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 Description

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.

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.

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
1. 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.
1. 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.

AI/ML Overview

Acceptance Criteria and Device Performance

Study Title	Acceptance Criteria (from study type)	Reported Device Performance (from study results)
Development of a Pediatric Cardiac ComputerAided Auscultation Decision Support System	Not explicitly stated, but implied to demonstrate diagnostic capabilities (sensitivity/specificity).	Specificity of 94% and sensitivity of 84% (relative to golden standard - echo)

Study Details:

Sample size used for the test set and the data provenance:
- Test set sample size: 1568 heart sounds.
- Data provenance: Not explicitly stated but the "APCA Clinical Report" suggests a clinical setting. It's unclear if the data is retrospective or prospective, or the country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document only mentions "golden standard - echo" and "all patients were echoed," indicating that echocardiography results were used as the ground truth, but not the number or qualifications of experts interpreting these echoes.
Adjudication method for the test set:
- Not specified. The ground truth was established by echocardiography, but the method for resolving discrepancies among echo interpretations (if multiple were involved) or for correlating echo findings with heart sounds is not detailed.
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:
- No MRMC comparative effectiveness study involving human readers with and without AI assistance was reported in the provided text. The studies focused on the standalone performance of the device and its usability.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The "Development of a Pediatric Cardiac Computer Aided Auscultation Decision Support System" reports on the specificity and sensitivity of the algorithm itself, comparing its output to the "golden standard - echo."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Echocardiography (echo) was used as the "golden standard" for establishing ground truth, as mentioned in the "Development of a Pediatric Cardiac Computer Aided Auscultation Decision Support System" and the "APCA Clinical Report."
The sample size for the training set:
- Not specified in the provided text. The document refers to validation and verification studies but does not detail the training set size for the algorithm's development.
How the ground truth for the training set was established:
- Not specified. The document mentions the use of echocardiography as a "golden standard" for ground truth in evaluation studies, but it does not describe how ground truth was established specifically for the training data used to develop the Sensi Diagnostic Heart Murmur Algorithm.

Summary

{0}------------------------------------------------

807.92(a)(1)

SEP 0 4 2013

510(k) Summary

807.92(c)

Electron Street Octo Place A3 Techno Park Stellenbosch

South Africa

+27 (0)21 880 2223

+27 (0)86 557 4381

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 DiagnosticHeart Murmur Software	K121617

DEVICE DESCRIPTION

807.92(a)(4)

Cardiology

{1}------------------------------------------------

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
1. 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.
1. 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 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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

Study Title	Results
SensiCardiac Mobi: Verification Study andComparison	FDA cleared SensiCardiac and SensiCardiac Mobi achieves the sameresults on the same data set. The two systems' diagnostic features aretherefore equivalent.
SensiCardiac Mobi: Graphical User InterfaceComparison	The graphical user interface of SensiCardiac Mobi compares favorablyto SensiCardiac with similarities between all the major display andinterface functions. SensiCardiac was used as baseline for thedevelopment; usability improved.
SensiCardiac Mobi: Acoustic PerformanceStudy	Results indicated that the iPhone 4S and 5 devices running iOS 6 aremore than adequate for this application.
SensiCardiac Mobi: Usability Verification	SensiCardiac Mobi scored high on usability and is seen as a majorimprovement on the PC version of this application.
Development of a Pediatric Cardiac ComputerAided Auscultation Decision Support System	Specificity of 94% and sensitivity of 84% (relative to golden standard -echo)
Qualitative Computer Aided Auscultation Studyby Intended Users	Usability validation was performed within real life clinical settings byintended users.On average all users scored the usability of the Sensi Software morethan 4 out of 5.
APCA Clinical Report	1568 heart sounds were accepted to meet the criteria of good qualityand match the recorded pathological condition (all patients were echoed- 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.

{4}------------------------------------------------

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.

{5}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{6}------------------------------------------------

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.

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'

Page of

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
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.