SENSICARDIAC

K121617 · Diacoustic Medical (Pty) · DQD · Jul 27, 2012 · Cardiovascular

Device Facts

• Record ID: K121617
• Device Name: SENSICARDIAC
• Applicant: Diacoustic Medical (Pty)
• Product Code: DQD · Cardiovascular
• Decision Date: Jul 27, 2012
• 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
K121617 · Jul 27, 2012	SENSICARDIAC	Diacoustic Medical (Pty)	Real-life clinical setting usability study; Clinical screening database of 43 patients with cleft lips and palates	The sponsor utilized data from a real-world clinical screening environment and a usability study in clinical settings to validate the Sensi V2 software performance and user interface.	Usability validation; Clinical screening; Retrospective database

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Feasibility & Usability Study; Observational/Usability	Intended users in clinical settings	Not applicable for this study	Usability score
Clinical screening environment validation; Retrospective database validation	43 patients with cleft lips and palates; Sample Size: 43	Sensi V1	Validation of Sensi V2 software

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Heart Murmur Detection	CAA algorithm	—	Specificity of 95% and sensitivity of 84%	1568 heart sounds accepted to meet criteria of good quality and match the recorded pathological condition	—	—	—

Indications for Use

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 Story

SensiCardiac is a decision support software system for heart auscultation. It acquires acoustic heart signals via a compatible electronic stethoscope (e.g., ThinkLabs ds32a+, Meditron Master Elite, RNK PCP/PC) at four main auscultation positions. The software runs on a Windows PC, recording 10-30 second .wav files (20Hz-10kHz range). The system processes these signals to identify S1, S2, and suspected murmurs, distinguishing between physiological and pathological murmurs. Used in clinical settings by physicians or trained personnel. Output includes recorded sounds, visual displays, and automated analysis results. The clinician uses this output as a decision support tool alongside physical examination and other patient data to inform clinical decision-making. Benefits include improved screening accuracy for heart murmurs.

Clinical Evidence

Evidence includes bench testing, usability studies, and comparative clinical performance analysis. Usability study in clinical settings yielded average user scores >4/5. Comparative study (Sensi V1 vs V2 vs Cardioscan) showed Sensi V2 achieved 69.7% accuracy. Design verification of the CAA algorithm demonstrated 95% specificity and 84% sensitivity. Validation of murmur classification in pediatric populations utilized a database of 1,568 heart sounds. Stethoscope comparison study verified technical equivalence across specified models.

Technological Characteristics

Software-based decision support system running on Windows PC. Interfaces with external electronic stethoscopes (20Hz-10kHz frequency response, >4kHz sampling). Data recorded as 16-bit mono .wav files. Employs signal processing and classification algorithms for heart sound identification. No internal sensors; relies on external stethoscope input. Connectivity via PC interface.

Indications for Use

Indicated for use in clinical settings by physicians or trained personnel under physician orders to assist in heart auscultation and evaluation of heart sounds (S1, S2, suspected murmurs) in patients. Not intended 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

• Zargis Acoustic Cardioscan (K083309)
• Stethographics Heart STG System (K052283)
• Sensi Cardiac Diagnostic Heart Murmur Software (K110704)

Submission Summary (Full Text)

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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

[phone]

[phone]

## 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 STG<br>System | K052283 |
| Diacoustic Medical Devices | Sensi Cardiac Diagnostic<br>Heart Murmur Software | K110704 |

### DEVICE DESCRIPTION

807.92(a)(4)

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

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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.
- 2. 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.

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# 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 life<br>clinical settings by intended users.<br>On average all users scored the usability of the Sensi<br>Software more than 4 out of 5. |
| Comparative Study between the FDA approved Zargis<br>and Sensi V1 systems and the Sensi V2 | Sensi V1 achieves overall accuracy of 70.8%.<br>Cardioscan achieves an accuracy of 67.9%<br>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's<br>graphical user interface and usability to that of the<br>FDA approved Sensi V1 | The Sensi V1 and Sensi V2 software packages uses<br>the same tested and trialed graphical user interface.<br>Functional and graphical differences are compared. |
| Validate algorithms used to distinguish between<br>functional and pathological heart murmurs in the<br>pediatric population. | 1568 heart sounds were accepted to meet the criteria,<br>of good quality and match the recorded pathological<br>condition. |

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Image /page/3/Picture/0 description: The image shows the logo for Diacoustic Medical Devices (PTY) LTD. 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" in a smaller, sans-serif font.

| Comparing Sensi V1 and Sensi V2 in a clinical<br>screening environment. | 43 patients with cleft lips and palates were screened<br>with Sensi V1 and the recorded database was used to<br>validate Sensi V2. |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Stethoscope Comparison Study | A study was conducted to verify the technical<br>equivalence 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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

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 [phone] or [phone] 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 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.

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 |

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