(281 days)
Not Found
No
The description explicitly states the device is a "passive electromechanical device" and describes signal processing using "passive electronics for noise reduction." There is no mention of AI, ML, or any learning algorithms.
No
The device converts physiological sounds into audio signals for diagnostic assessment by healthcare professionals, but it does not treat or cure any medical condition.
No
Explanation: The device is explicitly stated as "not intended for self-diagnosis" and its purpose is to convert auscultation sounds into audio signals for remote healthcare professionals to assist with physical assessment, rather than providing a diagnosis itself.
No
The device description explicitly states it is a "passive electromechanical device" with a "chest piece," "handle housing electronics," and a "cable," indicating it includes physical hardware components beyond just software.
Based on the provided information, the eClinic Stethopod is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- eClinic Stethopod Function: The eClinic Stethopod is an electronic stethoscope. It works by listening to sounds produced inside the body (in vivo) and converting them into audio signals. It does not analyze or test any bodily specimens.
- Intended Use: The intended use clearly states it converts patient auscultation sound and transmits it for remote healthcare professionals' physical assessment. This is a physical examination tool, not a diagnostic test performed on a specimen.
Therefore, the eClinic Stethopod falls under the category of a medical device used for physical examination, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DOD, DQD
Device Description
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.
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.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
2 years and older.
Intended User / Care Setting
professional users in a clinical environment or by lay users in a nonclinical or clinical environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
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.
1
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
2
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
3
Image /page/3/Picture/0 description: The image shows the logo for HomeDiagnostic LLC. The logo features a stylized blue house with a curved line underneath it. The text "HomeDiagnostic LLC" is written in a gray sans-serif font to the right of the house icon.
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
4
Image /page/4/Picture/1 description: The image contains the logo for HomeDiagnostic LLC. The logo features a stylized house icon in blue, with a curved line underneath. The text "HomeDiagnostic LLC" is written in a sans-serif font to the right of the house icon.
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 |