The LiveOne is intended to be used on subjects ≥ 27 years old and who have a palpable radial pulse. Software is used to provide data to qualified medical professionals for the purpose of assessing the patient's cardiac health via blood pressure readings in clinic setting by health care professional. LiveOne is intended only for measurement and display; it makes no diagnosis.

Device Description

The LiveOne is a non-invasive blood pressure monitor that utilizes a single patient use non-invasive pressure sensor placed on the wrist over the radial artery, and an electronic interface module. The device uses proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, and pulse rate and a pressure waveform. The device allows the healthcare provider to monitor blood pressure (based on visual waveform) in a clinical setting.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies conducted for the LiveOne LM1P device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (ISO 81060-2:2018 Standard)	Reported Performance (ICU Study)	Reported Performance (General Population Study)
Systolic BP	Mean bias and standard deviation within ISO 81060-2:2018 limits	Mean bias: 0.7 ± 6.6 mmHg	Mean bias: -1.3 ± 7.2 mmHg
Diastolic BP	Mean bias and standard deviation within ISO 81060-2:2018 limits	Mean bias: 2.0 ± 5.5 mmHg	Mean bias: -0.4 ± 5.7 mmHg
Heart Rate	Relative distance within ISO 81060-2:2018 limits	Relative distance: 2.9	Relative distance: 1.36

Note: The document explicitly states that the reported results are "within the acceptance criteria for the accuracy of blood pressure monitors" and "comply with the ISO standard requirements." However, the exact numerical acceptance criteria from ISO 81060-2:2018 are not detailed in the provided text. Typically, for ISO 81060-2, the mean difference (bias) for both systolic and diastolic measurements should be within ±5 mmHg, with a standard deviation no greater than 8 mmHg.

2. Sample Sizes and Data Provenance

ICU Accuracy Study:

Sample Size (Test Set): 26 subjects
Data Provenance: Not explicitly stated as retrospective or prospective, but described as a "multi-center, non-randomized, single arm study," which typically implies prospective data collection for a validation study. The country of origin is not specified.

General Population Accuracy Study:

Sample Size (Test Set): 8 subjects
Data Provenance: Not explicitly stated as retrospective or prospective, but described as a "single-center, non-randomized, single arm study," typically implying prospective data collection. The country of origin is not specified. The subjects are described as "healthy subjects."

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth in the traditional sense of consensus reading for image-based diagnostics. For blood pressure measurement devices, the ground truth is typically established by a reference standard measurement.

4. Adjudication Method

Not applicable, as the studies are focused on direct comparison to a reference standard (arterial line) rather than expert adjudication of qualitative findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI algorithms where human readers interpret results, and the AI's impact on their performance is measured. The LiveOne LM1P is a non-invasive blood pressure monitor, not an AI for image interpretation.

6. Standalone (Algorithm Only) Performance

Yes, the studies conducted (ICU accuracy study and General population accuracy study) assessed the standalone performance of the LiveOne LM1P device. The device's measurements (systolic BP, diastolic BP, HR) were directly compared against the arterial line (A-line) measurements, which served as the gold standard. There is no mention of a human-in-the-loop interaction for the accuracy assessment itself, only that "Software is used to provide data to qualified medical professionals for the purpose of assessing the patient's cardiac health."

7. Type of Ground Truth Used

The ground truth used in both clinical studies was arterial line (A-line) measurements. This is a direct, invasive, and generally accepted gold standard for continuous blood pressure monitoring.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set of the LiveOne LM1P's proprietary algorithms. The clinical studies described are for validation/testing of the device's accuracy against a gold standard.

9. How the Ground Truth for the Training Set Was Established

The document does not describe how the ground truth for the training set was established. It only discusses the validation studies against arterial line measurements. Given that the device uses "proprietary algorithms to analyze the radial artery pressure," it is highly probable that some form of data (likely also compared to arterial line or other reference methods) was used for algorithm development and training, but this is not detailed in the provided text.

Summary

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May 4, 2022

LiveMetric (Medical) S.A. Chen Botvin Senior Regulatory and Clinical Manager 40 Rue Glesener Luxembourg, L-1630 Luxembourg

Re: K201302

Trade/Device Name: LiveOne LM1P Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 22, 2022 Received: April 22, 2022

Dear Chen Botvin:

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,

LCDR Stephen Browning 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) K201302

Device Name LiveOne LM1P

Indications for Use (Describe)

The LiveOne is intended to be used in patients who have a need for a noninvasive blood pressure and hemodynamic monitor.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY LiveMetric's LiveOne LM1P

Submitter Information:

Submitter:	LiveMetric (Medical) S.A.
	40 Rue Glesener,
	Luxembourg L-1630
	Luxembourg
Contact Person:	Tomer Bentzion
	Chief Executive Officer
Phone:	+1 650-285-7222
eMail:	tomer.bentzion@livemetric.com
Date Prepared:	May 13, 2020
Device Information:
Trade Name:	LiveOne LM1P
Common or Usual Name:	Noninvasive Blood Pressure Monitor
Classification Name:	Noninvasive Blood Pressure Monitor Measurement System
Regulatory Class:	Class II
Product Code:	21CFR870.1130 DXN

Predicate Devices:

The LiveOne LM1P is substantially equivalent in indications for use to the devices shown in table below, that have been cleared for marketing:

Device Name	Manufacturer	510(K)
TL300 Tensymeter NoninvasiveBlood Pressure Monitor	Tensys Medical, Inc.	K123446
TL10 Tensymeter Non-invasiveBlood Pressure Monitor	Tensys Medical, Inc.	K020537

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Device Description

Intended Use

LiveOne is a non-invasive blood pressure monitor, intended to capture the arterial waveform on the wrist and use it to as the basis of measurement of the systolic and diastolic blood pressure and pulse rate in the adult patient population. The blood pressure is thereby measured on the patient's wrist.

The LiveOne provides intermittent blood pressure values to a medical professional. The LiveOne displays continuous radial arterial pressure waveform prior measurement to a medical professional.

The Interpretation of the numerical values will be made by medical professionals only. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers and the tracing.

The LiveOne is intended to be used for patients who have a need for a noninvasive blood pressure monitor and is intended for use in clinical settings only. It does not provide any alarms and is not intended to clinically monitor patients in operating rooms, intensive care units (ICU) and electrophysiology laboratories.

Indications for Use

The LiveOne is intended to be used in patients who have a need for a non-invasive blood pressure and hemodynamic monitor.

The LiveOne is intended to be used on subjects ≥ 27 years old and who have a palpable radial pulse. Software is used to provide data to qualified medical professionals for the purpose of assessing the patient's cardiac health via blood pressure readings taken in a clinical setting by health care professional . LiveOne is intended only for measurement and display; it makes no diagnosis.

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Summary of Technological Characteristics

The intended use of LiveOne LM1P has the same intended use as its predicate device(s) TL300 (K123446) and its predicate TL10 (K020537). The technological characteristics of LiveOne LM1P are substantially similar to the technological characteristics of the predicate device(s), TL300 (K123446) and TL10 (K020537). Subject device and predicate device(s) are considered NIBP monitors; both subject device and predicate device(s) are based on applanation tonometry; they both apply the physical principle of applanation tonometry on the radial artery with the use of pressure sensor data. The reading from the sensor are transformed to a pressure waveform, from which, the values of systolic and diastolic pressure are calculated. Both subject device and predicate device(s) are auto-calibrating; do not require any external calibration using a cuff. Both devices use the radial artery site as the primary pressure source for the system, whereas, TL300 utilizes a single sensor on its wrist-worn bracelet, LiveOne LM1P also operates under this same underlying principle, but it reads and processes the pressure waveform using a high-resolution, MEMS-based sensor array. The predicate device(s) utilizes an algorithm to define an optimum pressure sensing position over the radial artery. The subject device uses a placement signal score module that ensures high fidelity, pressure waveform signal, sampled at a frequency of 100Hz, and extracts the systole, diastole and heart rate to be displayed on the device's dedicated monitor. Any differences in the technological characteristics between the LiveOne LM1P and the predicate device do not raise any new issues of safety or effectiveness. Therefore, the LiveOne LM1P is substantially equivalent to the predicate device(s).

Functionality	LiveOne LM1P	TL10 Tensymeter Non-invasive Blood PressureMonitorK020537	TL300 TensymeterNoninvasive BloodPressure MonitorK123446
Regulatorycompliance	ISO 81060-2:2016 (Thesuccessor of AAMISP10:1992; AAMISP10:2002; IEC 81060-2:2009 standard; ISO81060-2:2013)	AAMI Standard SP-10 -2002	IEC 81060-2:2009The accuracy of the devicewill be compared to thestandard radial arterycatheter, as well as to thenon-invasive blood pressurecuff.
Product CodeIntended Use	DXNLiveOne is a non-invasive blood pressuremonitor. The blood	DXNThis device is intendedfor use by medicallytrained personnel in a	DXNTL-300 is a non-invasivehemodynamic monitor.
	pressure waveform ismeasured on thepatient's wrist.	clinical setting tocontinuously monitorand display diastolic,systolic, and mean bloodpressures.
	Provides intermittentblood pressure values toa medical professional.The LiveOne displayscontinuous radialarterial pressurewaveform priormeasurement to amedical professional.Software is used toprovide data to qualifiedmedical professionalsfor the purpose ofassessing the patient'scardiac health via bloodpressure readings in aclinical setting.The LiveOne isintended to be used onsubjects≥27 years oldand who have apalpable radial pulse.	This device is intendedfor use by medicallytrained personnel in aclinical setting tocontinuously monitorand display diastolic,systolic, and mean bloodpressures.The device is intendedfor use on adult patientswith a palpable pulse.This device is intendedfor use by medicallytrained personnel in aclinical setting tocontinually monitor anddisplay diastolic,systolic, and mean blood	TL-300 doescontinuous beat-to-beatwaveform and bloodpressure monitoring.
	The Interpretation of thenumerical values willbe made by medicalprofessionals only.The device does notreport any diagnosis butprovides numericalvalues. It is thephysician'sresponsibility to makeproper judgments basedon these numbers.LiveOne is intendedonly for measurementand display; it makes nodiagnosis.	pressures and pulse rate.
TechnologicalCharacteristics	LiveOne is placed onthe wrist over the areaof the radial artery pulsewhile the sensorinterface acts as apressure transducer.	The design of the TL10Tensymeter utilizes asemiconductor pressure-sensing element appliedto the wrist, over theradial artery, to obtain a	The T-line device will beplaced over the radial arteryat the distal wrist.

	LiveOne LM1P alsooperates under thissame underlyingprinciple (Tonometry),but it reads andprocesses the pressurewaveform at the radialartery by the use of ahigh-resolution,MEMS-based sensorarrayThe LiveOne wristbandis similar in size andweight to a sportswristwatch.LiveOne is monitoringat the wrist usingarterial tonometryAn embeddedmicrocontrollersupervises the actions ofthe monitorUtilizes asemiconductor pressure-sensing element/ arrayof elements applied tothe wrist, over the radialartery, to obtain apressure waveformThe LiveOne LM1Puses weight, height, ageand sex in its signalprocessing and pressuremeasurementalgorithms.LiveOne LM1P iscomprised of awristband and an off-the-shelf tablet as acompanion device.	pressure waveform.The TL10 Tensymeter isa non-invasive bloodpressure monitor thatutilizes a single patientuse non-invasivepressure sensor placed onthe wrist, over the radialartery, and an electronicinterface module.The monitor has a sizeand weight similar to asports type wrist watch.Blood pressuremonitoring at the wristusing arterial tonometry.An embeddedmicrocontrollersupervises the actions ofthe monitor.The monitor is applied tothe wrist with a pressuretransducer placed overthe radial artery.	To attach the device, asingle-use sterile sensor isplaced over the radial arteryand the device then gentlyclamped around the wrist toincorporate the sensor.The T-Line uses Body MassIndex (BMI, computed usingheight and weight) in itssignal processing andpressure measurementalgorithms.The TL-300 T-Line systemcomprises a sensor, bracelet,wrist positioner, and a tabletmonitor to form anintegrated system.
Non-ClinicalTests Submitted	ANSI/AAMI ES60601-1:2005 / A2:2010Medical electricalequipment - Part 1:General requirementsfor basic safety andessential performanceIEC 60601-1Medical electricalequipment - Part 1:General requirementsfor basic safety andessential performanceIEC 60601-1-2	ANSI/AAMI ES60601-1:2005 / A2:2010IEC 60601-1IEC 60601-1-2
	Medical electricalequipment – Part 1-2:General requirementsfor safety –Electromagneticcompatibility –Requirements and testsISO 10993-1Biological evaluation ofmedical devices – Part1: Evaluation andtesting	ISO 10993-1
TargetPopulation	The LiveOne targetspatients, over 27 yearsof age, who have a needfor non-invasive bloodpressure monitoring	The device is intendedfor use on adult patientswith a palpable pulse.
Anatomical Site	LiveOne is placed onthe wrist over the areaof the radial artery pulse	The monitor is placed onthe wrist over the area ofthe radial artery pulse
End User	The LiveOne isintended to be used forpatients who have aneed for a noninvasiveblood pressure monitorand is intended for usein clinical settings only.	This device is intendedfor use by medicallytrained personnel in aclinical setting tocontinuously monitorand display diastolic,systolic, and mean bloodpressures.

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Performance data

Non-clinical testing

Biocompatibility testing

The biocompatibility evaluation for the LiveOne device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, '' May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

· Cytotoxicity
Sensitization
Irritation
Systemic toxicity

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The LiveOne device is considered tissue contacting for a duration of more than 24 hours.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the LiveOne device, consisting of the LiveOne wristband and the Microsoft Surface tablet. The system complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was 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 was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Clinical testing

Multi-center ICU accuracy study:

This was a multi-center, non-randomized, single arm study of 26 subjects. The study was conducted in accordance with ISO 81060-2:2018 standard. This LiveOne device accuracy was compared to arterial line in ICU patients.

Primary endpoint

The results of the Subject Device compared to the A-line measurement in the ICU accuracy validation data set were as follows: (1) mean bias of systolic BP: 0.7+6.6, (2) mean diastolic bias: 2.0 ±5.5 mmHg, and (3) HR relative distance: 2.9. Those results are within the acceptance criteria for the accuracy of blood pressure monitors. The study demonstrated that the Subject Device is accurate, and the study population and results comply with the ISO standard requirements.

General population accuracy study:

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This was a single-center, non-randomized, single arm study of 8 subjects. The study was conducted in accordance with ISO 81060-2:2018 standard. This LiveOne device accuracy was compared to arterial line in healthy subjects.

Primary endpoint

The results of the Subject Device compared to the A-line measurement in the general population validation data set were as follows: (1) mean bias for systolic BP: -1.3 ± 7.2 mmHg(2) mean bias of diastolic BP: -0.4 ± 5.7 mmHg(3) HR relative distance 1.36. Those results are within the acceptance criteria for the accuracy of blood pressure monitors. The study demonstrated that the Subject Device is accurate, and the study population and results comply with the ISO standard requirements.

Conclusion

The LiveOne LM1P is as safe and as effective as the TL300 and its predicate TL10. The LiveOne LM1P has the same intended uses and similar indications, as its predicate device. The minor differences in indications do not alter the intended use. The LiveOne LM1P is as safe and effective as the Tensymeter's TL300 and the TL10. The LiveOne LM1P has the same technological characteristics, and principles of operation as its predicate device(s). In addition, the minor technological differences between the LiveOne LM1P and its predicate device(s) raise no new issues of safety or effectiveness. The nonclinical data support the safety of the device and the hardware and software verification and validation demonstrate that the LiveOne LM1P device should perform as intended in the specified use conditions. The clinical testing demonstrated that the LiveOne LM1P device is accurate according to the applicable ISO 81060-2-2018 standard. Thus, the LiveOne LM1P is substantially equivalent to the predicate.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).