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 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.

Key product features:

Capturing chest sounds using the smartphone microphone:
- Real-time listening to chest sounds,
- Recording of chest sounds,
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,
- Diaphragm: Traditional filter used for higher frequency sounds of heart and lungs, and
- Starling: Filter for listening to the full frequency of chest 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.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria in the typical format expected for comprehensive regulatory submissions. The document is an FDA 510(k) summary, which provides a high-level overview.

However, based on the available text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Sparrow Acoustics Inc. submitted performance testing information in this 510(k) to demonstrate safety and efficacy of Stethophone, to validate that the device meets predetermined specifications and performs according to pre-specified acceptance criteria, and to support the substantial equivalence determination."

It also mentions the types of tests conducted: "Testing includes repeatability and reproducibility tests, performance tests using an anechoic chamber, internal tests run by a medical analysts' team, tests involving lay users and external medical specialists with auscultation experience."

Without the full performance testing report, specific numeric acceptance criteria and detailed reported performance cannot be provided in a table format. The summary only broadly states that the device "meets predetermined specifications and performs according to pre-specified acceptance criteria."

Here's an example of what such a table would look like if the specific data were available:

Acceptance Criterion	Reported Device Performance
[Specific metric, e.g., Frequency Response Accuracy (Bell Filter)]	[Specific measured value vs. accepted range, e.g., "Within +/- 3dB of target response across 25-300 Hz"]
[Specific metric, e.g., Amplification Gain Consistency]	[Specific measured value vs. accepted range, e.g., "Standard deviation of amplification gain < 5% across devices"]
[Specific metric, e.g., Sound Clarity (Qualitative Rating)]	[Specific score/rating vs. accepted threshold, e.g., "Average expert rating > 4 on a 5-point scale for clarity"]
[Specific metric, e.g., Repeatability (Inter-measurement variability)]	[Specific statistical measure vs. accepted threshold, e.g., "Coefficient of Variation < 10%"]
[Specific metric, e.g., Usability for Lay Users]	[Specific success rate/feedback score vs. accepted threshold, e.g., "95% task completion rate for lay users"]

2. Sample size used for the test set and the data provenance

The document mentions "tests involving lay users and external medical specialists with auscultation experience." However, it does not specify the sample size for the test set nor the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document indicates "external medical specialists with auscultation experience" were involved. It does not specify the number of experts or their detailed qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document is for an electronic stethoscope software, not an AI-assisted diagnostic tool in the sense of image interpretation. It describes features like "amplification, filtering, and transmission of auscultation sound data (heart and lungs)" and "Cloud storage with sound record sending capabilities, filtering for selected frequency ranges, and visualization." While it offers "decision support," it doesn't describe an AI algorithm providing diagnostic interpretations or classifications that would lend itself to a traditional MRMC study comparing human reader performance with and without AI assistance for interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study of human readers improving with AI vs. without AI assistance was not conducted or reported in this summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is an "electronic stethoscope software application that operates on smartphones" and is intended for use by "healthcare providers" and "home users" for capturing and aiding in listening/visualizing sounds. It is explicitly stated as a "decision support device" and "not intended for self-diagnosis." This phrasing suggests a human-in-the-loop context where the device assists a user, rather than functioning as a standalone diagnostic algorithm. Therefore, a standalone algorithm-only performance study in the sense of a fully automated diagnostic output does not seem applicable or described here. The performance tests mentioned focus on the technical aspects of sound capture, amplification, filtering, repeatability, and usability by human users.

7. The type of ground truth used

For tests involving "lay users and external medical specialists with auscultation experience," the ground truth for assessing performance (e.g., sound quality, clarity, ability to discern features) would likely be based on expert consensus or expert evaluation of the captured sounds against a known "true" sound or a reference standard. However, the document does not explicitly state the type of ground truth used.

8. The sample size for the training set

The document does not mention a training set as it is focusing on the performance of the Stethophone device, which is an electronic stethoscope software, not a machine learning model that would typically require a training set in the context of diagnostic AI.

9. How the ground truth for the training set was established

As there's no mention of a traditional training set for a machine learning model, this information is not applicable based on the provided document. The device's functionality primarily revolves around audio processing (amplification, filtering) and transmission, rather than de novo diagnostic inference from complex data patterns that would necessitate a large, labeled training dataset.

Summary

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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)

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
1. Submitter: Sparrow Acoustics Inc. 2416 Natura Dr. Lucasville, NS Canada, B4B 0X3 Tel: +1 (902) 989-3908
1. Correspondent: Nadia Ivanova
1. Device Trade Name: Stethophone
Device Common Smartphone stethoscope ട. Name:
1. Classification: Electronic Stethoscope 21 CFR 870.1875(b) Class II Product Code: DQD Panel: Cardiovascular
1. 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.
1. 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.

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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:
Stethophone v1510(k) Number: K222871Manufacturer: Sparrow Acoustics Inc.Product Code: DQDClassification: 870.1875	Eko CORE510(k) Number: K200776Manufacturer: Eko Devices, Inc.Product Code: DQDClassification: 870.1875

1. 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(primary)	Eko CORE	Comments
Classification
Classification	Class II device	Class II device	Class II device	Same
Regulation	21 CFR870.1875(b)	21 CFR870.1875(b)	21 CFR 870.1875(b)	Same
Product code	DQD	DQD	DQD	Same
Device	Stethoscope,Electronic	Stethoscope,Electronic	Stethoscope,Electronic	Same
FDA Clearance	Pending	K222871	K200776
Intended Use/Indications for Use
IntendedUse/Indicationsfor Use	Stethophone is anelectronicstethoscope thatenables detection,amplification,filtering, andtransmission ofauscultation sounddata (heart andlungs), whereby aclinician at onelocation can listen	Stethophone v1 isintended formedical diagnosticpurposes only. Itmay be used fordetection andamplification ofsounds from theheart and lungswith the use ofselective frequencyranges. It can be	The Eko CORE is anelectronicstethoscope thatenablesamplification,filtering, andtransmission ofauscultation sounddata (heart, lungs,bowel, arteries, andveins), whereby aclinician at one	SubstantiallyEquivalent

	sounds of a patientacquired on site orat a differentlocation.Stethophone isintended for use onadult patients.Stethophone isintended to be usedby professional orlay users in aclinical ornonclinicalenvironment.Stethophone is notintended for self-diagnosis.	undergoingphysicalassessment.	can listen to theauscultationsounds of a patienton site or at adifferent location onthe network. EkoCORE is intended foruse on pediatric andadultpatients. The EkoCORE is intended tobe used byprofessional users ina clinicalenvironment or bylay users in anonclinicalenvironment. Thedevice is notintended for self-diagnosis.
Prescription/OTS	Prescription andOTC	Prescription	Prescription andOTC	Same
Population Type	Adults	Adults	Pediatric and adults	Same withStethophonev1, narrowerpopulationthan EkoCORE, whichdoesn't affectsafety andperformancefor theproposedintended use
Principles of Operation
Form Factor	Device that is heldin the Doctor'shand is the form ofthe smartphone	Device that is heldin the Doctor'shand is the form ofthe smartphone	Attachment to ananalog stethoscope	Same asStethophonev1. Differentthan EkoCORE, whichdoesn't affectsafety andperformance
DedicatedDevice vs.iPhone	Operates oniPhone smartphoneusing its hardwareand operatingsystem	Operates oniPhone smartphoneusing its hardwareand operatingsystem	Dedicatedproprietary hardware(Attachment to ananalog stethoscope)	Same asStethophonev1. Differentthan EkoCORE, whichdoesn't affectsafety andperformance
iPhone modelCompatibility	6s, 6S Plus, SE 1stgeneration, 7, 7Plus, 8, 8 Plus, X,	6s, 6S Plus, SE 1stgen, 7, 7 Plus, 8, 8Plus, X, XS, XS	Any model	Stethophone isavailable for alarger number
	XS, XS MAX, XR,SE 2nd generation,11, 11 Pro, 11 ProMax, 12, 12 Pro, 12Mini, 12 Pro Max,13 mini, 13, 13 Pro,13 Pro Max, SE 3rdgeneration, 14, 14Pro, 14 Pro Max	MAX, XR, SE 2generation, 11, 11Pro, 11 Pro Max,12, 12 Pro, 12 Mini,12 Pro Max, 13mini, 13, 13 Pro, 13Pro Max		of iPhonemodels thanStethophonev1, which mayaffectavailability, butdoesn't affectsafety andperformanceasstethoscopes
SoftwarePlatform	iOS	iOS	iOS, Android	Same asStethophonev1. narrowerthan EkoCORE, whichmay affectavailability, butdoesn't affectsafety andperformanceasstethoscopes
Sound Type	Heart, lungs	Heart, lungs	Heart, lungs, bowel,arteries, and veins	Same asStethophonev1. narrowerthan EkoCORE, whichmay affectavailability, butdoesn't affectsafety andperformancefor theproposedintended use
Signal InputMethod	Uses microphoneof the smartphoneto acquire a sound	Uses microphoneof the smartphoneto acquire a sound	Uses attachedanalog stethoscopeto acquire sound andsmartphone to recordsound	Same asStethophonev1. Differentthan EkoCORE, whichdoesn't affectsafety andperformance
Audio OutputMethod	Headphones	Headphones	Eartubes of theattached analogstethoscope.Bluetoothheadphones pairedwith Eko Appinstalled on asmartphone can alsobe used	Same asStethophonev1, equivalentto Eko CORE
Record andPlaybackSounds	Yes	Yes	Yes	Same
Real-TimeAuscultation	Yes	Yes	Yes	Same
Filter Selection	Yes	Yes	Yes	Same
Digital SignalProcessing(DSP)	Yes	Yes	Yes	Same
Display	Smartphone screen	Smartphone screen	Smartphone screenvia Eko App	Same
SoundVisualization	Yes	Yes	Yes	Same
Technical Characteristics
FrequencyResponse	Stethophone picksup and amplifiesthe sound between20 and 2000 Hz.Based on theselected audiofilter, specificfrequency rangesare furtheremphasized:Bell filteremphasizes rangefrom 25 to 300 HzDiaphragm filteremphasizesfrequency spectrumrange 170-850 Hz,Starling filter worksbetween 60 -1400Hz.	Stethophone v1picks up andamplifies the soundbetween 20 and2000 Hz. Based onthe selected audiofilter, specificfrequency rangesare furtheremphasized:Bell filteremphasizes rangefrom 25 to 300 HzDiaphragm filteremphasizesfrequency spectrumrange 170-850 Hz,Starling filter worksbetween 60 -1400Hz.	The default filter isWide but Cardiacand Pulmonary filterscan also be selectedto allow the lowerand higherfrequencies to beemphasized in thesound profile,respectively	Same withStethophonev1;substantiallyequivalent toEko CORE
Volume Control	Yes	Yes	Yes	Same
Battery	Uses a built-inbattery of asmartphone	Uses a built-inbattery of asmartphone	Uses a built-inbattery	Same withStethophonev1;substantiallyequivalent toEko CORE
RecordingLengths	20 sec	20 sec	15-120 sec	Same withStethophonev1;substantiallyequivalent toEko CORE
Available SoundVisualization	Spectrogram,oscillogram	Spectrogram,oscillogram	Oscillogram	Same withStethophonev1;substantiallyequivalent toEko 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 this510(k) to demonstrate safety and efficacy of Stethophone, to validatethat the device meets predetermined specifications and performsaccording to pre-specified acceptance criteria, and to support thesubstantial equivalence determination.
		Testing includes repeatability and reproducibility tests, performancetests using an anechoic chamber, internal tests run by a medicalanalysts' team, tests involving lay users and external medical specialistswith auscultation experience.
12.	BiocompatibilityTesting:	Not Applicable (Standalone Software)
13.	Sterilization & Shelf-life Testing:	Not Applicable (Standalone Software). Therefore, it is a non-steriledevice and shelf-life is not applicable to this device because of lowlikelihood of time-dependent product degradation.
14.	Electrical safety andelectromagneticcompatibility (EMC):	Not Applicable (Standalone Software). Therefore, there is no source ofrisk for electrical safety or electromagnetic compatibility associateddirectly with the device.
15.	Animal Study:	Animal performance testing was not required to demonstrate safety andeffectiveness of the device.
16.	Clinical PerformanceTesting:	Clinical testing was not required to demonstrate the safety andeffectiveness of the device.
17.	Statement ofSubstantialEquivalence:	Stethophone and the predicates have the same intended use andsimilar indications, technological characteristics, and principles ofoperation. The minor differences do not present different questions ofsafety or effectiveness than the predicate device. Performance datademonstrates that Stethophone is as safe and effective as the predicatedevices. Thus, Stethophone is substantially equivalent to the predicatedevices.

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

Regulation Number and Section

§ 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.