Stethophone
Device Facts
| Record ID | K231551 |
|---|---|
| Device Name | Stethophone |
| Applicant | Sparrow Acoustics, Inc. |
| Product Code | DQD · Cardiovascular |
| Decision Date | Oct 12, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1875 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
Stethophone is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis.
Device Story
Stethophone is a smartphone-based electronic stethoscope application. It utilizes the smartphone's built-in microphone to capture heart and lung sounds. The software provides real-time listening, recording, and cloud storage for later analysis. It features three audio filters (Bell, Diaphragm, Starling) and visualizes sounds via oscillogram and spectrogram. Used by healthcare professionals and lay users in clinical or non-clinical environments; enables remote monitoring and specialist consultation via sound transmission. Healthcare providers use the output to assist in physical examinations and clinical decision-making. Benefits include remote access to auscultation data and improved visualization of chest sounds.
Clinical Evidence
No clinical data. Bench testing only, including repeatability and reproducibility tests, anechoic chamber performance testing, and internal testing by medical analysts and lay users.
Technological Characteristics
Standalone software application operating on iOS smartphones. Uses smartphone microphone for sound acquisition. Frequency response: 20-2000 Hz. Audio filters: Bell (25-300 Hz), Diaphragm (170-850 Hz), Starling (60-1400 Hz). Features digital signal processing (DSP) for amplification and filtering. Visualizations: oscillogram and spectrogram. Cloud-based storage and transmission capabilities.
Indications for Use
Indicated for adult patients for the detection, amplification, filtering, and transmission of heart and lung auscultation sounds. Intended for use by professional or lay users in clinical or nonclinical settings. Not intended for self-diagnosis.
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
Submission Summary (Full Text)
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October 12, 2023
Sparrow Acoustics Inc. Nadia Ivanova Chief Product Officer 2416 Natura Dr Lucasville, NS B4B 0X3 Canada
Re: K231551
Trade/Device Name: Stethophone Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: Mav 29, 2023 Received: May 30, 2023
Dear Nadia Ivanova:
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,
# Robert T. Kazmierski -S
for
LCDR 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
Submission Number (if known)
K231551
Device Name
Stethophone
Indications for Use (Describe)
Stethophone is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis.
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/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue, sans-serif font. To the right of the word is a graphic of a bird inside of a circle, with sound waves emanating from the circle. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, gray, sans-serif font.
## K231551 - 510(k) SUMMARY
- 1. Summary Date: May 31, 2023
- 2. Submitter: Sparrow Acoustics Inc. 2416 Natura Dr. Lucasville, NS Canada, B4B 0X3 Tel: +1 (902) 989-3908
- 3. Correspondent: Nadia Ivanova
- 4. Device Trade Name: Stethophone
- Device Common Smartphone stethoscope ട. Name:
- 6. Classification: Electronic Stethoscope 21 CFR 870.1875(b) Class II Product Code: DQD Panel: Cardiovascular
- 7. Intended Use/ Stethophone is an electronic stethoscope that enables detection, Indications for Use: amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis.
- 8. Device Description: Stethophone is an electronic stethoscope software application that operates on smartphones. Stethophone is designed for use by both healthcare professionals and home users.
Stethophone enables the capture and amplification of chest sounds for real-time or recorded listening. Cloud storage with sound record sending capabilities, filtering for selected frequency ranges, and visualization all assist with sound analysis.
Stethophone is designed to assist healthcare providers both in hearing and visualizing heart and lung sounds during a physical examination of a patient and in storing recorded sounds in cloud for later analysis. It also enables home users to record and send chest sounds to their physicians.
Stethophone is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Assessment is performed by healthcare providers, while sound capturing can be performed by both healthcare providers and home users.
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Image /page/4/Picture/1 description: The image shows the logo for Sparrow Acoustics. The logo features the word "SPARROW" in a light blue sans-serif font, with the letter "O" replaced by a stylized image of a bird in a circle. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font.
Kev product features:
- · Capturing chest sounds using the smartphone microphone:
- Real-time listening to chest sounds, O
- Recording of chest sounds, o
- · Sending examinations to specialists for assessment
- · Two modes of sound visualization: oscillogram and spectrogram, and
- · Selection of three audio filters for listening:
- Bell: Traditional filter used for low frequency sounds, O
- Diaphragm: Traditional filter used for higher frequency o sounds of heart and lungs, and
- Starling: Filter for listening to the full frequency of chest O sounds.
Collectively, these features enable a healthcare professional to examine and monitor patients, seek out second opinions from specialists, and use the device in a telemedicine context.
| Predicate Devices: | |
|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| <b>Stethophone v1</b><br>510(k) Number: K222871<br>Manufacturer: Sparrow Acoustics Inc.<br>Product Code: DQD<br>Classification: 870.1875 | <b>Eko CORE</b><br>510(k) Number: K200776<br>Manufacturer: Eko Devices, Inc.<br>Product Code: DQD<br>Classification: 870.1875 |
- 10. Comparison to The comparison chart below provides evidence to facilitate the substantial Predicates: equivalence determination between Stethophone to the predicate devices with respect to intended use, technological characteristics, and principles of operation.
| | Stethophone | Stethophone v1<br>(primary) | Eko CORE | Comments |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | | | | |
| Classification | Class II device | Class II device | Class II device | Same |
| Regulation | 21 CFR<br>870.1875(b) | 21 CFR<br>870.1875(b) | 21 CFR 870.1875(b) | Same |
| Product code | DQD | DQD | DQD | Same |
| Device | Stethoscope,<br>Electronic | Stethoscope,<br>Electronic | Stethoscope,<br>Electronic | Same |
| FDA Clearance | Pending | K222871 | K200776 | |
| Intended Use/Indications for Use | | | | |
| Intended<br>Use/Indications<br>for Use | Stethophone is an<br>electronic<br>stethoscope that<br>enables detection,<br>amplification,<br>filtering, and<br>transmission of<br>auscultation sound<br>data (heart and<br>lungs), whereby a<br>clinician at one<br>location can listen | Stethophone v1 is<br>intended for<br>medical diagnostic<br>purposes only. It<br>may be used for<br>detection and<br>amplification of<br>sounds from the<br>heart and lungs<br>with the use of<br>selective frequency<br>ranges. It can be | The Eko CORE is an<br>electronic<br>stethoscope that<br>enables<br>amplification,<br>filtering, and<br>transmission of<br>auscultation sound<br>data (heart, lungs,<br>bowel, arteries, and<br>veins), whereby a<br>clinician at one | Substantially<br>Equivalent |
| | | | | |
| | sounds of a patient<br>acquired on site or<br>at a different<br>location.<br>Stethophone is<br>intended for use on<br>adult patients.<br>Stethophone is<br>intended to be used<br>by professional or<br>lay users in a<br>clinical or<br>nonclinical<br>environment.<br>Stethophone is not<br>intended for self-<br>diagnosis. | undergoing<br>physical<br>assessment. | can listen to the<br>auscultation<br>sounds of a patient<br>on site or at a<br>different location on<br>the network. Eko<br>CORE is intended for<br>use on pediatric and<br>adult<br>patients. The Eko<br>CORE is intended to<br>be used by<br>professional users in<br>a clinical<br>environment or by<br>lay users in a<br>nonclinical<br>environment. The<br>device is not<br>intended for self-<br>diagnosis. | |
| Prescription/OTS | Prescription and<br>OTC | Prescription | Prescription and<br>OTC | Same |
| Population Type | Adults | Adults | Pediatric and adults | Same with<br>Stethophone<br>v1, narrower<br>population<br>than Eko<br>CORE, which<br>doesn't affect<br>safety and<br>performance<br>for the<br>proposed<br>intended use |
| Principles of Operation | | | | |
| Form Factor | Device that is held<br>in the Doctor's<br>hand is the form of<br>the smartphone | Device that is held<br>in the Doctor's<br>hand is the form of<br>the smartphone | Attachment to an<br>analog stethoscope | Same as<br>Stethophone<br>v1. Different<br>than Eko<br>CORE, which<br>doesn't affect<br>safety and<br>performance |
| Dedicated<br>Device vs.<br>iPhone | Operates on<br>iPhone smartphone<br>using its hardware<br>and operating<br>system | Operates on<br>iPhone smartphone<br>using its hardware<br>and operating<br>system | Dedicated<br>proprietary hardware<br>(Attachment to an<br>analog stethoscope) | Same as<br>Stethophone<br>v1. Different<br>than Eko<br>CORE, which<br>doesn't affect<br>safety and<br>performance |
| iPhone model<br>Compatibility | 6s, 6S Plus, SE 1st<br>generation, 7, 7<br>Plus, 8, 8 Plus, X, | 6s, 6S Plus, SE 1st<br>gen, 7, 7 Plus, 8, 8<br>Plus, X, XS, XS | Any model | Stethophone is<br>available for a<br>larger number |
| | XS, XS MAX, XR,<br>SE 2nd generation,<br>11, 11 Pro, 11 Pro<br>Max, 12, 12 Pro, 12<br>Mini, 12 Pro Max,<br>13 mini, 13, 13 Pro,<br>13 Pro Max, SE 3rd<br>generation, 14, 14<br>Pro, 14 Pro Max | MAX, XR, SE 2<br>generation, 11, 11<br>Pro, 11 Pro Max,<br>12, 12 Pro, 12 Mini,<br>12 Pro Max, 13<br>mini, 13, 13 Pro, 13<br>Pro Max | | of iPhone<br>models than<br>Stethophone<br>v1, which may<br>affect<br>availability, but<br>doesn't affect<br>safety and<br>performance<br>as<br>stethoscopes |
| Software<br>Platform | iOS | iOS | iOS, Android | Same as<br>Stethophone<br>v1. narrower<br>than Eko<br>CORE, which<br>may affect<br>availability, but<br>doesn't affect<br>safety and<br>performance<br>as<br>stethoscopes |
| Sound Type | Heart, lungs | Heart, lungs | Heart, lungs, bowel,<br>arteries, and veins | Same as<br>Stethophone<br>v1. narrower<br>than Eko<br>CORE, which<br>may affect<br>availability, but<br>doesn't affect<br>safety and<br>performance<br>for the<br>proposed<br>intended use |
| Signal Input<br>Method | Uses microphone<br>of the smartphone<br>to acquire a sound | Uses microphone<br>of the smartphone<br>to acquire a sound | Uses attached<br>analog stethoscope<br>to acquire sound and<br>smartphone to record<br>sound | Same as<br>Stethophone<br>v1. Different<br>than Eko<br>CORE, which<br>doesn't affect<br>safety and<br>performance |
| Audio Output<br>Method | Headphones | Headphones | Eartubes of the<br>attached analog<br>stethoscope.<br>Bluetooth<br>headphones paired<br>with Eko App<br>installed on a<br>smartphone can also<br>be used | Same as<br>Stethophone<br>v1, equivalent<br>to Eko CORE |
| Record and<br>Playback<br>Sounds | Yes | Yes | Yes | Same |
| Real-Time<br>Auscultation | Yes | Yes | Yes | Same |
| Filter Selection | Yes | Yes | Yes | Same |
| Digital Signal<br>Processing<br>(DSP) | Yes | Yes | Yes | Same |
| Display | Smartphone screen | Smartphone screen | Smartphone screen<br>via Eko App | Same |
| Sound<br>Visualization | Yes | Yes | Yes | Same |
| Technical Characteristics | | | | |
| Frequency<br>Response | Stethophone picks<br>up and amplifies<br>the sound between<br>20 and 2000 Hz.<br>Based on the<br>selected audio<br>filter, specific<br>frequency ranges<br>are further<br>emphasized:<br>Bell filter<br>emphasizes range<br>from 25 to 300 Hz<br>Diaphragm filter<br>emphasizes<br>frequency spectrum<br>range 170-850 Hz,<br>Starling filter works<br>between 60 -1400<br>Hz. | Stethophone v1<br>picks up and<br>amplifies the sound<br>between 20 and<br>2000 Hz. Based on<br>the selected audio<br>filter, specific<br>frequency ranges<br>are further<br>emphasized:<br>Bell filter<br>emphasizes range<br>from 25 to 300 Hz<br>Diaphragm filter<br>emphasizes<br>frequency spectrum<br>range 170-850 Hz,<br>Starling filter works<br>between 60 -1400<br>Hz. | The default filter is<br>Wide but Cardiac<br>and Pulmonary filters<br>can also be selected<br>to allow the lower<br>and higher<br>frequencies to be<br>emphasized in the<br>sound profile,<br>respectively | Same with<br>Stethophone<br>v1;<br>substantially<br>equivalent to<br>Eko CORE |
| Volume Control | Yes | Yes | Yes | Same |
| Battery | Uses a built-in<br>battery of a<br>smartphone | Uses a built-in<br>battery of a<br>smartphone | Uses a built-in<br>battery | Same with<br>Stethophone<br>v1;<br>substantially<br>equivalent to<br>Eko CORE |
| Recording<br>Lengths | 20 sec | 20 sec | 15-120 sec | Same with<br>Stethophone<br>v1;<br>substantially<br>equivalent to<br>Eko CORE |
| Available Sound<br>Visualization | Spectrogram,<br>oscillogram | Spectrogram,<br>oscillogram | Oscillogram | Same with<br>Stethophone<br>v1;<br>substantially<br>equivalent to<br>Eko CORE |
| Ability to Zoom | Yes | Yes | Yes | Same |
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Image /page/5/Picture/0 description: The image shows the logo for Sparrow Acoustics. The logo features the word "SPARROW" in large, light blue sans-serif font, with a stylized image of a bird inside a circle replacing the second "R". Below "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font, with the letters spaced out.
Stethophone K231551
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Image /page/6/Picture/0 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside the second "R". Below "SPARROW", the word "ACOUSTICS" is written in smaller, light blue letters.
Stethophone K231551
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Image /page/7/Picture/0 description: The image is a logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside of a circle in the middle of the word. Below the word "SPARROW" is the word "ACOUSTICS" written in smaller, light blue letters.
Stethophone K231551
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Image /page/8/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside the "O". Below "SPARROW" is the word "ACOUSTICS" written in smaller, light blue letters. The logo is clean and modern, with a focus on the company name and a subtle visual element.
| 11. | Performance Data: | Sparrow Acoustics Inc. submitted performance testing information in this<br>510(k) to demonstrate safety and efficacy of Stethophone, to validate<br>that the device meets predetermined specifications and performs<br>according to pre-specified acceptance criteria, and to support the<br>substantial equivalence determination. |
|-----|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Testing includes repeatability and reproducibility tests, performance<br>tests using an anechoic chamber, internal tests run by a medical<br>analysts' team, tests involving lay users and external medical specialists<br>with auscultation experience. |
| 12. | Biocompatibility<br>Testing: | Not Applicable (Standalone Software) |
| 13. | Sterilization & Shelf-<br>life Testing: | Not Applicable (Standalone Software). Therefore, it is a non-sterile<br>device and shelf-life is not applicable to this device because of low<br>likelihood of time-dependent product degradation. |
| 14. | Electrical safety and<br>electromagnetic<br>compatibility (EMC): | Not Applicable (Standalone Software). Therefore, there is no source of<br>risk for electrical safety or electromagnetic compatibility associated<br>directly with the device. |
| 15. | Animal Study: | Animal performance testing was not required to demonstrate safety and<br>effectiveness of the device. |
| 16. | Clinical Performance<br>Testing: | Clinical testing was not required to demonstrate the safety and<br>effectiveness of the device. |
| 17. | Statement of<br>Substantial<br>Equivalence: | Stethophone and the predicates have the same intended use and<br>similar indications, technological characteristics, and principles of<br>operation. The minor differences do not present different questions of<br>safety or effectiveness than the predicate device. Performance data<br>demonstrates that Stethophone is as safe and effective as the predicate<br>devices. Thus, Stethophone is substantially equivalent to the predicate<br>devices. |
This summary of 510(k) safety and effectiveness information is submitted in accordance with the
requirements of 21 CFR §807.92.
