Feelix Stethoscope

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 14, 2020 Sonavi Labs, Inc. Ian Mclane Chief Technology Officer 1100 Wicomico St., Suite 600 Baltimore, Maryland 21230 Re: K200862 Trade/Device Name: Feelix Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: August 11, 2020 Received: August 12, 2020 Dear Ian Mclane: 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. 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K200862 Device Name Feelix Stethoscope Indications for Use (Describe) The Feelix Stethoscope is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. It can be used on any person undergoing a physical examination. Type of Use (Select one or both, as applicable) | <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |------------------------------------------------------------------------------------| | <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Below the company name is the address "1100 Wicomico St., Suite 600 Baltimore, MD 21230". # 510(k) Summary - K200862 (per 21 CFR 807.92) ## Submitter Information | Name | Sonavi Labs, Inc. | |----------------|-----------------------------------------------------| | Address | 1100 Wicomico St., Suite 600<br>Baltimore, MD 21230 | | Phone Number | (410) 417-8167 | | Contact Person | lan McLane<br>Chief Technology Officer | | Date Prepared | March 30, 2020 | ### Device Information | Trade Name | Feelix Stethoscope | |----------------|------------------------------------| | Common Name | Electronic Stethoscope | | Classification | Stethoscope | | | 21 CFR 870.1875 (Product Code DQD) | ### Predicate Device Information | Device Name | M3DICINE's Stethee Pro 1 | |-------------|--------------------------| | K Number | K172296 | #### Device Description Sonavi Labs, in collaboration with Johns Hopkins University, has developed a next generation stethoscope with pristine digital audio to help clinicians and healthcare workers detect, amplify, and record sounds during physical examination. The Feelix Stethoscope (Feelix) re-engineers the classic stethoscope and offers three major improvements: (1) more uniform sensitivity over its entire face so that sound quality is less dependent on placement on the body (2) leading noise suppression and sound volume control, and (3) onboard real-time algorithms so the device can operate as a stand-alone rather than requiring connection to a computer. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Sonavi Labs. The logo consists of a stylized molecular structure above the company name, which is written in a simple, sans-serif font. Below the company name is the address: 1100 Wicomico St., Suite 600, Baltimore, MD 21230. ### Intended Use To detect, amplify, and record sounds during a physical examination ### Indications for Use The Feelix Stethoscope is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. It can be used on any person undergoing a physical examination. #### Comparison to Predicate The Feelix Stethoscope's indications for use statement includes a couple minor differences from the predicate device. These changes were implemented to better represent expected use, without impacting the underlying intended use. ### Technological Characteristics As shown in Table 1, many technological similarities exist between the subject and predicate devices. The operating mechanism utilized in the Feelix Stethoscope is microphone-based, which is the same as the predicate device. Both devices demonstrate both safety and effectiveness by the ability to obtain a sound (signal acquisition) and to suppress surrounding noise without impacting the sound of interest. This is proven through scientific evidence presented in the premarket notification. Other technological characteristics of the Feelix Stethoscope, including software, EMC and ES testing, are similar to the predicate device. | Characteristic | Subject Device<br>Feelix Electronic Stethoscope | Predicate Device (K172296)<br>M3DICINE StetheeTM Pro 1 | Comparison | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Feelix (or Feelix Pro)<br>Stethoscope | StetheeTM Pro 1 | Different<br>Trade name differences have<br>no impact on substantial<br>equivalence. | | Common Name | Electronic Stethoscope | Electronic Stethoscope | Same | | 510(K) Number | Unknown | K172296 | Different<br>510(k) numbers have no<br>impact on substantial<br>equivalence. | | Regulation Classification | 21 CFR 870.1875(b) | 21 CFR 870.1875(b) | Same | | Product Code | DQD | DQD | Same | | Intended Use | Detection, amplification and<br>recording of sounds | Detection, amplification and<br>recording of sounds | Same<br>Note that the recording of<br>sounds is present in<br>M3DICINE's marketing<br>materials (e.g., website). | | Characteristic | Subject Device<br>Feelix Electronic Stethoscope | Predicate Device (K172296)<br>M3DICINE Stethee™ Pro 1 | Comparison | | Indications for Use | The Feelix Stethoscope is<br>intended for the detection,<br>amplification and recording of<br>sounds from the heart, lungs,<br>anterior and posterior chest,<br>abdomen, neck, limbs,<br>arteries, veins and other<br>internal organs with selective<br>frequency ranges. It can be<br>used on any person<br>undergoing a physical<br>examination. | The Stethee™ Pro 1 is an<br>electronic stethoscope<br>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,<br>arteries, veins, and other<br>internal organs. It can be used<br>on any person undergoing a<br>physical assessment. | Equivalent<br>Minor differences in language<br>add clarity and do not change<br>the overall intended use of<br>the device. | | Anatomical Use Areas | Heart, lungs, anterior and<br>posterior chest, abdomen,<br>neck, limbs, arteries, veins<br>and other internal organs | Heart, lungs, arteries, veins,<br>and other internal organs | Equivalent<br>Minor differences in language<br>add clarity and do not change<br>the overall intended use of<br>the device. | | Use Environment | Clinical, Transport (e.g.,<br>Ambulance), and Home | unknown | Undetermined<br>Predicate device marketing<br>materials state that device is<br>"telehealth ready" which<br>implies the same use<br>environment as Feelix.<br>Clinical and transport<br>environments are<br>commonplace for<br>stethoscope use. | | Rx or OTC | Rx | Rx | Same | | Power Source | Lithium | Lithium | Same | | Battery Life | < 3 hours (continuous use) | unknown | Undetermined<br>Differences in battery life do<br>not have an impact on safety<br>or effectiveness. | | Wire/Wireless Charging | Both | Wired | Different<br>The additional capability for<br>Feelix to be charged<br>wirelessly does not have an<br>impact on safety or<br>effectiveness. | | Direct Listening | Sounds can be heard in real<br>time using a Bluetooth<br>enabled headset; sounds can<br>also be heard in real time by<br>wired headset | Sounds can be heard in real<br>time using a Bluetooth<br>enabled headset | Equivalent<br>The additional capability for<br>Feelix to have direct listening<br>by headset does not have an<br>impact on safety or<br>effectiveness. This function is<br>common to other electronic<br>stethoscopes. | | Characteristic | Subject Device<br>Feelix Electronic Stethoscope | Predicate Device (K172296)<br>M3DICINE Stethee™ Pro 1 | Comparison | | Noise Reduction Type | Proprietary Noise<br>Cancellation (Active) | Proprietary Noise<br>Cancellation | Equivalent<br>Effectiveness is proven out in<br>testing for both devices. | | Amplification | Up to 25X | Up to 24X | Equivalent<br>Both devices have a ceiling to<br>prevent excessively loud<br>outputs that could cause<br>hearing damage. | | Number of Recordings<br>(Capacity) | 50 recordings | None on device itself | Different<br>The additional capability for<br>Feelix is a non-medical<br>feature that does not impact<br>safety or effectiveness. | | Length of Recordings | 10 seconds | 20 seconds | Different<br>Differences in recording<br>length do not have an impact<br>on safety or effectiveness. | | Software | Proprietary Software<br>Compliant to IEC 62304:2015 | Proprietary Software<br>Compliant to IEC 62304:2015 | Same | | Data Transfer | Bluetooth or Wired | Bluetooth | Equivalent<br>The additional capability for<br>Feelix to have a wired<br>connection does not have an<br>impact on safety or<br>effectiveness. This connection<br>type is common to other<br>electronic stethoscopes. | | Cleaning | lsopropyl alcohol | Isopropyl alcohol | Same | | ES & EMC | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-1-12 | IEC 60601-1<br>IEC 60601-1-2<br>[unknown if additional<br>collateral tests were<br>conducted] | Different<br>Additional tests performed by<br>Sonavi Labs do not raise new<br>or different questions of<br>safety or effectiveness. | #### Table 1 - Technological Comparison {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Sonavi Labs. The logo consists of the word "SONAVI" in large, sans-serif font, with the word "LABS" in a smaller font below it. Above the word "SONAVI" is a graphic of three connected circles, with a color gradient from purple to yellow. 1100 Wicomico St., Suite 600 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Sonavi Labs. The logo features a stylized molecular structure in shades of purple, orange, and yellow above the word "SONAVI" in a sans-serif font. Below "SONAVI" is the word "LABS" in a smaller, sans-serif font. 1100 Wicomico St., Suite 600 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Sonavi Labs. The logo consists of the word "SONAVI" in large, sans-serif font, with the word "LABS" in a smaller font underneath. Above the word "SONAVI" is a graphic of three connected circles that transition in color from purple to yellow. 1100 Wicomico St., Suite 600 Baltimore, MD 21230 | Characteristic | Subject Device<br>Feelix Electronic Stethoscope | Predicate Device (K172296)<br>M3DICINE Stethee™ Pro 1 | Comparison | |---------------------|-------------------------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Testing | Usability Testing<br>Acoustic Performance | Performance (over range of<br>operation) | Different<br>The additional usability test<br>performed by Sonavi Labs<br>does not raise new or<br>different questions of safety<br>or effectiveness.<br>It is likely that the<br>performance testing was<br>different, as no information is<br>available on the predicate<br>device's testing regimen. The<br>subject device's acoustic<br>performance test<br>demonstrated that the device<br>was as effective as other<br>legally marketed electronic<br>stethoscopes. | ### Performance Data Bench performance data were collected to support a substantial equivalence determination. Animal and clinical testing were not necessary. Bench performance testing included software verification and validation, electrical safety and EMC testing (including home and EMT collaterals), usability testing, and evaluation of signal acquisition and noise suppression functions. Performance test results demonstrate reasonable assurance that the Feelix Stethoscope can safely and effectively detect, amplify, and record sounds during a physical examination. These data suggest the Feelix Stethoscope is as safe and as effective as the identified predicate device. #### Conclusions The Feelix Stethoscope and its predicate device have intended use and similar indications, both serving as medical devices to detect, amplify, and record sounds during a physical examination. As described above, the minor technological differences between the Feelix Stethoscope and its predicate do not present any new or different issues of safety or effectiveness. Performance testing further confirms that these differences do not raise different questions of safety or effectiveness. Based upon this analysis and valid scientific evidence it can be concluded that the Feelix Stethoscope is substantially equivalent to its predicate device.