ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33

K083309 · Zargis Medical Corp. · DQD · Feb 13, 2009 · Cardiovascular

Device Facts

• Record ID: K083309
• Device Name: ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33
• Applicant: Zargis Medical Corp.
• Product Code: DQD · Cardiovascular
• Decision Date: Feb 13, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The Zargis Acoustic Cardioscan; (ZAC), 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 Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

Device Story

Zargis Acoustic Cardioscan (ZAC) is an electronic auscultatory system; acquires/records heart acoustic signals via Bluetooth-enabled electronic stethoscope; transmits data to PC via USB transceiver. Software analyzes signals to identify S1, S2, and suspected murmurs. Used in clinical settings by physicians or trained personnel. Output displayed on PC for physician review; supports clinical decision-making by providing automated sound identification. Not a sole diagnostic tool; requires physician over-read and integration with other patient data. Benefits include enhanced auscultation support.

Clinical Evidence

Bench testing only. Software verification performed at module and system levels. Integrated ZAC system evaluated via graphic user interface testing. Clinical software validation performed to ensure performance of enhanced software algorithm.

Technological Characteristics

Electronic auscultatory device; Bluetooth wireless connectivity; USB transceiver for PC interface. Software-based signal analysis. Complies with FCC requirements for Bluetooth transceiver.

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 intended as a sole diagnostic tool; requires physician over-read.

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 (K031517)
• Zargis Acoustic Cardioscan (K042128)
• Zargis Acoustic Cardioscan (K060197)
• AViTA Bluetooth Blood Pressure Monitor (K072137)
• CardioBelffM Electrode Belt (K063044)
• Nonin Medical, Inc. Model 4100 Patient Oximeter Module (K043359)

Submission Summary (Full Text)

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K083309
R1/2

#### 510(k) Summary of Safety and Effectiveness FEB 1 3 2009

## Zargis Acoustic Cardioscan

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Zargis Medical Corporation is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Zargis Medical chooses to submit a summary of information respecting safety and effectiveness.

| Trade Name: | Zargis Acoustic Cardioscan (ZAC) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Heart Sound Analyzer |
| Regulation Number: | 21 CFR 870.1875, 870.2390 |
| Classification Name: | Stethoscope, Electronic; Phonocardiograph |
| Product Code: | DQD, DQC |
| Regulatory Class: | Class II |
| Submitter Information: | Zargis Medical Corporation<br>2 Research Way, 1st Floor<br>Princeton, NJ 08540<br>Tel: [phone]<br>Fax: [phone] |
| Summary Prepared By: | John Kallassy<br>CEO |
| Date Prepared: | November 3, 2008 |
| Predicate Devices: | Zargis Acoustic Cardioscan, K031517, K042128, K060197<br>AViTA Bluetooth Blood Pressure Monitor, K072137<br>CardioBelffM Electrode Belt, K063044<br>Nonin Medical, Inc. Model 4100 Patient Oximeter Module<br>K043359 |

Device Description: The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds.

The complete system is a CD comprising software and instructions for use with an included USB transceiver for connection with a PC and capable of wireless

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communication with a Bluetooth-enabled electronic stethoscope.

Intended Use: The Zargis Acoustic Cardioscan; (ZAC), 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 Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

Substantial Equivalence: The modified ZAC is similar in design/technological characteristics, indications for use, and performance characteristics to the currently cleared ZAC product and other medical devices capable of wireless transmission of physiological data through use of Bluetooth technology. In addition, non-clinical performance testing has been conducted to demonstrate the performance of the modified ZAC device and that it meets its intended use.

Safety and Performance: A comprehensive list of verification and validation testing was performed in accordance with Zargis' Design Control procedures.

Software verification of the modified components was performed at the module and system level. The integrated ZAC system was further evaluated to verify the graphic user interface software and the ZAC system as an integrated product.

Validation of the ZAC was performed to ensure that the ZAC device consistently fulfills its intended use and the needs of the user. A clinical software validation was performed to insure the performance of the enhanced software algorithm.

The Bluetooth transceiver complies with all relevant FCC requirements.

Conclusion: Based upon the indications for use, technological characteristics and safety and performance testing, the Zargis Acoustic Cardioscan (ZAC) has been shown to be substantially equivalent to the currently cleared predicate devices under the Federal Food, Drug, and Cosmetic Act.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 3 2009

Zargis Medical Corp. c/o Mr. John Kallassy, CEO 2 Research Way, 1st floor Princeton, NJ 08540

Re: K083309

> Trade/Device Name: Zargis Acoustic Cardioscan Regulation Number: 21 CFR 8.70.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD, DQC Dated: January 13, 2009 Received: January 14, 2009

Dear Mr. Kallassy:

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 preinarket 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. John Kallassy

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

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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## INDICATION FOR USE

510(k) Number (if known): Not Assigned

Device Name:

Zargis Acoustic Cardioscan

Indications for Use:

The Zargis Acoustic Cardioscan, (ZAC) is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.

The product will acquire and record the acoustic signals of the heart and analyze 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 Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

| Prescription Use: | X | AND/OR | Over-The Counter Use: |
|----------------------------|-----------------|--------|-----------------------|
| (Per 21 CFR 801 Subpart D) | (Per 21 CFR 801 | | |
| SubpartC) | | | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | for B Zuckerman |
|------------------------------------|-----------------|
| Division of Cardiovascular Devices | 2/13/09 |

| 510(k) Number | K083309 |
|---------------|---------|
|---------------|---------|

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