Stethophone v1

K222871 · Sparrow Acoustics, Inc. · DQD · Mar 29, 2023 · Cardiovascular

Device Facts

• Record ID: K222871
• Device Name: Stethophone v1
• Applicant: Sparrow Acoustics, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Mar 29, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Stethophone v1 is intended for medical diagnostic purposes only. It may be used for detection and amplification of sounds from the heart and lungs with the use of selective frequency ranges. It can be used on adults undergoing physical assessment.

Device Story

Stethophone v1 is an electronic stethoscope software application for smartphones; captures chest sounds via smartphone microphone; amplifies and filters sounds for real-time auscultation or recording; provides oscillogram and spectrogram visualizations; includes three selectable frequency filters (Bell, Diaphragm, Starling). Used by healthcare providers in clinical and non-clinical environments to assist in physical examinations; supports decision-making by allowing providers to hear, visualize, and store chest sounds for later analysis. Benefits include enhanced sound clarity and visual representation of heart/lung sounds for improved diagnostic assessment.

Clinical Evidence

Bench testing only. No clinical data required. Performance validated via repeatability and reproducibility tests, anechoic chamber testing, internal medical analyst evaluations, and an independent usability and performance study involving external medical specialists.

Technological Characteristics

Standalone software application operating on iOS smartphones. Uses smartphone microphone for sound acquisition. Features digital signal processing (DSP) for frequency filtering (Bell: 25-300 Hz; Diaphragm: 170-850 Hz; Starling: 60-1400 Hz) and visualization (oscillogram/spectrogram). Non-sterile, no electrical/EMC risks as it is standalone software.

Indications for Use

Indicated for detection and amplification of heart and lung sounds in adults undergoing physical assessment. Prescription use only.

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

• Steth IO® Smartphone Stethoscope and Phonocardiogram, Model 1.0 (K160016)
• 3M™ Littmann® Electronic Stethoscope, Model 3200 (K083903)

Submission Summary (Full Text)

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March 29, 2023

Sparrow Acoustics Inc. Nadezda Ivanova Chief Product Officer 2416 Natura Drive Lucasville, NS B4B 0X3 Canada

Re: K222871

Trade/Device Name: Stethophone v1 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: September 21, 2022 Received: September 22, 2022

Dear Nadezda 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 ([e-mail]) or phone [phone] 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

510(k) Number (if known) K222871

Device Name

Stethophone v 1

Indications for Use (Describe)

Stethophone v1 is intended for medical diagnostic purposes only. It may be used for detection and amplification of sounds from the heart and lungs with the use of selective frequency ranges. It can be used on adults undergoing physical assessment.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div><span style="font-size:120%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|------------------------------------------------------------------------------------------------|
| <div><span style="font-size:120%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in a sans-serif font in a light blue color. To the right of the word "SPARROW" is a graphic of a bird inside of a circle with sound waves emanating from it. Below the word "SPARROW" is the word "ACOUSTICS" written in a smaller sans-serif font.

## 510(k) SUMMARY

- 1. Summary Date: September 21, 2022
- 2. Submitter: Sparrow Acoustics Inc. 2416 Natura Dr. Lucasville, NS Canada. B4B 0X3 Tel: [phone]
- 3. Correspondent: Nadia Ivanova
- 4. Device Trade Name: Stethophone v1
- 5. Device Common Smartphone stethoscope Name:
- 6. Classification: Electronic Stethoscope 21 CFR 870.1875(b) Class II Product Code: DQD Panel: Cardiovascular
- 7. Intended Use/ Stethophone v1 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart and Indications for Use: lungs with the use of selective frequency ranges. It can be used on adults undergoing physical assessment.
- 8. Device Description: Stethophone v1 is an electronic stethoscope software application that operates on smartphones. Stethophone v1 allows for the capture and amplification of chest sounds

that are listened in real-time or recorded, cloud storage of sound records, sound filtering for selected frequency ranges, and visualization to assist in sound analysis.

Stethophone v1 is designed to assist healthcare providers to hear and visualize heart and lung sounds during a physical examination of a patient as well as storing recorded sounds for later analysis. Stethophone v1 is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Key product features:

- Acquiring sound through the smartphone microphone ●
- Real-time listening of chest sounds .
- Recording of chest sounds .
- Two modes of sound visualization: oscillogram and spectrogram ●
- Selecting among three sound filters for listening: ●
- Bell: Classic filter used for low frequency sounds O
- Diaphraqm: Classic filter used for higher frequency sounds of O heart and lungs
- Starling: Filter for listening to the full frequency of chest sounds O

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Image /page/4/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in a large, sans-serif font in a light blue color. To the right of the word "SPARROW" is a stylized image of a bird inside of a circle with sound waves emanating from it. Below the word "SPARROW" is the word "ACOUSTICS" written in a smaller, sans-serif font.

| 9. | Predicate Devices: | Steth IO® Smartphone Stethoscope<br>and Phonocardiogram, Model 1.0 | 3M™ Littmann® Electronic<br>Stethoscope, Model 3200 |
|-----|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | | 510(k) Number: K160016<br>Manufacturer: StratoScientific, Inc.<br>Product Code: DQD<br>Classification: 870.1875(b) | 510(k) Number: K083903<br>Manufacturer: 3M Company<br>Product Code: DQD<br>Classification: 870.1875(b) |
| 10. | Comparison to<br>Predicates: | The comparison chart below provides evidence to facilitate the<br>substantial equivalence determination between Stethophone v1 to the<br>predicate devices with respect to intended use, technological<br>characteristics, and principles of operation. | |

| | Stethophone v1 | Steth IO®<br>(primary) | 3M™ Littmann®<br>Model 3200 | 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<br>870.1875(b) | Same |
| Product code | DQD | DQD | DQD | Same |
| Device | Stethoscope,<br>Electronic | Stethoscope,<br>Electronic | Stethoscope,<br>Electronic | Same |
| FDA Clearance | Pending | k160016 | K083903 | |
| Intended Use/Indications for Use | | | | |
| Intended Use/<br>Indications for<br>Use | Stethophone v1 is<br>intended for<br>medical<br>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<br>frequency ranges.<br>It can be used on<br>adults undergoing<br>physical<br>assessment. | The StratoScientific<br>Steth IO<br>Stethoscope and<br>Phonocardiogram<br>Model 1.0 is<br>intended for<br>medical diagnostic<br>purposes only. It<br>may be used for the<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 has been<br>tested for use on<br>adults undergoing a<br>physical<br>assessment. | The 3M™<br>Littmann®<br>Electronic<br>Stethoscope, Model<br>3200 is intended for<br>medical diagnostic<br>purposes only. It<br>may be used for the<br>detection and<br>amplification of<br>sounds from the<br>heart, lungs,<br>arteries, veins, and<br>other internal<br>organs with the use<br>of a selective<br>frequency. It can be<br>used on any person<br>undergoing a<br>physical<br>assessment. | Substantially<br>equivalent |
| Prescription/<br>OTS | Prescription | Prescription | Prescription | Same |
| Population Type | Adults | Adults | All types of patients | Same with Steth<br>IO, narrower<br>population than<br>Littmann 3200 |
| | | | | |
| | | | | which doesn't<br>affect safety and<br>performance for<br>the proposed<br>intended use |
| Principles of Operation | | | | |
| Form Factor | Device that is<br>held in the<br>Doctor's hand is<br>the form of the<br>smartphone | Device that is held<br>in the Doctor's<br>hand is the form of<br>the smartphone | Similar to a<br>traditional<br>stethoscope | Same as Steth IO.<br>Different than<br>Littmann 3200,<br>which doesn't<br>affect safety and<br>performance |
| Dedicated<br>Device vs.<br>iPhone | Operates on<br>iPhone<br>smartphone using<br>its hardware and<br>operating system | Operates on<br>iPhone smartphone<br>using its hardware<br>and operating<br>system | Dedicated<br>proprietary<br>hardware (chest<br>piece) | Same as Steth IO.<br>Different than<br>Littmann 3200,<br>which doesn't<br>affect safety and<br>performance |
| iPhone model<br>Compatibility | 6s, 6S Plus, SE<br>1st gen, 7, 7 Plus,<br>8, 8 Plus, X, XS,<br>XS MAX, XR, SE<br>2 generation, 11,<br>11 Pro, 11 Pro<br>Max, 12, 12 Pro,<br>12 Mini, 12 Pro<br>Max, 13 mini, 13,<br>13 Pro, 13 Pro<br>Max | iPhone 6, 7/8, 7+ or<br>8+, X | N/A | Stethophone v1 is<br>available for a<br>larger number of<br>iPhone models<br>than Steth IO,<br>which may affect<br>availability, but<br>doesn't affect<br>safety and<br>performance as<br>stethoscopes |
| Software<br>Platform | iOS | iOS | Windows, MacOS | Same as Steth IO.<br>Different than<br>Littmann 3200,<br>which may affect<br>availability, but<br>doesn't affect<br>safety and<br>performance as<br>stethoscopes |
| Sound Type | Heart, lungs | Heart, lungs | Heart, lungs,<br>arteries, veins, and<br>other internal<br>organs | Same with Steth<br>IO, narrower than<br>Littmann 3200,<br>which doesn't<br>affect safety and<br>performance for<br>the proposed<br>intended use |
| Signal Input<br>Method | Uses microphone<br>of the smartphone<br>to acquire a<br>sound | Uses microphone<br>of the smartphone<br>to acquire a sound | Uses microphone<br>of the stethoscope<br>to acquire a sound | Same as Steth IO,<br>equivalent to<br>Littmann 3200 |
| Audio Output<br>Method | Headphones | Headphones | Eartubes with<br>eartips | Same as Steth IO,<br>equivalent to<br>Littmann 3200 |
| 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<br>screen | Smartphone screen | LCD display of the<br>device | Same as Steth IO,<br>equivalent to<br>Littmann 3200 |
| Sound<br>Visualization | Yes | Yes | Yes | Same |
| Technical Characteristics | | | | |
| Frequency<br>Response | Stethophone v1<br>picks up and<br>amplifies the<br>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<br>range from 25 to<br>300 Hz<br>Diaphragm filter<br>emphasizes<br>frequency<br>spectrum range<br>170-850 Hz,<br>Starling filter<br>works between 60<br>-1400 Hz | Steth IO has two<br>filters: Heart and<br>Lung. The specific<br>frequency filtration<br>of these filters<br>corresponds to<br>Stethophone's Bell<br>(high-cut filter) and<br>closely to<br>Stethophone's<br>Diaphragm and<br>Starling filters. This<br>correspondence is<br>based on frequency<br>response curves. | The Bell mode<br>amplifies sounds<br>from 20 - 1000 HZ,<br>but emphasizes<br>lower frequency<br>sounds between 20<br>- 200Hz.<br>The Diaphragm<br>mode amplifies<br>sounds from 20 -<br>2000 Hz but<br>emphasizes the<br>sounds between<br>100 - 500 Hz.<br>The Extended<br>Range mode<br>amplifies sounds<br>from 20 - 2000Hz<br>similar to the<br>Diaphragm Mode<br>but provides more<br>Low-frequency<br>response between<br>50 - 500Hz. | Substantially<br>equivalent |
| 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 of a<br>chestpiece | Same as Steth IO,<br>equivalent to<br>Littmann 3200 |
| Recording<br>Lengths | 20 sec | Up to 1 min | Maximum of 29<br>seconds for on-<br>board recording, up<br>to 1 min for<br>wireless recording<br>to computer<br>software | Substantially<br>Equivalent,<br>differences don't<br>affect safety and<br>effectiveness |
| Available Sound<br>Visualization | Spectrogram,<br>oscillogram | Spectrogram,<br>oscillogram | Spectrogram,<br>oscillogram | Same |
| 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 word "SPARROW" is written in a light blue sans-serif font, with a stylized image of a bird in the middle of the second "R". Above the bird are three curved lines, resembling sound waves. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font.

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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 "O". Below the word "SPARROW", the word "ACOUSTICS" is written in smaller, light blue letters.

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Image /page/7/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 "W" replaced by a stylized image of a bird inside of three concentric circles. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font.

The proposed device Stethophone v1 and the predicate devices Steth IO and Littmann 3200 share the same intended use, design, user functions and fundamental scientific operational technology. The devices are functionally the same: all three devices capture, amplify the sound, use frequency filters, visualize via two types of graphs (oscillogram and spectrogram), store records and allow auscultating heart and lung sound in real time. Software comparison and their validation support the equivalency claim. Performance and usability comparison testing was performed to support the equivalence claims.

- Sparrow Acoustics Inc. submitted performance testing information in this 11. Performance Data: 510(k) to demonstrate safety and efficacy of Stethophone v1, to validate that the device meets predetermined specifications and performs according to pre-specified acceptance criteria, and to support the substantial equivalence determination.
Testing includes repeatability and reproducibility tests, performance tests using an anechoic chamber, internal tests run by a medical analysts' team, tests involving external medical specialists with auscultation experience, as well as a usability and performance study conducted by an independent medical facility.

- 12. Biocompatibility Not Applicable (Standalone Software) Testing:
- Sterilization & Shelf-Not Applicable (Standalone Software). Therefore, it is a non-sterile 13. life Testing: device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.
- 14. Electrical safety and Not Applicable (Standalone Software). Therefore, there is no source of electromagnetic risk for electrical safety or electromagnetic compatibility associated compatibility (EMC): directly with the device.
- 15. Animal Study: Animal performance testing was not required to demonstrate safety and effectiveness of the device.
- 16. Human Clinical Clinical testing was not required to demonstrate the safety and Performance Testing: effectiveness of the device.
- 17. Statement of Stethophone v1 and the predicate devices Steth IO and Littmann 3200 Substantial share the same intended use, design, user functions and fundamental Equivalence: scientific operational technology. The devices are functionally the same. Software comparison and their validation support the equivalency claim. The differences that exist between the devices do not affect the relative safety and/or effectiveness.

Sparrow Acoustics believes the Stethophone v1 device and its predicates Steth IQ (Model 1.0) and 3M Littmann Electronic Stethoscope, Model 3200 used in conjunction with the Littmann StethAssist phonocardiogram software, are substantially equivalent.

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.