Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The summary explicitly mentions "machine learning analysis algorithms" and "clinical validation of the performance accuracy of the device's machine learning analysis algorithms".

Therapeutic

No
The device is described as an electronic stethoscope for screening and medical diagnostic purposes, focusing on detection and amplification of sounds, not on treating or restoring health.

Diagnostic

Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for screening and medical diagnostic purposes only."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Stethee Pro 1 "consists of hardware and embedded software" and describes hardware components like sound capture, digital signal processing, volume control, haptic feedback, LED display, and wireless data transfer. While it interacts with software systems, the core medical device itself includes hardware.

IVD (In Vitro Diagnostic)

Based on the provided text, the Stethee™ Pro 1 is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Stethee Pro 1 Function: The Stethee Pro 1 is an electronic stethoscope that detects and amplifies sounds from within the body (heart, lungs, etc.). It does not analyze specimens taken from the body.
Intended Use: The intended use clearly states it's for "screening and medical diagnostic purposes only" by detecting and amplifying internal body sounds.

While the device uses software for analysis and management of the collected sounds, the core function of the device itself is not based on analyzing biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

No
The provided text does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is marked "Not Found," indicating the absence of such language.

Overview

Intended Use / Indications for Use

The Stethee™ Pro 1 is an electronic stethoscope intended for screening and medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective frequencies. It can be used on any person undergoing a physical assessment.

Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable recording, playback, visualization, analysis, management and reporting of patient samples, and sharing this data with other authorized users.

Product codes

DQD, DRG, DQC, BZQ

Device Description

The Stethee Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment.

The Stethee Pro 1 consists of hardware and embedded software which controls all of the various features found in the device, such as sound capture, digital signal processing, volume control, haptic feedback for user, LED display ring, and wireless data transfer (via Bluetooth®). No patient data is stored on the Stethee Pro 1 device itself.

After amplification and filtering of the sounds detected, Stethee Pro 1 transfers the sounds to the User's ears via any Bluetooth® connected headphones, or by wired headphones connected to Stethee Pro 1 using an AUX adaptor at the device's USB port.

The Stethee Pro 1 also includes features that permit it to stream sounds to a peripheral smart device (e.g., mobile phone) as an audio buffer to a smart device (iOS or Android) via a Bluetooth® connection. The audio buffer is handled on the smart device by a separate standalone software application called the Stethee Pro Software System.

Stethee Pro Software System (SPS) is a series of software applications (Stethee Pro Mobile Applications and the Stethee Pro Central Web Application) that work with the Stethee Pro 1 electronic stethoscope. Stethee Pro Software System is supported by M3DICINE's proprietary software platform M3DICINE Cloud Services (MCS) which provides various services including database, security, and core business logic services so that services for data sharing and multiple sign-ins from multiple devices can be implemented.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

"...successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices, as identified in the summary comparison tables above, with documentation submitted in this 510(k)."

Input Imaging Modality

Not Found

Anatomical Site

Heart, lungs, arteries, veins, and other internal organs

Indicated Patient Age Range

"any person"

Intended User / Care Setting

Prescription Use, Healthcare professional

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)

M3DICINE submitted performance testing information in this 510(k) demonstrating that the Stethee Pro 1 and the companion stand-alone Stethee Pro Software System both perform as intended.

Performance testing included bench testing and software verification and software simulated validation testing. Additionally, successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices, as identified in the summary comparison tables above, with documentation submitted in this 510(k).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Heart Rate: 30-200 BPM with an allowable readout error rate of no greater than ±10 % (i.e., 10% consistency) of the input rate or ±5 bpm, whichever is less.
Respiration Rate: 6 - 50 breaths per minute ±1 breath per min.

Predicate Device(s)

K172296

Reference Device(s)

K083903, K150272

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

October 9, 2020

M3DICINE Pty Ltd. % Ginger Cantor Founder/Principal Consultant Centaur Consulting LLC W9281 710th Avenue River Falls, Wisconsin 54022

Re: K193631

Trade/Device Name: Stethee Pro 1 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD, DRG, DQC, BZQ Dated: December 24, 2019 Received: December 27, 2019

Dear Ginger Cantor:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 (OS) 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 mediation-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,

LT 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) K193631

Device Name Stethee Pro 1

Indications for Use (Describe)

The Stethee™ Pro 1 is an electronic stethoscope intended for screening and medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective frequencies. It can be used on any person undergoing a physical assessment.

Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable recording, playback, visualization, analysis, management and reporting of patient samples, and sharing this data with other authorized users.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

MEDICINE

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

510(k) Submitter	M3DICINE Pty Ltd.
	Level 1, 88 Brandl Street
	Eight Mile Plains QLD 4113
	AUSTRALIA
Contact Person	Ginger Cantor, RAC
	Centaur Consulting, LLC
	Phone: (715) 307-1850
	centaurconsultingllc@gmail.com
Date Summary
Prepared:	August 19, 2020
Trade Name:	Stethee™ Pro 1 System
	(Stethee™ Pro 1 with Stethee Pro Software System)
Classification Name:	Electronic Stethoscope
	Regulation Number: 21 CFR §870.1875(b)
Primary Product Code:	DQD
	Secondary Product Codes: DQC, DRG, BZQ
Classification Panel:	Cardiovascular
Device Classification:	Class II

Intended Use/Indications for Use

The M3DICINE Stethee™ Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment.

Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable sample recording, playback, visualization, analysis, reporting and sharing with other authorized users.

4

K193631

MEDICINE

Predicate Device:

Stethee Pro 1 (and Stethee App) [K172296]

Reference Devices:

Littmann® Model 3200 Electronic Stethoscope [K083903] Capnostream™ 35, Portable Respiratory Monitor [K150272]

Description of Device:

Stethee Pro 1:

The Stethee Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment.

The Stethee Pro 1 consists of hardware and embedded software which controls all of the various features found in the device, such as sound capture, digital signal processing, volume control, haptic feedback for user, LED display ring, and wireless data transfer (via Bluetooth®). No patient data is stored on the Stethee Pro 1 device itself.

After amplification and filtering of the sounds detected, Stethee Pro 1 transfers the sounds to the User's ears via any Bluetooth® connected headphones, or by wired headphones connected to Stethee Pro 1 using an AUX adaptor at the device's USB port.

The Stethee Pro 1 also includes features that permit it to stream sounds to a peripheral smart device (e.g., mobile phone) as an audio buffer to a smart device (iOS or Android) via a Bluetooth® connection. The audio buffer is handled on the smart device by a separate standalone software application called the Stethee Pro Software System.

Stethee Pro Software System:

Stethee Pro Software System (SPS) is a series of software applications (Stethee Pro Mobile Applications and the Stethee Pro Central Web Application) that work with the Stethee Pro 1 electronic stethoscope. Stethee Pro Software System is supported by M3DICINE's proprietary software platform M3DICINE Cloud Services (MCS) which provides various services including database, security, and core business logic services so that services for data sharing and multiple sign-ins from multiple devices can be implemented.

5

Comparison to Predicate and Reference Devices:

	Comparison of Classification, Regulation and Pro Codes
	Modified Device System
Stethee™ Pro 1 and
Stethee Pro Software
System
510(k) [K193631]	Predicate Device System
Stethee™ Pro 1 and
Stethee App
510(k) [K172296]	Reference Device
Littmann® Model 3200
Electronic Stethoscope
510(k) [K083903]	Reference Device
Capnostream™ 35
Portable Respiratory
Monitor
510(k) [K150272]
Classification	Stethee Pro 1 Electronic
Stethoscope: Class II
Stethee Pro Software
System: Class II	Stethee Pro 1 Electronic
Stethoscope: Class II
Stethee App Software:
Class I, 510(k) exempt	Electronic Stethoscope,
Class II	Carbon Dioxide Gas
Analyzer, Class II
Regulation	Stethee Pro 1
21 CFR 870.1875(b)
Stethee Pro Software
System:
21 CFR 870.2910,
21 CFR 870.2390
21 CFR 868.2375	Stethee Pro 1:
21 CFR 870.1875(b)
Stethee App:
21 CFR 870.2390	21 CFR 870.1875(b)	21 CFR 868.1400
FDA Pro Code	Primary Product Code:
DQD
Secondary Product
Codes: DRG, DQC, BZQ	Stethee Pro 1: DQD,
Stethee App: DQC	Product Code: DQD	Primary Product Code:
CCK
Secondary Product
Codes: DQA, MNR
Comparison of Intended Use/Indications for Use
Device	Stethee Pro 1
and Stethee Pro
Software System
510k TBD	Stethee Pro 1
and Stethee App
[K172296]	Reference Device
3M™ Littmann®
Model 3200
510(k) [K083903]	Reference Device
Capnostream™ 35
510(k) [K150272]
Intended Use / Indications
for Use	The Stethee™ Pro 1 is an
electronic stethoscope
intended for screening
and medical diagnostic
purposes only. It may be
used for the detection and
amplification of sounds
from the heart, lungs,
arteries, veins, and other
internal organs with or
without the use of
selective frequencies. It
can be used on any
person undergoing a
physical assessment.

Stethee Pro 1 is intended
for use with the Stethee
Pro Software System,
whose features enable
recording, playback, vis
ualization, analysis,
management and
reporting of patient
samples, and sharing this
data with other
authorized users. | The Stethee™ Pro 1 is an
electronic stethoscope
intended for medical
diagnostic purposes only.
It may be used for the
detection and
amplification of sounds
from the heart, lungs,
arteries, veins, and other
internal organs. It can be
used on any person
undergoing a physical
assessment. | The 3M™ Littmann®
Electronic Stethoscope,
Model 3200 is intended
for medical diagnostic
purposes only. It may be
used for the detection and
amplification of sounds
from the heart, lungs,
arteries, veins, and other
internal organs with the
use of a selective
frequency. It can be used
on any person undergoing
a physical assessment. | The Capnostream™ 35 is a portable
capnograph/pulse
oximeter, intended to
provide professionally
trained health care
providers with
continuous non-
invasive monitoring of
carbon dioxide
concentration of the
expired and inspired
breath, respiration
rate, arterial oxygen
saturation (SpO2) and
pulse rate of adult,
pediatric, and neonatal
patients. The pulse
oximeter is intended
for use during both no
motion and motion
conditions and for
patients who are well
or poorly perfused.
The Capnostream™35
also provides the
clinician with
integrated pulmonary
index (IPI), apnea per
hour (A/hr) and
oxygen desaturation
index (ODI) values.
IPI is intended for
pediatric and adult
patients only. A/hr and
ODI are intended for
age 22 and up.
The device is intended
for use in hospitals,
hospital-type facilities,
during intra-hospital
transport, and out-of-
hospital Emergency
Medical Service
applications that
include ground and air
transport. |
| Contraindications | None | None | None | None |

6

MEDICINE

7

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| Feature | Stethee Pro 1
and Stethee Pro Software System | Stethee Pro 1
and Stethee App | Comments Regarding
SE comparison of
SP1/SPS System [K193631] | Reference Device
Littmann®
Model 3200 | Reference Device
Capnostream™ 35 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------|
| | 510k [K193631] | [K172296] | To
SP1/Stethee App [K172296] | 510(k) [K083903] | 510(k) [K150272] |
| Pickup Sensor and
Processing | Microphone
(-26 dBFS sensitivity)
Sampling Rate: 16 kHz
Bit Rate: 16 bits | Microphone
(-22 dB sensitivity)
Sampling Rate: 16 kHz
Bit Rate: 16 bits | Substantially Equivalent | Piezoelectric sensor
Sampling Rate: 4 kHz
Bit Rate: 16 bits | Not Applicable |
| Frequency Response | Responsive from 20-2000 Hz
(Extended Mode (Default))
Bell (20-1000 Hz)
Diaphragm (100-500 Hz)
Mid-Range (50-500 Hz)
Heart (20-150Hz) | Responsive from 20-2000 Hz | SP1 Extended Mode [K193631] is
same as default filter described in
[K172296]
Bell: a filter amplifies 20-1000 Hz
with emphasis at 20-200 Hz
Diaphragm: a filter amplifies from
20-2000 Hz with emphasis at 100-
500 Hz
Mid-Range filter amplifies 20-2000
Hz with emphasis of low frequency
sounds of 50-500Hz
Heart: a filter that amplifies 20-500
Hz with emphasis from 20-150 Hz | Bell (20-1000 Hz)
Diaphragm (20-2000 Hz)
"Extended Range" (20-2000
Hz) | Not Applicable |
| Maximum Sound
Level | Amplifies up to 24X on the Stethee
Pro 1 device | Amplifies up to 24X on the
Stethee Pro 1 device | Same | Amplifies up to 24X | Not Applicable |
| Volume Control | Yes, in 8 steps | Yes, in 8 steps | Same | Yes, in 8 steps | Not Applicable |
| Power Source | Rechargeable Lithium-ion polymer
battery | Rechargeable Lithium-ion
polymer battery | Same | Single AA, NiMH
(rechargeable) or Lithium
batteries may be used | Not Applicable |
| Low Battery
Indicator | Yes | Yes | Same | Yes | Not Applicable |
| Operating Controls
and Indicators | ON/OFF features by electronics.
LEDs on device indicate devices
status (ON/OFF, charging,
Bluetooth® synchronization). | ON/OFF features by
electronics.
LEDs on device indicate
devices status (ON/OFF,
charging, Bluetooth®
synchronization). | Same | ON/OFF features by
electronics.
LCD display on device
indicates device status. | Not Applicable |

Stethee Pro 1/Stethee Pro Software System 510(k) Summar

Page 5 of 11 19 Aug 2020

8

œ

| Feature | Stethee Pro 1 (SP1)
and Stethee Pro Software System
(SPS) | Stethee Pro 1
and Stethee App | Comments Regarding
SE comparison of
SP1/SPS System [K193631]
to
SP1/Stethee App [K172296] | Reference Device
Littmann®
Model 3200 | Reference Device
Capnostream™ 35
Portable Respiratory
Monitor |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) K193631 | 510(k) [K172296] | | 510(k) [K083903] | 510(k) [K150272] |
| Direct Listening | Stethee Pro 1 sounds can be
listened to in real time using a
Bluetooth® enabled headset or a
wired headset. | Stethee Pro 1 sounds can be
listened to in real time using a
Bluetooth® enabled headset. | New Feature – device can
accommodate direct listening by
use of a wired headset connected
through USB port | Littmann® Model 3200
allows direct listening to
sounds in real time through
the device's attached
binaurals. | Not Applicable |
| Recording and
Playback | Not on the Stethee Pro 1 device
itself, but with use of companion
Stethee Pro Software System | Not on the Stethee Pro 1
device itself, but with use of
companion Stethee App | Substantially Equivalent | Yes – stores twelve (12) 30
second tracks on device | Not Applicable |
| Wireless Technology
and Peripheral
Platform
Compatibility | Yes– uses Bluetooth® at 2.4 GHz
Compatible with Android and iOS
devices | Yes - uses Bluetooth® at 2.4
GHz
Compatible with Android and
iOS devices | Same | Yes - uses Bluetooth® at 2.4
GHz,
Compatible with Android
devices, not compatible with
iOS devices*. (Littmann®
web page states it is not
compatible with Apple
devices. | Not Applicable
Device has wireless
features but comparison as
reference device not
performed. |
| Ambient and
Frictional Noise
Reduction | Yes | Yes | Same | Yes | Not Applicable |
| Heart Rate:
Detection and
Display | Yes -using companion Stethee Pro
Software System | Yes -using companion
Stethee™ App (a MMA). | Same | Yes - displayed on the
Littmann® Model 3200
integrated LCD. | Not Applicable |
| Heart Rate:
Minimum Audio
Sample
Requirements | Requires minimum initial 5 second
recording. | Requires minimum initial 5
second recording. | Same | Requires initial 5 second
recording. | Not Applicable |
| Feature | Stethee Pro 1 (SP1)
and Stethee Pro Software System
(SPS)
510(k) K193631 | Stethee Pro 1
and Stethee App
510(k) [K172296] | Comments Regarding
SE comparison of
SP1/SPS System
[K193631]
to
SP1/Stethee App
[K172296] | Reference Device
Littmann®
Model 3200
510(k) [K083903] | Reference Device
Capnostream™ 35
Portable Respiratory
Monitor
510(k) [K150272] |
| Heart Rate:
Methodology | Performs continuous real-time
calculation after initial sampling
and updates heart rate display after
each heartbeat | Performs continuous real-time calculation
after initial sampling and updates heart rate
display after each heartbeat | Same | The heart rate is updated
every 2 seconds after the
initial 5 second sampling. | Not Applicable |
| Heart Rate:
Range of Detection
and Accuracy | 30-200 BPM with an allowable
readout error rate of no greater than
$±10 %$ (i.e., 10% consistency) of
the input rate or $±5$ bpm,
whichever is less. | 30-200 BPM with an allowable readout error
rate of no greater than $±10 %$ (i.e., 10%
consistency) of the input rate or $±5$ bpm,
whichever is less | Same | 30-199 BPM with an
allowable readout error rate
of no greater than $±10 %$ (i.e.,
10% consistency) of the input
rate. | Not Applicable |
| Visualization Modes | Sounds can be visualized as
phonocardiograph (PCG) and/or
Spectrogram using companion
software Stethee Pro Software
System | Sounds can be visualized as
phonocardiograph (PCG) using companion
software Stethee™ App | New Feature of
Spectrogram Visualization | Sounds can be visualized as
phonocardiograph using
software StethAssist™. | Not Applicable |
| Heart Cycle Duration
Display | Individual and average systole and
diastole duration (milliseconds)
calculated from PCG displayed
linearly and as Aida Cycle (a
circular representation of PCG) | Not Applicable | | Note: Littmann Model 3200
System serves as Reference
PCG, but it does not calculate
and display to user the systole
and diastole durations from
its PCG. | Not Applicable |
| Heart Rate- Handling
of Inconsistent
Sounds | Inconsistent sounds displayed on
Stethee Pro Mobile Applications
and Stethee Pro Central Web App
GUI as "--". | Inconsistent sounds displayed on Stethee
App GUI as "--". | Same analysis, handling
and display feature, now
extended to new Stethee
Pro Central Web as
interface (part of SPS) | Inconsistent sounds displayed
on Littmann® Model 3200
LCD screen as "--". | Not Applicable |
| Respiration Rate | Companion apps in the Stethee Pro
Software accurately calculate and
display respiration rates in
respirations per minute for a
clinically validated range of 6 - 50
breaths per minute $±1$ breath per
min. | Not Applicable | New Feature -
The Respiration Rate
feature was clinically
validated against the
Reference Device
Capnostream 35. | Not Applicable | Capnostream™ 35
monitors and displays
patient's respiration rate
over a range of 0-150
breaths per minute (bpm)
with the following claimed
accuracy:
0-70 bpm: $±1$ bpm
71-120 bpm: $±2$ bpm
121-150 bpm: $±3$ bpm |

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tethee Pro 1/Stethee Pro Software System 510(k) Summar

Page 7 of 11

19 Aug 2020

K193631

10

1
	O

I

	Comparison of Technical Principles of Operation and Features (Continued)
Feature	Stethee Pro 1 (SP1)
and Stethee Pro Software System
(SPS)	Stethee Pro 1
and Stethee App	Comments Regarding
SE comparison of
SP1/SPS System
[K193631]
to
SP1/Stethee App
[K172296]	Reference Device
Littmann®
Model 3200	Reference Device
Capnostream™ 35
Portable Respiratory
Monitor
Geolocation	510(k) K193631

SPS Applications allow user to
collect/identify the geolocation
where and environmental
conditions when patient sample
was collected. | 510(k) [K172296] | New Feature | 510(k) [K083903] | 510(k) [K150272] |
| Sample Comparison | Patient Sample analysis (heart rate,
systole duration, diastole duration)
can be compared with those of the
previous sample or the averaged of
those parameters for all the
samples collected from the patient.
This allows the user to see how
patient condition has changed over
time. | Not Applicable | New Feature of Sample
Comparison Analysis | Not Applicable | Not Applicable |
| Data Sharing | Healthcare professional can share
patient files with another
authorized HCP through Stethee
Pro Cloud Services. | Not Applicable | New Feature of Data
Sharing | Not Applicable | Not Applicable |
| Report Generation | Users can generate patient reports
using Stethee Pro Software System
features | Not Applicable | New Feature of Report
Generation | Not Applicable | Not Applicable |
| Web Portal to Access
Recorded Data | Stethee Pro Central Web
Application provides patient
management features, sample
management features, dashboard,
visualization and display of heart
analytics and respiration rate. | Not Applicable | New platform for
accessing data stored on
Stethee Pro Cloud Services | Not Applicable | Not Applicable |

K193631

11

V	1
-
l
C

| |
| C | |
| 1 | |
| | A |

Comparison of Technical Principles of Operation and Features (Continued)
Feature	Stethee Pro 1 (SP1)
and Stethee Pro Software System
(SPS)	Stethee Pro 1
and Stethee App	Comments Regarding
SE comparison of
SP1/SPS System [K193631]
to
SP1/Stethee App [K172296]	Reference Device
Littmann®
Model 3200	Reference Device
Capnostream™ 35
Portable Respiratory
Monitor
510(k)	510(k) K193631	510(k) [K172296]	New Feature - Stethee Pro
Quick Settings	510(k) [K083903]	510(k) [K150272]
Control of Stethee
Pro 1 Features	Stethee Pro Mobile Applications
provides user the ability to
monitor, and configure Stethee Pro
1 settings: including: battery level,
firmware version, filters, heartbeat
locator	Not Applicable	Not Applicable	Not Applicable	Not Applicable
Android Application	Stethee Android Application's
patient management features,
sample management features,
analysis heart sound visualization
and displaying of heart analytics
and respiration rate.	Not Applicable	New platform for accessing data
for the Stethee Pro Cloud
Services; system now supports
Android as well as iOS devices.	Compatible with Android devices.	Not Applicable
				Not Applicable	Not Applicable

19 Aug 2020

12

MEDICINE

Performance Testing

M3DICINE submitted performance testing information in this 510(k) demonstrating that the Stethee Pro 1 and the companion stand-alone Stethee Pro Software System both perform as intended.

Performance testing included bench testing and software verification and software simulated validation testing. Additionally, successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices, as identified in the summary comparison tables above, with documentation submitted in this 510(k).

Safety, Electromagnetic Compatibility (EMC) and Coexistence Compliance

M3DICINE submitted information demonstrating the Stethee Pro 1 complied with the requirements of IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (2012 Reprint; Ed. 3.1) as translated into the US national version (AAMI ES60601-1:2005 +A1).

M3DICINE also submitted information demonstrating the Stethee Pro 1 fully complies with the international standard IEC 60601-1-2:2014, Medical Electrical Equipment –Part 1: General Requirements for Safety: Collateral Standard: Electromagnetic Compatibility Requirements and Tests (Ed. 4.0).

In addition to general safety and EMC testing, M3DICINE has successfully addressed FDA's requirements for wireless coexistence testing of the Stethee™ Pro 1.

Software Testing and Standards Compliance

M3DICINE submitted software verification and validation information and documentation required for the Stethee Pro 1 and the Stethee Pro Software System under FDA's Guidance Content of Premarket Submission for Software Contained in Medical Devices (May 11, 2005). M3DICINE is compliant with the requirements of IEC 62304:2015, Medical Device Software -Software Life Cycle Processes.

Animal Testing

No animal testing was submitted in this 510(k).

13

Image /page/13/Picture/1 description: The image shows the word "MEDICINE" in a simple, sans-serif font. The letters are all capitalized and evenly spaced. The color of the text is a muted gray, and the background is white. The "E" in medicine is stylized with three horizontal lines.

Conclusion

M3DICINE's evaluation of substantial equivalence was based on comparison of the Stethee Pro 1 (with companion stand-alone Stethee Pro Software System) to the predicate Stethee Pro 1 and companion stand-alone software Stethee Pro App cleared under [K172296]. Successful clinical validation was performed against the identified References Devices. The comparison was related to device classification, intended use/indications for use, contraindications, and technical features and operating characteristics.

Based on this comparison, M3DICINE concludes that Stethee Pro 1 and Stethee Pro Software System is substantially equivalent to the predicate Stethee Pro 1 and companion stand-alone software Stethee Pro App cleared under [K172296].