Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard audio processing (amplification, filtering, recording, sharing) and Bluetooth transmission. There is no mention of AI, ML, or any related concepts like pattern recognition, classification, or diagnostic algorithms based on the audio data. The performance studies listed are standard device testing (biocompatibility, electrical safety, software V&V), not studies evaluating the performance of an AI/ML algorithm.

Therapeutic

No
The device is described as amplifying, filtering, and transmitting auscultation sounds for diagnostic purposes, not for treating a condition.

Diagnostic

No

The device is described as an amplification, filtering, and transmission tool for auscultation sounds. The "Intended Use" explicitly states, "The device is not intended for self-diagnosis," which suggests its role is data acquisition rather than direct diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is made of a "Bluetooth® stethoscope and a companion medical mobile application". The stethoscope is a hardware component that picks up body sounds.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
Device Function: The Smart Wireless Stethoscope amplifies, filters, and transmits auscultation sounds from within the body (heart, lungs, bowel, arteries, and veins). It is used to listen to sounds produced by the body, not to analyze samples taken from the body.
Intended Use: The intended use is for medical professionals and lay users to listen to body sounds for diagnostic purposes, but it does not involve the analysis of biological samples.

The device is a diagnostic tool, but it falls under the category of a non-IVD medical device that aids in diagnosis by providing auditory information from within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Smart Wireless Stethoscope enables amplification, filtering, and transmission of auscultation sounds from the heart, lungs, bowel, arteries, and veins. A medical professional at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The device is intended for use on pediativ and adult patients. The device 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.

Product codes

DOD

Device Description

The proposed smart wireless stethoscope is made of a Bluetooth® stethoscope and a companion medical mobile application that runs on a smartphone or a tablet. The stethoscope picks human body sounds with an acoustic structure that is similar to the chest piece of a traditional stethoscope. Then the sounds are converted to electrical audio signals by a microphone in the device. The electrical audio signals are further processed and transmitted through Bluetooth® protocol. The device has three models STEMO300, STEMO500 and STEMO700. All the three models can work with the companion app running on a smartphone or tablet. When they work this way, the stethoscope transmits audio to the app and the sounds can be further processed in the app. The app provides functions such as amplification, filtering, recording, sharing, etc. STEMO500 and STEMO700 have an ambient noise cancelling option while STEMO300 not. Unlike STEMO300 or STEMO500, STEMO700 has an option to directly transmit audio to paired Bluetooth earphones.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

heart, lungs, bowel, arteries, and veins

Indicated Patient Age Range

pediatric and adult patients.

Intended User / Care Setting

professional users in a clinical environment or by lay users in a nonclinical 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

Biocompatibility Testing: The biocompatibility evaluation for this device was conducted in accordance with the FDA Guidance "Use of International Standard ISO10993-1, 'Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" and the International Standard ISO 10993-1 Fourth Edition 2009-10-15, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process [Including: Technical Corrigendum 1 (2010)], as recognized by FDA. The testing included the following tests: Cytotoxicity, Sensitization, Irritation.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on this device. The system complies with the IEC 60601-1 and IEC 60601-1-11 standard for safety, IEC 60601-1-2 for EMC, and ANSI IEEE C63.27-2017 and AAMI TIR69:2017/(R2020) for wireless co-existence.
Software Verification and Validation Testing: The software of this device is verified and validated according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Clinical Test: No clinical test is submitted in this 510(k).

Key Metrics

Not Found

Predicate Device(s)

K200776

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

May 23, 2022

Shanghai Hulu Devices Co., Ltd % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K220470

Trade/Device Name: Smart Wireless Stethoscope (Model: STEMO300, STEMO700) Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: April 22, 2022 Received: April 25, 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.

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

1

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 medical devices and radiation-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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220470

Device Name

Smart Wireless Stethoscope (Model: STEMO300, STEMO500, STEMO700)

Indications for Use (Describe)

The Smart Wireless Stethoscope enables amplification, filtering, and transmission of auscultation sounds from the heart, lungs, bowel, arteries, and veins. A medical professional at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The device is intended for use on pediativ and adult patients. The device 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.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5 510(k) Summary

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510(k) Summary

Submitter	Shanghai Hulu Devices Co., Ltd
Address	No. 509 Caobao Road, Room 101-2 Bld 9, Xuhui District,
Shanghai, China
Contact Person:	Junfeng Zhao
Phone: 0086-18621892190
Email: zhaoap@hotmail.com
Date Prepared:	Dec 31, 2021
Device Name:	Smart Wireless Stethoscope
Models	STEMO300, STEMO500, STEMO700
Common Name:	Electronic Stethoscope
Classification:	II
Regulation Number	870.1875
Regulation Name:	Electronic Stethoscope
Product Code:	DQD

5.1 General Information

5.2 Predicate Device

510(k) Number	Comparison
K200776	Intended use, prescription or OTC use, technology, major
functions such as auscultation, recording, amplification,
mobile application support and livestream.

5.3 Device Description

The proposed smart wireless stethoscope is made of a Bluetooth® stethoscope and a companion medical mobile application that runs on a smartphone or a tablet. The stethoscope picks human body sounds with an acoustic structure that is similar to the chest piece of a traditional stethoscope. Then the sounds are converted to electrical audio signals by a microphone in the device. The electrical audio signals are further processed and transmitted through Bluetooth® protocol. The device has three models STEMO300, STEMO500 and STEMO700. All the three models can work with the companion app running on a smartphone or tablet. When they work this way, the stethoscope transmits audio to the app and the sounds can be further processed in the app. The app provides functions such as amplification, filtering, recording, sharing, etc. STEMO500 and STEMO700 have an ambient noise cancelling option while STEMO300 not. Unlike STEMO300 or STEMO500, STEMO700 has an option to directly transmit audio to paired Bluetooth earphones. Here is a comparison of these three models.

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	Comparison Item	STEMO300	STEMO500	STEMO700
1	App support	Work with the same companion app
2	Hardware Operation	Similar way to switch on/off; similar notification light
3	Noise cancelling option	NO	YES	YES
4	Option to directly transmit
audio to Bluetooth®
earphones	NO	NO	YES

5.4 Indications for Use

The Smart Wireless Stethoscope enables amplification, filtering, and transmission of auscultation sounds from the heart, lungs, bowel, arteries, and veins. A medical professional at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The device is intended for use on pediatric and adult patients. The device 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.

5.5 Technology Characteristics

The Proposed smart wireless stethoscope has substantially equivalent indications for use and very similar technology characteristics as its predicate devices. Here is a comparison on the major technology characteristics between the current device and the preliminary predicate device.

Item	Current Device	Predicate Device	Comparison
Classification	Class II	Class II	Same
Regulation	21 CFR 870.1875	21 CFR 870.1875	Same
Product code	DQD	DQD	Same
Regulation name	Electronic Stethoscope	Electronic Stethoscope	Same
Indications for
use	The Smart Wireless
Stethoscope enables
amplification, filtering, and
transmission of
auscultation sounds from
the heart, lungs, bowel,
arteries, and veins. A
medical professional at one
location on network can
listen to the auscultation
sounds of a patient on site
or at a different location on
the network. The device is
intended for use on	The Eko CORE is an
electronic stethoscope that
enables amplification,
filtering, 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. Eko CORE is
intended for use on	Substantially
Equivalent
	pediatric and adult patients.
The device 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.	pediatric and adult patients.
The Eko CORE 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.
Prescription or
OTC use	OTC	OTC	Same
Transducer	Microphone	Microphone	Same
Frequency range	20-2000Hz	20-2000Hz	Same
Sample rate	4000Hz	4000Hz	Same
Software
platform	Compatible with Android
and iOS devices	Compatible with Android
and iOS devices	Same
Transmission
over Bluetooth®	YES	YES	Same
Listening
through the
companion app	YES. The sounds can be
heard via earphones
connected to a phone or a
tablet that runs the
companion app.	YES. The sounds can be
heard via earphones
connected to a phone or a
tablet that runs the

                                                                                                                                                                                                                                                                                           | Same                                                                                                                               |

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Overall, the proposed device has the same or similar technology characteristics of the predicate device.

5.6 Performance Data

The following performance data were provided in support of the substantial equivalence determination.

5.6.1 Biocompatibility Testing

The biocompatibility evaluation for this device was conducted in accordance with the FDA Guidance "Use of International Standard ISO10993-1, 'Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" and the International Standard ISO 10993-1 Fourth Edition 2009-10-15, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process [Including: Technical Corrigendum 1 (2010)], as recognized by FDA. The testing included the following tests:

. Cytotoxicity
Sensitization .
Irritation

5.6.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on this device. The system complies with the IEC 60601-1 and IEC 60601-1-11 standard for safety, IEC 60601-1-2 for EMC, and ANSI IEEE C63.27-2017 and AAMI TIR69:2017/(R2020) for wireless co-existence.

5.6.3 Software Verification and Validation Testing

The software of this device is verified and validated according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

5.6.4 Clinical Test

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No clinical test is submitted in this 510(k).

5.7 Conclusion

Based on the technological characteristics of the devices and the intended use, we can conclude that the proposed smart wireless stethoscope and its predicate devices are substantially equivalent. The differences do not raise any new issues of safety or effectiveness.