(719 days)
Not Found
No
The summary mentions "proprietary algorithms" but does not explicitly state or imply the use of AI or ML. There is no mention of training or test sets, which are typical for ML models.
No.
The device is a non-invasive blood pressure and hemodynamic monitor intended for measurement and display of blood pressure readings and making no diagnosis, rather than providing therapy.
No
The device is described as "intended only for measurement and display; it makes no diagnosis."
No
The device description explicitly states it utilizes a "single patient use non-invasive pressure sensor placed on the wrist over the radial artery, and an electronic interface module," indicating the presence of hardware components beyond just software.
Based on the provided information, the LiveOne device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- LiveOne's Function: The LiveOne device is a non-invasive blood pressure and hemodynamic monitor. It measures blood pressure and pulse rate by analyzing the pressure from the radial artery on the wrist. This is a direct measurement from the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it's for "noninvasive blood pressure and hemodynamic monitor" and provides data for "assessing the patient's cardiac health via blood pressure readings." This aligns with a physiological monitoring device, not an IVD.
- Device Description: The description reinforces that it's a "non-invasive blood pressure monitor" using a sensor placed on the wrist.
Therefore, the LiveOne device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LiveOne is intended to be used in patients who have a need for a noninvasive 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 in clinic setting by health care professional. LiveOne is intended only for measurement and display; it makes no diagnosis.
Product codes
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist over the radial artery pulse
Indicated Patient Age Range
≥ 27 years old
Intended User / Care Setting
qualified medical professionals; clinical setting
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
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.
General population accuracy study: 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Multi-center ICU accuracy study:
- Study type: Multi-center, non-randomized, single arm study.
- Sample size: 26 subjects.
- Key results: 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:
- Study type: Single-center, non-randomized, single arm study.
- Sample size: 8 subjects.
- Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
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
1
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
2
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.
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.
| 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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3
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 Noninvasive | ||
| Blood Pressure Monitor | Tensys Medical, Inc. | K123446 |
| TL10 Tensymeter Non-invasive | ||
| Blood Pressure Monitor | Tensys Medical, Inc. | K020537 |
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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.
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.
5
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 Pressure
Monitor
K020537 | TL300 Tensymeter
Noninvasive Blood
Pressure Monitor
K123446 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory
compliance | ISO 81060-2:2016 (The
successor of AAMI
SP10:1992; AAMI
SP10:2002; IEC 81060-
2:2009 standard; ISO
81060-2:2013) | AAMI Standard SP-10 -
2002 | IEC 81060-2:2009
The accuracy of the device
will be compared to the
standard radial artery
catheter, as well as to the
non-invasive blood pressure
cuff. |
| Product Code
Intended Use | DXN
LiveOne is a non-
invasive blood pressure
monitor. The blood | DXN
This device is intended
for use by medically
trained personnel in a | DXN
TL-300 is a non-invasive
hemodynamic monitor. |
| | pressure waveform is
measured on the
patient's wrist. | clinical setting to
continuously monitor
and display diastolic,
systolic, and mean blood
pressures. | |
| | Provides intermittent
blood pressure values to
a medical professional.
The LiveOne displays
continuous radial
arterial pressure
waveform prior
measurement to a
medical professional.
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 a
clinical setting.
The LiveOne is
intended to be used on
subjects≥27 years old
and who have a
palpable radial pulse. | This device is intended
for use by medically
trained personnel in a
clinical setting to
continuously monitor
and display diastolic,
systolic, and mean blood
pressures.
The device is intended
for use on adult patients
with a palpable pulse.
This device is intended
for use by medically
trained personnel in a
clinical setting to
continually monitor and
display diastolic,
systolic, and mean blood | TL-300 does
continuous beat-to-beat
waveform and blood
pressure monitoring. |
| | 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.
LiveOne is intended
only for measurement
and display; it makes no
diagnosis. | pressures and pulse rate. | |
| Technological
Characteristics | LiveOne is placed on
the wrist over the area
of the radial artery pulse
while the sensor
interface acts as a
pressure transducer. | The design of the TL10
Tensymeter utilizes a
semiconductor pressure-
sensing element applied
to the wrist, over the
radial artery, to obtain a | The T-line device will be
placed over the radial artery
at the distal wrist. |
| | | | |
| | LiveOne LM1P also
operates under this
same underlying
principle (Tonometry),
but it reads and
processes the pressure
waveform at the radial
artery by the use of a
high-resolution,
MEMS-based sensor
array
The LiveOne wristband
is similar in size and
weight to a sports
wristwatch.
LiveOne is monitoring
at the wrist using
arterial tonometry
An embedded
microcontroller
supervises the actions of
the monitor
Utilizes a
semiconductor pressure-
sensing element/ array
of elements applied to
the wrist, over the radial
artery, to obtain a
pressure waveform
The LiveOne LM1P
uses weight, height, age
and sex in its signal
processing and pressure
measurement
algorithms.
LiveOne LM1P is
comprised of a
wristband and an off-
the-shelf tablet as a
companion device. | pressure waveform.
The TL10 Tensymeter 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 monitor has a size
and weight similar to a
sports type wrist watch.
Blood pressure
monitoring at the wrist
using arterial tonometry.
An embedded
microcontroller
supervises the actions of
the monitor.
The monitor is applied to
the wrist with a pressure
transducer placed over
the radial artery. | To attach the device, a
single-use sterile sensor is
placed over the radial artery
and the device then gently
clamped around the wrist to
incorporate the sensor.
The T-Line uses Body Mass
Index (BMI, computed using
height and weight) in its
signal processing and
pressure measurement
algorithms.
The TL-300 T-Line system
comprises a sensor, bracelet,
wrist positioner, and a tablet
monitor to form an
integrated system. |
| Non-Clinical
Tests Submitted | ANSI/AAMI ES60601-
1:2005 / A2:2010
Medical electrical
equipment - Part 1:
General requirements
for basic safety and
essential performance
IEC 60601-1
Medical electrical
equipment - Part 1:
General requirements
for basic safety and
essential performance
IEC 60601-1-2 | ANSI/AAMI ES60601-
1:2005 / A2:2010
IEC 60601-1
IEC 60601-1-2 | |
| | Medical electrical
equipment – Part 1-2:
General requirements
for safety –
Electromagnetic
compatibility –
Requirements and tests
ISO 10993-1
Biological evaluation of
medical devices – Part
1: Evaluation and
testing | ISO 10993-1 | |
| Target
Population | The LiveOne targets
patients, over 27 years
of age, who have a need
for non-invasive blood
pressure monitoring | The device is intended
for use on adult patients
with a palpable pulse. | |
| Anatomical Site | LiveOne is placed on
the wrist over the area
of the radial artery pulse | The monitor is placed on
the wrist over the area of
the radial artery pulse | |
| End User | 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. | This device is intended
for use by medically
trained personnel in a
clinical setting to
continuously monitor
and display diastolic,
systolic, and mean blood
pressures. | |
6
7
8
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
9
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:
10
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.