(56 days)
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No
The provided text describes a device that amplifies, filters, and transfers body sounds and ECG waveforms. It mentions displaying and storing these waveforms but does not include any terms or descriptions related to AI, ML, image processing, or data analysis beyond basic signal processing and display. There is no mention of algorithms that learn or adapt.
No
Explanation: The device is intended for electronic amplification, filtering, and transfer of body sounds and ECG waveforms for diagnostic purposes (physical examination), not for treating a condition.
Yes
The 'Intended Use / Indications for Use' section states that the device can be used to record various body sounds "during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary, or abdominal organ systems." This implies its use in identifying or characterizing conditions. Additionally, it mentions that the data is "significant when used in conjunction with physician over read as well as consideration of other relevant patient data," which further suggests its role in aiding diagnosis.
No
The description explicitly states the device is a "System" that "electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms." This implies the presence of hardware components (amplifiers, filters, sensors for ECG and body sounds) in addition to the accompanying mobile application (software).
Based on the provided information, the Eko Model E5 System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The description of the Eko Model E5 System clearly states its intended use is to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. It also displays these waveforms and phonocardiogram waveforms.
- The device is used for physical examination by listening to sounds from the cardiac, vascular, pulmonary, or abdominal organ systems and recording heart sounds, murmurs, bruits, and respiratory/abdominal sounds.
- This process involves listening to and recording signals directly from the patient's body, not analyzing specimens in vitro.
Therefore, the Eko Model E5 System falls under the category of a medical device used for physical examination and physiological signal acquisition, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Eko Model E5 System is intended to be used by healthcare professionals to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko Model E5 System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for storage and sharing (when prescribed or used under the care of a physician). It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary, or abdominal organ systems. The device can be used on adults and pediatrics.
The data offered by the device is only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.
The device should not be used on infants weighing less than 10kg.
Product codes
DOD, DPS
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
Adults and pediatrics. The device should not be used on infants weighing less than 10kg.
Intended User / Care Setting
Healthcare professionals
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 is a logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure with three faces in profile, suggesting care and support. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2017
Eko Devices, Inc. % Mr. Michael Righter Principal Regulatory Affairs Righter Consulting Group, LLC PO Box 63 Tolovana Park, Oregon 97145
Re: K170874
Trade/Device Name: Eko Model E5 System (EME5), Eko Duo Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD, DPS Dated: March 17, 2017 Received: March 24, 2017
Dear Mr. 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. Iisting 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 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 (reporting of medical device
1
related 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.
M.G. Willemen
for
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) K170874
Device Name Eko Model E5
Indications for Use (Describe)
The Eko Model E5 System is intended to be used by healthcare professionals to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko Model E5 System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for storage and sharing (when prescribed or used under the care of a physician). It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary, or abdominal organ systems. The device can be used on adults and pediatrics.
The data offered by the device is only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.
The device should not be used on infants weighing less than 10kg.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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