Stethee Pro

{0}------------------------------------------------ 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); {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 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.<br>Suite 14 BTP Hub<br>8 Clunies Ross Court,<br>Eight Mile Plains QLD 4113<br>AUSTRALIA | |------------------|-----------------------------------------------------------------------------------------------------------| |------------------|-----------------------------------------------------------------------------------------------------------| | 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) {4}------------------------------------------------ ### 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 | Predicate<br>3MTM Littmann® Model<br>3200<br>510(k) 083903 | Comment | |---------------------------|--|---------------------------------------|------------------------------------------------------------|---------| | Classification | | Electronic<br>Stethoscope | Electronic Stethoscope | Same | | Regulation | | 21 CFR 870.1875(b)<br>Class II device | 21 CFR 870.1875(b)<br>Class II device | Same | | FDA Proceed | | DQD | DQD | Same | {5}------------------------------------------------ | Intended Use/Indications for Use/Contraindications Comparison | | | | |---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | | Stethee™ Pro 1 | 3M™ Littmann®<br>Model 3200<br>FDA 510(k) K083903 | Comment | | Intended Use/Indications for<br>Use | 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 amplification<br>of sounds from the heart,<br>lungs, arteries, veins, and<br>other internal organs. It<br>can be used on any person<br>undergoing a physical<br>assessment. | The 3M™ Littmann®<br>Electronic Stethoscope, Model<br>3200 is intended for medical<br>diagnostic purposes only. It<br>may be used for the detection<br>and amplification of sounds<br>from the heart, lungs, arteries,<br>veins, and other internal<br>organs with the use of a<br>selective frequency. It can be<br>used on any person<br>undergoing a physical<br>assessment. | Substantially<br>equivalent | | Contraindications | None | None | Same | | Technical Characteristics Comparison | | | | |-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Stethee™ Pro 1 | 3MTM Littmann®<br>Model 3200 (K083903) | Comments | | Pickup sensor<br>and processing | Microphone (-22 dB sensitivity)<br>Sampling Rate: 16kHz<br>Bit Rate: 16 bits | Piezoelectric sensor<br>Sampling Rate: 4 kHz<br>Bit Rate: 16 bits | Both mechanisms<br>convert sound waves<br>into a digital signal via<br>digital signal<br>processing. They are<br>functionally equivalent. | | Frequency<br>Response | Responsive from 20-2000Hz | Bell (20-1000 Hz)<br>Diaphragm (20-2000 Hz)<br>"Extended Range" (20-2000 Hz) | Note that 3M<br>Littmann® has<br>qualified these response<br>claims in their<br>Instruction for Use as<br>follows:<br>Littmann®'s Bell mode<br>emphasizes 20-200Hz).<br>Littmann®'s<br>Diaphragm mode<br>emphasizes 100-<br>500Hz).<br>Littmann®'s "Extended<br>Range" provides more<br>low frequency response<br>between 50-500Hz. | | Maximum<br>Sound 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®<br>Model 3200 (K083903) | Comments | | Power Source | Rechargeable Lithium-ion<br>polymer battery | Single AA, NiMH<br>(rechargeable) or Lithium<br>batteries may be used | The Littmann® Model<br>3200 uses a single AA<br>alkaline battery as the<br>default setting but<br>states rechargeable<br>NiMH or Lithium<br>batteries may be used. | | Low Battery<br>Indicator | Yes | Yes | The color of Stethee™<br>Pro 1's LEDs on the<br>device indicate low<br>battery condition;<br>Littmann® Model 3200<br>uses a low battery icon<br>in the LCD display on<br>the stethoscope. | | Operating<br>Controls and<br>Indicators | ON/OFF features by electronics.<br>LEDs on device indicate devices<br>status (ON/OFF, charging,<br>Bluetooth® synchronization). | ON/OFF features by electronics.<br>LCD display on device indicates<br>device status. | Stethee™ Pro 1 uses a<br>tapping mechanism to<br>turn it on and off.<br>Littmann® Model 3200<br>uses a physical on/off<br>button. Both are<br>controlled through<br>electronics and<br>software. | | Heart Rate:<br>Detection and<br>Display | Yes -using companion Stethee™<br>App (a MMA). | Yes - displayed on the<br>Littmann® Model 3200<br>integrated LCD. | Substantially<br>equivalent. Heart Rate<br>is not displayed on<br>device, but is displayed<br>on a peripheral device<br>running the companion<br>Stethee™ App. | | Heart Rate:<br>Minimum Audio<br>Sample<br>Requirements | Requires initial 0.3-2 second<br>recording. | Requires initial 5 second<br>recording. | Substantially<br>equivalent | | Heart Rate:<br>Methodology | Performs continuous real-time<br>calculation after initial 0.3-2<br>second sampling and updates<br>heart rate display after each<br>heart beat | The heart rate is updated every 2<br>seconds after the initial 5 second<br>sampling. | Substantially<br>equivalent | | Heart Rate:<br>Range of<br>Detection and<br>Accuracy | 30-200 BPM with an allowable<br>readout error rate of no greater<br>than ±10 % (i.e., 10%<br>consistency) of the input rate or<br>±5 bpm. | 30-199 BPM with an allowable<br>readout error rate of no greater<br>than ±10 % (i.e., 10%<br>consistency) of the input rate. | Substantially<br>equivalent | | Heart Rate-<br>Handling of<br>inconsistent<br>sounds | Inconsistent sounds displayed on<br>Stethee™ App GUI as "-". | Inconsistent sounds displayed on<br>Littmann® Model 3200 LCD<br>screen as "-". | Substantially<br>equivalent | | Technical Characteristics Comparison | | | | | Feature | Stethee™ Pro 1 | 3MTM Littmann® | Comments | | | | Model 3200 (K083903) | | | Direct Listening | Stethee™ Pro 1 sounds can be<br>listened to in real time using a<br>Bluetooth® enabled headset. | Littmann® Model 3200 allows<br>direct listening to sounds in real<br>time through the device's<br>attached binaurals. | Substantially<br>equivalent. The<br>healthcare professional<br>can use the device to<br>listen in real-time. | | Recording and<br>Playback | Not on the device itself, but with<br>Stethee™ App. | Yes - stores twelve (12) 30<br>second tracks on device | Stethee™ App can be<br>used to record and<br>playback the sounds on<br>the User's Smart<br>device. Number of<br>sounds is only limited<br>by the phone's<br>memory. | | Visualization | Sounds can be visualized as<br>phonocardiograph using<br>companion software Stethee™<br>App | Sounds can be visualized as<br>phonocardiograph using<br>software StethAssist™. | Substantially<br>equivalent. Both<br>devices rely on external<br>software to visualize<br>the sound, under the<br>same software<br>classification of<br>phonocardiograph<br>(21 CFR 870.2390). | | Wireless<br>Technology and<br>Peripheral<br>Platform<br>Compatibility | Yes - uses Bluetooth® at 2.4<br>GHz<br>Compatible with Android and<br>iOS devices | Yes - uses Bluetooth® at 2.4<br>GHz,<br>Compatible with Android<br>devices, not compatible with<br>iOS devices* | *Littmann® web page<br>states it is not<br>compatible with Apple<br>devices.<br>Littmann® Model 3200<br>manual states an<br>additional USB<br>Bluetooth® adaptor is<br>required for this<br>function. | | Ambient &<br>Frictional Noise<br>Reduction<br>Technology | Yes | Yes | Substantially<br>equivalent. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ### 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. {9}------------------------------------------------ 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.