SIGNAL

K090493 · Zargis Medical Corp. · DQD · Aug 7, 2009 · Cardiovascular

Device Facts

• Record ID: K090493
• Device Name: SIGNAL
• Applicant: Zargis Medical Corp.
• Product Code: DQD · Cardiovascular
• Decision Date: Aug 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

Signal is an electronic device intended to support the physician in the evaluation of heart sounds, lung sounds, bowel sounds and other acoustic signals in patients. The device allows for the recording of multiple, simultaneous acoustic signals and includes a single-lead electrocardiograph that produces a visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is not intended for diagnostic use. The device also allows the sharing of data through the Internet and provides a means to attach patient information to the stored sound files. Signal is intended for use by healthcare professionals only.

Device Story

Signal is an electronic auscultation system; acquires, records, and displays heart, lung, and bowel sounds. Includes single-lead ECG input to synchronize phonocardiogram with heart cycle on PC monitor. Used by healthcare professionals in clinical settings. Device enables data storage, attachment of patient information to sound files, and internet-based data sharing. ECG output is non-diagnostic; intended solely for visual synchronization of acoustic signals. Benefits include enhanced visualization and documentation of auscultation findings for clinical evaluation.

Clinical Evidence

Bench testing only. No clinical data provided. Performance demonstrated via verification and validation testing, including biocompatibility, electrical safety, and EMC testing, confirming adherence to product specifications.

Technological Characteristics

Electronic auscultation device; single-lead ECG integration; PC-based display; internet connectivity for data sharing. Class II device. Biocompatibility, electrical safety, and EMC testing performed per design controls.

Indications for Use

Indicated for healthcare professionals to support evaluation of heart, lung, bowel, and other body acoustic signals in patients. Includes non-diagnostic single-lead ECG for phonocardiogram synchronization.

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

• CADIscope Electronic Stethoscope and Integrated ECG (K990809)
• eStation Model DR200 Electronic Stethoscope (K001788)
• Meditron II, thestethoscope system (K013725)

Submission Summary (Full Text)

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Kd90493

AUG 0 7 2009

# Section 5

# 510(k) Summary of Safety and Effectiveness

# Signal™

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: | Signal™ |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electronic Stethoscope and Phonocardiograph |
| 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>President/CEO |
| Date Prepared: | February 20, 2009 |
| Predicate Devices: | 1) CADIscope Electronic Stethoscope and Integrated ECG,<br>K990809<br>2) eStation Model DR200 Electronic Stethoscope, K001788 |

3) Meditron II, thestethoscope system, K013725

Device Description: Signal™ is an electronic auscultation device intended to acquire, record, and display heart sounds and other body sounds. Signal includes a single-lead electrocardiograph to produce an ECG on the laptop monitor to enable the health care

Signal 510(k) February 20, 2009 Confidential

13

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professional to synchronize the phonocardiogram with the beginning of the heart cycle.

The device also allows the sharing of data through the Internet and provides a means to attach patient information to the stored sound files.

Intended Use: Signal is a noninyasive, non-interpretive, device indicated for the following:

Signal is an electronic device intended to support the physician in the evaluation of heart sounds, lung sounds, bowel sounds and other acoustic signals in patients. The device allows for the recording of multiple, simultaneous acoustic signals and includes a singlelead electrocardiograph that produces a visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is not intended for diagnostic use. The device also allows the sharing of data through the Internet and provides a means to attach patient information to the stored sound files. Signal is intended for use by healthcare professionals only.

Substantial Equivalence: The Signal device is similar in design/technological characteristics, indications for use, and performance characteristics to the currently cleared electronic stethoscopes cited above.

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

Non-clinical performance testing has been conducted to demonstrate the performance of the Signal device and that it meets its intended use. Specifically, the Signal has been assessed for applicable biocompatibility testing, electrical safety and EMC testing, and software verification and validation testing. All product specifications were met.

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

Signal 510(k) February 20, 2009 Confidential

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 0 7 2009

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

Re: K090493

> Trade/Device Name: Signal™ Regulatory Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (Two) Product Code: DOD Dated: July 31, 2009 Received: August 4, 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 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. 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 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/industry/support/index.html.

Sincerely yours.

R. Lachner

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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# 8090493

## Section 4

## INDICATION FOR USE

510(k) Number (if known):

Not Assigned K090493

Signal™ Device Name:

Indications for Use:

Signal is an electronic device intended to support the physician in the evaluation of heart sounds, lung sounds, bowel sounds and other acoustic signals in patients. The device allows for the recording of multiple, simultaneous acoustic signals and includes a single-lead electrocardiograph that produces a visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is not intended for diagnostic use. The device also allows the sharing of data through the Internet and provides a means to attach patient information to the stored sound files. Signal is intended for use by healthcare professionals only.

Prescription Use: Jo 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)

Duna R. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K090493

Signal 510(k) February 20, 2009

Confidential