(102 days)
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Not Found
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks descriptions of training/test sets or performance metrics typically associated with AI/ML devices.
No.
The device is used for diagnostic decision support by recording and transferring physiological sounds, not for direct treatment or therapy.
Yes
The device is explicitly stated to be intended for "diagnostic decision support in clinical settings" and can be used to record sounds for patients with "suspected diseases."
No
The device description explicitly states it can "electronically amplify, filter and transfer sounds," indicating the presence of hardware components beyond just software.
Based on the provided information, the Eko Electronic Stethoscope System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description clearly states the Eko system is used "as a part of a patient" and for "physical examination." It records sounds directly from the patient's body.
- The intended use and device description focus on physical examination and recording sounds from within the body. There is no mention of analyzing blood, urine, tissue, or any other biological sample.
Therefore, the Eko Electronic Stethoscope System falls under the category of a medical device used for physical examination and diagnostic support, but not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
DQD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cardiac, vascular, pulmonary or abdominal organ systems
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
healthcare professionals for diagnostic decision support in clinical settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of the department's name encircling a symbol. The symbol features three stylized human profiles facing right, stacked on top of each other, with flowing lines beneath them.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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