a LifeSignals WiApp Software App (WiApp SW), and a compatible commercial iOS device (iPad, iPad 2, iPad Air or iPad Air 2)
- software, when installed on a compatible hardware, establishes a connection to any one of the LifeSignals WiPatches connected to the same wireless network/Access Point through a pairing process.
- receives the transmitted signals from the paired WiPatch wirelessly, processes the signals and displays heart rate, ECG (ECG-A and ECG-B) waveforms on its LCD display for monitoring purposes by trained clinical personnel.
- has audio and visual alarms to alert clinical personnel when heart rate of a patient is outside the set limits, lead off, when the battery is low (either the WiPatch or the WiApp System - iPad), or when there is a loss of communication link between the WiApp System and the WiPatch.
Access Point:
An access point is a commercially available hardware device (a.k.a wireless router) that allows wireless capable devices connect through a wireless standard (e.g. 802.11b). LifeSignals WiPatch and WiApp system communicate through an access point.
The provided text describes the 510(k) summary for the LifeSignals WiPoint Biosensor iOS Receiver App System (LifeSignals WiPatch & WiApp System), which is intended for spot check and short-term monitoring of ECG & heart rate in adult patients (18 years or older) at rest or transportable within an antenna network.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document specifies heart rate accuracy.
| Performance Metric | Acceptance Criteria (from Simulator study Note 1) | Reported Device Performance (from On-body performance study Note 1) |
|---|---|---|
| Heart Rate Accuracy | +/- 3 BPM or better for 100% of data | +/- 3 BPM or better for 97% of data |
Note 1: These values are explicitly stated in the "Table of Comparison" and the subsequent "Note 1" section.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "a non-randomized, self-control comparative clinical study" for validating heart rate accuracy and on-body adhesion. However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.
6. Standalone (Algorithm Only) Performance
The document details performance testing for the "LifeSignals WiPatch & WiApp System" which includes the "WiPatch" (hardware sensor) and the "WiApp Software App" (algorithm/software). The performance metrics for heart rate accuracy are presented for the overall system, not solely for the algorithm in isolation without human interaction. Therefore, a standalone (algorithm only) performance is not explicitly detailed as such, though the heart rate accuracy is a measurement of the system's output.
7. Type of Ground Truth Used
The document mentions a "Simulator study" and an "on-body performance study" for heart rate accuracy. This implies the ground truth for the simulator study would be from the simulator's known output, and for the on-body study, it would be from a reference device or method used to establish true heart rate during the clinical study. However, the exact nature of this reference method is not explicitly stated (e.g., gold standard ECG, manually counted pulses, etc.).
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set. This is common for 510(k) summaries which focus on validation rather than development.
9. How the Ground Truth for the Training Set Was Established
As no training set sample size is provided, the document similarly does not provide any information on how the ground truth for a training set was established.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 14, 2018
LifeSignals, Inc. for HMicro, Inc. % Saravanan Balasubramanian Principal Consultant LifeSignals, Inc. 39355 California St., Ste. 305 Fremont, CA 94538
Re: K172011
LifeSignals WiPoint Biosensor iOS Receiver App System (LifeSignals WiPatch & Trade/Device Name: WiApp System) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Codes: DRG, DRX, DRT Dated: June 1, 2018 Received: June 4, 2018
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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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/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Willemsen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172011
Device Name
LifeSignals WiPoint Biosensor iOS Receiver App System (LifeSignals WiPatch & WiApp System)
Indications for Use (Describe)
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 trate 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 use on critical care patients.
The LifeSignals WiPatch & WiApp System is contraindicated for use on patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD) & left ventricular assist devices (LVAD); for use in a magnetic resonance (MR) environment; for use during surgical procedures when electro-surgical equipment is operational.
| 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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Image /page/3/Picture/1 description: The image shows the logo for LifeSignals. The logo consists of a blue square with a white waveform inside, followed by the word "LifeSignals" in a blue, sans-serif font. The waveform is a stylized representation of a signal, possibly indicating the company's focus on monitoring or analyzing life signals. The font used for "LifeSignals" is modern and clean, contributing to the overall professional and technological feel of the logo.
510(k) Summary for LifeSignals WiPoint Biosensor_iOS Receiver_App System
| 1. Company name: | LifeSignals, Inc. |
|---|---|
| Contact: | Saravanan Balasubramanian, Principal ConsultantEmail: saravanan@lifesignals.comTel: 510.770.6412 Ext. 4 |
-
- Date prepared: June 11, 2018
-
ကံ Device
| Trade Name: | LifeSignals WiPoint Biosensor_iOS Receiver_App System |
|---|---|
| Model Name: | LifeSignals WiPatch & WiApp System |
| Common Name: | Monitor, cardiac (incl. cardio-tachometer and rate alarm) |
4. Classification
| Device Panel | RegulationClassification | ProductCode | Description |
|---|---|---|---|
| Cardiovascular | 21 CFR 870.2910Class II | DRG | RF physiological signaltransmitter and receiver |
| Cardiovascular | 21 CFR 870.2360Class II | DRX | Electrocardiograph electrode |
| Cardiovascular | 21 CFR 870.2300Class II | DRT | Monitor, cardiac (incl. cardio-tachometer & rate alarm) |
5. Predicate Device
Vios Monitoring System (K150992)
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6. Intended Use
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 use on critical care patients
The LifeSignals WiPatch & WiApp System is contraindicated for use on patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillators (ICD) and left ventricular assist devices (LVAD); for use in a magnetic resonance (MR) environment; for use during surgical procedures when electro-surgical equipment is operational.
Device description 7.
Image /page/4/Picture/7 description: The image shows a WiPatch device, a Wi-Fi access point, and an iPad installed with WiApp software. The WiPatch device is a small, white, flower-shaped device with several sensors on its surface. The Wi-Fi access point is a blue tower with a circular antenna on top. The iPad is showing a graph of data collected by the WiPatch device. The image suggests that the WiPatch device is used to collect data, which is then transmitted wirelessly to the iPad for analysis.
WiPatch
Image /page/4/Figure/9 description: This image is a title for a figure. The title says "Figure -1 Illustration of WiPatch and WiApp System". The title is written in a bold, sans-serif font. The title is centered on the image.
The LifeSignals WiPatch & WiApp System consists of the 1) LifeSignals WiPatch 2) LifeSignals WiApp System and 3) Access Point as described below.
The LifeSignals WiPatch:
- . is a wireless ECG patch that--when attached to the upper left chest of a patient -continuously acquires physiological signals and transmits these signals wirelessly to any compatible receiver.
- is disposable and integrated with four adhesive electrodes for body interface.
- acquires two channels of electrocardiograph (ECG-A and ECG-B) signals
- transmits acquired signals after initial pre-processing to a compatible receiver wirelessly using the 802.11b communication protocol (2.4 GHz).
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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 a stylized waveform inside, followed by the word "LifeSignals" in a sans-serif font, also in blue. The waveform graphic is composed of several vertical lines of varying heights, resembling a signal or sound wave.
- is powered by two-coin cell batteries (zinc air) with an operating life up to 72 hours.
- . has an integrated switch to power it on, and has bi-color LED indicators to indicate the communication status with the receiver.
The LifeSignals WiApp System:
- . consists of a LifeSignals WiApp Software App (WiApp SW), and a compatible commercial iOS device (iPad, iPad 2, iPad Air or iPad Air 2)
- . software, when installed on a compatible hardware, establishes a connection to any one of the LifeSignals WiPatches connected to the same wireless network/Access Point through a pairing process.
- receives the transmitted signals from the paired WiPatch wirelessly, processes the signals and displays heart rate, ECG (ECG-A and ECG-B) waveforms on its LCD display for monitoring purposes by trained clinical personnel.
- . has audio and visual alarms to alert clinical personnel when heart rate of a patient is outside the set limits, lead off, when the battery is low (either the WiPatch or the WiApp System - iPad), or when there is a loss of communication link between the WiApp System and the WiPatch.
Access Point:
An access point is a commercially available hardware device (a.k.a wireless router) that allows wireless capable devices connect through a wireless standard (e.g. 802.11b). LifeSignals WiPatch and WiApp system communicate through an access point.
Summary Table of Substantial Equivalence 8.
Table 12-1: Table of Comparison
| Comparison | WiPatch & WiApp System(Subject) | VIOS MonitoringSystem(Predicate) |
|---|---|---|
| 510(k) | K172011 | K150992 |
| Sponsor | LifeSignals, Inc.Fremont, CA | Vios Medical, Inc.St. Paul, MN |
| Comparison | WiPatch & WiApp System(Subject) | VIOS MonitoringSystem(Predicate) |
| Intended use/Indications for use | 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 use on critical care patients. | The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological and vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of ECG, heart rate, pulse rate, functional oxygen saturation of arterial hemoglobin, and axillary temperature. |
| Intended Population | Adults ≥ 18 | Adults ≥ 18 |
| Intended Use Environment | Healthcare facility | Healthcare facility or clinical pharmacological unit |
| Heart Rate | Yes | Yes |
| Temperature | No | Yes |
| ECG Display | ECG-A and ECG-B | Channel I and II |
| SpO2 | No | Optional |
| Pulse Rate | No | Optional |
| NIBP | No | Optional |
| Sensor | Wireless patch design—RF/Wi-Fi 2.4 GHz 802.11b | Wireless patch design—RF/Bluetooth 2.4 GHz |
| Wear duration | 72 hours (maximum) | |
| Hardware Platform | Standard commercial iOS tablet (iPad, iPad2, iPad Air, iPad Air2) | Standard commercial IT equipment |
| TECHNICAL SPECIFICATION (HEART RATE) | ||
| Display Range | 30 to 250 BPM | |
| Accuracy | +/- 3 BPM Note 1 | |
| Resolution | 1 BPM | |
| Comparison | WiPatch & WiApp System(Subject) | VIOS Monitoring System(Predicate) |
| ALARMS | ||
| Vital signs parameter | Visual and audio | Visual and audio |
| Technical alarms – System LowBattery, Patch Low Battery, LeadOff, Connection Lost | Visual and audio | Visual and audio |
| Power (sensor module) | Two zinc air coin cellbatteries | Lithium battery |
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Image /page/6/Picture/1 description: The image shows the logo for LifeSignals. The logo consists of a blue square with white waveforms inside, followed by the word "LifeSignals" in a stylized blue font. The waveforms in the square represent the "signals" aspect of the company's name, while the text clearly identifies the brand.
Table 12-1: Table of Comparison
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Image /page/7/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 blue, sans-serif font. The logo is clean and modern, and the sound wave graphic suggests a connection to health monitoring or communication.
Table 12-1: Table of Comparison
Note 1:
Heart Rate accuracy on Simulator study is +/- 3 BPM or better for 100% of data.
Heart Rate accuracy on-body performance study is +/- 3 BPM or better for 97% of data
Minor differences are: 1) the predicate device has an ability to display additional parameters, including SpO2 (optional), pulse rate (optional) and temperature, while the subject device (WiPatch & WiApp System) does not support or display these additional parameters - SpO2, pulse rate and temperature; 2) the subject device is battery powered with two zinc air coin cell batteries while the predicate device is powered with a lithium battery.
9. Summary of Performance Testing
The following non-clinical testing has been completed to demonstrate safety and effectiveness of the LifeSignals WiPatch & WiApp System: -
- Bio-compatibility testing per ISO 10993-1, ISO 10993-5 and ISO 10993-10:2003 ●
- . Safety and performance testing per IEC 60601-1:2012, AAMI/ANSI/EC 60601-1-2:2007/(R)2012, IEC 60601-2-27:2011, ANSI/AAMI/EC12:2000/r2015, IEC 60601-1-8:2012, 47 CFR 15 FCC Part 15C, and ANSI C63.27:2017
- Battery safety testing as per IEC 60086-5:2016
- Design verification and validation: Software Unit(s) verification and Software System verification & validation as per IEC 62304:2015 / USFDA Guidance-General Principles of Software validation; Wireless performance (QoS); Product Design verification.
- . Usability engineering as per IEC 62366:2007 +A1:2014
In addition, performance data for heart rate accuracy and on-body adhesion for determination of wear duration was validated using a non-randomized, self-control comparative clinical study.
10. Conclusion
The LifeSignals WiPoint Biosensor iOS Receiver App System (WiPatch & WiApp System) is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device for its intended use.
§ 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).