Smart Wireless Stethoscope

K220470 · Shanghai Hulu Devices Co., Ltd. · DQD · May 23, 2022 · Cardiovascular

Device Facts

• Record ID: K220470
• Device Name: Smart Wireless Stethoscope
• Applicant: Shanghai Hulu Devices Co., Ltd.
• Product Code: DQD · Cardiovascular
• Decision Date: May 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric, 3rd-Party Reviewed

Intended 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.

Device Story

Smart Wireless Stethoscope (STEMO300, STEMO500, STEMO700) captures body sounds via chest-piece microphone; converts to electrical audio signals; transmits via Bluetooth to companion mobile app (smartphone/tablet). App provides amplification, filtering, recording, and sharing. STEMO500/700 include ambient noise cancellation; STEMO700 supports direct Bluetooth earphone streaming. Used by clinicians or lay users; enables remote listening via IP network. Output visualized as phonocardiogram in app; assists healthcare providers in diagnostic assessment; facilitates remote patient monitoring.

Clinical Evidence

No clinical data submitted. Bench testing only, including biocompatibility (cytotoxicity, sensitization, irritation per ISO 10993-1), electrical safety (IEC 60601-1, IEC 60601-1-11), EMC (IEC 60601-1-2), and wireless coexistence (ANSI IEEE C63.27-2017, AAMI TIR69:2017).

Technological Characteristics

Rechargeable Lithium-ion polymer battery; microphone transducer; 20-2000Hz frequency range; 4000Hz sample rate; Bluetooth connectivity; Micro USB charging. Models STEMO500/700 feature ambient noise cancellation. Software compatible with Android/iOS. Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ANSI IEEE C63.27-2017, AAMI TIR69:2017.

Indications for Use

Indicated for pediatric and adult patients for auscultation of heart, lung, bowel, arterial, and venous sounds. Intended for professional use in clinical settings or lay use in nonclinical settings. 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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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

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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 ([e-mail]) or phone [phone] 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,<br>Shanghai, China |
| Contact Person: | Junfeng Zhao<br>Phone: [phone]<br>Email: [e-mail] |
| 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<br>functions such as auscultation, recording, amplification,<br>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<br>audio to Bluetooth®<br>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<br>use | The Smart Wireless<br>Stethoscope enables<br>amplification, filtering, and<br>transmission of<br>auscultation sounds from<br>the heart, lungs, bowel,<br>arteries, and veins. A<br>medical professional at one<br>location on network can<br>listen to the auscultation<br>sounds of a patient on site<br>or at a different location on<br>the network. The device is<br>intended for use on | The Eko CORE is an<br>electronic stethoscope that<br>enables amplification,<br>filtering, and transmission<br>of auscultation sound data<br>(heart, lungs, bowel,<br>arteries, and veins),<br>whereby a clinician at one<br>location on network can<br>listen to the auscultation<br>sounds of a patient on site<br>or at a different location on<br>the network. Eko CORE is<br>intended for use on | Substantially<br>Equivalent |
| | pediatric and adult patients.<br>The device is intended to<br>be used by professional<br>users in a clinical<br>environment or by lay users<br>in a nonclinical<br>environment. The device is<br>not intended for<br>self-diagnosis. | pediatric and adult patients.<br>The Eko CORE is intended<br>to be used by professional<br>users in a clinical<br>environment or by lay users<br>in a nonclinical<br>environment. The device is<br>not intended for<br>self-diagnosis. | |
| Prescription or<br>OTC use | OTC | OTC | Same |
| Transducer | Microphone | Microphone | Same |
| Frequency range | 20-2000Hz | 20-2000Hz | Same |
| Sample rate | 4000Hz | 4000Hz | Same |
| Software<br>platform | Compatible with Android<br>and iOS devices | Compatible with Android<br>and iOS devices | Same |
| Transmission<br>over Bluetooth® | YES | YES | Same |
| Listening<br>through the<br>companion app | YES. The sounds can be<br>heard via earphones<br>connected to a phone or a<br>tablet that runs the<br>companion app. | YES. The sounds can be<br>heard via earphones<br>connected to a phone or a<br>tablet that runs the<br> | Same |
| Direct listening | Model STEMO300 and<br>STEMO500 do not have<br>direct listening function.<br>STEMO700 has direct<br>listening function and<br>allows direct listening in<br>real time using a<br>Bluetooth® enabled<br>headset. | Eko CORE allows direct<br>listening to sounds in real<br>time through the device's<br>attached earpieces. | Substantially<br>Equivalent.<br>Direct<br>listening is an<br>optional<br>feature that<br>an electronic<br>stethoscope<br>can have. |
| Recording and<br>Playback | Not on the device itself, but<br>with its companion app. | Not on the device itself, but<br>with its companion app. | Same |
| Sound<br>amplification | YES | YES | Same |
| Phonocardiogram | Displayed in the<br>companion app. | Displayed in the<br>companion app. | Same |
| Power source | Rechargeable Lithium-ion<br>polymer battery | Rechargeable Lithium-ion<br>polymer battery | Same |
| Connections | Micro USB connector only<br>to charge internal battery<br>of the device | Micro USB connector only<br>to charge internal battery<br>of the device | Same |
| Ambient noise | Model STEMO300 does | Has ambient noise | Substantially |
| cancelling | not have ambient noise<br>cancelling feature. Model<br>STEMO500 and<br>STEMO700 have ambient<br>noise cancelling feature<br>that can be turned on/off in<br>its companion app. | cancelling feature. It can be<br>turned on/off in its<br>companion app. | Equivalent.<br>Ambient noise<br>cancelling is<br>an optional<br>feature that an<br>electronic<br>stethoscope<br>can have. |
| Livestream | The livestream function<br>transfers stethoscope<br>sounds over IP network. | The livestream function<br>transfers stethoscope<br>sounds over IP network. | Substantially<br>Equivalent. |

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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.