(287 days)
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.
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.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the typical format of an AI/ML medical device submission. The document is a 510(k) summary for the Stethee Pro 1, an electronic stethoscope, and its accompanying software system.
It primarily focuses on demonstrating substantial equivalence to a predicate device (Stethee Pro 1 and Stethee App [K172296]) and outlining the device's features, intended use, and general compliance with medical device standards. While it mentions "successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices," it does not elaborate on the specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications for this validation.
Therefore, I cannot fully complete the requested table and answer all questions directly from the provided text. However, I can extract what is implied or mentioned in general terms:
Inferred Information from the Document:
The acceptance criteria are implicitly related to the performance accuracy of features like "Heart Rate: Detection and Display" and "Respiration Rate" as validated against "Reference Device Capnostream 35."
Here's an attempt to structure the available information, with acknowledges of missing details:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied / From Reference Device) | Reported Device Performance (as stated for Stethee Pro 1 / SPS) |
|---|---|---|
| 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 (as per predicate device [K172296]). | 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. (States "Same" as predicate) |
| Respiration Rate | Clinically validated range of 6 - 50 breaths per minute with an accuracy of ±1 breath per min (against Capnostream™ 35 which has 0-70 bpm: ±1 bpm, 71-120 bpm: ±2 bpm, 121-150 bpm: ±3 bpm). | 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. |
| Acoustic Performance (Pickup Sensor, Frequency Response, Max Sound Level, Volume Control) | Substantially Equivalent to predicate ([K172296]) which has: Microphone (-22 dB sensitivity), Sampling Rate: 16 kHz, Bit Rate: 16 bits. Responsive from 20-2000 Hz. Amplifies up to 24X. Volume control in 8 steps. | Microphone (-26 dBFS sensitivity), Sampling Rate: 16 kHz, Bit Rate: 16 bits. Responsive from 20-2000 Hz. Amplifies up to 24X. Volume control in 8 steps. (Stated as "Substantially Equivalent" or "Same" regarding predicate, despite slight microphone sensitivity difference) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the document for any specific clinical validation. The document states "successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers improve with AI vs without AI Assistance
- The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated for improvement. The focus is on the device's standalone performance and its equivalence to established devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms" against reference devices (like the Capnostream 35 for respiration rate) suggests a standalone evaluation of the algorithm's performance against a clinical standard, separate from a human-in-the-loop study. The "Heart Rate: Methodology" Section mentions "Performs continuous real-time calculation after initial sampling and updates heart rate display after each heartbeat," indicating an algorithmic function.
7. The Type of Ground Truth Used
- For Heart Rate and Respiration Rate: The ground truth appears to be derived from the "Reference Devices" (Stethee App [K172296] and Capnostream™ 35 [K150272]). For respiration rate, it states "The Respiration Rate feature was clinically validated against the Reference Device Capnostream 35." This implies the Capnostream 35's readings served as the ground truth.
8. The Sample Size for the Training Set
- Not specified. The document only mentions "machine learning analysis algorithms" without detailing training data specifics.
9. How the Ground Truth for the Training Set was Established
- Not specified.
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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 (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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (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.
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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 SystemStethee™ Pro 1 andStethee Pro SoftwareSystem510(k) [K193631] | Predicate Device SystemStethee™ Pro 1 andStethee App510(k) [K172296] | Reference DeviceLittmann® Model 3200Electronic Stethoscope510(k) [K083903] | Reference DeviceCapnostream™ 35Portable RespiratoryMonitor510(k) [K150272] | |
| Classification | Stethee Pro 1 ElectronicStethoscope: Class IIStethee Pro SoftwareSystem: Class II | Stethee Pro 1 ElectronicStethoscope: Class IIStethee App Software:Class I, 510(k) exempt | Electronic Stethoscope,Class II | Carbon Dioxide GasAnalyzer, Class II |
| Regulation | Stethee Pro 121 CFR 870.1875(b)Stethee Pro SoftwareSystem:21 CFR 870.2910,21 CFR 870.239021 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:DQDSecondary ProductCodes: DRG, DQC, BZQ | Stethee Pro 1: DQD,Stethee App: DQC | Product Code: DQD | Primary Product Code:CCKSecondary ProductCodes: DQA, MNR |
| Comparison of Intended Use/Indications for Use | ||||
| Device | Stethee Pro 1and Stethee ProSoftware System510k TBD | Stethee Pro 1and Stethee App[K172296] | Reference Device3M™ Littmann®Model 3200510(k) [K083903] | Reference DeviceCapnostream™ 35510(k) [K150272] |
| Intended Use / Indicationsfor Use | The Stethee™ Pro 1 is anelectronic stethoscopeintended for screeningand medical diagnosticpurposes only. It may beused for the detection andamplification of soundsfrom the heart, lungs,arteries, veins, and otherinternal organs with orwithout the use ofselective frequencies. Itcan be used on anyperson undergoing aphysical assessment.Stethee Pro 1 is intendedfor use with the StetheePro Software System,whose features enablerecording, playback, visualization, analysis,management andreporting of patientsamples, and sharing thisdata with otherauthorized users. | The Stethee™ Pro 1 is anelectronic stethoscopeintended for medicaldiagnostic purposes only.It may be used for thedetection andamplification of soundsfrom the heart, lungs,arteries, veins, and otherinternal organs. It can beused on any personundergoing a physicalassessment. | The 3M™ Littmann®Electronic Stethoscope,Model 3200 is intendedfor medical diagnosticpurposes only. It may beused for the detection andamplification of soundsfrom the heart, lungs,arteries, veins, and otherinternal organs with theuse of a selectivefrequency. It can be usedon any person undergoinga physical assessment. | The Capnostream™ 35 is a portablecapnograph/pulseoximeter, intended toprovide professionallytrained health careproviders withcontinuous non-invasive monitoring ofcarbon dioxideconcentration of theexpired and inspiredbreath, respirationrate, arterial oxygensaturation (SpO2) andpulse rate of adult,pediatric, and neonatalpatients. The pulseoximeter is intendedfor use during both nomotion and motionconditions and forpatients who are wellor poorly perfused.The Capnostream™35also provides theclinician withintegrated pulmonaryindex (IPI), apnea perhour (A/hr) andoxygen desaturationindex (ODI) values.IPI is intended forpediatric and adultpatients only. A/hr andODI are intended forage 22 and up.The device is intendedfor use in hospitals,hospital-type facilities,during intra-hospitaltransport, and out-of-hospital EmergencyMedical Serviceapplications thatinclude ground and airtransport. |
| Contraindications | None | None | None | None |
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MEDICINE
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| - | |
|---|---|
| V11O | |
| C | |
| -A |
| Feature | Stethee Pro 1and Stethee Pro Software System | Stethee Pro 1and Stethee App | Comments RegardingSE comparison ofSP1/SPS System [K193631] | Reference DeviceLittmann®Model 3200 | Reference DeviceCapnostream™ 35 |
|---|---|---|---|---|---|
| 510k [K193631] | [K172296] | ToSP1/Stethee App [K172296] | 510(k) [K083903] | 510(k) [K150272] | |
| Pickup Sensor andProcessing | Microphone(-26 dBFS sensitivity)Sampling Rate: 16 kHzBit Rate: 16 bits | Microphone(-22 dB sensitivity)Sampling Rate: 16 kHzBit Rate: 16 bits | Substantially Equivalent | Piezoelectric sensorSampling Rate: 4 kHzBit 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] issame as default filter described in[K172296]Bell: a filter amplifies 20-1000 Hzwith emphasis at 20-200 HzDiaphragm: a filter amplifies from20-2000 Hz with emphasis at 100-500 HzMid-Range filter amplifies 20-2000Hz with emphasis of low frequencysounds of 50-500HzHeart: a filter that amplifies 20-500Hz with emphasis from 20-150 Hz | Bell (20-1000 Hz)Diaphragm (20-2000 Hz)"Extended Range" (20-2000Hz) | Not Applicable |
| Maximum SoundLevel | Amplifies up to 24X on the StetheePro 1 device | Amplifies up to 24X on theStethee 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 polymerbattery | Rechargeable Lithium-ionpolymer battery | Same | Single AA, NiMH(rechargeable) or Lithiumbatteries may be used | Not Applicable |
| Low BatteryIndicator | Yes | Yes | Same | Yes | Not Applicable |
| Operating Controlsand Indicators | ON/OFF features by electronics.LEDs on device indicate devicesstatus (ON/OFF, charging,Bluetooth® synchronization). | ON/OFF features byelectronics.LEDs on device indicatedevices status (ON/OFF,charging, Bluetooth®synchronization). | Same | ON/OFF features byelectronics.LCD display on deviceindicates device status. | Not Applicable |
Stethee Pro 1/Stethee Pro Software System 510(k) Summar
Page 5 of 11 19 Aug 2020
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| œ | |
|---|---|
| Feature | Stethee Pro 1 (SP1)and Stethee Pro Software System(SPS) | Stethee Pro 1and Stethee App | Comments RegardingSE comparison ofSP1/SPS System [K193631]toSP1/Stethee App [K172296] | Reference DeviceLittmann®Model 3200 | Reference DeviceCapnostream™ 35Portable RespiratoryMonitor |
|---|---|---|---|---|---|
| 510(k) K193631 | 510(k) [K172296] | 510(k) [K083903] | 510(k) [K150272] | ||
| Direct Listening | Stethee Pro 1 sounds can belistened to in real time using aBluetooth® enabled headset or awired headset. | Stethee Pro 1 sounds can belistened to in real time using aBluetooth® enabled headset. | New Feature – device canaccommodate direct listening byuse of a wired headset connectedthrough USB port | Littmann® Model 3200allows direct listening tosounds in real time throughthe device's attachedbinaurals. | Not Applicable |
| Recording andPlayback | Not on the Stethee Pro 1 deviceitself, but with use of companionStethee Pro Software System | Not on the Stethee Pro 1device itself, but with use ofcompanion Stethee App | Substantially Equivalent | Yes – stores twelve (12) 30second tracks on device | Not Applicable |
| Wireless Technologyand PeripheralPlatformCompatibility | Yes– uses Bluetooth® at 2.4 GHzCompatible with Android and iOSdevices | Yes - uses Bluetooth® at 2.4GHzCompatible with Android andiOS devices | Same | Yes - uses Bluetooth® at 2.4GHz,Compatible with Androiddevices, not compatible withiOS devices*. (*Littmann®web page states it is notcompatible with Appledevices. | Not Applicable*Device has wirelessfeatures but comparison asreference device notperformed. |
| Ambient andFrictional NoiseReduction | Yes | Yes | Same | Yes | Not Applicable |
| Heart Rate:Detection andDisplay | Yes -using companion Stethee ProSoftware System | Yes -using companionStethee™ App (a MMA). | Same | Yes - displayed on theLittmann® Model 3200integrated LCD. | Not Applicable |
| Heart Rate:Minimum AudioSampleRequirements | Requires minimum initial 5 secondrecording. | Requires minimum initial 5second recording. | Same | Requires initial 5 secondrecording. | Not Applicable |
| Feature | Stethee Pro 1 (SP1)and Stethee Pro Software System(SPS)510(k) K193631 | Stethee Pro 1and Stethee App510(k) [K172296] | Comments RegardingSE comparison ofSP1/SPS System[K193631]toSP1/Stethee App[K172296] | Reference DeviceLittmann®Model 3200510(k) [K083903] | Reference DeviceCapnostream™ 35Portable RespiratoryMonitor510(k) [K150272] |
| Heart Rate:Methodology | Performs continuous real-timecalculation after initial samplingand updates heart rate display aftereach heartbeat | Performs continuous real-time calculationafter initial sampling and updates heart ratedisplay after each heartbeat | Same | The heart rate is updatedevery 2 seconds after theinitial 5 second sampling. | Not Applicable |
| Heart Rate:Range of Detectionand Accuracy | 30-200 BPM with an allowablereadout error rate of no greater than$±10 %$ (i.e., 10% consistency) ofthe input rate or $±5$ bpm,whichever is less. | 30-200 BPM with an allowable readout errorrate of no greater than $±10 %$ (i.e., 10%consistency) of the input rate or $±5$ bpm,whichever is less | Same | 30-199 BPM with anallowable readout error rateof no greater than $±10 %$ (i.e.,10% consistency) of the inputrate. | Not Applicable |
| Visualization Modes | Sounds can be visualized asphonocardiograph (PCG) and/orSpectrogram using companionsoftware Stethee Pro SoftwareSystem | Sounds can be visualized asphonocardiograph (PCG) using companionsoftware Stethee™ App | New Feature ofSpectrogram Visualization | Sounds can be visualized asphonocardiograph usingsoftware StethAssist™. | Not Applicable |
| Heart Cycle DurationDisplay | Individual and average systole anddiastole duration (milliseconds)calculated from PCG displayedlinearly and as Aida Cycle (acircular representation of PCG) | Not Applicable | Note: Littmann Model 3200System serves as ReferencePCG, but it does not calculateand display to user the systoleand diastole durations fromits PCG. | Not Applicable | |
| Heart Rate- Handlingof InconsistentSounds | Inconsistent sounds displayed onStethee Pro Mobile Applicationsand Stethee Pro Central Web AppGUI as "--". | Inconsistent sounds displayed on StetheeApp GUI as "--". | Same analysis, handlingand display feature, nowextended to new StetheePro Central Web asinterface (part of SPS) | Inconsistent sounds displayedon Littmann® Model 3200LCD screen as "--". | Not Applicable |
| Respiration Rate | Companion apps in the Stethee ProSoftware accurately calculate anddisplay respiration rates inrespirations per minute for aclinically validated range of 6 - 50breaths per minute $±1$ breath permin. | Not Applicable | New Feature -The Respiration Ratefeature was clinicallyvalidated against theReference DeviceCapnostream 35. | Not Applicable | Capnostream™ 35monitors and displayspatient's respiration rateover a range of 0-150breaths per minute (bpm)with the following claimedaccuracy:0-70 bpm: $±1$ bpm71-120 bpm: $±2$ bpm121-150 bpm: $±3$ bpm |
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tethee Pro 1/Stethee Pro Software System 510(k) Summar
Page 7 of 11
19 Aug 2020
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| 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 1and Stethee App | Comments RegardingSE comparison ofSP1/SPS System[K193631]toSP1/Stethee App[K172296] | Reference DeviceLittmann®Model 3200 | Reference DeviceCapnostream™ 35Portable RespiratoryMonitor |
| Geolocation | 510(k) K193631SPS Applications allow user tocollect/identify the geolocationwhere and environmentalconditions when patient samplewas 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 theprevious sample or the averaged ofthose parameters for all thesamples collected from the patient.This allows the user to see howpatient condition has changed overtime. | Not Applicable | New Feature of SampleComparison Analysis | Not Applicable | Not Applicable |
| Data Sharing | Healthcare professional can sharepatient files with anotherauthorized HCP through StetheePro Cloud Services. | Not Applicable | New Feature of DataSharing | Not Applicable | Not Applicable |
| Report Generation | Users can generate patient reportsusing Stethee Pro Software Systemfeatures | Not Applicable | New Feature of ReportGeneration | Not Applicable | Not Applicable |
| Web Portal to AccessRecorded Data | Stethee Pro Central WebApplication provides patientmanagement features, samplemanagement features, dashboard,visualization and display of heartanalytics and respiration rate. | Not Applicable | New platform foraccessing data stored onStethee Pro Cloud Services | Not Applicable | Not Applicable |
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| V | 1 |
|---|---|
| -lC- | |
| 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 1and Stethee App | Comments RegardingSE comparison ofSP1/SPS System [K193631]toSP1/Stethee App [K172296] | Reference DeviceLittmann®Model 3200 | Reference DeviceCapnostream™ 35Portable RespiratoryMonitor |
| 510(k) | 510(k) K193631 | 510(k) [K172296] | New Feature - Stethee ProQuick Settings | 510(k) [K083903] | 510(k) [K150272] |
| Control of StetheePro 1 Features | Stethee Pro Mobile Applicationsprovides user the ability tomonitor, and configure Stethee Pro1 settings: including: battery level,firmware version, filters, heartbeatlocator | Not Applicable | Not Applicable | Not Applicable | Not Applicable |
| Android Application | Stethee Android Application'spatient management features,sample management features,analysis heart sound visualizationand displaying of heart analyticsand respiration rate. | Not Applicable | New platform for accessing datafor the Stethee Pro CloudServices; system now supportsAndroid 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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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].
§ 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.