eClinic Stethopod
Device Facts
| Record ID | K220099 |
|---|---|
| Device Name | eClinic Stethopod |
| Applicant | Homediagnostic, LLC |
| Product Code | DQD · Cardiovascular |
| Decision Date | Oct 20, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1875 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
eClinic Stethopod is an Electronic Stethoscope. It converts patient auscultation sound (heart, lungs, bowel, arteries, and veins) into audio signal and transmits it to clinically defined virtual appointment methods. It is intended to be used by professional users in a clinical environment or by lay users in a nonclinical or clinical environment to assist remote healthcare professionals' physical assessment. The device is not intended for self-diagnosis. eClinic Stethopod is intended for patients or customers who are 2 years and older. It is for both prescription use and over the counter use.
Device Story
Electronic stethoscope; captures physiological sounds via chest piece; converts acoustic signals to audio via microphone/passive electronics; transmits real-time audio via cable to smartphones, tablets, or computers. Used in clinical or non-clinical settings by professionals or lay users during telehealth appointments. Integrates with standard communication platforms (e.g., Zoom, phone calls) to enable remote auscultation. Healthcare providers listen to transmitted audio to assist in physical assessment and clinical decision-making. Benefits include remote access to patient auscultation data, facilitating telehealth physical examinations.
Clinical Evidence
Bench testing only. Design verification and validation tests confirmed device meets requirements for sound rhythm, heartbeat rate, frequency spectrum, and signal-to-noise ratio. Qualitative evaluation by clinicians and volunteers confirmed acceptable sound quality via phone calls and Zoom.
Technological Characteristics
Passive electromechanical electronic stethoscope. Chest piece (48mm) with anti-chill silicone ring. Frequency range 20-2000Hz. Wired connectivity (3.5mm jack) to host devices (iOS/Android). No internal battery (powered by host). Biocompatible materials per ISO 10993-1. No active amplification or recording/playback features.
Indications for Use
Indicated for pediatric and adult patients (2 years and older) for auscultation of heart, lung, bowel, arterial, and venous sounds to assist remote physical assessment by healthcare professionals. Not for self-diagnosis.
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
- Eko Core (K200776)
Submission Summary (Full Text)
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October 20, 2022
HomeDiagnostic LLC % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K220099
Trade/Device Name: eClinic Stethopod Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: October 4, 2022 Received: October 7, 2022
## Dear Dave Yungvirt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K220099
Device Name eClinic Stethopod
#### Indications for Use (Describe)
eClinic Stethopod is an Electronic Stethoscope. It converts patient auscultation sound (heart, lungs, bowel, arteries, and veins) into audio signal and transmits it to clinically defined virtual appointment methods. It is intended to be used by professional users in a clinical environment or by lay users in a nonclinical or clinical environment to assist remote healthcare professionals' physical assessment. The device is not intended for self-diagnosis. eClinic Stethopod is intended for patients or customers who are 2 years and older. It is for both prescription use and over the counter use.
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (6/20)
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### K220099
### 510(K) SUMMARY
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR §807.92.
### 5.1 Applicant's Information
| Name: | HomeDiagnostic LLC |
|-------------------|--------------------------------|
| Address: | 3160 De La Cruz Blvd Suite 100 |
| Phone: | 18669764038 |
| Contact Person: | Jian Gong |
| Email: | info@eclinicdx.com |
| Preparation Date: | 18 Oct 2022 |
### 5.2 Device Name
| Product/Trade Name: | eClinic Stethopod (K220099) |
|----------------------|-----------------------------|
| Common Name: | Stethoscope |
| Classification Name: | Electronic Stethoscope |
| Regulatory Class: | Class II |
| Regulatory Number: | 21 CFR870.1875 |
| Product Code: | DQD |
### 5.3 Legally Marketed Predicate Device
The predicate device for eClinic Stethopod is legally marketed Eko Core (K200776).
### 5.4 Device Description
### 5.4.1 Device Identification
eClinic Stethopod is an electronic stethoscope that is designed to be used with virtual communication systems for telehealth. It provides patient auscultation sounds for clinicians during virtual appointments while maintaining communication between clinicians and patients.
#### 5.4.2 Device Characteristics
The eClinic Stethopod is a passive electromechanical device. It converts physiological sounds into audio signals through a microphone. It further processes the signal through passive electronics for noise reduction and then transmits the real time data to clinically defined communication applications that connect patients and clinicians.
#### 5.4.3 Environment of Use
The eClinic Stethopod is used during physical assessment. The environment of use could be anywhere where physical assessment is done, for example non-clinical environment or healthcare facilities.
### 5.4.4 Brief Description of the Device
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eClinic Stethopod has a chest piece to pick up acoustic signal, a handle housing electronics that converts acoustic signal to audio signal and a cable to connect with communication devices. eClinic Stethopod needs to be connected to a communication device to achieve its intended use. There are two accessories: Apple ear pod and Apple adapter (lighting to 3.5 mm jack).
# 5.4.5 Materials of Use
eClinic Stethopod is not intended to have direct contact to body fluid. It is intended to contact human intact skin for a very short period. The eClinic Stethopod parts that contact the skin are composed of biocompatible materials and compliance to ISO 10993-Part 1 Biological Evaluation of Medical Devices.
### 5.4.6 Essential Performance Characteristics
The essential performance characteristics of the eClinic Stethopod are listed in Table 1.
| Feature | Specification |
|----------------------|-------------------------------------------------------------------------|
| Chest Piece | Single Cup Chest piece |
| Chest Piece Diameter | 48 mm |
| Chest Piece Ring | Anti-Chill silicone |
| Frequency Range | 20-2000Hz |
| Weight | <250g |
| Compatible Software | iOS 13 or later, Android 8 and above, Zoom 5.4.3 and above |
| Compatible Devices | iPhone 6 or later, iPad Pro, iPad Mini, iPad 2 or later; iPod touch 4th |
| | generation; |
| | Android 8.0 and above |
### Table 1: eClinic Stethopod Essential Performance Characteristics
# 5.5 Intended Use
eClinic Stethopod is an Electronic Stethoscope. It converts patient auscultation sound (heart, lungs, bowel, arteries, and veins) into audio signal and transmits it to clinically defined virtual appointment methods. It is intended to be used by professional users in a clinical environment or by lay users in a nonclinical or clinical environment to assist remote healthcare professionals' physical assessment. The device is not intended for selfdiagnosis.
eClinic Stethopod is intended for patients or customers who are 2 years and older. It is for both prescription use and over the counter use.
The predicate device is legally marketed Eko Core (K200776) manufactured by Eko Devices Inc.
| Product/Trade Name: | Eko Core |
|----------------------|------------------------|
| Common Name: | Stethoscope |
| Classification Name: | Electronic Stethoscope |
| Regulatory Class: | Class II |
| Regulatory Number: | 21 CFR870.1875 |
| Product Code: | DQD |
Eko Core is an electronic stethoscope that enables amplification, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. It is intended for use on pediatric
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and adult patients. It is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.
### eClinic Stethopod is equivalent to the predicate device in:
- Both are electronic stethoscope: O
- Both convert auscultation sound into audio signal and transmits it to clinicians; O
- Both are used to be part of a physical assessment remotely; O
- Both could be used by lay users in non-clinical environment or clinical environment; O The transmitted auscultation sound will be used by professionals sitting remotely to assist diagnoses.
- Both are not used for self-diagnostics. O
The intended use of eClinic Stethopod is the same to the predicate devices for remote physical assessment. The statement variation between eClinic Stethopod and predicate device is not critical to the intended use of the device. The differences do not affect the safety and effectiveness of the device.
### 5.6 Comparison of Technological Characteristics with the Predicate Device
The principal operation of the eClinic Stethopod is the same to the predicate devices. Acoustic physiology sound is picked up by microphone and converted into audio signal. Then it is transmitted to advanced communication tools to be heard remotely by clinicians.
The following technological characteristics of the eClinic Stethopod is equivalent to the predicate devices:
- Use mechanical chest piece to collect physiological sounds; O
- Use microphone and electronics to digitalize the physiological sounds; O
- Use electronics to reduce noise; O
- O Use advanced communication tools (smart phones and operation system IOS or Android);
The following technological characteristics of the eClinic Stethopod is different to the predicate device:
- eClinic Stethopod sends data via a cable to smartphones, tablets, or computers. The predicate device uses O RF wireless transmission.
- eClinic Stethopod works with phone calls or virtual appointment systems defined by clinics or hospitals. O The recommended video system is Zoom. For the predicate device, its own App is needed to function.
The implementation differences such as wire/wireless transmission, and virtual appointment system software/ device's own App, do not impact the device's safety and efficacy for the intended use of the device.
### 5.7 Performance data
The performance of the eClinic Stethpod described in this submission was evaluated according to the quality system regulation (21 CFR §820). Design verification and design validation tests confirmed that all design requirements were met and that the device functions as intended.
Based on design verification test, eClinic Stethopod is equivalent to the predicate device on sound rhythm, heartbeat rate, frequency spectrum and signal to noise ratio for its intended application.
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eClinic stethopod sound quality are further evaluated by clinicians and volunteers in design validation. It is concluded eClinc stethopod sound quality through phone calls and Zoom is acceptable and it is easy to use.
### 5.8 Conclusions
The eClinic Stethopod's intended use, and technological characteristic are equivalent to those of the predicate device. Differences in implementation between the eClinic Stehopod and the predicate do not raise any concerns in regard to safety or effectiveness. It is concluded that the proposed eClinic Stethopod is substantially equivalent to the predicate device within the meaning of the Medical Device Amendments Act of 1976.
| Elements of<br>Comparison | eClinic Stethopod<br>(K220099) | Eko CORE<br>(K200776) |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Regulatory Class | Class II | Class II |
| Classification name | Electronic Stethoscope | Electronic Stethoscope |
| Regulation Number | 21 CFR870.1875 | 21 CFR870.1875 |
| Product Code | DQD | DQD |
| Manufacturer | HomeDiagnostic LLC | Eko Devices, Inc |
| FDA Clearance | Pending | 510K cleared (K200776) |
| Indications for Use | eClinic Stethopod is an Electronic<br>Stethoscope. It converts patient auscultation<br>sound (heart, lungs, bowel, arteries, and<br>veins) into audio signal and transmits it to<br>clinicians by clinically defined virtual<br>appointment methods.<br>It is intended to be used by professional<br>users in a clinical environment or by lay<br>users in a nonclinical or clinical<br>environment to assist remote healthcare<br>professionals' physical assessment. The<br>device is not intended for self-diagnosis.<br>eClinic Stethopod is intended for patients or<br>customers who are 2 years and older. It is<br>for both prescription use and over the<br>counter use. | The Eko CORE is an electronic<br>stethoscope that enables amplification,<br>filtering, and transmission of<br>auscultation sound data (heart, lungs,<br>bowel, arteries, and veins), whereby a<br>clinician at one location on network<br>can listen to the auscultation sounds of<br>a patient on site or at a different<br>location on the network. Eko CORE is<br>intended for use on pediatric and adult<br>patients. The Eko CORE is intended to<br>be used by professional users in a<br>clinical environment or by lay users in<br>a nonclinical environment. The device<br>is not intended for self-diagnosis. |
| Patient Group | Pediatric and adult patients | Pediatric and adult patients |
| Type of Users | Patients and Health-care professional | Patients and Health-care professional |
| Use Environment | Nonclinical or Clinical settings | Nonclinical or Clinical settings |
| Clinical Conditions | Heart, Lung and other human body sounds | Heart, Lung and other human body<br>sounds |
| Prescribed | OTC and Rx | OTC and Rx |
| Characteristics | | |
| Principles of Operation | Microphone and electronics for converting physiology sound to audio signal, reducing noise, and sending data to clinically defined virtual appointment systems through advanced communication tools, such as smartphones, tablets or computers. | Eko CORE is a modified version of the previously cleared predicate device (K151319). The principles of operation is the same as K151319: Electronic stethoscope that gives sound amplification and audio transmission to a smartphone |
| Stethoscope Type | Stand-alone electronic stethoscope with chest pieces sourced from analog stethoscope | Attachment to an analog stethoscope (Core) |
| Real time sound | Real time auscultation sound | Real time auscultation sound |
| Record and Playback Sounds | No | Yes |
| Communication | Patient and clinician real time communication. | Patient and clinician real time communication. |
| Compatibility (Chest piece) | Chest Piece is part of eClinic Stethopods | Littmann 3M Cardiology II/III<br>-WelchAllyn Harvey Elite<br>-ADC601 lines of analog stethoscopes |
| Compatibility App | Direct phone calls on iOS 6 and above or Android 8 and above;<br>Zoom 5.4.3 and above | Eko App |
| Technical Equivalence | | |
| User Interface | • 3.5mm headphone jack<br>• Mobile App (Clinical defined) | • On/Off Power button<br>• Volume adjustment<br>• LED status indicator<br>• Mobile App |
| Analog/Digital Interoperability | Yes | Yes |
| Connectivity | Cable | Bluetooth |
| Sound Amplification | No | Yes |
| Data Transfer to compatible computing platforms | Yes | Yes |
| Energy Source | Power derived from connected digital device. No additional battery needed. | Lithium Ion Battery |
| Compatible Devices | IOS and Android smartphones, Computers | IOS and Android smartphones, Computers |
| Frequency range | 20Hz -2kHz | 20Hz to 2kHz |
| Standards | N/A | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11 |
## Table 2. Comparison with the Predicate Device
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