HeartBuds Electronic Stethoscope
Device Facts
| Record ID | K212906 |
|---|---|
| Device Name | HeartBuds Electronic Stethoscope |
| Applicant | Heartbuds, LLC |
| Product Code | DQD · Cardiovascular |
| Decision Date | Mar 14, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1875 |
| Device Class | Class 2 |
Indications for Use
The HeartBuds Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location via the HeartBuds mobile application can listen to the auscultation sounds of a patient at a different location. The HeartBuds Stethoscope is intended to be used by professional users in a clinical environment or by non medical professional adult users in a non clinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
Device Story
HeartBuds is a handheld electronic stethoscope with an integral plastic diaphragm; connects to smartphones (iOS/Android) via audio cable. User operates HeartBuds mobile app to listen to, display, and record heart/lung sounds. App allows real-time sampling before recording; files are named by anatomical location and stored in cloud (Firebase). Users share recordings via email for remote review by healthcare providers. Used in clinical or non-clinical settings by professionals or adult lay users. Provides digital auscultation data to assist clinicians in diagnostic decision-making; enables remote physical assessment.
Clinical Evidence
No clinical data was required for this device. Evidence consists of bench testing for electrical and mechanical safety (ANSI/AAMI 60601-1, IEC 60601-1-2), biocompatibility (ISO 10993), usability (ISO 62366-1), and software verification/validation.
Technological Characteristics
Handheld electronic stethoscope with plastic diaphragm. Wired connection to smartphone audio jack. Frequency range 50–3000 Hz. Compliant with ANSI/AAMI 60601-1, IEC 60601-1-2, ISO 10993, and ISO 62366. Software-based signal processing via mobile app. No internal battery.
Indications for Use
Indicated for auscultation of heart and lung sounds in patients undergoing physical assessment. Intended for use by professional users in clinical environments or non-medical professional adult users in non-clinical environments. Not intended 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
- Tyto Stethoscope (K181612)
Submission Summary (Full Text)
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March 14, 2023
Heartbuds LLC % Michelle Lott Principal and Founder leanRAQA 2081 Longden Circle Los Altos, California 94024
Re: K212906
Trade/Device Name: HeartBuds Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: March 7, 2023 Received: March 8, 2023
Dear Sheila Pickering:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Robert T. Kazmierski -S
for
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) K212906
Device Name HeartBuds Stethoscope
#### Indications for Use (Describe)
The HeartBuds Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location via the HeartBuds mobile application can listen to the auscultation sounds of a patient at a different location. The HeartBuds Stethoscope is intended to be used by professional users in a clinical environment or by non medical professional adult users in a non clinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
Type of Use (Select one or both, as applicable)
| <span></span> | Deposition Use (Part 21 CFR 321 Subpart B) |
|---------------|---------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 331 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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## HeartBuds Electronic Stethoscope K212906 510(k) Summary Prepared August 11 2022
| Sponsor: | HeartBuds LLC<br>711 London Road<br>Winter Park, Florida 32792 |
|-----------------------|----------------------------------------------------------------|
| Contact Person: | Seth Ellis |
| Telephone: | 407 906 2484 |
| Submission Date: | August 10, 2022 |
| Device Name: | HeartBuds Electronic Stethoscope |
| Common Name: | Electronic Stethoscope |
| Trade Name: | HeartBuds Model 1 |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | 21 CFR 870.1875 (DQD) |
| Classification Panel: | Cardiovascular diagnostics |
## A. Legally Marketed Predicate Devices
The predicate device is the Tyto Stethoscope (K181612).
## B. Device Description:
HeartBuds is an electronic stethoscope intended to auscultate heart and lung sounds. HeartBuds Stethoscope can be used on any patient undergoing a physical assessment. This stethoscope consists of a hand-held device with integral plastic sound diaphragm, that must be used together with a smartphone equipped with the HeartBuds application software. HeartBuds Stethoscope allows users to digitally record heart and lung internal auscultation and transmit the sound data to a medical professional in another location. The HeartBuds system includes two (2) main components: The HeartBuds Electronic Stethoscope and the HeartBuds mobile app.
The HeartBuds Electronic Stethoscope connects to mobile devices (Apple and Android) by means of an audio cable. The HeartBuds app with the integrated HeartBuds software provides users a platform to listen, display, and record sounds simultaneously using an external microphone. The users can share their recordings with their healthcare provider within the HeartBuds app for remote examination
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## C. Intended Use / Indications for Use
The HeartBuds Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location via the HeartBuds mobile application can listen to the auscultation sounds of a patient at a different location. The HeartBuds Stethoscope is intended to be used by professional users in a clinical environment or by non medical professional adult users in a non clinical environment. The device is for medical diagnostics purposes only. The device is not intended for selfdiagnosis
# D. Substantial Equivalence
The HeartBuds electronic stethoscope (HeartBuds) is substantially equivalent to the Tyto Stethoscope manufactured by Tyto Care Ltd. and cleared pursuant to 510(k) premarket notification K181612. Both are portable hand-held devices intended to enable transmission of auscultation sound data. A detailed comparison of the HeartBuds device and the predicate is presented in the Table below.
| # | Parameters | Subject Device | Predicate Device Tyto<br>Stethoscope<br>(K181612) | Substantially<br>Equivalent (SE) |
|----|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| 1 | Trade Name | HeartBuds | Tyto Stethoscope | N/A |
| 2 | Manufacturer | HeartBuds LLC | Tyto Care Ltd. | N/A |
| 3 | Classification | Class II | Class II | Same |
| 4 | Regulation No. | 21 CFR 870.1875 | 21 CFR 870.1875 | Same |
| 5 | Product<br>Code(s) | DQD | DQD | Same |
| 6 | Indications<br>for use | The HeartBuds Stethoscope is<br>an electronic stethoscope that<br>enables transmission of<br>auscultation sound data,<br>whereby a clinician at one<br>location via the HeartBuds<br>mobile application can listen<br>to the auscultation sounds of a<br>patient at a different location.<br>The HeartBuds Stethoscope is<br>intended to be used by<br>professional users in a clinical<br>environment or by lay users in<br>a nonclinical environment.<br>The device is for medical<br>diagnostics purposes only. The<br>device is not intended for self-<br>diagnosis. | The Tyto Stethoscope<br>is an electronic<br>stethoscope that<br>enables transmission of<br>auscultation sound<br>data, whereby a<br>clinician at one<br>location on an IP<br>network can listen to<br>the auscultation sounds<br>of a patient on site or<br>at a different location<br>on the IP network with<br>the signal carried on an<br>IP connection between<br>the two locations. The<br>Tyto Stethoscope is<br>intended to be used by<br>professional users in a | SE |
| | | | clinical environment or<br>by lay users in a<br>nonclinical<br>environment. The<br>device is for medical<br>diagnostics purposes<br>only. The device is not<br>intended for self-<br>diagnosis. | |
| 7 | Device<br>Description | The HeartBuds Stethoscope<br>when connected to the<br>HeartBuds App, captures<br>sounds by the HeartBuds<br>Stethoscope which can be<br>recorded by the App and<br>stored to the cloud for future<br>use. The HeartBuds mobile<br>application on the smartphone<br>records those sounds as an<br>audio recording to be stored<br>and if desired by the user to be<br>shared with a healthcare<br>provider. The HeartBuds App<br>requires a user to register and<br>create a secure login in order<br>to provide a means to associate<br>the recordings to each<br>individual user and to be<br>stored in the cloud (Google<br>application Firebase). The<br>HeartBuds App provides the<br>capability to start and stop<br>recording at the user's<br>discretion. The HeartBuds<br>App also provides the<br>capability for the user to<br>sample the sounds received<br>from the HeartBuds<br>Stethoscope before starting a<br>recording. This provides a<br>means for the user to either<br>change the position of the<br>Stethoscope to ensure the<br>recording includes sounds of<br>the heart or lung. The user<br>stops the recording, the<br>HeartBuds App names the file<br>to facilitate future<br>identification (both the user<br>and a specific anatomical<br>location) and loads it to the | The Tyto Stethoscope<br>(OTC) is designed for<br>use by professional as<br>well as lay users in<br>clinical or non-clinical<br>environments. It<br>enables four types of<br>stethoscope exams:<br>Heart, Lungs, Heart<br>Rate and Audio (Audio<br>is for clinician only).<br>The operation process<br>of the Tyto<br>Stethoscope uses four<br>(4) primary functional<br>elements: (1) The Tyto<br>Stethoscope<br>(composed of a<br>Stethoscope Tip and a<br>Base Unit - Tyto<br>Device and supported<br>with proprietary<br>software). (2) A<br>mobile device (e.g., a<br>smartphone, not part of<br>the Tyto Stethoscope<br>device, not supplied by<br>TytoCare, on which<br>the proprietary<br>TytoCare App is<br>running), (3) The Tyto<br>Server platform<br>(composed of server<br>hardware not part of<br>the Tyto Stethoscope<br>device, not supplied by<br>TytoCare, on which<br>the proprietary server<br>software is running).<br>(4) A clinician<br>receiving platform<br>located in a clinical | SE |
| | | cloud for storage. The | environment (e.g., a | |
| | | HeartBuds App provides the | PC at the clinic, not | |
| | | user a list of all saved | part of the Tyto | |
| | | recordings. From the list of | Stethoscope device, | |
| | | recordings the user can select | not supplied by | |
| | | one for replaying or to share | TytoCare, on which | |
| | | via email. | the proprietary | |
| | | | Clinician App is | |
| | | | running). | |
| | | | Two operational flows | |
| | | | are optional for using | |
| | | | the Tyto Stethoscope: | |
| | | | store-and forward flow | |
| | | | and on-line exam flow. | |
| | | | Both flows are | |
| | | | essentially similar and | |
| | | | share the same | |
| | | | fundamental steps: | |
| | | | performing one or | |
| | | | more measurements…
