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 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.

AI/ML Overview

The provided text describes the HeartBuds Electronic Stethoscope, which is an electronic stethoscope enabling the transmission of auscultation sound data. It specifically states that "Clinical data was not required for this type of device" (page 11), indicating that no clinical study was conducted to prove the device meets acceptance criteria related to its diagnostic performance.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Tyto Stethoscope K181612) through verification and validation activities against recognized standards. These activities are designed to ensure the device's safety and effectiveness in its stated use, rather than clinical diagnostic accuracy.

Therefore, the following information cannot be extracted from the provided text as it pertains to clinical studies that were not performed:

A table of acceptance criteria and the reported device performance regarding diagnostic accuracy.
Sample size used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done (as this device transmits sound data for a clinician to interpret, it's inherently human-in-the-loop).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for diagnostic performance.
The sample size for the training set (as no AI algorithm for diagnostic inference is mentioned).
How the ground truth for the training set was established.

However, the document does provide information on performance testing related to safety and usability. These are not diagnostic performance metrics, but rather engineering and operational validations.

Here's a summary of the acceptance criteria and performance as described for the device's overall design verification and validation:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Standard/Requirement	Reported Device Performance
Risk Management	ISO 14971: Application of risk management to medical devices	Potential risks identified, analyzed, and mitigated. All risk mitigations were satisfactorily verified and validated.
Electrical & Mechanical Safety	ANSI/AAMI 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance	Compliant with the standard. Successful bench testing results included in submission.
Electromagnetic Disturbances	IEC 60601-1-2: Electromagnetic disturbances	Compliant with the standard. Successful bench testing results included in submission.
Usability Engineering	IEC 62366-1: Application of usability engineering to medical devices	Compliant with the standard. Human factors testing demonstrated usability in a simulated use environment for both healthcare professionals and lay users.
Biocompatibility	ISO 10993 (5th ed, 2018): Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process	Compliant with the standard for patient contacting materials.
Software Testing	Company's Design Control process (21 CFR Part 820.30)	Verification and validation testing performed, including test cases for off-the-shelf software and cybersecurity features. Results were successful.
Cybersecurity	Not explicitly stated as a standard, but a specific mention	Cybersecurity controls incorporated, and supporting data provided in software information sections.

2. Sample size used for the test set and the data provenance: Not applicable as no clinical diagnostic performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical diagnostic performance study was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical diagnostic performance study was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device transmits raw sound data; it does not include AI for diagnostic assistance. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device's function is to transmit sound data for human interpretation; it does not perform standalone diagnostic analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the verification and validation listed (e.g., electrical safety, usability), the "ground truth" would be compliance with the respective standards and design requirements, as demonstrated by successful test results. For instance, for usability, the ground truth was that users could effectively operate the device in a simulated environment. For biocompatibility, the ground truth was meeting ISO 10993 requirements.

8. The sample size for the training set: Not applicable as there is no mention of a machine learning algorithm or AI model requiring a training set for diagnostic classification.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary

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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)

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

	Deposition Use (Part 21 CFR 321 Subpart B)
	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 LLC711 London RoadWinter 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:

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C. Intended Use / Indications for Use

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 TytoStethoscope(K181612)	SubstantiallyEquivalent (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	ProductCode(s)	DQD	DQD	Same
6	Indicationsfor use	The HeartBuds Stethoscope isan electronic stethoscope thatenables transmission ofauscultation sound data,whereby a clinician at onelocation via the HeartBudsmobile application can listento the auscultation sounds of apatient at a different location.The HeartBuds Stethoscope isintended to be used byprofessional users in a clinicalenvironment or by lay users ina nonclinical environment.The device is for medicaldiagnostics purposes only. Thedevice is not intended for self-diagnosis.	The Tyto Stethoscopeis an electronicstethoscope thatenables transmission ofauscultation sounddata, whereby aclinician at onelocation on an IPnetwork can listen tothe auscultation soundsof a patient on site orat a different locationon the IP network withthe signal carried on anIP connection betweenthe two locations. TheTyto Stethoscope isintended to be used byprofessional users in a	SE
			clinical environment orby lay users in anonclinicalenvironment. Thedevice is for medicaldiagnostics purposesonly. The device is notintended for self-diagnosis.
7	DeviceDescription	The HeartBuds Stethoscopewhen connected to theHeartBuds App, capturessounds by the HeartBudsStethoscope which can berecorded by the App andstored to the cloud for futureuse. The HeartBuds mobileapplication on the smartphonerecords those sounds as anaudio recording to be storedand if desired by the user to beshared with a healthcareprovider. The HeartBuds Apprequires a user to register andcreate a secure login in orderto provide a means to associatethe recordings to eachindividual user and to bestored in the cloud (Googleapplication Firebase). TheHeartBuds App provides thecapability to start and stoprecording at the user'sdiscretion. The HeartBudsApp also provides thecapability for the user tosample the sounds receivedfrom the HeartBudsStethoscope before starting arecording. This provides ameans for the user to eitherchange the position of theStethoscope to ensure therecording includes sounds ofthe heart or lung. The userstops the recording, theHeartBuds App names the fileto facilitate futureidentification (both the userand a specific anatomicallocation) and loads it to the	The Tyto Stethoscope(OTC) is designed foruse by professional aswell as lay users inclinical or non-clinicalenvironments. Itenables four types ofstethoscope exams:Heart, Lungs, HeartRate and Audio (Audiois for clinician only).The operation processof the TytoStethoscope uses four(4) primary functionalelements: (1) The TytoStethoscope(composed of aStethoscope Tip and aBase Unit - TytoDevice and supportedwith proprietarysoftware). (2) Amobile device (e.g., asmartphone, not part ofthe Tyto Stethoscopedevice, not supplied byTytoCare, on whichthe proprietaryTytoCare App isrunning), (3) The TytoServer platform(composed of serverhardware not part ofthe Tyto Stethoscopedevice, not supplied byTytoCare, on whichthe proprietary serversoftware is running).(4) A clinicianreceiving platformlocated 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
			using the Tyto
			Stethoscope, recording
			the data and sending to
			a clinician, review of
			the recorded
			measurements by the
			clinician, and user
			receiving a written
			summary from the
			clinician presenting
			his/her assessment
			and/or
			recommendations.
			While in the store and-
			forward flow the user
			can perform the
			measurements and
			send the recorded data
			to the clinician
			whenever convenient
			for him/her, an on-line
			flow may be executed
			only when also the
			clinician is available
			on-line
8	Intended users	Health care professionals and	professional as well as	SE
		adult lay users (i.e., users who	lay users in clinical or
		are not health careprofessionals)	nonclinical
			environments
9	Intended UseEnvironments	clinical or non-clinicalenvironments	clinical or non-clinicalenvironments	Same
10	Types ofstethoscopeexams	Heart, Lungs, and Audio	Heart, Lungs, HeartRate and Audio	SE
11	Functionalelements	stethoscopeA mobile device (e.g., asmartphone, not part of theHeartBuds Stethoscope device.not supplied by HeartBuds, on which the proprietaryHeartBuds App is running),	stethoscopea mobile device (e.g., asmartphone, not part ofthe Tyto Stethoscopedevice, not supplied byTytoCare, on which theproprietary TytoCareApp is running),The Tyto Server platform(composed of serverhardware not part of theTyto Stethoscope device,not supplied byTytoCare, on which theproprietary serversoftware is running).A clinician receivingplatform located in aclinical environment(e.g., a PC at the clinic,not part of the TytoStethoscope device, notsupplied by TytoCare, onwhich the proprietaryClinician App isrunning).	SE
12	Hardware andsoftwareplatforms	Android and iOS	Android and iOS	Same
13	Dimensions	2.0 x 1.7 x 1.375 inchesHeartBuds Stethoscope only	3.35 x 2.87 x 1.85 inch(85 x 73 x 47mm)	SE
14	Weight	1.44 ounces ( 41 grams)HeartBuds Stethoscope only	0.33 lbs. (0.15kg)	SE
15	Display	No Display	2.4" LCD touch screen	SE
16	Audio OutputPort	USB-C connection with audiojack adaptor provided by thephone manufacturer or only anaudio jack if the smart device.	Standard 3.5mmheadphone connector	SE
17	Audio outputmethod	Headphone or audio recording	Audio recording	SE
18	Power Output	No power output	Proprietary plug,5Vdc, 2.0A	SE
19	Frequencyrange	50 – 3000 Hz	20 - 3,500 Hz	SE
20	Audio Output	A recording playback on thesmartphone.	3.5mm standardheadphone connector	SE
21	Battery	No battery provided	Li-ion, built-in,rechargeable	SE
22	Typical Batterylife	No battery provided.	Up to 400 cycles ofcharge/discharge	SE
23	Dimensions	2.0 x 1.7 x 1.375 inchesHeartBuds Stethoscope only	1.57 x 1.53 inch (40 x39 mm)	SE
24	Weight	1.44 ounces (41 grams)HeartBuds Stethoscope only	0.13 lbs. (0.06kg)	SE
25	Operationalflows/Methodof transmittingrecording tophysician	Cloud stored and forward bythe user by email.	store-and forward flowand on-line exam flow	SE
26	OperatingEnvironment	Temp range: 5°C - 40°CHumidity range: 15%-90%(non-condensing)Pressure: 700 hPa to 1060 hPa	5° - 40°C (41° - 104°F)15 - 70% (non-condensing)700hPa to 1060hPa	SE
27	Communication	Wired	Wireless	SE
28	Connections	A wire connected to thesmartphone audio jack	Information NotAvailable in productlabeling	SE
29	Permits datatransfer ofstored digitalsignals	Yes	Yes	Same
30	Signal storage	Yes, virtually in the cloud	Yes	Same
31	Diaphragmdiameter	1.45 inch diameter	Information NotAvailable in productlabeling	Same
32	User interface	Smartphone device display	Smartphone devicedisplay	Same
33	Amplification	Amplification by the smartphone volume control	Information NotAvailable in productlabeling	Same
34	Waterproof	No	No	Same
35	Patientcontactingmaterials	Compliant with ISO 10993	Materials informationnot available;Compliant with ISO10993	Same
36	ElectricalSafety	Compliant with ANSI/AMMI60601-1 and IEC 60601-1-2	Compliant withANSI/AMMI 60601-1and 60601-1-2	Same
37	Usability	Compliant with ISO 62366	Compliant with ISO62366	Same

Substantial Equivalence Table

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Discussion of Similarities and Differences

Summary of Similar Technological Characteristics.

The HeartBuds electronic stethoscope and the predicate are both electronic stethoscopes intended for projecting the sounds associated with vibrations or sounds of the human body. Therefore, they have the same intended use and core technology,

Both the Tyto Stethoscope and the HeartBuds Stethoscope are intended to transmit the recorded auscultation sounds to a remote location where a clinician can listen to them. In addition, both these devices are indicated for use by adult lay users (i.e., adults who are not health care professionals).

As shown in the table above, the HeartBuds Stethoscope shares with its predicate device similar structural design and similar principles and mode of operation as follows:

The indications for use is similar with the subject device having fewer capabilities for data 1. collection and processing.
1. The core technology is the same, although the predicate utilizes wireless communications
The classification code is the same 3.
1. Both devices are indicated for OTC devices that can be used in the home as well as in a clinical environment.
1. Both devices are compliant with relevant safety standards (see performance data in this submission for ISO 10993, IEC 60601-1, IEC 60601-1-2 and ISO 62366)
Both devices use downloadable Apps for Android and iOS 6.
Both the HeartBuds Stethoscope and the Tyto Stethoscope record auscultation 7.
1. Both the HeartBuds Stethoscope and the Tyto Stethoscope store the recording on smart phone storage
1. Both the HeartBuds Stethoscope and the Tyto Stethoscope allow the user to share the recording
1. Both the HeartBuds Stethoscope and the Tyto Stethoscope provide a transfer of the recording to on-line applications (via email, cloud storage)

Summary of Different Technological Characteristics.

As shown in the table above, the HeartBuds Stethoscope has some differences from the predicate device. Where these differences exist, performance data is provided in this submission to demonstrate that the differences do not raise any new issues of safety or effectiveness.

The HeartBuds device has more limited capabilities than the Tyto device as listed in the table 1. above. Because there are fewer capabilities there are fewer risks associated with the correct delivery of information to the health care professional who will review the device output.
Information on the specific materials used for the predicate are not available but are ISO 10993 2. compliant. Therefore, although the materials are not the same, both are substantially equivalent in that they are both compliant with ISO 10993.

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K212906

1. The HeartBuds device is wired whereas the Tyto device is wireless so that wireless transmission protocols were not required as part of the performance data provided in this submission.
1. The software application is different in the HeartBuds and the Tyto device each using proprietary software algorithms. Details of the predicate software design are not available. However, the subject device software has been formally verified and validated according to the company's
1. Design Control process (see performance data provided in the software information sections)
1. There is no information available regarding cybersecurity protections in the predicate device. However, cybersecurity controls have been incorporated in the subject device and supporting data provided in the software information sections of this submission.

Discussion of Similarities and Differences

Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30. Successful results for the following tests are included in the submission as performance data supporting substantial equivalence:

1. Bench testing for electrical and mechanical safety in compliance with applicable standards
Software testing, consisted of verification and validation testing, including test cases related to off 2. the shelf software, as well as cybersecurity features.
Human factors testing to demonstrate usability in a simulated use environment when used by 3. health care professionals and lay users.

Based on the comparison of indication for use and technological characteristics, the subject device is substantially equivalent to the predicate device. Based on the performance data provided in the submission the differences do not introduce new issues related to safety and efficacy.

E. Performance Data

Every specification of the HeartBuds Electronic Stethoscope has been verified and validated as required by the risk analysis. All design verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.

ISO 14971	Application of risk management to medical devices
ANSI/AAMI 60601-1	Medical electrical equipment- General requirements for basic safety andessential performance
IEC 60601-1-2	Electromagnetic disturbances
IEC 62366-1	Application of usability engineering to medical devices
ISO 10993	ISO 10993 5 ed, 2018, Biological evaluation of medical devices- Part 1Evaluation and testing within a risk management process

The verification and validation testing included testing to the following applicable standards:

Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30. Successful results for the following tests were included in the submission as performance data supporting substantial equivalence:

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1. Bench testing for electrical and mechanical safety in compliance with the standards cited above.
Software testing, consisted of verification and validation testing, including test cases 2. related to off the shelf software, as well as cybersecurity features.
1. Human factors testing to demonstrate usability in a simulated use environment when used by health care professionals and lay users.

Clinical data was not required for this type of device.

F. Conclusion

Potential risks were identified according to the ISO 62366 Standards. The risks were analyzed with regard to risk/benefit category and mitigations were implemented and tested as part of the performance testing described above. All risk mitigations were satisfactorily verified and validated. Where there were technological differences from the predicate, these were shown not to result in any new issues of safety or efficacy according to the performance data submitted.

Therefore, the HeartBuds Electronic Stethoscope is substantially equivalent to the predicate device with regards to intended use and technological characteristics. Results of performance testing demonstrated that the device met the design requirements and as well as the user needs.

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.