(547 days)
Not Found
No
The document describes a device for recording and transmitting auscultation sounds, but there is no mention of AI or ML being used for analysis, interpretation, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as being for "medical diagnostics purposes only" and is intended to "auscultate heart and lung sounds" and "record heart and lung internal auscultation." It facilitates remote examination by allowing sound data transmission, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device is for medical diagnostics purposes only."
No
The device description explicitly states that the system includes a "hand-held device with integral plastic sound diaphragm" and an "Electronic Stethoscope" component, which are hardware components.
Based on the provided information, the HeartBuds Stethoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- HeartBuds Function: The HeartBuds Stethoscope is used for auscultation, which is the act of listening to internal sounds of the body, primarily the heart and lungs, using a stethoscope. This is a non-invasive method of physical examination.
- Specimen Analysis: The HeartBuds Stethoscope does not analyze any specimens derived from the human body (like blood, tissue, or urine). It captures and transmits sound data from within the body.
Therefore, the HeartBuds Stethoscope falls under the category of a medical device used for physical examination and remote auscultation, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
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 self-diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
DOD
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, Lungs
Indicated Patient Age Range
Adult users (not specified numerically, but inferred from "adult lay users")
Intended User / Care Setting
Professional users in a clinical environment or by non medical professional adult users in a non 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)
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:
-
- 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.
Clinical data was not required for this type of device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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
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,
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
2
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)
| 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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3
HeartBuds Electronic Stethoscope K212906 510(k) Summary Prepared August 11 2022
| Sponsor: | HeartBuds LLC
711 London Road
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
4
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
Stethoscope
(K181612) | Substantially
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
Code(s) | DQD | DQD | Same |
| 6 | 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 lay users in
a nonclinical environment.
The device is for medical
diagnostics purposes only. The
device is not intended for self-
diagnosis. | The Tyto Stethoscope
is an electronic
stethoscope that
enables transmission of
auscultation sound
data, whereby a
clinician at one
location on an IP
network can listen to
the auscultation sounds
of a patient on site or
at a different location
on the IP network with
the signal carried on an
IP connection between
the two locations. The
Tyto Stethoscope is
intended to be used by
professional users in a | SE |
| | | | clinical environment or
by lay users in a
nonclinical
environment. The
device is for medical
diagnostics purposes
only. The device is not
intended for self-
diagnosis. | |
| 7 | Device
Description | The HeartBuds Stethoscope
when connected to the
HeartBuds App, captures
sounds by the HeartBuds
Stethoscope which can be
recorded by the App and
stored to the cloud for future
use. The HeartBuds mobile
application on the smartphone
records those sounds as an
audio recording to be stored
and if desired by the user to be
shared with a healthcare
provider. The HeartBuds App
requires a user to register and
create a secure login in order
to provide a means to associate
the recordings to each
individual user and to be
stored in the cloud (Google
application Firebase). The
HeartBuds App provides the
capability to start and stop
recording at the user's
discretion. The HeartBuds
App also provides the
capability for the user to
sample the sounds received
from the HeartBuds
Stethoscope before starting a
recording. This provides a
means for the user to either
change the position of the
Stethoscope to ensure the
recording includes sounds of
the heart or lung. The user
stops the recording, the
HeartBuds App names the file
to facilitate future
identification (both the user
and a specific anatomical
location) and loads it to the | The Tyto Stethoscope
(OTC) is designed for
use by professional as
well as lay users in
clinical or non-clinical
environments. It
enables four types of
stethoscope exams:
Heart, Lungs, Heart
Rate and Audio (Audio
is for clinician only).
The operation process
of the Tyto
Stethoscope uses four
(4) primary functional
elements: (1) The Tyto
Stethoscope
(composed of a
Stethoscope Tip and a
Base Unit - Tyto
Device and supported
with proprietary
software). (2) A
mobile device (e.g., a
smartphone, not part of
the Tyto Stethoscope
device, not supplied by
TytoCare, on which
the proprietary
TytoCare App is
running), (3) The Tyto
Server platform
(composed of server
hardware not part of
the Tyto Stethoscope
device, not supplied by
TytoCare, on which
the proprietary server
software is running).
(4) A clinician
receiving platform
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 | |
| | | | 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 care
professionals) | nonclinical | |
| | | | environments | |
| 9 | Intended Use
Environments | clinical or non-clinical
environments | clinical or non-clinical
environments | Same |
| 10 | Types of
stethoscope
exams | Heart, Lungs, and Audio | Heart, Lungs, Heart
Rate and Audio | SE |
| 11 | Functional
elements | stethoscope
A mobile device (e.g., a
smartphone, not part of the
HeartBuds Stethoscope device.
not supplied by HeartBuds, on which the proprietary
HeartBuds App is running), | stethoscope
a mobile device (e.g., a
smartphone, not part of
the Tyto Stethoscope
device, not supplied by
TytoCare, on which the
proprietary TytoCare
App is running),
The Tyto Server platform
(composed of server
hardware not part of the
Tyto Stethoscope device,
not supplied by
TytoCare, on which the
proprietary server
software is running).
A clinician receiving
platform located in a
clinical environment
(e.g., a PC at the clinic,
not part of the Tyto
Stethoscope device, not
supplied by TytoCare, on
which the proprietary
Clinician App is
running). | SE |
| 12 | Hardware and
software
platforms | Android and iOS | Android and iOS | Same |
| 13 | Dimensions | 2.0 x 1.7 x 1.375 inches
HeartBuds 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 Output
Port | USB-C connection with audio
jack adaptor provided by the
phone manufacturer or only an
audio jack if the smart device. | Standard 3.5mm
headphone connector | SE |
| 17 | Audio output
method | Headphone or audio recording | Audio recording | SE |
| 18 | Power Output | No power output | Proprietary plug,
5Vdc, 2.0A | SE |
| 19 | Frequency
range | 50 – 3000 Hz | 20 - 3,500 Hz | SE |
| 20 | Audio Output | A recording playback on the
smartphone. | 3.5mm standard
headphone connector | SE |
| 21 | Battery | No battery provided | Li-ion, built-in,
rechargeable | SE |
| 22 | Typical Battery
life | No battery provided. | Up to 400 cycles of
charge/discharge | SE |
| 23 | Dimensions | 2.0 x 1.7 x 1.375 inches
HeartBuds Stethoscope only | 1.57 x 1.53 inch (40 x
39 mm) | SE |
| 24 | Weight | 1.44 ounces (41 grams)
HeartBuds Stethoscope only | 0.13 lbs. (0.06kg) | SE |
| 25 | Operational
flows/Method
of transmitting
recording to
physician | Cloud stored and forward by
the user by email. | store-and forward flow
and on-line exam flow | SE |
| 26 | Operating
Environment | Temp range: 5°C - 40°C
Humidity 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 the
smartphone audio jack | Information Not
Available in product
labeling | SE |
| 29 | Permits data
transfer of
stored digital
signals | Yes | Yes | Same |
| 30 | Signal storage | Yes, virtually in the cloud | Yes | Same |
| 31 | Diaphragm
diameter | 1.45 inch diameter | Information Not
Available in product
labeling | Same |
| 32 | User interface | Smartphone device display | Smartphone device
display | Same |
| 33 | Amplification | Amplification by the smart
phone volume control | Information Not
Available in product
labeling | Same |
| 34 | Waterproof | No | No | Same |
| 35 | Patient
contacting
materials | Compliant with ISO 10993 | Materials information
not available;
Compliant with ISO
10993 | Same |
| 36 | Electrical
Safety | Compliant with ANSI/AMMI
60601-1 and IEC 60601-1-2 | Compliant with
ANSI/AMMI 60601-1
and 60601-1-2 | Same |
| 37 | Usability | Compliant with ISO 62366 | Compliant with ISO
62366 | Same |
Substantial Equivalence Table
5
6
7
8
9
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.
-
- The core technology is the same, although the predicate utilizes wireless communications
- The classification code is the same 3.
-
- Both devices are indicated for OTC devices that can be used in the home as well as in a clinical environment.
-
- 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.
-
- Both the HeartBuds Stethoscope and the Tyto Stethoscope store the recording on smart phone storage
-
- Both the HeartBuds Stethoscope and the Tyto Stethoscope allow the user to share the recording
-
- 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.
10
K212906
-
- 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.
-
- 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
-
- Design Control process (see performance data provided in the software information sections)
-
- 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:
-
- 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 and |
| essential 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 1 |
| Evaluation 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:
11
-
- 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.
-
- 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.