Who is the manufacturer of Integrated CardioRespiratory System?

Sensydia, Inc. filed the 510(k) submission for Integrated CardioRespiratory System (K173156).

What is the FDA product code for Integrated CardioRespiratory System?

MWJ. It is classified under 21 CFR 870.2800 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Integrated CardioRespiratory System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Integrated CardioRespiratory System?

Vasocom, Inc. Physioflow Q-Link (K140102); Inovise Medical, Inc. Audicor, Hemo Ambulatory Monitor (K073545).

Who can help prepare an FDA 510(k) submission like Integrated CardioRespiratory System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Integrated CardioRespiratory System

K173156 · Sensydia, Inc. · MWJ · Jun 8, 2018 · Cardiovascular

Device Facts

Record ID	K173156
Device Name	Integrated CardioRespiratory System
Applicant	Sensydia, Inc.
Product Code	MWJ · Cardiovascular
Decision Date	Jun 8, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2800
Device Class	Class 2

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.

Device Story

The ICR System is a non-invasive, point-of-care device used in healthcare facilities by trained personnel. It utilizes four acoustic sensors and ECG electrodes placed on the patient's chest to capture heart sound and electrical signals. The system processes these inputs to identify and characterize the amplitude and timing of S1 and S2 heart sounds, computing an estimated left ventricle Ejection Fraction (EF). The output is presented on a monitor for clinician review. The device serves as an adjunct to standard clinical evaluation, providing data that must be interpreted by a physician alongside other patient information. By offering a non-invasive estimate of EF comparable to 2-D echocardiography, the device assists in the assessment of cardiac function, potentially streamlining clinical decision-making.

Clinical Evidence

Two clinical studies were conducted: a measurement validation study and a measurement variability evaluation. The validation study enrolled 81 patients across four sites, comparing the ICR System to 2-D echocardiography and cardiac MRI (cMRI) to evaluate EF measurement agreement. Results demonstrated performance comparable to echocardiography. The variability study assessed operator and device performance, showing low and acceptable variability in EF measurements.

Technological Characteristics

The system consists of four acoustic sensors, ECG electrodes, a sensor application system, and a patient monitor. It utilizes external wearable sensors for non-invasive signal acquisition. The device is intended for point-in-time assessment in healthcare facilities. Materials are biocompatible for skin contact. The system performs signal processing and computation to derive EF values.

Indications for Use

Indicated for use in adults (≥18 years) for the estimation of left ventricle Ejection Fraction (EF) as an aid to physicians in evaluating heart function. Not for continuous monitoring or as a sole diagnostic means.

Regulatory Classification

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.

Predicate Devices

Vasocom, Inc. Physioflow Q-Link (K140102)
Inovise Medical, Inc. Audicor, Hemo Ambulatory Monitor (K073545)

Submission Summary (Full Text)

{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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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: - 1. ICR Acoustic Sensors - 2. ECG Sensor Electrodes - 3. ICR Sensor Application System - 4. 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.

Integrated CardioRespiratory System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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