ZARGIS ACOUSTIC CARDIOSCAN

K031517 · Zargis Medical Corp. · DQD · May 26, 2004 · Cardiovascular

Device Facts

• Record ID: K031517
• Device Name: ZARGIS ACOUSTIC CARDIOSCAN
• Applicant: Zargis Medical Corp.
• Product Code: DQD · Cardiovascular
• Decision Date: May 26, 2004
• Decision: SESE
• Submission Type: Traditional
• 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 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.

Device Story

Electronic auscultatory device; acquires/records/analyzes heart acoustic signals. System includes electronic stethoscope, notebook computer, software, printer, isolation transformer. Used in clinical settings by physicians/trained personnel. Algorithm identifies S1, S2, and suspected murmurs. Output provides visual/auditory support for physician evaluation; requires physician over-read and correlation with other clinical data. Benefits include enhanced heart sound assessment support.

Clinical Evidence

No clinical trials reported. Evidence consists of bench testing, software verification, and clinical software validation of the heart sound detection algorithm. Usability (simulated use), reproducibility, and software component validation were performed to ensure device fulfills intended use.

Technological Characteristics

Electronic stethoscope, notebook computer, printer, isolation transformer. Software-based heart sound analysis. Hardware components independently evaluated; system-level verification for printer/cabling. Software verification at module/system levels.

Indications for Use

Indicated for use in clinical settings by physicians or trained personnel under physician orders to support heart sound evaluation in patients. Not intended as a sole diagnostic tool; requires physician over-read and integration with other patient data.

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

• ELI 200+ Audicor (K031182)
• 2010 Holter Plus Monitor (K010949)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

## 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 |
| Classification Name: | Phonocardiograph with Waveform Analysis - 21 CFR<br>870.2390. This device is categorized as DQC and is<br>regulated as Class II. |
| Submitter Information: | Zargis Medical Corporation<br>755 College Road East<br>Princeton, NJ 08540<br>Tel: [phone]<br>Fax: [phone] |
| Summary Prepared By: | Shahram Hejazi, Ph.D.<br>President/CEO |
| Date Prepared: | March 26, 2004 |
| Predicate Devices: | ELI 200+ Audicor -- K031182<br>2010 Holter Plus Monitor - K010949 |

Device Description: The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds. Heart sounds identified are S1, S2 and suspected murmurs.

The complete system is comprised of an electronic stethoscope, a notebook computer, software, a printer and an isolation transformer.

## Intended 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

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signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include \$1, \$2, 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 ZAC is similar in design/technological characteristics. indications for use, and performance characteristics to the other commercialized devices named above. In addition, non-clinical performance testing has been conducted to demonstrate the performance of the 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.

The ZAC product consists of hardware and software components. The electronic stethoscope, processing platform, and isolation transformer were independently evaluated as hardware components. The printer and interface cabling were verified at the system level.

Software verification 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 heart sound detection algorithm. In addition, usability validation (i.e., simulated use), reproducibility validation, and software component validation were performed.

Conclusion: Based upon the indications for use, technological characteristics and safety and performance testing, the Zargis Acoustic CardioScan has been shown to be substantially equivalent to legally marketed predicate devices under the Federal Food. Drug, and Cosmetic Act.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2004

Zargis Medical Corporation c/o Shahram Hejazi, Ph.D. President/CEO 755 College Rd. East Princeton, NJ 08540

Re: K031517

Trade Name: Zargis Acoustic Cardioscan (ZAC) Regulation Number: 21 CFR 870.1875, 870.2390 Regulation Name: Stethoscope, Phonocardiograph Regulatory Class: II (two) Product Code: DQD, DQC Dated: March 29, 2004 Received: March 30, 2004

Dear Dr. Hejazi:

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 - Shahram Hejazi, Ph.D.

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 presided 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neat K.P. Ogden

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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## Indications for Use

510(k) Number (if known):

Zargis Acoustic Cardioscan (ZAC) Device Name:

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 (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 IF NEEDED)

> evice Evaluation (ODE) Concurrence of CDRH.

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K031517

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