SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION

K131044 · Diacoustic Medical Devices (Pty) , Ltd. · DQD · Sep 4, 2013 · Cardiovascular

Device Facts

• Record ID: K131044
• Device Name: SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
• Applicant: Diacoustic Medical Devices (Pty) , Ltd.
• Product Code: DQD · Cardiovascular
• Decision Date: Sep 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K131044 · Sep 4, 2013	SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION	Diacoustic Medical Devices (Pty) , Ltd.	Real-life clinical settings; APCA Clinical Report (clinical patient data)	The device underwent usability validation in real-life clinical settings by intended users and performance evaluation using a clinical dataset of 1568 heart sounds matched to echocardiogram golden standards.	Usability validation; Clinical setting; Heart sound analysis

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Qualitative Computer Aided Auscultation Study by Intended Users; Usability validation in real-life clinical settings	Intended users (physicians/trained personnel)	Not applicable for this study	Usability scoring (average > 4 out of 5)
APCA Clinical Report; Retrospective clinical data analysis	Patients with recorded heart sounds; Sample Size: 1568 heart sounds	Echocardiogram (golden standard)	Diagnostic accuracy of heart sound analysis

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Heart Murmur Detection	—	—	Specificity of 94% and sensitivity of 84%	—	—	Development of a Pediatric Cardiac Computer Aided Auscultation Decision Support System: 1568 heart sounds (APCA Clinical Report)	—

Indications for Use

The SensiCardiac Mobi is an electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds. The product acquires and records the acoustic signals of the heart and analyzes these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The interpretations of heart sounds offered by the SensiCardiac Mobi are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

Device Story

SensiCardiac Mobi is a decision support system for heart auscultation; utilizes compatible electronic stethoscope (ThinkLabs ds32a+) to capture acoustic heart signals (20-10,000 Hz) at four auscultation positions; records 10-30 second .wav files. Data transmitted via TCP/IP to hosted server environment running Sensi Diagnostic Heart Murmur Algorithm; algorithm analyzes signals to identify S1, S2, and suspected murmurs. Mobile device (iPhone 4S+) serves as interface for data capture, display, and patient info entry. Used in clinical settings by physicians/trained staff; output requires physician over-read and integration with other patient data. Benefits include improved auscultation accuracy and decision support.

Clinical Evidence

Bench testing and clinical validation performed. Studies included verification of algorithm performance (identical to predicate), usability testing (scoring >4/5), and acoustic performance on iPhone 4S/5. Clinical report (APCA) analyzed 1568 heart sounds validated against echocardiography (golden standard). Pediatric study reported 94% specificity and 84% sensitivity.

Technological Characteristics

System comprises mobile device (iPhone 4S+), hosted server (Linux), and external electronic stethoscope (ThinkLabs ds32a+). Connectivity via TCP/IP. Audio captured at >4.000 Hz, 16-bit mono .wav. Algorithm is software-based diagnostic support. No computational functions performed on mobile device.

Indications for Use

Indicated for use in clinical settings by physicians or trained personnel under physician orders to support evaluation of heart sounds in patients. Not for use as a sole diagnostic tool.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Sensi Cardiac Diagnostic Heart Murmur Software (K121617)

Submission Summary (Full Text)

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807.92(a)(1)

SEP 0 4 2013

## 510(k) Summary

807.92(c)

Electron Street Octo Place A3 Techno Park Stellenbosch

South Africa

[phone]

[phone]

7600

#### SPONSOR

Company Name: Company Address:

Telephone: Fax: Contact Person: Summary Preparation Date:

## DEVICE NAME

Trade Name:

Common/Usual Name Classification Name Regulation Number Product Code Device Class Reviewing Panel:

### PREDICATE DEVICE

Legally Marketed Equivalent Device

Matthys Cronie March 13, 2013 807.92(a)(2) SensiCardiac Mobi Diagnostic Heart Murmur Application Electronic Stethoscope/Heart Sounds Analyzer Electronic Stethoscope; Phonocardiograph 21 CFR 870.1875, 870.2390 DQD, DQC Class II

Diacoustic Medical Devices (Pty) Ltd.

807.92(a)(3)

| Company | Product | 510(k) |
|----------------------------|---------------------------------------------------|---------|
| Diacoustic Medical Devices | Sensi Cardiac Diagnostic<br>Heart Murmur Software | K121617 |

#### DEVICE DESCRIPTION

807.92(a)(4)

The SensiCardiac Mobi Diagnostic Heart Murmur Application is a decision support device intended to acquire, record, and anlyze heart sounds. It is used to distinguish between normal/ physiological and pathological heart murmurs by recording the acoustic signal of the heart by means of an electronic stethoscope.

Cardiology

The complete system is a software application comprising Sensi Diagnostic Heart Murmur Algorithm that runs on a hosted server environment with Linux operating system, a hand held device to capture patient data, instructions for use and the electronic stethoscope that captures the acoustic heart signals. The user must provide a compatible electronic stethoscope.

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SensiCardiac Mobi is a decision support software package intended to assist medical examiners in heart auscultation.

The SensiCardiac Mobi system consists of the following components:

- 1. The Sensi Diagnostic Heart Murmur Algorithm running within a hosted environment with TCP/IP interfaces to:
- o a hand held mobile device (iPhone 4S or later)
- o A database with patient and health worker information
- 2. A hand held mobile device (iPhone 4S or later) with the following uses:
- o electronic transfer of the medical device data (TCP/IP interface)
- o the electronic interfacing and conversion of the electronic stethoscope audio signal.
- o The electronic display of medical device data.
- o Capturing of basic patient information.
- 3. A compatible electronic stethoscope with characteristics
- o Recording Frequency Range: 20 Hz to 10,000 Hz
- o Sampling Frequency: > 4.000 Hz
- o Data Recording: Standard .wav files at resolution of 16bit, mono
- Recording Time: o minimum 10 sec, maximum 30 sec
- o Electronic stethoscope: compatible model: ThinkLabs Medical ds32a+
- Number of Sensors: o 1

The Sensi Diagnostic Heart Murmur Algorithm distinguishes between normal/ physiological and pathological heart murmurs by analyzing the acoustic heart signals captured with an electronic stethoscope. The device will record the acoustic sound of the hear at the four main auscultation positions. The acoustic heart signal is analyzed to identify heart sounds that may be present, identified sounds include S1, S2 and suspected murmurs.

The Sensi Diagnostic Heart Murmur Algorithm or the application running on the hand held mobile device does not control the medical device (electronic stethoscope) or actively monitoring the patient.

### .DEVICE INDICATIONS FOR USE

807.92(a)(5)

The SensiCardiac Mobi is an electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds.

The product acquires and records the acoustic signals of the heart and analyzes these signals. The analysis procedure will identify specific heart sounds that may be present. ldentified sounds include S1, S2, and suspected murmurs. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.

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The interpretations of heart sounds offered by the SensiCardiac Mobi are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. ·

### COMPARISON OF TECHNICAL CHARACTERISTICS

807.92(a)(6)

The SensiCardiac Mobi software device features were directly compared with the FDA cleared Sensi Cardiac Diagnostic Heart Murmur Software. Both systems use the exact same Diagnostic Heart Murmur Algorithm and electronic stethoscope to capture the heart sounds. The user interface was adapted to function on the latest mobile hand held devices and the algorithm implemented as a hosted service.

Synopsis of the comparison analysis:

- . Both systems use the exact same (identical) Diagnostic Heart Murmur Algorithm for analyzing the heart sounds. No modifications were made to the FDA cleared Sensi Cardiac Diagnostic Heart Murmur Software's algorithm and used as is within SensiCardiac Mobi.
- . Both systems use equivalent computer platforms to execute the Diagnostic Heart Murmur Algorithm. No computational or control functions were implemented on the mobile hand held device.
- . Both systems interfaces to the same electronic stethoscope (ThinkLabs Medical ds32a+).
- . Equivalent patient information is captured on both platforms.
- The clinical performance of both systems is equivalent. .
- · An equivalent workflow and graphical user interface were implemented on SensiCardiac Mobi, as used within the FDA cleared
- . The new SensiCardiac Mobi software's graphical user interface is nearly identical to the previous FDA cleared Sensi Cardiac Diagnostic Heart Murmur Software.

After analyzing bench test and user testing data, it is the conclusion of Diacoustic Medical that the SensiCardiac Mobi device consisting of the Sensi Diagnostic Heart Murmur Software and compatible electronic stethoscopes is as safe and effective as the predicate device and raises no new issues of safety and effectiveness.

#### SAFETY AND EFFECTIVENESS

#### 807.92(b)

A comprehensive list of verification and validation testing was performed in accordance to Diacoustic's Design Control procedures.

Software validation was performed for all aspects of the SensiCardiac Mobi system and software. The graphical user interface and usability were compared to the predicate devices.

Validation of the SensiCardiac Mobi was performed to ensure that the SensiCardiac Mobi system consistently fulfills its intended use and the needs of the user. Software validation was performed to insure the performance of the software algorithm is identical to that of the Sensi Cardiac Diagnostic Heart Murmur Software.

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| Study Title | Results |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SensiCardiac Mobi: Verification Study and<br>Comparison | FDA cleared SensiCardiac and SensiCardiac Mobi achieves the same<br>results on the same data set. The two systems' diagnostic features are<br>therefore equivalent. |
| SensiCardiac Mobi: Graphical User Interface<br>Comparison | The graphical user interface of SensiCardiac Mobi compares favorably<br>to SensiCardiac with similarities between all the major display and<br>interface functions. SensiCardiac was used as baseline for the<br>development; usability improved. |
| SensiCardiac Mobi: Acoustic Performance<br>Study | Results indicated that the iPhone 4S and 5 devices running iOS 6 are<br>more than adequate for this application. |
| SensiCardiac Mobi: Usability Verification | SensiCardiac Mobi scored high on usability and is seen as a major<br>improvement on the PC version of this application. |
| Development of a Pediatric Cardiac Computer<br>Aided Auscultation Decision Support System | Specificity of 94% and sensitivity of 84% (relative to golden standard -<br>echo) |
| Qualitative Computer Aided Auscultation Study<br>by Intended Users | Usability validation was performed within real life clinical settings by<br>intended users.<br>On average all users scored the usability of the Sensi Software more<br>than 4 out of 5. |
| APCA Clinical Report | 1568 heart sounds were accepted to meet the criteria of good quality<br>and match the recorded pathological condition (all patients were echoed<br>- golden standard) |

## CONCLUSION

### 807.92(b)(3)

Based upon the indications for use, technological characteristics and safety and performance testing, it is the conclusion of Diacoustic Medical that the SensiCardiac Mobi device consisting of the Sensi Diagnostic Heart Murmur Algorithm, a mobile hand held device and a compatible electronic stethoscope is as safe and effective as the predicate device and raises no new issues of safety and effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10003 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20943-0002

September 4, 2013

Diacoustic Medical Devices (Pty) Ltd. c/o Ms. Yolanda Smith Consultant Smith Associates 1468 Harvell Ave Crofton. MD 21114

Re: K131044

Trade/Device Name; Diacoustic Medical Devices (PTY) Ltd Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD, DQC Dated: July 15, 2013 Received: July 16, 2013

Dear Ms. Smith:

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. 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.

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Page 2 - Ms. Yolanda Smith

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.jtm.

Sincerely vours.

**Owen P. Faris -S**

for

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): K131044

Device Name: SensiCardiac Mobi

Indications for Use:

The SensiCardiac Mobi is an electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds.

The product acquires and records the acoustic signals of the heart and analyzes these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include SI, S2, and suspected murmurs. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.

The interpretations of heart sounds offered by the SensiCardiac Mobi are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Owen Farls -5
Date: 2013.09.04 10:18:27 -04'00'

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