(166 days)
Unknown
The description mentions "onboard real-time algorithms" but does not specify if these algorithms utilize AI or ML techniques. The absence of mentions of AI, DNN, ML, training sets, or test sets makes it impossible to definitively confirm the presence of AI/ML.
No
The device is intended for the detection, amplification, and recording of sounds for physical examination, not for treating or curing a condition.
No
Explanation: The device is intended for the "detection, amplification and recording of sounds" from various internal organs "for a physical examination," and is therefore limited to acquisition and display of information, not diagnosis. Although it mentions "real-time algorithms," the description does not specify that these algorithms perform diagnostic functions. It is described as a re-engineered stethoscope aiming to help clinicians "detect, amplify, and record sounds," aligning with an information acquisition and display device rather than a diagnostic one.
No
The device description explicitly states it is a "next generation stethoscope" and mentions "onboard real-time algorithms so the device can operate as a stand-alone rather than requiring connection to a computer," indicating it is a physical device with integrated software, not software only. The performance studies also include electrical safety and EMC testing, which are relevant to hardware.
Based on the provided information, the Feelix Stethoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Feelix Stethoscope Function: The Feelix Stethoscope is described as a device for detecting, amplifying, and recording sounds from the body (heart, lungs, etc.) during a physical examination. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for detecting and recording sounds from internal organs, not for analyzing biological samples.
Therefore, the Feelix Stethoscope falls under the category of a medical device used for physical examination, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
DQD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs
Indicated Patient Age Range
any person
Intended User / Care Setting
Use Environment: Clinical, Transport (e.g., Ambulance), and Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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
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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 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 |