Who is the manufacturer of Feelix Stethoscope?

Sonavi Labs, Inc. filed the 510(k) submission for Feelix Stethoscope (K200862).

What is the FDA product code for Feelix Stethoscope?

DQD. It is classified under 21 CFR 870.1875 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Feelix Stethoscope?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Feelix Stethoscope?

M3DICINE's Stethee Pro 1 (K172296).

Who can help prepare an FDA 510(k) submission like Feelix Stethoscope?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Feelix Stethoscope

K200862 · Sonavi Labs, Inc. · DQD · Sep 14, 2020 · Cardiovascular

Device Facts

Record ID	K200862
Device Name	Feelix Stethoscope
Applicant	Sonavi Labs, Inc.
Product Code	DQD · Cardiovascular
Decision Date	Sep 14, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1875
Device Class	Class 2

Intended 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.

Device Story

Electronic stethoscope; microphone-based signal acquisition; captures heart, lung, and other internal organ sounds. Features active noise cancellation; up to 25X amplification; real-time audio output via Bluetooth or wired headset. Operates as standalone device; stores up to 50 recordings (10 seconds each). Used in clinical, transport, and home environments by healthcare professionals. Provides digital audio for physical examination; aids clinicians in auscultation; improves sound quality and consistency via uniform face sensitivity and noise suppression.

Clinical Evidence

Bench testing only. No clinical or animal data required. Bench testing included software verification/validation, electrical safety (IEC 60601-1, -1-2, -1-11, -1-12), usability testing, and evaluation of signal acquisition and noise suppression functions. Results demonstrate acoustic performance equivalent to other legally marketed electronic stethoscopes.

Technological Characteristics

Microphone-based sensing; lithium power source; Bluetooth and wired connectivity; active noise cancellation; 25X amplification. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-1-12. Software compliant with IEC 62304:2015. Cleaning via isopropyl alcohol.

Indications for Use

Indicated for detection, amplification, and recording of body sounds (heart, lungs, abdomen, etc.) in any person undergoing a physical examination.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

M3DICINE's Stethee Pro 1 (K172296)

Related Devices

K242971 — AccurSound Electronic Stethoscope (AS101) · Heroic Faith International , Ltd. · Nov 25, 2024
K121144 — ELECTRONIC STETHOSCOPE · Sharp Corporation · Sep 26, 2012
K220466 — ibiomedi Electronic Stethoscope ES-2020 · Sound Land Corp. · Nov 3, 2022
K172296 — Stethee Pro · M3Dicine Pty , Ltd. · Oct 30, 2017
K212709 — VoqX Electronic Stethoscope · Sanolla , Ltd. · Mar 15, 2022

Submission Summary (Full Text)

{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. 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 {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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### 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. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Sonavi Labs. The logo consists of a stylized graphic of connected circles in purple and yellow above the company name in a simple sans-serif font. 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 Baltimore, MD 21230 | | Phone Number | (410) 417-8167 | | Contact Person | lan McLane 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 Feelix Electronic Stethoscope | Predicate Device (K172296) M3DICINE StetheeTM Pro 1 | Comparison | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Feelix (or Feelix Pro) Stethoscope | StetheeTM Pro 1 | Different Trade name differences have no impact on substantial equivalence. | | Common Name | Electronic Stethoscope | Electronic Stethoscope | Same | | 510(K) Number | Unknown | K172296 | Different 510(k) numbers have no impact on substantial equivalence. | | Regulation Classification | 21 CFR 870.1875(b) | 21 CFR 870.1875(b) | Same | | Product Code | DQD | DQD | Same | | Intended Use | Detection, amplification and recording of sounds | Detection, amplification and recording of sounds | Same Note that the recording of sounds is present in M3DICINE's marketing materials (e.g., website). | | Characteristic | Subject Device Feelix Electronic Stethoscope | Predicate Device (K172296) M3DICINE Stethee™ Pro 1 | Comparison | | 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. | 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. | Equivalent Minor differences in language add clarity and do not change the overall intended use of the device. | | Anatomical Use Areas | Heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs | Heart, lungs, arteries, veins, and other internal organs | Equivalent Minor differences in language add clarity and do not change the overall intended use of the device. | | Use Environment | Clinical, Transport (e.g., Ambulance), and Home | unknown | Undetermined Predicate device marketing materials state that device is "telehealth ready" which implies the same use environment as Feelix. Clinical and transport environments are commonplace for stethoscope use. | | Rx or OTC | Rx | Rx | Same | | Power Source | Lithium | Lithium | Same | | Battery Life | < 3 hours (continuous use) | unknown | Undetermined Differences in battery life do not have an impact on safety or effectiveness. | | Wire/Wireless Charging | Both | Wired | Different The additional capability for Feelix to be charged wirelessly does not have an impact on safety or effectiveness. | | Direct Listening | Sounds can be heard in real time using a Bluetooth enabled headset; sounds can also be heard in real time by wired headset | Sounds can be heard in real time using a Bluetooth enabled headset | Equivalent The additional capability for Feelix to have direct listening by headset does not have an impact on safety or effectiveness. This function is common to other electronic stethoscopes. | | Characteristic | Subject Device Feelix Electronic Stethoscope | Predicate Device (K172296) M3DICINE Stethee™ Pro 1 | Comparison | | Noise Reduction Type | Proprietary Noise Cancellation (Active) | Proprietary Noise Cancellation | Equivalent Effectiveness is proven out in testing for both devices. | | Amplification | Up to 25X | Up to 24X | Equivalent Both devices have a ceiling to prevent excessively loud outputs that could cause hearing damage. | | Number of Recordings (Capacity) | 50 recordings | None on device itself | Different The additional capability for Feelix is a non-medical feature that does not impact safety or effectiveness. | | Length of Recordings | 10 seconds | 20 seconds | Different Differences in recording length do not have an impact on safety or effectiveness. | | Software | Proprietary Software Compliant to IEC 62304:2015 | Proprietary Software Compliant to IEC 62304:2015 | Same | | Data Transfer | Bluetooth or Wired | Bluetooth | Equivalent The additional capability for Feelix to have a wired connection does not have an impact on safety or effectiveness. This connection type is common to other electronic stethoscopes. | | Cleaning | lsopropyl alcohol | Isopropyl alcohol | Same | | ES & EMC | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-1-12 | IEC 60601-1 IEC 60601-1-2 [unknown if additional collateral tests were conducted] | Different Additional tests performed by Sonavi Labs do not raise new or different questions of 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 Feelix Electronic Stethoscope | Predicate Device (K172296) M3DICINE Stethee™ Pro 1 | Comparison | |---------------------|-------------------------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Testing | Usability Testing Acoustic Performance | Performance (over range of operation) | Different The additional usability test performed by Sonavi Labs does not raise new or different questions of safety or effectiveness. It is likely that the performance testing was different, as no information is available on the predicate device's testing regimen. The subject device's acoustic performance test demonstrated that the device was as effective as other legally marketed electronic 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.