Stethee Pro 1, Stethee Pro Software System

K193631 · M3Dicine Pty , Ltd. · DQD · Oct 9, 2020 · Cardiovascular

Device Facts

• Record ID: K193631
• Device Name: Stethee Pro 1, Stethee Pro Software System
• Applicant: M3Dicine Pty , Ltd.
• Product Code: DQD · Cardiovascular
• Decision Date: Oct 9, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended 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.

Device Story

Electronic stethoscope capturing internal body sounds via microphone; transmits audio via Bluetooth or wired AUX connection to headphones or smart devices. Stethee Pro Software System (SPS) on mobile/web platforms provides recording, playback, visualization (phonocardiograph/spectrogram), and analysis. Features include heart rate detection (30-200 BPM) and respiration rate calculation (6-50 breaths/min). Used by clinicians in clinical settings for physical assessment. SPS integrates with M3DICINE Cloud Services for data management, reporting, and sharing between authorized users. Output aids clinical decision-making by allowing longitudinal comparison of patient samples and visualization of cardiac/respiratory cycles.

Clinical Evidence

Clinical validation performed to assess performance accuracy of machine learning analysis algorithms. Respiration rate feature validated against Capnostream 35 reference device. Bench testing, software verification, and simulated validation testing also conducted. Device complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Technological Characteristics

Electronic stethoscope with microphone (-26 dBFS sensitivity, 16 kHz sampling, 16-bit). Rechargeable Li-ion polymer battery. Connectivity via Bluetooth (2.4 GHz) and wired AUX. Software-based filtering (Bell, Diaphragm, Mid-Range, Heart). Complies with IEC 60601-1, IEC 60601-1-2, and IEC 62304.

Indications for Use

Indicated for screening and diagnostic purposes in any person undergoing a physical assessment. Used for detection and amplification of heart, lung, arterial, venous, and other internal organ sounds.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Stethee Pro 1 (and Stethee App) (K172296)

Reference Devices

• Littmann® Model 3200 Electronic Stethoscope (K083903)
• Capnostream™ 35, Portable Respiratory Monitor (K150272)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] |
| | [e-mail] |
| 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.

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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.

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## Comparison to Predicate and Reference Devices:

| | Comparison of Classification, Regulation and Pro Codes | | | |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Modified Device System<br>Stethee™ Pro 1 and<br>Stethee Pro Software<br>System<br>510(k) [K193631] | Predicate Device System<br>Stethee™ Pro 1 and<br>Stethee App<br>510(k) [K172296] | Reference Device<br>Littmann® Model 3200<br>Electronic Stethoscope<br>510(k) [K083903] | Reference Device<br>Capnostream™ 35<br>Portable Respiratory<br>Monitor<br>510(k) [K150272] |
| Classification | Stethee Pro 1 Electronic<br>Stethoscope: Class II<br>Stethee Pro Software<br>System: Class II | Stethee Pro 1 Electronic<br>Stethoscope: Class II<br>Stethee App Software:<br>Class I, 510(k) exempt | Electronic Stethoscope,<br>Class II | Carbon Dioxide Gas<br>Analyzer, Class II |
| Regulation | Stethee Pro 1<br>21 CFR 870.1875(b)<br>Stethee Pro Software<br>System:<br>21 CFR 870.2910,<br>21 CFR 870.2390<br>21 CFR 868.2375 | Stethee Pro 1:<br>21 CFR 870.1875(b)<br>Stethee App:<br>21 CFR 870.2390 | 21 CFR 870.1875(b) | 21 CFR 868.1400 |
| FDA Pro Code | Primary Product Code:<br>DQD<br>Secondary Product<br>Codes: DRG, DQC, BZQ | Stethee Pro 1: DQD,<br>Stethee App: DQC | Product Code: DQD | Primary Product Code:<br>CCK<br>Secondary Product<br>Codes: DQA, MNR |
| Comparison of Intended Use/Indications for Use | | | | |
| Device | Stethee Pro 1<br>and Stethee Pro<br>Software System<br>510k TBD | Stethee Pro 1<br>and Stethee App<br>[K172296] | Reference Device<br>3M™ Littmann®<br>Model 3200<br>510(k) [K083903] | Reference Device<br>Capnostream™ 35<br>510(k) [K150272] |
| Intended Use / Indications<br>for Use | The Stethee™ Pro 1 is an<br>electronic stethoscope<br>intended for screening<br>and medical diagnostic<br>purposes only. It may be<br>used for the detection and<br>amplification of sounds<br>from the heart, lungs,<br>arteries, veins, and other<br>internal organs with or<br>without the use of<br>selective frequencies. It<br>can be used on any<br>person undergoing a<br>physical assessment.<br><br>Stethee Pro 1 is intended<br>for use with the Stethee<br>Pro Software System,<br>whose features enable<br>recording, playback, vis<br>ualization, analysis,<br>management and<br>reporting of patient<br>samples, and sharing this<br>data with other<br>authorized users. | The Stethee™ Pro 1 is an<br>electronic stethoscope<br>intended for medical<br>diagnostic purposes only.<br>It may be used for the<br>detection and<br>amplification of sounds<br>from the heart, lungs,<br>arteries, veins, and other<br>internal organs. It can be<br>used on any person<br>undergoing a physical<br>assessment. | The 3M™ Littmann®<br>Electronic Stethoscope,<br>Model 3200 is intended<br>for medical diagnostic<br>purposes only. It may be<br>used for the detection and<br>amplification of sounds<br>from the heart, lungs,<br>arteries, veins, and other<br>internal organs with the<br>use of a selective<br>frequency. It can be used<br>on any person undergoing<br>a physical assessment. | The Capnostream™ 35 is a portable<br>capnograph/pulse<br>oximeter, intended to<br>provide professionally<br>trained health care<br>providers with<br>continuous non-<br>invasive monitoring of<br>carbon dioxide<br>concentration of the<br>expired and inspired<br>breath, respiration<br>rate, arterial oxygen<br>saturation (SpO2) and<br>pulse rate of adult,<br>pediatric, and neonatal<br>patients. The pulse<br>oximeter is intended<br>for use during both no<br>motion and motion<br>conditions and for<br>patients who are well<br>or poorly perfused.<br>The Capnostream™35<br>also provides the<br>clinician with<br>integrated pulmonary<br>index (IPI), apnea per<br>hour (A/hr) and<br>oxygen desaturation<br>index (ODI) values.<br>IPI is intended for<br>pediatric and adult<br>patients only. A/hr and<br>ODI are intended for<br>age 22 and up.<br>The device is intended<br>for use in hospitals,<br>hospital-type facilities,<br>during intra-hospital<br>transport, and out-of-<br>hospital Emergency<br>Medical Service<br>applications that<br>include ground and air<br>transport. |
| Contraindications | None | None | None | None |

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# MEDICINE

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

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

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

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

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19 Aug 2020

K193631

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| | Comparison of Technical Principles of Operation and Features (Continued) | | | | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------|------------------------------------------------------------------------|
| Feature | Stethee Pro 1 (SP1)<br>and Stethee Pro Software System<br>(SPS) | Stethee Pro 1<br>and Stethee App | Comments Regarding<br>SE comparison of<br>SP1/SPS System<br>[K193631]<br>to<br>SP1/Stethee App<br>[K172296] | Reference Device<br>Littmann®<br>Model 3200 | Reference Device<br>Capnostream™ 35<br>Portable Respiratory<br>Monitor |
| Geolocation | 510(k) K193631<br><br>SPS Applications allow user to<br>collect/identify the geolocation<br>where and environmental<br>conditions when patient sample<br>was collected. | 510(k) [K172296] | New Feature | 510(k) [K083903] | 510(k) [K150272] |
| Sample Comparison | Patient Sample analysis (heart rate,<br>systole duration, diastole duration)<br>can be compared with those of the<br>previous sample or the averaged of<br>those parameters for all the<br>samples collected from the patient.<br>This allows the user to see how<br>patient condition has changed over<br>time. | Not Applicable | New Feature of Sample<br>Comparison Analysis | Not Applicable | Not Applicable |
| Data Sharing | Healthcare professional can share<br>patient files with another<br>authorized HCP through Stethee<br>Pro Cloud Services. | Not Applicable | New Feature of Data<br>Sharing | Not Applicable | Not Applicable |
| Report Generation | Users can generate patient reports<br>using Stethee Pro Software System<br>features | Not Applicable | New Feature of Report<br>Generation | Not Applicable | Not Applicable |
| Web Portal to Access<br>Recorded Data | Stethee Pro Central Web<br>Application provides patient<br>management features, sample<br>management features, dashboard,<br>visualization and display of heart<br>analytics and respiration rate. | Not Applicable | New platform for<br>accessing data stored on<br>Stethee Pro Cloud Services | Not Applicable | Not Applicable |

K193631

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| V | 1 |
|------------------|---|
| -<br>l<br>C<br>- | |
| C | |
| 1 | |
| | A |

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

19 Aug 2020

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# 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).

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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].