The SensiCardiac 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 are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

Device Description

The Sensi Diagnostic Heart Murmur Software 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 package comprising Sensi Diagnostic Heart Murmur Software that runs on a computer with Windows operating system, instructions for use and the electronic stethoscope that captures the acoustic heart signals. The user must provide a compatible electronic stethoscope.

The Sensi system consists of the following components:

The Sensi Diagnostic Heart Murmur Software program running on a personal computer (PC) with interfaces to:
o a compatible electronic stethoscope
o A database with patient and health worker information
o Functions to record, display, analyze, save and playback heart sounds.
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
o Recording Time: minimum 10 sec, maximum 30 sec
o Acoustic Sensors: Electronic stethoscope; compatible models include: ThinkLabs Medical ds32a+, Meditron Master Elite, RNK PCP/PC Stethoscope.
Number of Sensors: 0

The Sensi Diagnostic Heart Murmur Software 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 heart 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Sensi Diagnostic Heart Murmur Software:

1. Table of Acceptance Criteria and Reported Device Performance

Study Type	Acceptance Criteria (Implied)	Reported Device Performance
Feasibility & Usability Study	High user satisfaction (e.g., > 4 out of 5 score)	On average all users scored the usability of the Sensi Software more than 4 out of 5.
Comparative Study (Accuracy)	Comparable accuracy to predicate devices (Sensi V1, Cardioscan)	Sensi V1 achieves overall accuracy of 70.8%. Cardioscan achieves an accuracy of 67.9%. Sensi V2 achieves overall accuracy 69.7%.
Design Verification (Algorithms)	Minimum specificity and sensitivity for CAA algorithm	Specificity of 95% and sensitivity of 84%
GUI/Usability Comparison	Graphical user interface and usability equivalent to Sensi V1	The Sensi V1 and Sensi V2 software packages uses the same tested and trialed graphical user interface. Functional and graphical differences are compared. (Implying no significant negative differences)
Validation of Algorithms (Pediatric)	Algorithms can distinguish functional/pathological murmurs	1568 heart sounds were accepted to meet the criteria, of good quality and match the recorded pathological condition. (Implies successful validation of algorithm application)
Sensi V1 vs. Sensi V2 Clinical Screening	Sensi V2 performs similarly to Sensi V1 in a clinical setting	43 patients with cleft lips and palates were screened with Sensi V1 and the recorded database was used to validate Sensi V2. (Implies successful validation of Sensi V2 using this dataset)
Stethoscope Comparison	Technical equivalence between specified stethoscopes	A study was conducted to verify the technical equivalence between the stethoscopes specified. (Implies equivalence was confirmed)

Notes on Acceptance Criteria: The document primarily lists study results rather than explicit, quantified acceptance criteria for all studies. The acceptance criteria in the table are inferred from the positive framing of the results (e.g., scoring "more than 4 out of 5" implies an acceptance threshold). For accuracy, the acceptance criterion is implicitly "not worse than" the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Comparative Study (Accuracy) - Sensi V2 Validation:
- No specific sample size is provided for the test set used to determine Sensi V2's 69.7% accuracy. The document mentions "Sensi V1 achieves overall accuracy of 70.8%. Cardioscan achieves an accuracy of 67.9% Sensi V2 achieves overall accuracy 69.7%." This implies a comparison was made, likely on a common dataset or comparable datasets. Without further detail, it's impossible to determine the Sensi V2 specific test set size for this accuracy calculation.
- Data Provenance: Not specified.
Validation of Algorithms (Pediatric Population):
- Sample Size: 1568 heart sounds.
- Data Provenance: Not specified.
Comparing Sensi V1 and Sensi V2 in a clinical screening environment:
- Sample Size: 43 patients with cleft lips and palates.
- Data Provenance: Not specified, but involved "a clinical screening environment." The data for Sensi V2 validation in this study was derived from a database recorded using Sensi V1.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not explicitly provided in the document for any of the studies mentioned. The document refers to "pathological condition" and "normal/physiological and pathological heart murmurs," implying expert assessment, but the number and qualifications of those experts are not detailed.

4. Adjudication Method for the Test Set

This information is not explicitly provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

Was it done?: No, a traditional MRMC comparative effectiveness study, evaluating human readers with and without AI assistance, is not described in this document. The "Comparative Study" mentioned only compares algorithmic accuracies (Sensi V1, Cardioscan, Sensi V2) directly. There is no mention of human reader performance improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the document presents results for the standalone algorithmic performance. The "Comparative Study" (Sensi V1: 70.8% accuracy, Cardioscan: 67.9% accuracy, Sensi V2: 69.7% accuracy) and the "Design verification of a CAA algorithm" (Specificity of 95% and sensitivity of 84%) are examples of standalone algorithm performance. The device is a "decision support software package," and its core function is to analyze heart sounds to "distinguish between normal/physiological and pathological heart murmurs," which are algorithmic functions without direct human intervention in the classification process itself.

7. The Type of Ground Truth Used

The document refers to establishing "pathological condition" and distinguishing "normal/physiological and pathological heart murmurs." This strongly implies expert consensus or clinical diagnosis as the ground truth. For the pediatric study, it mentions "match the recorded pathological condition," which further supports this. There is no mention of pathology reports or direct outcomes data being used as ground truth.

8. The Sample Size for the Training Set

This information is not explicitly provided anywhere in the document. The document describes tests and validations but does not detail the training process or the size of any training datasets used to develop the algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not explicitly provided in the document, as the training set details are absent.

Summary

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K | 2 | k | 7

iacoustIC
MEDICAL DEVICES (PTY) LTD

JUL 2 7 2012

807.92(a)(1)

510(k) Summary

807.92(c)

Techno Park Stellenbosch

South Africa

May 22, 2012

7600

19 Quantum Street

+27 (0)21 880 2033

+27 (0)86 557 4381

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

PREDICATE DEVICE

Legally Marketed Equivalent Device

807.92(a)(2) Sensi Cardiac Diagnostic Heart Murmur Software 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)
Zargis Medical Corp	Zargis Acoustic Cardioscan	K083309
Stethographics Inc.	Stethographics Heart STGSystem	K052283
Diacoustic Medical Devices	Sensi Cardiac DiagnosticHeart Murmur Software	K110704

DEVICE DESCRIPTION

807.92(a)(4)

The complete system is a software package comprising Sensi Diagnostic Heart Murmur Software that runs on a computer with Windows operating system, instructions for use and

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the electronic stethoscope that captures the acoustic heart signals. The user must provide a compatible electronic stethoscope.

DEVICE INDICATIONS FOR USE

807.92(a)(5)

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

The Sensi system consists of the following components:

1. The Sensi Diagnostic Heart Murmur Software program running on a personal computer (PC) with interfaces to:
- o a compatible electronic stethoscope
- A database with patient and health worker information o
- o Functions to record, display, analyze, save and playback heart sounds.
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
- o Recording Time: minimum 10 sec, maximum 30 sec
- Acoustic Sensors: Electronic stethoscope; compatible models o

include: ThinkLabs Medical ds32a+, Meditron Master Elite, RNK PCP/PC Stethoscope.

Number of Sensors: 0
The Sensi Diagnostic Heart Murmur Software 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 heart 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.

COMPARISON OF TECHNICAL CHARACTERISTICS

807.92(a)(6)

The Sensi software device features were directly compared with the FDA cleared Sensi, Zargis Acoustic Cardioscan and Stethographics Heart STG System.

Synopsis of the comparison analysis:

. All three software systems uses equivalent computer platforms.

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Image /page/2/Picture/0 description: The image shows the logo for Diacoustic Medical Devices (PTY) LTD. The logo is in black and white. The word "diacoustic" is in a bold, sans-serif font, with the "T" in "diacoustic" being taller than the other letters. Below the word "diacoustic" is the text "MEDICAL DEVICES (PTY) LTD", which is in a smaller, sans-serif font.

Both Sensi and Stethographics uses equivalent accessories, electronic stethoscope. The acoustic performance between the specified electronic stethoscopes are equivalent.
Both Sensi and Cardioscan uses equivalent signal processing algorithms by analyzing . only the recorded acoustic heart signal at the four main recording locations. The new Sensi software's classifier and feature extraction algorithm are identical to the previous FDA cleared Sensi software.
Patient information and signal display handling are in all three cases equivalent. .
Sensi and Cardioscan's clinical performances are equivalent.
. The new Sensi software's graphical user interface is nearly identical to the previous FDA cleared Sensi software.

After analyzing bench test and user testing data, it is the conclusion of Diacoustic Medical that the Sensi 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 Sensi System and Software. The graphical user interface and usability were compared to the predicate devices.

Validation of the Sensi was performed to ensure that the Sensi system consistently fulfills its intended use and the needs of the user. Software validation was performed to insure the performance of the software algorithm

Study Type.	Results
Feasibility & Usability Study	Usability validation was performed within real lifeclinical settings by intended users.On average all users scored the usability of the SensiSoftware more than 4 out of 5.
Comparative Study between the FDA approved Zargisand Sensi V1 systems and the Sensi V2	Sensi V1 achieves overall accuracy of 70.8%.Cardioscan achieves an accuracy of 67.9%Sensi V2 achieves overall accuracy 69.7%
Design verification of a CAA algorithm	Specificity of 95% and sensitivity of 84%
Comparison of the Sensi V2 software program'sgraphical user interface and usability to that of theFDA approved Sensi V1	The Sensi V1 and Sensi V2 software packages usesthe same tested and trialed graphical user interface.Functional and graphical differences are compared.
Validate algorithms used to distinguish betweenfunctional and pathological heart murmurs in thepediatric population.	1568 heart sounds were accepted to meet the criteria,of good quality and match the recorded pathologicalcondition.

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Comparing Sensi V1 and Sensi V2 in a clinicalscreening environment.	43 patients with cleft lips and palates were screenedwith Sensi V1 and the recorded database was used tovalidate Sensi V2.
Stethoscope Comparison Study	A study was conducted to verify the technicalequivalence between the stethoscopes specified.

CONCLUSION

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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 2 7 2012

Diacoustic Medical Devices C/O E.J.Smith 1468 Harwell Avenue Crofton, Maryland 21114

Re: K121617

Trade/Device Name: SensiCardiac Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: May 24, 2012 Received: June 1, 2012

Dear Mr. 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.

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Page 2 - Mr. Smith

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SensiCardiac

Indications for Use:

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

Prescription Use (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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K121617

Page	of
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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.