(166 days)
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.
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.
The provided text does not contain specific acceptance criteria or an explicit study that uses precise quantitative metrics to prove the device meets those criteria. Instead, it details a 510(k) submission for the Feelix Stethoscope, asserting substantial equivalence to a predicate device (M3DICINE's Stethee Pro 1) based on functional and technological similarities, and general performance testing.
Therefore, many of the requested sections regarding specific acceptance criteria, reported performance, sample sizes for test/training sets, expert details, adjudication methods, or MRMC studies cannot be extracted directly from this document.
However, based on the information provided, here's what can be gathered:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific numerical acceptance criteria for performance metrics (e.g., decibel gain, signal-to-noise ratio thresholds) nor direct reported performance against such criteria. The "Performance Testing" section states: "Acoustic Performance...demonstrated that the device was as effective as other legally marketed electronic stethoscopes." This is a qualitative statement of effectiveness rather than a quantitative performance metric.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to detect, amplify, and record sounds (General Function) | Yes, as confirmed by acoustic performance testing. |
| Active Noise Cancellation Effectiveness | "Proprietary Noise Cancellation (Active)" - effectiveness "proven out in testing." |
| Amplification (Up to 25X) | Achieves up to 25X amplification. |
| Software compliance with IEC 62304:2015 | Compliant |
| Electrical Safety (ES) & Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-12 |
| Usability | Usability Testing conducted. |
| Safety and Effectiveness comparable to predicate device | "As effective as other legally marketed electronic stethoscopes," "Performance test results demonstrate reasonable assurance that the Feelix Stethoscope can safely and effectively...suggest the Feelix Stethoscope is as safe and as effective as the identified predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "Bench performance data were collected," but does not provide details on the number of subjects, recordings, or specific test cases used for acoustic performance, noise suppression, or usability testing.
- Data Provenance: Not explicitly stated. The testing was conducted as "Bench performance data," implying lab-based testing. There is no information about country of origin, retrospective or prospective nature of the data, or if patient data was even used since it mentions "Animal and clinical testing were not necessary."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not describe a process involving human experts to establish ground truth for the performance testing. The "acoustic performance" and "noise suppression" would likely be evaluated against objective engineering specifications or benchmarks, not expert consensus on physiological sounds.
4. Adjudication Method for the Test Set
Not applicable, as expert-based ground truth establishment is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document explicitly states: "Animal and clinical testing were not necessary," and an MRMC study typically involves human readers (clinicians) interpreting cases, often with and without AI assistance, which falls under clinical testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "onboard real-time algorithms so the device can operate as a stand-alone rather than requiring connection to a computer." This implies the device has standalone processing capabilities, but it does not describe a standalone performance study (e.g., comparing algorithm output to ground truth without human intervention). The performance data cited is for the overall device's function (signal acquisition, noise suppression).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document implies objective, engineering-based ground truth for acoustic performance, signal acquisition, and noise suppression. It would likely involve known sound inputs and measurements of the device's output and processing capabilities (e.g., signal-to-noise ratio measurements, frequency response analysis). It explicitly states that "Animal and clinical testing were not necessary," which means no pathology, outcomes data, or expert clinical consensus on patient cases were used as ground truth for this submission.
8. The Sample Size for the Training Set
Not specified. The document describes the device's features and performance testing for regulatory submission, but it does not detail the development or training of any internal algorithms (e.g., for noise suppression or sound processing).
9. How the Ground Truth for the Training Set Was Established
Not specified. As the document does not detail algorithmic training, it does not describe how ground truth for such a training set would be established.
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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
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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,
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) 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) |
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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 600Baltimore, MD 21230 |
| Phone Number | (410) 417-8167 |
| Contact Person | lan McLaneChief 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.
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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 DeviceFeelix Electronic Stethoscope | Predicate Device (K172296)M3DICINE StetheeTM Pro 1 | Comparison |
|---|---|---|---|
| Trade Name | Feelix (or Feelix Pro)Stethoscope | StetheeTM Pro 1 | DifferentTrade name differences haveno impact on substantialequivalence. |
| Common Name | Electronic Stethoscope | Electronic Stethoscope | Same |
| 510(K) Number | Unknown | K172296 | Different510(k) numbers have noimpact on substantialequivalence. |
| Regulation Classification | 21 CFR 870.1875(b) | 21 CFR 870.1875(b) | Same |
| Product Code | DQD | DQD | Same |
| Intended Use | Detection, amplification andrecording of sounds | Detection, amplification andrecording of sounds | SameNote that the recording ofsounds is present inM3DICINE's marketingmaterials (e.g., website). |
| Characteristic | Subject DeviceFeelix Electronic Stethoscope | Predicate Device (K172296)M3DICINE Stethee™ Pro 1 | Comparison |
| Indications for Use | The Feelix Stethoscope isintended for the detection,amplification and recording ofsounds from the heart, lungs,anterior and posterior chest,abdomen, neck, limbs,arteries, veins and otherinternal organs with selectivefrequency ranges. It can beused on any personundergoing a physicalexamination. | The Stethee™ Pro 1 is anelectronic stethoscopeintended for medicaldiagnostic purposes only. Itmay be used for the detectionand amplification of soundsfrom the heart, lungs,arteries, veins, and otherinternal organs. It can be usedon any person undergoing aphysical assessment. | EquivalentMinor differences in languageadd clarity and do not changethe overall intended use ofthe device. |
| Anatomical Use Areas | Heart, lungs, anterior andposterior chest, abdomen,neck, limbs, arteries, veinsand other internal organs | Heart, lungs, arteries, veins,and other internal organs | EquivalentMinor differences in languageadd clarity and do not changethe overall intended use ofthe device. |
| Use Environment | Clinical, Transport (e.g.,Ambulance), and Home | unknown | UndeterminedPredicate device marketingmaterials state that device is"telehealth ready" whichimplies the same useenvironment as Feelix.Clinical and transportenvironments arecommonplace forstethoscope use. |
| Rx or OTC | Rx | Rx | Same |
| Power Source | Lithium | Lithium | Same |
| Battery Life | < 3 hours (continuous use) | unknown | UndeterminedDifferences in battery life donot have an impact on safetyor effectiveness. |
| Wire/Wireless Charging | Both | Wired | DifferentThe additional capability forFeelix to be chargedwirelessly does not have animpact on safety oreffectiveness. |
| Direct Listening | Sounds can be heard in realtime using a Bluetoothenabled headset; sounds canalso be heard in real time bywired headset | Sounds can be heard in realtime using a Bluetoothenabled headset | EquivalentThe additional capability forFeelix to have direct listeningby headset does not have animpact on safety oreffectiveness. This function iscommon to other electronicstethoscopes. |
| Characteristic | Subject DeviceFeelix Electronic Stethoscope | Predicate Device (K172296)M3DICINE Stethee™ Pro 1 | Comparison |
| Noise Reduction Type | Proprietary NoiseCancellation (Active) | Proprietary NoiseCancellation | EquivalentEffectiveness is proven out intesting for both devices. |
| Amplification | Up to 25X | Up to 24X | EquivalentBoth devices have a ceiling toprevent excessively loudoutputs that could causehearing damage. |
| Number of Recordings(Capacity) | 50 recordings | None on device itself | DifferentThe additional capability forFeelix is a non-medicalfeature that does not impactsafety or effectiveness. |
| Length of Recordings | 10 seconds | 20 seconds | DifferentDifferences in recordinglength do not have an impacton safety or effectiveness. |
| Software | Proprietary SoftwareCompliant to IEC 62304:2015 | Proprietary SoftwareCompliant to IEC 62304:2015 | Same |
| Data Transfer | Bluetooth or Wired | Bluetooth | EquivalentThe additional capability forFeelix to have a wiredconnection does not have animpact on safety oreffectiveness. This connectiontype is common to otherelectronic stethoscopes. |
| Cleaning | lsopropyl alcohol | Isopropyl alcohol | Same |
| ES & EMC | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-1-12 | IEC 60601-1IEC 60601-1-2[unknown if additionalcollateral tests wereconducted] | DifferentAdditional tests performed bySonavi Labs do not raise newor different questions ofsafety or effectiveness. |
Table 1 - Technological Comparison
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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
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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
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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 DeviceFeelix Electronic Stethoscope | Predicate Device (K172296)M3DICINE Stethee™ Pro 1 | Comparison |
|---|---|---|---|
| Performance Testing | Usability TestingAcoustic Performance | Performance (over range ofoperation) | DifferentThe additional usability testperformed by Sonavi Labsdoes not raise new ordifferent questions of safetyor effectiveness.It is likely that theperformance testing wasdifferent, as no information isavailable on the predicatedevice's testing regimen. Thesubject device's acousticperformance testdemonstrated that the devicewas as effective as otherlegally marketed electronicstethoscopes. |
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.
§ 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.