Stethophone Pro is intended to provide decision support to clinicians in their evaluation of patients heart sounds. The software analyzes heart sounds and phonocardiograms and can automatically detect murmurs that may be present, sound timing and character, including S1, S2, and the absence of a heart murmur.

Stethophone Pro is not intended to be used as a sole means of diagnosis and is for use in environments where health care is provided by clinicians. The interpretations offered by the software are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment. The interpretations are not diagnoses. Stethophone Pro is intended for use on adult patients.

Device Description

Stethophone Pro is an electronic stethoscope software application that operates on smartphones. Stethophone Pro is designed for use by healthcare professionals or on the order of healthcare professionals.
Stethophone Pro 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 Pro is designed to assist healthcare professionals in both hearing and visualizing heart and lung sounds during a physical examination of a patient and in storing recorded sounds in the cloud for later analysis. It also enables home users to record and send chest sounds to their physicians.

Stethophone Pro can be used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Assessment is performed by healthcare professionals, while sound capturing can be performed by both healthcare professionals and home users.

Stethophone Pro performs basic analysis of heart sounds allowing to detect the presence of murmurs, locate heartbeats on the timeline (S1/S2), and calculate timing between them.

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,
Detecting murmurs, timing for S1 and S2 sounds, and calculating heart rate,
Selecting from three audio filters for listening:
- Bell: Traditional filter used in stethoscopes 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 users to acquire heart sounds and receive basic reporting, so as enable healthcare professionals to examine and monitor patients on site and remotely, seek out second opinions from specialists, and use the device in a telemedicine context.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Stethophone Pro, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a pass/fail form (e.g., "must achieve >X% sensitivity"). Instead, it presents the reported performance metrics. For this response, I will list the reported performance metrics as the de facto "met performance" from the validation study.

Metric (Heart Sound Analysis)	Dataset	Reported Performance (95% CI)
S1 Precision	America	97.1 (96.7 to 97.5)
	Multi-Device	96.9 (96.6 to 97.3)
S1 Sensitivity (Recall)	America	97.3 (97.0 to 97.7)
	Multi-Device	97.9 (97.7 to 98.1)
S2 Precision	America	97.5 (97.2 to 97.9)
	Multi-Device	97.1 (96.7 to 97.4)
S2 Sensitivity (Recall)	America	96.5 (96.1 to 97.0)
	Multi-Device	97.7 (97.5 to 97.9)
Murmur Detection Sensitivity	America	88.7 (87.2 to 89.8)
	Multi-Device	93.0 (91.9 to 94.2)
Murmur Detection Specificity	America	89.2 (87.2 to 91.3)
	Multi-Device	94.4 (93.7 to 95.4)
Murmur Detection Accuracy	America	88.8 (87.6 to 89.8)
	Multi-Device	93.8 (93.2 to 94.6)
Murmur Detection ROC AUC	America	96.9 (96.1 to 97.3)
	Multi-Device	97.9 (97.5 to 98.3)
Heart Rate MAE (bpm)	America	0.482 (0.418 to 0.557)
	Multi-Device	0.389 (0.346 to 0.430)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): 7,304 heart sound recordings from 2,277 adult subjects.
Data Provenance: The data consisted of both proprietary and public clinical data. 4,396 recordings were from a proprietary dataset, recorded using various devices including smartphones and commercially available stethoscopes. Data appears to be from adult subjects ranging from 18 to 91 years old. Ethnicity representation: 86.1% white, 6.1% Latino, 5.0% Asian, and 2.7% African American. The country of origin for the "America" dataset or "Multi-Device" dataset is not explicitly stated but implies a broad representation. The study was retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: "Multiple expert cardiologists." The exact number is not specified beyond "multiple".
Qualifications: "Expert cardiologists." Specific experience levels (e.g., "10 years of experience") are not provided.

4. Adjudication Method for the Test Set

The document states that "Each recording in a testing dataset was annotated by multiple expert cardiologists." It does not explicitly describe an adjudication method (such as 2+1 or 3+1 consensus). It simply states they were annotated by multiple experts, implying that their annotations formed the ground truth, likely through consensus or independent review that established the final label.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not explicitly stated or described. The performance data presented is for the standalone algorithm.

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

Yes, a standalone performance study was done. The results presented in the tables (S1 precision, S2 sensitivity, Murmur detection, etc.) are for the "Stethophone Pro algorithms for heart sound analysis," without mentioning human-in-the-loop performance. The preamble to the performance data states: "Stethophone Pro underwent a thorough testing process to ensure its safety, reliability and effectiveness. Testing included both software verification and validation, as well as clinical validation." And "Stethophone Pro algorithms for heart sound analysis have been validated in both retrospective and clinical performance testing..." This confirms standalone algorithm performance.

7. The Type of Ground Truth Used

Expert Consensus: The ground truth for heart sound analysis (presence of murmur, S1/S2 timings) was established by "multiple expert cardiologists" who annotated each recording.

8. The Sample Size for the Training Set

The sample size for the training set is not provided in the document. It only states that there was "no overlap between subjects and recordings included in the testing and training data."

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established. It only mentions that the "validation was performed after the algorithm development and training was finalized."

Summary

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September 19, 2024

Sparrow Acoustics Inc. Nadia Ivanova Chief Product Officer 2416 Natura Dr Lucasville, NS B4B0X3 Canada

Re: K240901

Trade/Device Name: Stethophone Pro Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: April 1, 2024 Received: April 2, 2024

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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 DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: 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) K240901

Device Name

Stethophone Pro

Indications for Use (Describe)

Stethophone Pro is an electronic stethoscope that enables detection, filtering, and transmission of auscultation sound data (heart and lungs).

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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510(k) SUMMARY

1. Summary Date: September 18, 2024
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 Pro
1. Device Common Smartphone stethoscope Name:
റ. Classification: Electronic Stethoscope 21 CFR 870.1875(b) Class II Product Code: DQD, DQC Panel: Cardiovascular
1. Stethophone Pro is an electronic stethoscope that enables detection, Intended Use/ Indications for Use: amplification, filtering, and transmission of auscultation sound data (heart and lungs).

Stethophone Pro is intended to provide decision support to clinicians in their evaluation of patients' heart sounds. The software analyzes heart sounds and phonocardiograms and can automatically detect murmurs that may be present, sound timing and character, including S1, S2, and the absence of a heart murmur.

Stethophone Pro is not intended to be used as a sole means of diagnosis and is for use in environments where health care is provided by clinicians. The interpretations of heart sounds offered by the software are meant only to provide decision support to the clinician. who may use the result in conjunction with their own evaluation and clinical judgment. The interpretations are not diagnoses. Stethophone Pro is intended for use on adult patients.

1. Device Description: Stethophone Pro is an electronic stethoscope software application that operates on smartphones. Stethophone Pro is designed for use by healthcare professionals or on the order of healthcare professionals.
  Stethophone Pro 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.

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Image /page/5/Picture/1 description: The image is a logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters. To the right of the word "SPARROW" is a graphic of a bird inside of a circle with curved lines behind it. Below the word "SPARROW" is the word "ACOUSTICS" written in smaller, light blue letters.

later analysis. It also enables home users to record and send chest sounds to their physicians.

Stethophone Pro performs basic analysis of heart sounds allowing to detect the presence of murmurs, locate heartbeats on the timeline (S1/S2), and calculate timing between them.

Key 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,
. Detecting murmurs, timing for S1 and S2 sounds, and calculating heart rate,
. Selecting from three audio filters for listening:
- Bell: Traditional filter used in stethoscopes for low o frequency sounds,
  - 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.

9.	Predicate Devices:	Stethophone	Eko Murmur Analysis Software
		510(k) Number: K231551Manufacturer: Sparrow Acoustics Inc.Product Code: DQDClassification: 870.1875	510(k) Number: K213794Manufacturer: Eko Devices, Inc.Product Code: DQD, DQC, DPSClassification: 870.1875
10.	Comparison to Predicates:	The comparison chart below provides evidence to facilitate the substantial equivalence determination between Stethophone Pro to the predicate

equivalence determination between Stethophone Pro to the predicate redicates devices with respect to intended use, technological characteristics, and principles of operation.

	Stethophone Pro	Stethophone(primary)	Eko Murmur AnalysisSoftware	iPhonemodelCompatibility	6s, 6S Plus, SE 1stgeneration, 7, 7 Plus, 8, 8Plus, X, XS, XS Max, XR, SE2nd generation, 11, 11 Pro,11 Pro Max, 12, 12 Pro, 12Mini, 12 Pro Max, 13 mini,13, 13 Pro, 13 Pro Max, SE3rd generation, 14, 14 Plus,14 Pro, 14 Pro Max, 15, 15Plus, 15 Pro, 15 Pro Max	6s, 6S Plus, SE 1stgeneration, 7, 7 Plus, 8, 8Plus, X, XS, XS Max, XR,SE 2nd generation, 11, 11Pro, 11 Pro Max, 12, 12Pro, 12 Mini, 12 Pro Max,13 mini, 13, 13 Pro, 13 ProMax, SE 3rd generation,14, 14 Plus, 14 Pro, 14 ProMax, 15, 15 Plus, 15 Pro,15 Pro Max	No dependency on thesmartphone model is notedwhen used as part of EkoApp
Classification	Class II device	Class II device	Class II device	SoftwarePlatform	iOS	iOS	Available for iOS or Androidwhen used as part of EkoApp
US FDARegulation	21 CFR 870.1875(b)	21 CFR 870.1875(b)	21 CFR 870.1875(b)	Sound Type	Heart, lungs	Heart, lungs	Heart
Product code	DQD, DQC	DQD	DQD, DQC, DPS	Signal InputforProcessing	Processes chest sound andanalyzes heart sounds andphonocardiograms	Processes chest sound andanalyzes heart sounds andphonocardiograms	Processes heart sound andanalyzes heart sounds andphonocardiograms
Device	Stethoscope, Electronic	Stethoscope, Electronic	Stethoscope, Electronic	SoundProcessing	Yes	Yes	Yes
US FDA501kNumber	K240901	K231551	K213794	Ability toVisualizeSound	Spectrogram, oscillogram	Spectrogram, oscillogram	Oscillogram
IntendedUse/Indications for Use	Stethophone Pro is anelectronic stethoscope thatenables detection,amplification, filtering, andtransmission of auscultationsound data (heart and lungs).Stethophone Pro is intendedto provide decision support toclinicians in their evaluationof patients' heart sounds.The software analyzes heartsounds andphonocardiograms and canautomatically detect murmursthat may be present, soundtiming and character,including S1, S2, and theabsence of a heart murmur.Stethophone Pro is notintended to be used as a solemeans of diagnosis and is foruse in environments wherehealth care is provided byclinicians. The interpretationsof heart sounds offered bythe software are meant onlyto provide decision support tothe clinician, who may usethe result in conjunction withtheir own evaluation andclinical judgment. Theinterpretations are notdiagnoses. Stethophone Prois intended for use on adultpatients.	Stethophone is anelectronic stethoscope thatenables detection,amplification, filtering, andtransmission of auscultationsound data (heart andlungs), whereby a clinicianat one location can listen tothe auscultation sounds ofa patient acquired on site orat a different location.Stethophone is intended foruse on adult patients.Stethophone is intended tobe used by professional orlay users in a clinical ornonclinical environment.Stethophone is notintended for self-diagnosis.	The Eko Murmur AnalysisSoftware is intended toprovide decision support toclinicians in their evaluationof patients' heart sounds.The software analyzes heartsounds andphonocardiograms (and ECGsignals, when available). Thesoftware will automaticallydetect murmurs that may bepresent, and the murmurtiming and character,including S1, S2, innocentheart murmurs, structuralheart murmurs, and theabsence of a heart murmur.The Eko Murmur AnalysisSoftware is not intended as asole means of diagnosis andis for use in environmentswhere health care is providedby clinicians. Theinterpretations of heartsounds offered by thesoftware are meant only toprovide decision support tothe clinician, who may usethe result in conjunction withtheir own evaluation andclinical judgment. Theinterpretations are notdiagnoses. The Eko MurmurAnalysis Software is intendedfor use on pediatric and adultpatients.	Murmurdetection	Yes	N/A	Yes
Prescription/OTC	Prescription	Prescription and OTC	Prescription	Heart soundtiming	Yes	N/A	Yes
PopulationType	Adults	Adults	Pediatric and adults	Signal qualityassessment	Yes	N/A	Yes
Device Type	Standalone software forsmartphone	Standalone software forsmartphone	Standalone software forfurther integration via API
DedicatedDevice vs.Smartphone	Operates on smartphoneusing its hardware andoperating system	Operates on smartphoneusing its hardware andoperating system	Operates on smartphoneusing its hardware andoperating system, when usedas part of Eko App

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Image /page/6/Picture/0 description: The image is a logo for Sparrow Acoustics. The word "SPARROW" is written in a light blue sans-serif font, with a stylized image of a sparrow inside the second "R". To the right of the word "SPARROW" are three curved lines, also in light blue, that resemble sound waves. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font, with a thin line underneath.

Stethophone Pro - K240901

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Stethophone Pro - K240901

11. Performance Data:

Sparrow Acoustics Inc. submitted performance testing information in this 510(k) to demonstrate safety and efficacy of Stethophone Pro, 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 and performance tests for acoustics as well as performance tests for heart sound analysis.

For validation of its proprietary algorithms for heart sound analysis, Stethophone Pro underwent a thorough testing process to ensure its safety, reliability and effectiveness. Testing included both software verification and validation, as well as clinical validation.

Stethophone Pro algorithms for heart sound analysis have been validated in both retrospective and clinical performance testing on a combination of proprietary and public clinical data. Validation was performed after the algorithm development and training was finalized.

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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 sans-serif font. To the right of the word "SPARROW" is a stylized image of a bird inside of a circle. Below the word "SPARROW" is the word "ACOUSTICS" written in a smaller, sans-serif font.

The retrospective testing data consisted of 7,304 heart sound recordings made on 2,277 adult subjects. Of these, 4,396 recordings belonged to a proprietary dataset and were recorded using a variety of devices including smartphones as well as commercially available stethoscopes. Out of those, 45.2% were females and 54.8% were males. The age of subjects ranged from 18 to 91 years old. Ethnicity is represented by 86.1% white, 6.1% as Latino, 5.0% as Asian, and 2.7% as African American.

Each recording in a testing dataset was annotated by multiple expert cardiologists. Annotation of each recording included determining the presence of a heart murmur of any type and providing timings of all S1 and S2 heart sounds that were audible in the recording. Heart murmurs were observed in 54.2% of recordings.

There was no overlap between subjects and recordings included in the testing and training data.

The following tables demonstrate the results of device performance for the primary indicators:

Metric	Dataset	Test result
S1 precision	America	97.195% CI: (96.7 to 97.5)
	Multi-Device	96.995% CI: (96.6 to 97.3)
S1 sensitivity(recall)	America	97.395% CI: (97.0 to 97.7)
	Multi-Device	97.995% CI: (97.7 to 98.1)
S2 precision	America	97.595% CI: (97.2 to 97.9)
	Multi-Device	97.195% CI: (96.7 to 97.4)
S2 sensitivity(recall)	America	96.595% CI: (96.1 to 97.0)
	Multi-Device	97.795% CI: (97.5 to 97.9)
Murmur detection
Metric	Dataset	Test result
Sensitivity	America	88.795% CI: (87.2 to 89.8)
	Multi-Device	93.095% CI: (91.9 to 94.2)
Specificity	America	89.295% CI: (87.2 to 91.3)
	Multi-Device	94.495% CI: (93.7 to 95.4)
Accuracy	America	88.895% CI: (87.6 to 89.8)
	Multi-Device	93.895% CI: (93.2 to 94.6)
ROC AUC	America	96.995% CI: (96.1 to 97.3)
	Multi-Device	97.995% CI: (97.5 to 98.3)
Heart rate
Metric	Dataset	Test result
MAE	America	0.482 bpm95% CI: (0.418 to 0.557)
	Multi-Device	0.389 bpm95% CI: (0.346 to 0.430)

Biocompatibility 12. Not Applicable (Standalone Software) Testing:

Sterilization & Shelf-Not Applicable (Standalone Software). Therefore, it is a non-sterile life Testing: device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.

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Image /page/9/Picture/0 description: The image is a logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters. To the right of the word "SPARROW" is a circular logo with a bird inside. Below the word "SPARROW" is the word "ACOUSTICS" written in smaller, gray letters.

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 trial was not required to demonstrate the safety andeffectiveness of the device. Bench testing mentioned in thePerformance section was done using clinically collected data.
17.	Statement ofSubstantialEquivalence:	Stethophone Pro and the predicates have the same intended use andsimilar indications, technological characteristics, and principles ofoperation, and were assessed on similar performance metrics with thecomparable results. The minor differences do not present differentquestions of safety or effectiveness than the predicate device. Extensiveperformance testing was conducted for both acoustics and heart soundanalysis algorithms. Performance data demonstrates that StethophonePro is as safe and effective as the predicate devices. Thus,Stethophone Pro is substantially equivalent to the predicate devices.The minor differences in indications do not introduce a new intendeduse and do not raise different questions of safety and effectiveness.

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.