(91 days)
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 M3DICINE Stethee™ Pro 1 is an electronic stethoscope that picks up sounds of the heart, arteries, veins, lungs and other internal organs. Stethee™ Pro 1 provides capability for auscultation in frequencies from 20-2000Hz.
After amplification and filtering, the sounds are transferred to the user's ears via any Bluetooth connected headphones. The Stethee™ Pro 1 includes features that permit it to record and store sounds on a peripheral smart device (e.g., mobile phone) by transferring the sounds as an audio buffer to the smart device via a Bluetooth® connection. The smart device makes use of a downloaded companion stand-alone Mobile Medical Application (MMA), Stethee™ App, to record, manage and replay the captured patient sounds on the smart device.
Stethee™ App is also able to display the audio file as a phonocardiograph (21 CFR 870.2390) on the user's smart device and can use the audio file to calculate and display a simple Heart Rate. Stethee™ App does not direct or influence the performance of Stethee™ Pro 1.
The Stethee™ Pro 1 device user interface includes a simple push down mechanism ("control knob") to start recording. It has a light-emitting diode (LED) display ring which indicates the device's status state (ON or OFF, charge status, and Bluetooth® synchronization status).
The Stethee™ Pro 1 operates on a rechargeable certified 3.7V lithium ion polymer battery.
The Stethee™ Pro 1 incorporates embedded software. The embedded software controls all the various features found in the Stethee™ Pro 1, such as sound capture, digital signal processing, volume control, LED display ring, and Bluetooth® transfer.
The document describes the Stethee™ Pro 1 electronic stethoscope and its equivalence to a predicate device, the 3M™ Littmann® Model 3200. However, it does not provide acceptance criteria in terms of specific performance metrics with numerical targets or a detailed study proving the device meets those specific acceptance criteria.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device through comparative performance testing.
Here's an attempt to answer your questions based on the provided text, highlighting what information is available and what is not:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of defined thresholds for different performance metrics. It rather presents a comparison of technical characteristics between the Stethee™ Pro 1 and the predicate device. The implied "acceptance criteria" is that the Stethee™ Pro 1 performs substantially equivalent to the predicate device in these characteristics.
| Feature | Implied Acceptance Criteria (Substantial Equivalence to Predicate) | Stethee™ Pro 1 Reported Performance |
|---|---|---|
| Classification | Electronic Stethoscope, Class II, DQD | Electronic Stethoscope, Class II, DQD |
| Intended Use | Medical diagnostic purposes, detection/amplification of internal sounds, used on any person undergoing physical assessment | Same as predicate |
| Contraindications | None | None |
| Pickup Sensor | Convert sound waves to digital signal | Microphone (-22 dB sensitivity), Sampling Rate: 16kHz, Bit Rate: 16 bits |
| Frequency Response | Responsive in audible ranges, comparable to predicate's Bell/Diaphragm/Extended Range | Responsive from 20-2000Hz |
| Maximum Sound Level | Amplifies up to 24X | Amplifies up to 24X |
| Volume Control | Yes, in 8 steps | Yes, in 8 steps |
| Power Source | Battery-powered | Rechargeable Lithium-ion polymer battery |
| Low Battery Indicator | Yes | Yes (LED color change) |
| Operating Controls & Indicators | ON/OFF, status indication | ON/OFF features by electronics (tapping mechanism), LEDs for status (ON/OFF, charging, Bluetooth® synchronization) |
| Heart Rate: Detection & Display | Yes, displayed on device or peripheral | Yes, using companion Stethee™ App (MMA) |
| Heart Rate: Minimum Audio Sample Requirements | 5 seconds recording | 0.3-2 second recording |
| Heart Rate: Methodology | Continuous real-time calculation, updated every few seconds | Continuous real-time calculation after initial 0.3-2 second sampling, updates after each heart beat |
| Heart Rate: Range of Detection & Accuracy | 30-199 BPM with ±10% consistency or ±5 bpm | 30-200 BPM with allowable readout error rate of no greater than ±10 % (i.e., 10% consistency) of the input rate or ±5 bpm |
| Heart Rate: Handling of inconsistent sounds | Inconsistent sounds indicated by "-" | Inconsistent sounds displayed on Stethee™ App GUI as "-" |
| Direct Listening | Real-time sound listening capability | Real-time listening using a Bluetooth® enabled headset |
| Recording and Playback | Capability to record and playback sounds | With Stethee™ App (not on device itself) |
| Visualization | Sounds visualized as phonocardiograph using software | Sounds visualized as phonocardiograph using companion software Stethee™ App |
| Wireless Technology & Peripheral Platform Compatibility | Bluetooth® at 2.4 GHz, compatible with devices | Bluetooth® at 2.4 GHz, compatible with Android and iOS devices |
| Ambient & Frictional Noise Reduction Technology | Yes | Yes |
2. Sample size used for the test set and the data provenance
The document states: "M3DICINE submitted performance testing information in this 510(k) demonstrating that the Stethee™ Pro 1 can perform over its intended range of operation (20-2000Hz). Comparative performance testing submitted in the 510(k) demonstrated the two devices perform in a substantially equivalent manner."
However, no specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) are mentioned for this comparative performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is comparative performance testing against a predicate device, not necessarily a diagnostic study requiring expert ground truth for classification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was described or performed. The device is an electronic stethoscope with an accompanying app that can display phonocardiographs and heart rate. It's not an AI-assisted diagnostic tool in the sense of improving human reader performance on complex image interpretation. The comparison is primarily on technical specifications and basic functionality.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document describes the performance of the Stethee™ Pro 1 device itself, which includes embedded software for sound capture, digital signal processing, volume control, and Bluetooth transfer. The heart rate calculation by the Stethee™ App can be considered an "algorithm only" function in terms of its calculation process.
- Heart Rate Calculation: The Stethee™ App "calculates and display a simple Heart Rate."
- Minimum Audio Sample Requirements: Requires initial 0.3-2 second recording (predicate requires 5 seconds).
- Methodology: Performs continuous real-time calculation after initial 0.3-2 second sampling and updates heart rate display after each heart beat (predicate updates every 2 seconds after initial 5 seconds).
- Range of Detection and Accuracy: 30-200 BPM with an allowable readout error rate of no greater than ±10 % or ±5 bpm (predicate: 30-199 BPM with ±10% consistency).
- Visualization: "Sounds can be visualized as phonocardiograph using companion software Stethee™ App." This is a standalone function of the software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the heart rate accuracy, the implied ground truth would be a validated heart rate measurement, likely from an ECG or a highly accurate reference device. However, the exact type of ground truth used for performance testing is not explicitly stated. For the broader "substantial equivalence" claim, the predicate device itself serves as the reference for comparison.
8. The sample size for the training set
The document does not mention a training set or any machine learning/AI model training in the context of diagnostic capabilities beyond basic heart rate calculation. The "embedded software" handles signal processing and device control but isn't described as a learnable AI model.
9. How the ground truth for the training set was established
As no training set is mentioned in the context of the device's diagnostic claims, this information is not applicable/provided.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
November 9, 2017
M3dicine Pty. Ltd. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K172296
Trade/Device Name: Stethee™ Pro 1 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: July 27, 2017 Received: July 31, 2017
Dear Mark Job:
This letter corrects our substantially equivalent letter of October 30, 2017.
We have reviewed vour 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M. A. Wilhelmsen
for Bram D. Zuckerman, M.D.
Director Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172296
Device Name
Stethee™ Pro 1
Indications for Use (Describe)
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.
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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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.Suite 14 BTP Hub8 Clunies Ross Court,Eight Mile Plains QLD 4113AUSTRALIA |
|---|---|
| ------------------ | ----------------------------------------------------------------------------------------------------------- |
| Contact person | Ginger Cantor, RAC |
|---|---|
| Centaur Consulting, LLC | |
| Phone: (715) 307-1850 | |
| centaurconsultingllc@gmail.com |
Date Summary Prepared: October 12, 2017
| Trade Name: | Stethee™ Pro 1 |
|---|---|
| Classification Name: | Electronic Stethoscope |
| Regulation Number: | 21 CFR §870.1875(b) |
| Product Code: | DQD |
| Classification Panel: | Cardiovascular |
| Device Classification: | Class II |
Intended Use/Indications for Use
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.
Predicate Device:
3MTM Littmann® Model 3200 (K083903)
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Description of Device:
The M3DICINE Stethee™ Pro 1 is an electronic stethoscope that picks up sounds of the heart, arteries, veins, lungs and other internal organs. Stethee™ Pro 1 provides capability for auscultation in frequencies from 20-2000Hz.
After amplification and filtering, the sounds are transferred to the user's ears via any Bluetooth connected headphones. The Stethee™ Pro 1 includes features that permit it to record and store sounds on a peripheral smart device (e.g., mobile phone) by transferring the sounds as an audio buffer to the smart device via a Bluetooth® connection. The smart device makes use of a downloaded companion stand-alone Mobile Medical Application (MMA), Stethee™ App, to record, manage and replay the captured patient sounds on the smart device.
Stethee™ App is also able to display the audio file as a phonocardiograph (21 CFR 870.2390) on the user's smart device and can use the audio file to calculate and display a simple Heart Rate. Stethee™ App does not direct or influence the performance of Stethee™ Pro 1.
The Stethee™ Pro 1 device user interface includes a simple push down mechanism ("control knob") to start recording. It has a light-emitting diode (LED) display ring which indicates the device's status state (ON or OFF, charge status, and Bluetooth® synchronization status).
The Stethee™ Pro 1 operates on a rechargeable certified 3.7V lithium ion polymer battery.
The Stethee™ Pro 1 incorporates embedded software. The embedded software controls all the various features found in the Stethee™ Pro 1, such as sound capture, digital signal processing, volume control, LED display ring, and Bluetooth® transfer.
Comparison to Predicate:
| Classification Comparison | Stethee™ Pro 1 | Predicate3MTM Littmann® Model3200510(k) 083903 | Comment | |
|---|---|---|---|---|
| Classification | ElectronicStethoscope | Electronic Stethoscope | Same | |
| Regulation | 21 CFR 870.1875(b)Class II device | 21 CFR 870.1875(b)Class II device | Same | |
| FDA Proceed | DQD | DQD | Same |
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| Intended Use/Indications for Use/Contraindications Comparison | |||
|---|---|---|---|
| Stethee™ Pro 1 | 3M™ Littmann®Model 3200FDA 510(k) K083903 | Comment | |
| Intended Use/Indications forUse | The Stethee™ Pro 1 is anelectronic stethoscopeintended for medicaldiagnostic purposes only.It may be used for thedetection and amplificationof sounds from the heart,lungs, arteries, veins, andother internal organs. Itcan be used on any personundergoing a physicalassessment. | The 3M™ Littmann®Electronic Stethoscope, Model3200 is intended for medicaldiagnostic purposes only. Itmay be used for the detectionand amplification of soundsfrom the heart, lungs, arteries,veins, and other internalorgans with the use of aselective frequency. It can beused on any personundergoing a physicalassessment. | Substantiallyequivalent |
| Contraindications | None | None | Same |
| Technical Characteristics Comparison | |||
|---|---|---|---|
| Feature | Stethee™ Pro 1 | 3MTM Littmann®Model 3200 (K083903) | Comments |
| Pickup sensorand processing | Microphone (-22 dB sensitivity)Sampling Rate: 16kHzBit Rate: 16 bits | Piezoelectric sensorSampling Rate: 4 kHzBit Rate: 16 bits | Both mechanismsconvert sound wavesinto a digital signal viadigital signalprocessing. They arefunctionally equivalent. |
| FrequencyResponse | Responsive from 20-2000Hz | Bell (20-1000 Hz)Diaphragm (20-2000 Hz)"Extended Range" (20-2000 Hz) | Note that 3MLittmann® hasqualified these responseclaims in theirInstruction for Use asfollows:Littmann®'s Bell modeemphasizes 20-200Hz).Littmann®'sDiaphragm modeemphasizes 100-500Hz).Littmann®'s "ExtendedRange" provides morelow frequency responsebetween 50-500Hz. |
| MaximumSound Level | Amplifies up to 24X | Amplifies up to 24X | Same |
| Volume Control | Yes, in 8 steps | Yes, in 8 steps | Same |
| Feature | Stethee™ Pro 1 | 3MTM Littmann®Model 3200 (K083903) | Comments |
| Power Source | Rechargeable Lithium-ionpolymer battery | Single AA, NiMH(rechargeable) or Lithiumbatteries may be used | The Littmann® Model3200 uses a single AAalkaline battery as thedefault setting butstates rechargeableNiMH or Lithiumbatteries may be used. |
| Low BatteryIndicator | Yes | Yes | The color of Stethee™Pro 1's LEDs on thedevice indicate lowbattery condition;Littmann® Model 3200uses a low battery iconin the LCD display onthe stethoscope. |
| OperatingControls andIndicators | ON/OFF features by electronics.LEDs on device indicate devicesstatus (ON/OFF, charging,Bluetooth® synchronization). | ON/OFF features by electronics.LCD display on device indicatesdevice status. | Stethee™ Pro 1 uses atapping mechanism toturn it on and off.Littmann® Model 3200uses a physical on/offbutton. Both arecontrolled throughelectronics andsoftware. |
| Heart Rate:Detection andDisplay | Yes -using companion Stethee™App (a MMA). | Yes - displayed on theLittmann® Model 3200integrated LCD. | Substantiallyequivalent. Heart Rateis not displayed ondevice, but is displayedon a peripheral devicerunning the companionStethee™ App. |
| Heart Rate:Minimum AudioSampleRequirements | Requires initial 0.3-2 secondrecording. | Requires initial 5 secondrecording. | Substantiallyequivalent |
| Heart Rate:Methodology | Performs continuous real-timecalculation after initial 0.3-2second sampling and updatesheart rate display after eachheart beat | The heart rate is updated every 2seconds after the initial 5 secondsampling. | Substantiallyequivalent |
| Heart Rate:Range ofDetection andAccuracy | 30-200 BPM with an allowablereadout error rate of no greaterthan ±10 % (i.e., 10%consistency) of the input rate or±5 bpm. | 30-199 BPM with an allowablereadout error rate of no greaterthan ±10 % (i.e., 10%consistency) of the input rate. | Substantiallyequivalent |
| Heart Rate-Handling ofinconsistentsounds | Inconsistent sounds displayed onStethee™ App GUI as "-". | Inconsistent sounds displayed onLittmann® Model 3200 LCDscreen as "-". | Substantiallyequivalent |
| Technical Characteristics Comparison | |||
| Feature | Stethee™ Pro 1 | 3MTM Littmann® | Comments |
| Model 3200 (K083903) | |||
| Direct Listening | Stethee™ Pro 1 sounds can belistened to in real time using aBluetooth® enabled headset. | Littmann® Model 3200 allowsdirect listening to sounds in realtime through the device'sattached binaurals. | Substantiallyequivalent. Thehealthcare professionalcan use the device tolisten in real-time. |
| Recording andPlayback | Not on the device itself, but withStethee™ App. | Yes - stores twelve (12) 30second tracks on device | Stethee™ App can beused to record andplayback the sounds onthe User's Smartdevice. Number ofsounds is only limitedby the phone'smemory. |
| Visualization | Sounds can be visualized asphonocardiograph usingcompanion software Stethee™App | Sounds can be visualized asphonocardiograph usingsoftware StethAssist™. | Substantiallyequivalent. Bothdevices rely on externalsoftware to visualizethe sound, under thesame softwareclassification ofphonocardiograph(21 CFR 870.2390). |
| WirelessTechnology andPeripheralPlatformCompatibility | Yes - uses Bluetooth® at 2.4GHzCompatible with Android andiOS devices | Yes - uses Bluetooth® at 2.4GHz,Compatible with Androiddevices, not compatible withiOS devices* | *Littmann® web pagestates it is notcompatible with Appledevices.Littmann® Model 3200manual states anadditional USBBluetooth® adaptor isrequired for thisfunction. |
| Ambient &Frictional NoiseReductionTechnology | Yes | Yes | Substantiallyequivalent. |
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Performance Testing
M3DICINE submitted performance testing information in this 510(k) demonstrating that the Stethee™ Pro 1 can perform over its intended range of operation (20-2000Hz). Comparative performance testing submitted in the 510(k) demonstrated the two devices perform in a substantially equivalent manner.
Safety, Electromagnetic Compatibility (EMC) and Coexistence Compliance
M3DICINE submitted information demonstrating compliance 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) and with the US translation of the IEC 60601-1 international standard (AAMI ES60601-1:2005 +A1).
M3DICINE also submitted information demonstrating full compliance with the international standard IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1: General Requirements for Safety: Collateral Standard: Electromagnetic Compatibility Requirements and Tests (Ed. 3.0).
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 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 and Clinical Testing
No animal or clinical testing was submitted in this 510(k).
Biocompatibility
M3DICINE's biocompatibility assessment and testing used standard risk assessment techniques of ISO14971:2007 and consideration of FDA & internationally recognized guidelines and standards (including ISO 10993-1 series). M3DICINE has concluded that the Stethee™ Pro 1 is safe for its intended use.
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Image /page/9/Picture/0 description: The image shows the word "MEDICINE" in a simple, sans-serif font. The letters are all in uppercase and are a light gray color. The "E" in the word is stylized with three horizontal lines instead of the traditional vertical line.
Conclusion
M3DICINE's evaluation of the substantial equivalence of the Stethee™ Pro 1 (with companion Stethee™ App) to the 3M™ Littmann® Model 3200 was based on a comparison of device classification, intended use, indications for use and contraindications, and technical characteristics. M3DICINE also compared the two device's risks and labeling. Based on this comparison, M3DICINE concludes that Stethee™ Pro 1 is substantially equivalent to the 3M™ Littmann® Model 3200 predicate device (K083903) without raising any new safety or effectiveness issues.
§ 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.