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.

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

AI/ML Overview

Here's an analysis of the provided text to extract information regarding the acceptance criteria and the study proving the device meets them:

Disclaimer: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the device, predicate devices, and testing performed to demonstrate substantial equivalence. It does not typically contain the detailed raw data or full study reports that would include specific acceptance criteria thresholds or comprehensive statistical results for every performance metric. Therefore, some information requested might not be explicitly present and can only be inferred or stated as "not specified."

Acceptance Criteria and Device Performance

The document broadly states that the device was evaluated for "equivalence to the Echocardiography method" and "agreement... to cardiac Magnetic Resonance Imaging (cMRI) EF measurements." However, specific numerical acceptance criteria (e.g., "within X% difference" or "sensitivity > Y%") for these comparisons are not explicitly stated in the provided text. The performance is summarized qualitatively as "comparable" and "low and acceptable variability."

Acceptance Criteria (Not explicitly stated numerically in the document)	Reported Device Performance (Qualitative Summary)
Equivalence to 2-D Echocardiography for Left Ventricle Ejection Fraction (EF) estimation	"the performance of the ICR system is comparable with the echocardiography method."
Agreement with Cardiac Magnetic Resonance Imaging (cMRI) for EF assessment (Gold Standard)	"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." (No direct statement of agreement achieved, but implies it was satisfactory enough for clearance).
Low Measurement Variability (Operator & Device)	"the ICR System has low and acceptable variability in EF measurements."
Software Verification and Validation	"meets the established specifications necessary for consistent performance."
Measurement Reproducibility	"meets the established specifications necessary for consistent performance."
Human Factors testing	(No specific performance metric mentioned, but implies it met requirements for safe and effective use)

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: "A total of 81 patients who arrived at the healthcare facility for some cardiac condition were enrolled."
- Data Provenance:
  - Country of Origin: Not specified in the provided text.
  - Retrospective or Prospective: Not explicitly stated, but the phrase "patients who arrived at the healthcare facility for some cardiac condition were enrolled" suggests a prospective enrollment for the study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: The ground truth methods were "2-D echocardiography" and "cardiac Magnetic Resonance Imaging (cMRI)". These procedures are performed and interpreted by trained medical professionals (e.g., cardiologists, sonographers, radiologists). The document refers to "qualified medical personnel" in the Indications for Use, but doesn't specify expert qualifications for ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The ground truth was established by comparison to echocardiography and cMRI, implying these methods served as the reference standard rather than human adjudication of the device's output.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. The study described is a direct comparison of the device's output (EF) against established medical imaging methods (echocardiography and cMRI), not an evaluation of human reader performance with and without AI assistance.
- Effect Size: Not applicable, as no MRMC study was performed to assess human reader improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes. The "measurement validation study" evaluated the "equivalence of the ICR System to the Echocardiography method" and "agreement... to cardiac Magnetic Resonance Imaging (cMRI) EF measurements." This inherently describes the algorithm's performance in estimating EF independently, as its output (the EF percentage value) is directly compared to the reference standards. The device's output is "presented to the clinician on the ICR Patient Monitor display," meaning the algorithm generates the EF value.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The primary ground truths were 2-D Echocardiography and Cardiac Magnetic Resonance Imaging (cMRI) EF measurements. cMRI is explicitly stated as "considered the gold standard for EF assessment."
The sample size for the training set:
- Not specified. The document only details the clinical study for the test set (81 patients). Information about the training set size or methodology is not included in this 510(k) summary.
How the ground truth for the training set was established:
- Not specified. As the training set size and details are not provided, how its ground truth was established is also not mentioned.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K173156

Device Name Integrated CardioRespiratory System

Indications for Use (Describe)

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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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

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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 ICR System consists of the following components:

1. ICR Acoustic Sensors
1. ECG Sensor Electrodes
1. ICR Sensor Application System
1. ICR Patient Monitor

INDICATIONS FOR USE [807.92(a)(5)]

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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 AmbulatoryMonitor (K073545)
Classification	Class II, 21CFR§870.2800	Class II, 21 CFR§870.2770Impedance plethysmograph	Class II, 21 CFR§870.2800
Product Code	MWJ,Electrocardiograph,Ambulatory (WithoutAnalysis)	DSB, Impedance plethysmograph	MWJ, Electrocardiograph,Ambulatory (WithoutAnalysis)
Indications forUse	The IntegratedCardioRespiratory(ICR) System, whenused with ICRAcoustic Sensors andECG SensorElectrodes on thechest wall, isintended for use inacquiring andanalyzing heartsound data andcomputing andreporting an estimateof left ventricleEjection Fraction thatis comparable to thatderived by 2-Dechocardiography.The device is notintended forcontinuousmonitoring ofEjection Fraction.The ICR System isnot intended as a solemeans of diagnosis.It does not supersedethe judgment of thequalified medicalpersonnel. The ICRSystem is intended toaid the physician inthe evaluation ofheart function. Theinterpretation of EF	Indicated for use in adults only.The PhysioFlow Q-Linknoninvasively measures cardiacoutput and other related cardiacparameters. These parametersinclude:CICardiac IndexCOCardiac OutputCTIContractility IndexdZ / dt maxMaximum value dZ / dtEDVEnd Diastolic VolumeEFEjection FractionHRHeart RateLCWILeft Cardiac Work IndexPEPPre-Ejection PeriodSVStroke VolumeSVRSystemic Vascular ResistanceSVRISystemic Vascular Resistance IndexTFIThoracic Fluid IndexVETVentricular Ejection TimeZOBase ImpedanceThe PhysioFlow Q-Link is intendedfor use under the direct supervisionof a licensed healthcare practitioneror personnel trained in its proper usewithin a hospital or facilityproviding healthcare.	The Audicor® System, whenused with AUDICORSensors on the chest wall, isintended for use in acquiring,analyzing and reporting ECGand heart sound data and toprovide interpretation of thedata in an integrated ACG(acoustic cardiograph) reportfor consideration byphysicians. Audicor systemsallow detection, reportingand interpretation of standardECG data as well asadvanced parameters such asEMAT, LVST, S3 strength,S4 strength, and SDI.Data may be reported in asingle snapshot report and ina trended report form wheremultiple data points aretrended over time. TheAudicor system also acceptsand analyzes downloads ofup to 48 hours of patient datafrom an optional ambulatoryECG/heart sounds collectiondevice.ECG and heart sound dataoffered by the device areonly significant when used inconjunction with physicianover read as well asconsideration of otherrelevant patient data.
	values offered by theICR System are onlysignificant when usedin conjunction withphysician over-read		The device is intended foruse only under the directsupervision of a physicianand is for use on adults (≥18years).
	as well as
	Sensydia, Inc.ICR System	Primary Predicate:Vasocom Inc.Physioflow Q-Link (K140102)	Secondary Predicate:Inovise Medical, Inc.Audicor Hemo AmbulatoryMonitor (K073545)
	consideration of allrelevant patient data.Indicated for use inadults only. The ICRSystem is intendedfor use under thedirect supervision ofa licensed healthcarepractitioner orpersonnel trained inits proper use withina hospital or facilityproviding healthcare.
		Technological Characteristics
ComponentsParametersMeasured	Acoustic SensorsECG ElectrodesPortable displaycomputerComputationalsoftwareEjection Fraction	Bioimpedance electrodesECG ElectrodesPortable display computerComputational software• Stroke Volume/Index• Cardiac Output/Index• Early Diagnostic Filling Ratio(Preload Index)• Systemic Vascular Resistance(Afterload)	Acoustic SensorsECG ElectrodesPortable display computerComputational softwareLVST (Left VentricularSystolic Time)LVDT (Left VentricularDiastolic Time)PADT (Pre-atrial DiastolicFilling Time)AAFT (Accelerated Atrial
		• Left Cardiac Work Index(surrogate of MVO2)• Contractility Index• Ventricular Ejection Time• Ejection Fraction (est.)/EndDiastolic Volume (est.)	Filling Time)EMAT (QS1,ElectromechanicalActivation Time)QS2R-R IntervalS3 StrengthS4 StrengthSDI (Systolic DysfunctionIndex)
Measurement	Point in timeassessment	Continuous, upon cliniciandiscretion for up to 24 hours	Continuous, upon cliniciandiscretion for up to 48 hours
System Contact	External wearablesensors in contactwith patient's chest	External wearable sensors in contactwith patient's chest and neck	External wearable sensors incontact with patient's chest
PatientContactingMaterials	Skin contact only,biocompatible	Skin contact only, biocompatible	Skin contact only,biocompatible
UseEnvironment	Healthcare facilities	Healthcare facilities	Healthcare facilities

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510(k) SUMMARY

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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

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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.

Regulation Number and Section

§ 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).

Indications for Use

Indications for Use (Describe)

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510(k) Notification K173156

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

Contact Person:

DEVICE INFORMATION [807.92(a)(2)]

Generic/Common Name:

Classification: Class II

PREDICATE DEVICE(S) [807.92(a)(3)]

DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

510(k) SUMMARY

SUBSTANTIAL EQUIVALENCE

PERFORMANCE DATA [807.92(b)]

[807.92(b)(1)] Nonclinical Testing Summary:

[807.92(b) (2)] Clinical Testing Summary:

CONCLUSIONS [807.92(b)(3)]

510(k) SUMMARY

SUMMARY

§ 870.2800 Medical magnetic tape recorder.

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