(252 days)
No
The description focuses on signal processing and computation of heart sound characteristics, without mentioning AI or ML algorithms.
No.
The device is intended for acquiring and analyzing heart sound data, computing and reporting an estimate of left ventricle Ejection Fraction, and aiding in the evaluation of heart function; it does not directly treat or cure a disease or condition.
Yes
The device is intended for use in "acquiring and analyzing heart sound data and computing and reporting an estimate of left ventricle Ejection Fraction" which aids in the "evaluation of heart function" and is explicitly stated as being intended to "aid the physician in the evaluation of heart function." This function of providing data and aiding in evaluation points to a diagnostic purpose, even though it is not a "sole means of diagnosis."
No
The device description explicitly lists hardware components (ICR Acoustic Sensors, ECG Sensor Electrodes) that are part of the system and are used to collect signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Description: The ICR System uses non-invasive sensors placed on the chest wall to collect heart sound and ECG data. It analyzes these signals to estimate Ejection Fraction. This process does not involve testing samples taken from the body.
- Intended Use: The intended use describes the device as acquiring and analyzing heart sound data and computing an estimate of Ejection Fraction. This is a physiological measurement based on external signals, not an analysis of a biological sample.
Therefore, the ICR System falls under the category of a medical device that performs physiological measurements, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Integrated CardioRespiratory (ICR) System, when used with ICR Acoustic Sensors and ECG Sensor Electrodes on the chest wall, is intended for use in acquiring and analyzing heart sound data and computing and reporting an estimate of left ventricle Ejection Fraction that is comparable to that derived by 2-D echocardiography. The device is not intended for continuous monitoring of Ejection Fraction.
The ICR System is not intended as a sole means of diagnosis. It does not supersede the judgment of the qualified medical personnel. The ICR System is intended to aid the physician in the evaluation of heart function. The interpretation of EF values offered by the ICR System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data.
Indicated for use in adults only. The ICR System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
Product codes
MWJ
Device Description
The Integrated CardioRespiratory (ICR) System is a non-invasive skin adhering sensors and computer based device that allows for measurement of Ejection Fraction (EF). The ICR System includes four acoustic sensors and ECG electrodes that are placed on the patient's chest to collect signals, which are combined to compute the EF percentage value. The ICR System performs signal processing computation to identify and characterize amplitude and time of event characteristics of S1 and S2 heart sounds. The computed EF percentage value is presented to the clinician on the ICR Patient Monitor display.
The ICR System consists of the following components:
-
- ICR Acoustic Sensors
-
- ECG Sensor Electrodes
-
- ICR Sensor Application System
-
- ICR Patient Monitor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall
Indicated Patient Age Range
adults only
Intended User / Care Setting
licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
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
Bench, clinical and human factors testing was conducted on the ICR System to support a determination of substantial equivalence.
Nonclinical Testing Summary:
The nonclinical, bench testing included:
- Specification testing;
- Software Verification and Validation testing;
- Measurement reproducibility testing; and
- Human Factors Testing.
The collective results of the nonclinical testing demonstrate that the ICR System meets the established specifications necessary for consistent performance during its intended use, which is equivalent to that of the predicate devices.
Clinical Testing Summary:
In support of the ICR System, two clinical studies have been performed, a measurement validation study and a measurement variability evaluation. The measurement validation study was performed to (1) evaluate the equivalence of the ICR System to the Echocardiography method and (2) to evaluate the agreement of the ICR System to cardiac Magnetic Resonance Imaging (cMRI) EF measurements, with cMRI being considered the gold standard for EF assessment. A total of 81 patients who arrived at the healthcare facility for some cardiac condition were enrolled across four (4) independent investigational sites. The study results demonstrate that the performance of the ICR system is comparable with the echocardiography method.
The measurement variability study addressed variability due to operator variability and device performance variability. The results of the study showed that the ICR System has low and acceptable variability in EF measurements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
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 8, 2018
Sensydia, Inc. % Anna Libman Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, California 95110
Re: K173156
Trade/Device Name: Integrated CardioRespiratory System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: May 10, 2018 Received: May 11, 2018
Dear Anna Libman:
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. Iisting 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about mediation-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. Wilhelm
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173156
Device Name Integrated CardioRespiratory System
Indications for Use (Describe)
The Integrated CardioRespiratory (ICR) System, when used with ICR Acoustic Sensors and ECG Sensor Electrodes on the chest wall, is intended for use in acquiring and analyzing heart sound data and computing and reporting an estimate of left ventricle Ejection Fraction that is comparable to that derived by 2-D echocardiography. The device is not intended for continuous monitoring of Ejection Fraction.
The ICR System is not intended as a sole means of diagnosis. It does not supersede the judgment of the qualified medical personnel. The ICR System is intended to aid the physician in the evaluation of heart function. The interpretation of EF values offered by the ICR System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data.
Indicated for use in adults only. The ICR System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
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) Notification K173156
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Sensydia, Inc. 907 Westwood Boulevard, Suite 358 Los Angeles, CA 90024 USA Phone: 310-593-3019
Contact Person:
Anna Libman Regulatory Consultant to Sensydia, Inc. Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 408-400-0856 FAX: 408-400-0865
Date Prepared: June 8, 2018
DEVICE INFORMATION [807.92(a)(2)]
Trade/Proprietary Name: Integrated CardioRespiratory System
Generic/Common Name:
21 CFR §870.2800, Electrocardiograph, Ambulatory (Without Analysis)
Classification: Class II
Product Code: MWJ
4
PREDICATE DEVICE(S) [807.92(a)(3)]
- . Primary predicate: Vasocom, Inc. Physioflow Q-Link (K140102)
- Secondary predicate: Inovise Medical, Inc. Audicor, Hemo Ambulatory Monitor ● (K073545)
DEVICE DESCRIPTION [807.92(a)(4)]
The Integrated CardioRespiratory (ICR) System is a non-invasive skin adhering sensors and computer based device that allows for measurement of Ejection Fraction (EF). The ICR System includes four acoustic sensors and ECG electrodes that are placed on the patient's chest to collect signals, which are combined to compute the EF percentage value. The ICR System performs signal processing computation to identify and characterize amplitude and time of event characteristics of S1 and S2 heart sounds. The computed EF percentage value is presented to the clinician on the ICR Patient Monitor display.
The ICR System consists of the following components:
-
- ICR Acoustic Sensors
-
- ECG Sensor Electrodes
-
- ICR Sensor Application System
-
- ICR Patient Monitor
INDICATIONS FOR USE [807.92(a)(5)]
The Integrated CardioRespiratory (ICR) System, when used with ICR Acoustic Sensors and ECG Sensor Electrodes on the chest wall, is intended for use in acquiring and analyzing heart sound data and computing and reporting an estimate of left ventricle Ejection Fraction that is comparable to that derived by 2-D echocardiography. The device is not intended for continuous monitoring of Ejection Fraction.
The ICR System is not intended as a sole means of diagnosis. It does not supersede the judgment of the qualified medical personnel. The ICR System is intended to aid the physician in the evaluation of heart function. The interpretation of EF values offered by the ICR System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data.
Indicated for use in adults only. The ICR System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
| | Sensydia, Inc.
ICR System | Primary Predicate:
Vasocom Inc.
Physioflow Q-Link (K140102) | Secondary Predicate:
Inovise Medical, Inc.
Audicor Hemo Ambulatory
Monitor (K073545) |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II, 21
CFR§870.2800 | Class II, 21 CFR§870.2770
Impedance plethysmograph | Class II, 21 CFR§870.2800 |
| Product Code | MWJ,
Electrocardiograph,
Ambulatory (Without
Analysis) | DSB, Impedance plethysmograph | MWJ, Electrocardiograph,
Ambulatory (Without
Analysis) |
| Indications for
Use | The Integrated
CardioRespiratory
(ICR) System, when
used with ICR
Acoustic Sensors and
ECG Sensor
Electrodes on the
chest wall, is
intended for use in
acquiring and
analyzing heart
sound data and
computing and
reporting an estimate
of left ventricle
Ejection Fraction that
is comparable to that
derived by 2-D
echocardiography.
The device is not
intended for
continuous
monitoring of
Ejection Fraction.
The ICR System is
not intended as a sole
means of diagnosis.
It does not supersede
the judgment of the
qualified medical
personnel. The ICR
System is intended to
aid the physician in
the evaluation of
heart function. The
interpretation of EF | Indicated for use in adults only.
The PhysioFlow Q-Link
noninvasively measures cardiac
output and other related cardiac
parameters. These parameters
include:
CI
Cardiac Index
CO
Cardiac Output
CTI
Contractility Index
dZ / dt max
Maximum value dZ / dt
EDV
End Diastolic Volume
EF
Ejection Fraction
HR
Heart Rate
LCWI
Left Cardiac Work Index
PEP
Pre-Ejection Period
SV
Stroke Volume
SVR
Systemic Vascular Resistance
SVRI
Systemic Vascular Resistance Index
TFI
Thoracic Fluid Index
VET
Ventricular Ejection Time
ZO
Base Impedance
The PhysioFlow Q-Link is intended
for use under the direct supervision
of a licensed healthcare practitioner
or personnel trained in its proper use
within a hospital or facility
providing healthcare. | The Audicor® System, when
used with AUDICOR
Sensors on the chest wall, is
intended for use in acquiring,
analyzing and reporting ECG
and heart sound data and to
provide interpretation of the
data in an integrated ACG
(acoustic cardiograph) report
for consideration by
physicians. Audicor systems
allow detection, reporting
and interpretation of standard
ECG data as well as
advanced parameters such as
EMAT, LVST, S3 strength,
S4 strength, and SDI.
Data may be reported in a
single snapshot report and in
a trended report form where
multiple data points are
trended over time. The
Audicor system also accepts
and analyzes downloads of
up to 48 hours of patient data
from an optional ambulatory
ECG/heart sounds collection
device.
ECG and heart sound data
offered by the device are
only significant when used in
conjunction with physician
over read as well as
consideration of other
relevant patient data. |
| | values offered by the
ICR System are only
significant when used
in conjunction with
physician over-read | | The device is intended for
use only under the direct
supervision of a physician
and is for use on adults (≥18
years). |
| | as well as | | |
| | Sensydia, Inc.
ICR System | Primary Predicate:
Vasocom Inc.
Physioflow Q-Link (K140102) | Secondary Predicate:
Inovise Medical, Inc.
Audicor Hemo Ambulatory
Monitor (K073545) |
| | consideration of all
relevant patient data.
Indicated for use in
adults only. The ICR
System is intended
for use under the
direct supervision of
a licensed healthcare
practitioner or
personnel trained in
its proper use within
a hospital or facility
providing healthcare. | | |
| | | Technological Characteristics | |
| Components
Parameters
Measured | Acoustic Sensors
ECG Electrodes
Portable display
computer
Computational
software
Ejection Fraction | Bioimpedance electrodes
ECG Electrodes
Portable display computer
Computational software
• Stroke Volume/Index
• Cardiac Output/Index
• Early Diagnostic Filling Ratio
(Preload Index)
• Systemic Vascular Resistance
(Afterload) | Acoustic Sensors
ECG Electrodes
Portable display computer
Computational software
LVST (Left Ventricular
Systolic Time)
LVDT (Left Ventricular
Diastolic Time)
PADT (Pre-atrial Diastolic
Filling Time)
AAFT (Accelerated Atrial |
| | | • Left Cardiac Work Index
(surrogate of MVO2)
• Contractility Index
• Ventricular Ejection Time
• Ejection Fraction (est.)/End
Diastolic Volume (est.) | Filling Time)
EMAT (QS1,
Electromechanical
Activation Time)
QS2
R-R Interval
S3 Strength
S4 Strength
SDI (Systolic Dysfunction
Index) |
| Measurement | Point in time
assessment | Continuous, upon clinician
discretion for up to 24 hours | Continuous, upon clinician
discretion for up to 48 hours |
| System Contact | External wearable
sensors in contact
with patient's chest | External wearable sensors in contact
with patient's chest and neck | External wearable sensors in
contact with patient's chest |
| Patient
Contacting
Materials | Skin contact only,
biocompatible | Skin contact only, biocompatible | Skin contact only,
biocompatible |
| Use
Environment | Healthcare facilities | Healthcare facilities | Healthcare facilities |
6
510(k) SUMMARY
7
SUBSTANTIAL EQUIVALENCE
The ICR System has the same intended use as the predicate devices of measuring cardiac function and specifically measuring EF like the Physioflow predicate. The indications for use for the ICR System are similar to those of the predicate devices with respect to the measurement of cardiac function. The differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness as evaluated via bench, clinical and human factors testing. Thus, the ICR System is substantially equivalent to the predicate devices.
PERFORMANCE DATA [807.92(b)]
Bench, clinical and human factors testing was conducted on the ICR System to support a determination of substantial equivalence.
[807.92(b)(1)] Nonclinical Testing Summary:
The nonclinical, bench testing included:
- . Specification testing;
- Software Verification and Validation testing;
- Measurement reproducibility testing; and ●
- . Human Factors Testing.
The collective results of the nonclinical testing demonstrate that the ICR System meets the established specifications necessary for consistent performance during its intended use, which is equivalent to that of the predicate devices.
[807.92(b) (2)] Clinical Testing Summary:
In support of the ICR System. two clinical studies have been performed, a measurement validation study and a measurement variability evaluation. The measurement validation study was performed to (1) evaluate the equivalence of the ICR System to the Echocardiography method and (2) to evaluate the agreement of the ICR System to cardiac Magnetic Resonance Imaging (cMRI) EF measurements, with cMRI being considered the gold standard for EF assessment. A total of 81 patients who arrived at the healthcare facility for some cardiac condition were enrolled across four (4) independent investigational sites. The study results demonstrate that the performance of the ICR system is comparable with the echocardiography method.
The measurement variability study addressed variability due to operator variability and device performance variability. The results of the study showed that the ICR System has low and acceptable variability in EF measurements.
CONCLUSIONS [807.92(b)(3)]
The ICR System has the same intended use, a subset of the indication for use, and similar technological characteristics as the primary predicate device, the PhysioFlow. Both devices non-invasively measure hemodynamic flow and then compute and display EF values in numeric and graphical format. The devices leverage different means for measuring hemodynamic flow, however. The PhysioFlow was validated to measure EF
8
510(k) SUMMARY
and the ICR System was verified to perform as intended and validated for measuring EF in direct comparison with the gold standard. Moreover, the method used by the ICR System has also been used with the Audicor secondary predicate device, which has the same intended use of measuring cardiac function parameters and has been cleared to do so safely and effectively. Lastly, like both predicate devices, the ICR System is to be used in adult patients by healthcare providers in the context of current standard of care for patient diagnosis and treatment. As such, the ICR System is substantially equivalent to the primary predicate device.
SUMMARY
The ICR System is substantially equivalent to the predicate devices.