The Sensi device consisting of the Sensi Diagnostic Heart Murmur Software, the WelchAllyn Master Elite Stethoscope and WelchAllyn USB Analyzer is a decision support device intended to be used on a single patient to assist the medical examiner in analyzing cardiac sounds for the identification and classification of suspected murmurs. It is used to distinguish between normal/physiological and pathological heart murmurs by recording the acoustic signal of the heart and the ECG signal simultaneously and analyze these signals. The acoustic heart signal is analyzed to identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected systolic murmurs.

Sensi indicates whether or not a recorded heart sound contains a suspected heart murmur and the confidence with which the analysis was made The device must be used in a clinical setting by trained personnel with the prescribed accessories and all relevant patient information must be taken into consideration before a diagnosis is made.

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

Sensi is not intended to be a diagnostic device. It does not supersede the judgment of the qualified medical personnel. The device is intended to aid the physician in the evaluation of heart sounds. The physicians responsible for reviewing and interpreting the results, along with the auscultatory findings and medical history, in making a referral decision.

Device Description

The Sensi with Diagnostic Heart Murmur Software is a decision support device intended to acquire, record, and analyze heart sounds. It is used to distinguish between normal/physiological and pathological heart murmurs by recording the acoustic signal of the heart and the ECG signal simultaneously and analyzing these signal.

The complete system is a CD comprising Sensi Diagnostic Heart Murmur Software that runs on a computer with Windows operating system, instructions for use, the WelchAllyn Master Elite Stethoscope and the WelchAllyn Meditron Analyzer that captures the acoustic heart and ECG signals.

The Sensi Diagnostic Heart Murmur Software distinguishes between normal/ physiological and pathological heart murmurs by analyzing the acoustic heart and ECG signals captured with the WelchAllyn Meditron Analyzer. The device will record the acoustic sound of the heart at the four main auscultation positions and a three lead ECG signal. The ECG signal is not intended for diagnostic use, only to synchronize with the beginning of each heart cycle. The acoustic heart signal is analyzed to identify heart sounds that may be present, identified sounds include S1, S2 and suspected systolic murmurs.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative "acceptance criteria" for the Sensi device in a tabular format as a prerequisite for clearance. Instead, it reports performance metrics from comparative and validation studies. The primary comparative study focuses on overall accuracy, while another section mentions specificity and sensitivity for a "CAA algorithm." It's important to note that the document highlights the device's equivalence to predicate devices rather than setting new, specific performance thresholds for clearance.

Acceptance Criterion (Implied)	Reported Device Performance
Overall Accuracy (compared to Zargis Cardioscan)	Sensi: 70.8% Cardioscan: 67.9%
Specificity (of a CAA algorithm, possibly a component of Sensi)	94%
Sensitivity (of a CAA algorithm, possibly a component of Sensi)	91%
Usability (scored by intended users)	On average, all users scored Sensi Software usability more than 4 out of 5
Graphical User Interface (GUI) and Usability (compared to others)	Sensi compares favorably to three other comparable software programs
Distinguishing functional vs. pathological murmurs in pediatrics	1568 heart sounds met criteria of good quality and matched recorded pathological condition.

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

The document provides limited details on the specific "test set" for the reported performance metrics.

Comparative Study (Accuracy): The sample size for the comparative study between Sensi and Cardioscan is not explicitly stated in the provided text.
CAA Algorithm (Specificity & Sensitivity): The sample size for the study reporting 94% specificity and 91% sensitivity for the "Design verification of a CAA algorithm" is not explicitly stated.
Pediatric Murmur Study: "1568 heart sounds were accepted to meet the criteria of good quality and match the recorded pathological condition." This might represent a test set, but it's not explicitly labeled as such. The provenance of these heart sounds (country of origin, retrospective/prospective) is not specified.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for any of the studies mentioned. The "1568 heart sounds" study mentions matching "the recorded pathological condition," implying expert diagnosis, but specifics are missing.

4. Adjudication Method for the Test Set:

The adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in any of the studies is not mentioned in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and Effect Size:

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The comparative study mentioned is between devices (Sensi vs. Cardioscan), not explicitly evaluating human reader performance with and without AI assistance. Therefore, there is no reported effect size regarding human reader improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

The reported accuracy, specificity, and sensitivity figures (70.8% accuracy for Sensi vs. 67.9% for Cardioscan, and 94% specificity / 91% sensitivity for the CAA algorithm) appear to be standalone algorithm performance results. The device is described as a "decision support device" that "assists the medical examiner" and its interpretations are "only significant when used in conjunction with physician over-read." However, the reported performance metrics are presented for the device/algorithm itself.

7. The Type of Ground Truth Used:

The type of ground truth used is implied but not explicitly defined for all studies.

For the comparative accuracy study and the CAA algorithm's specificity/sensitivity, the ground truth source is not explicitly stated. It can be inferred to be expert diagnosis or a "gold standard" for murmur classification, but no details are given.
For the pediatric murmur study, it states "match the recorded pathological condition," suggesting that the ground truth was based on a recorded pathological diagnosis, presumably established by a medical professional.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size used for the training set of the Sensi's algorithms.

9. How the Ground Truth for the Training Set was Established:

The document does not provide any information on how the ground truth for the training set was established.

Summary

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K110704
page 1 of 3

510(k) Summary 807.92(c)

JUN 2 4 2011

SPONSOR Company Name:

807.92(a)(1) Diacoustic Medical Devices (Pty) Ltd

Company Address

19 Quantum Street Techno Park Stellenbosch, South Africa 7600

Telephone: Fax: Contact Person: 27 21 880 2033 27 86 557 4391 Matthys L. Cronje

Summary Preparation Date: March 2, 2011

DEVICE NAME

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

807.92(a)(2)

Sensi with Diagnostic Heart Murmur Software Electronic Stethoscope/Heart Sounds Analyzer Electronic Stethoscope; Phonocardiograph 21 CFR 870.1875. 870.2390 DQD, DQC Class II

PREDICATE DEVICE

807.92(a)(3)

Legally Marketed Equivalent Device
Company	Product	510(k) #
Zargis Medical Corp	Zargis Acoustic Cardioscan	K083309
Meditron AS	Meditron II Thestethoscope System	K013725

DEVICE DESCRIPTION

807.92(a)(4)

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beginning of each heart cycle. The acoustic heart signal is analyzed to identify heart sounds that may be present, identified sounds include S1, S2 and suspected systolic murmurs.

DEVICE INDICATIONS FOR USE

807.92(a)(5)

The interpretations of heart sounds offered by the Sensi device 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 Sensi software device features were directly compared with the FDA cleared Zargis Acoustic Cardioscan and Meditron Stethoscope Analyzer.

Synopsis of the comparison analysis:

All three software systems uses equivalent computer platforms. .
Both Sensi and Meditron uses equivalent accessories (electronic stethoscope and ● USB Analyzer - ECG). The acoustic performance between the Littmann and WelchAllyn electronic stethoscopes are equivalent.
Both Sensi and Cardioscan uses equivalent signal processing algorithms. Sensi . uses the ORS peak information from the ECG to segment the heart beats. No additional issues are introduced using this standard processing method and makes the process only more safe and effective.
Patient information and signal display handling are in all three cases equivalent. .
Sensi and Cardioscan's clinical performances are equivalent. ●

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K110704
page 3 of 3

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. A clinical software validation was performed to insure the performance of the software algorithm

Study Type	Results
Feasibility & Usability Study	Usability validation was performed within real life clinicalsettings by intended users.On average all users scored the usability of the SensiSoftware more than 4 out of 5.
Comparative Study between the FDAapproved Zargis system and the Sensi	Sensi achieves overall accuracy of 70.8%Cardioscan achieves an accuracy of 67.9%
Design verification of a CAAalgorithm	Specificity of 94% and sensitivity of 91%
Comparison of the Sensi softwareprogram's graphical user interface andusability to that of three othercomparable software programs	The graphical user Sensi compares favorably to the threeauscultation analysis packages with similarities between allthe major display and interface functions
Validate algorithms used todistinguish between functional andpathological heart murmurs in thepediatric population.	1568 heart sounds were accepted to meet the criteria ofgood quality and match the recorded pathological condition

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 Sensi device consisting of the Sensi Diagnostic Heart Murmur Software, the WelchAllyn Master Elite Stethoscope and WelchAllyn USB Analyzer is as safe and effective as the predicate devices and raises no new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol in blue, which is a symbol associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the symbol in a circular fashion.

Public Health Service

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

JUL 22 2011

Diacoustic Medical Devices (Pty) Ltd. c/o Mr. E.J. Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114

Re: K110704

Trade Name: Sensi Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: June 6, 2011 Received: June 6, 2011

Dear Mr. Smith:

This letter corrects our substantially equivalent letter of June 24. 2011.

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. E.J. 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bran D. Zuckerman, M.D.
Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K110704

Indications for Use

510(k) Number (if known):

Device Name: Sensi

Indications for Use:

The interpretations of heart sounds offered by the Sensi device 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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K110704
Page	1 of 1

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.