Eko Electronic Stethoscope System

K151319 · Eko Devices, Inc. · DQD · Aug 28, 2015 · Cardiovascular

Device Facts

• Record ID: K151319
• Device Name: Eko Electronic Stethoscope System
• Applicant: Eko Devices, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Aug 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Eko Electronic Stethoscope System is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing. It can used to record heart sounds and cardiac murmurs, bruits, respiratory sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

Device Story

Eko Electronic Stethoscope System consists of electronic stethoscope hardware and mobile application; captures acoustic heart, vascular, and respiratory sounds; amplifies and filters signals; transmits data to mobile app via wireless/wired connection; enables storage, playback, and sharing of recordings; used by healthcare professionals in clinical settings; facilitates physical examination and diagnostic decision support; provides visual representation of sounds; aids in detection of cardiac murmurs, bruits, and respiratory abnormalities.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison.

Technological Characteristics

Electronic stethoscope system; includes amplification and filtering circuitry; mobile application interface; connectivity via wireless/wired transmission; intended for pediatric and adult use; Class II device (21 CFR 870.1875).

Indications for Use

Indicated for pediatric and adult patients for electronic amplification, filtering, and recording of heart, cardiac murmur, bruit, and respiratory sounds during physical examinations by healthcare professionals to support diagnostic decisions.

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.

Submission Summary (Full Text)

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Public Health Service

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

August 28, 2015

Eko Devices, Inc. % Michael Righter Principal, Regulatory Affairs Righter Consulting Group, LLC Po Box 63 Tolovana Park, Oregon 97145

Re: K151319

Trade/Device Name: Eko Electronic Stethoscope System Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: July 22, 2015 Received: July 24, 2015

Dear Michael Righter:

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.

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

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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 of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mitchell Stein

for 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) K151319

Device Name Eko Electronic Stethoscope System

#### Indications for Use (Describe)

The Eko Electronic Stethoscope System is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing. It can used to record heart sounds and cardiac murmurs, bruits, respiratory sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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