Stethophone

K240901 · Sparrow Acoustics, Inc. · DQD · Sep 19, 2024 · Cardiovascular

Device Facts

• Record ID: K240901
• Device Name: Stethophone
• Applicant: Sparrow Acoustics, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Sep 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

Stethophone Pro is an electronic stethoscope that enables detection, 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 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 Story

Stethophone Pro is a smartphone-based electronic stethoscope software application. It utilizes the smartphone microphone to capture, amplify, and filter chest sounds (heart and lungs). The device provides real-time listening, recording, and cloud storage capabilities. It features three audio filters (Bell, Diaphragm, Starling) and visualizes sounds via oscillograms and spectrograms. The software performs automated analysis of heart sounds and phonocardiograms to detect murmurs, identify S1/S2 timing, and calculate heart rate. Used by healthcare professionals in clinical/non-clinical settings or by home users to record and transmit sounds to physicians. The output serves as decision support for clinicians to aid in physical examinations, monitoring, and telemedicine consultations. It does not provide a diagnosis; clinicians integrate findings with their own clinical judgment.

Clinical Evidence

Bench testing using retrospective clinical data. Dataset included 7,304 heart sound recordings from 2,277 adult subjects (18-91 years old). Murmur detection sensitivity: 88.7-93.0%; specificity: 89.2-94.4%; ROC AUC: 96.9-97.9%. S1/S2 timing precision and sensitivity >96%. Heart rate MAE <0.5 bpm. No clinical trial required.

Technological Characteristics

Standalone software application operating on smartphone hardware. Utilizes smartphone microphone for signal input. Features digital signal processing for audio filtering (Bell, Diaphragm, Starling) and visualization (oscillogram, spectrogram). Proprietary algorithms for heart sound analysis. Cloud-based storage and transmission capabilities. Non-sterile, no electrical/EMC components.

Indications for Use

Indicated for adult patients to assist clinicians in the evaluation of heart sounds via detection, filtering, and transmission of auscultation data. Provides decision support for murmur detection and S1/S2 timing/character. Not for sole diagnostic use.

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

• Stethophone (K231551)
• Eko Murmur Analysis Software (K213794)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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).

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.

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

| <div> <span> <b> <span style="font-size:16px">☑</span> </b> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> <b> <span style="font-size:16px">☐</span> </b> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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Image /page/4/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" are three concentric circles, with a small bird silhouette in the center. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font, with a thin line underneath.

## 510(k) SUMMARY

- 1. Summary Date: September 18, 2024
- 2. Submitter: Sparrow Acoustics Inc. 2416 Natura Dr. Lucasville, NS Canada, B4B 0X3 Tel: [phone]
- 3. Correspondent: Nadia Ivanova
- 4. Device Trade Name: Stethophone Pro
- 5. Device Common Smartphone stethoscope Name:
- റ. Classification: Electronic Stethoscope 21 CFR 870.1875(b) Class II Product Code: DQD, DQC Panel: Cardiovascular
- 7. 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.

- 8. 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

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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 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, 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.

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.

| 9. | Predicate Devices: | Stethophone | Eko Murmur Analysis Software |
|-----|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| | | 510(k) Number: K231551<br>Manufacturer: Sparrow Acoustics Inc.<br>Product Code: DQD<br>Classification: 870.1875 | 510(k) Number: K213794<br>Manufacturer: Eko Devices, Inc.<br>Product Code: DQD, DQC, DPS<br>Classification: 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<br>(primary) | Eko Murmur Analysis<br>Software | iPhone<br>model<br>Compatibility | 6s, 6S Plus, SE 1st<br>generation, 7, 7 Plus, 8, 8<br>Plus, X, XS, XS Max, XR, SE<br>2nd generation, 11, 11 Pro,<br>11 Pro Max, 12, 12 Pro, 12<br>Mini, 12 Pro Max, 13 mini,<br>13, 13 Pro, 13 Pro Max, SE<br>3rd generation, 14, 14 Plus,<br>14 Pro, 14 Pro Max, 15, 15<br>Plus, 15 Pro, 15 Pro Max | 6s, 6S Plus, SE 1st<br>generation, 7, 7 Plus, 8, 8<br>Plus, X, XS, XS Max, XR,<br>SE 2nd generation, 11, 11<br>Pro, 11 Pro Max, 12, 12<br>Pro, 12 Mini, 12 Pro Max,<br>13 mini, 13, 13 Pro, 13 Pro<br>Max, SE 3rd generation,<br>14, 14 Plus, 14 Pro, 14 Pro<br>Max, 15, 15 Plus, 15 Pro,<br>15 Pro Max | No dependency on the<br>smartphone model is noted<br>when used as part of Eko<br>App |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Classification | Class II device | Class II device | Class II device | Software<br>Platform | iOS | iOS | Available for iOS or Android<br>when used as part of Eko<br>App |
| US FDA<br>Regulation | 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 Input<br>for<br>Processing | Processes chest sound and<br>analyzes heart sounds and<br>phonocardiograms | Processes chest sound and<br>analyzes heart sounds and<br>phonocardiograms | Processes heart sound and<br>analyzes heart sounds and<br>phonocardiograms |
| Device | Stethoscope, Electronic | Stethoscope, Electronic | Stethoscope, Electronic | Sound<br>Processing | Yes | Yes | Yes |
| US FDA<br>501k<br>Number | K240901 | K231551 | K213794 | Ability to<br>Visualize<br>Sound | Spectrogram, oscillogram | Spectrogram, oscillogram | Oscillogram |
| Intended<br>Use/Indicatio<br>ns for Use | Stethophone Pro is an<br>electronic stethoscope that<br>enables detection,<br>amplification, filtering, and<br>transmission of auscultation<br>sound data (heart and lungs).<br>Stethophone Pro is intended<br>to provide decision support to<br>clinicians in their evaluation<br>of patients' heart sounds.<br>The software analyzes heart<br>sounds and<br>phonocardiograms and can<br>automatically detect murmurs<br>that may be present, sound<br>timing and character,<br>including S1, S2, and the<br>absence of a heart murmur.<br>Stethophone Pro is not<br>intended to be used as a sole<br>means of diagnosis and is for<br>use in environments where<br>health care is provided by<br>clinicians. The interpretations<br>of heart sounds offered by<br>the software are meant only<br>to provide decision support to<br>the clinician, who may use<br>the result in conjunction with<br>their own evaluation and<br>clinical judgment. The<br>interpretations are not<br>diagnoses. Stethophone Pro<br>is intended for use on adult<br>patients. | Stethophone is an<br>electronic stethoscope that<br>enables detection,<br>amplification, filtering, and<br>transmission of auscultation<br>sound data (heart and<br>lungs), whereby a clinician<br>at one location can listen to<br>the auscultation sounds of<br>a patient acquired on site or<br>at a different location.<br>Stethophone is intended for<br>use on adult patients.<br>Stethophone is intended to<br>be used by professional or<br>lay users in a clinical or<br>nonclinical environment.<br>Stethophone is not<br>intended for self-diagnosis. | The Eko Murmur Analysis<br>Software is intended to<br>provide decision support to<br>clinicians in their evaluation<br>of patients' heart sounds.<br>The software analyzes heart<br>sounds and<br>phonocardiograms (and ECG<br>signals, when available). The<br>software will automatically<br>detect murmurs that may be<br>present, and the murmur<br>timing and character,<br>including S1, S2, innocent<br>heart murmurs, structural<br>heart murmurs, and the<br>absence of a heart murmur.<br>The Eko Murmur Analysis<br>Software is not intended as a<br>sole means of diagnosis and<br>is for use in environments<br>where health care is provided<br>by clinicians. The<br>interpretations of heart<br>sounds offered by the<br>software are meant only to<br>provide decision support to<br>the clinician, who may use<br>the result in conjunction with<br>their own evaluation and<br>clinical judgment. The<br>interpretations are not<br>diagnoses. The Eko Murmur<br>Analysis Software is intended<br>for use on pediatric and adult<br>patients. | Murmur<br>detection | Yes | N/A | Yes |
| Prescription/<br>OTC | Prescription | Prescription and OTC | Prescription | Heart sound<br>timing | Yes | N/A | Yes |
| Population<br>Type | Adults | Adults | Pediatric and adults | Signal quality<br>assessment | Yes | N/A | Yes |
| Device Type | Standalone software for<br>smartphone | Standalone software for<br>smartphone | Standalone software for<br>further integration via API | | | | |
| Dedicated<br>Device vs.<br>Smartphone | Operates on smartphone<br>using its hardware and<br>operating system | Operates on smartphone<br>using its hardware and<br>operating system | Operates on smartphone<br>using its hardware and<br>operating system, when used<br>as 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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Image /page/7/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 is a circular graphic with a bird inside. Below the word "SPARROW" is the word "ACOUSTICS" in smaller letters.

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 | 97.1<br>95% CI: (96.7 to 97.5) |
| | Multi-Device | 96.9<br>95% CI: (96.6 to 97.3) |
| S1 sensitivity<br>(recall) | America | 97.3<br>95% CI: (97.0 to 97.7) |
| | Multi-Device | 97.9<br>95% CI: (97.7 to 98.1) |
| S2 precision | America | 97.5<br>95% CI: (97.2 to 97.9) |
| | Multi-Device | 97.1<br>95% CI: (96.7 to 97.4) |
| S2 sensitivity<br>(recall) | America | 96.5<br>95% CI: (96.1 to 97.0) |
| | Multi-Device | 97.7<br>95% CI: (97.5 to 97.9) |
| Murmur detection | | |
| Metric | Dataset | Test result |
| Sensitivity | America | 88.7<br>95% CI: (87.2 to 89.8) |
| | Multi-Device | 93.0<br>95% CI: (91.9 to 94.2) |
| Specificity | America | 89.2<br>95% CI: (87.2 to 91.3) |
| | Multi-Device | 94.4<br>95% CI: (93.7 to 95.4) |
| Accuracy | America | 88.8<br>95% CI: (87.6 to 89.8) |
| | Multi-Device | 93.8<br>95% CI: (93.2 to 94.6) |
| ROC AUC | America | 96.9<br>95% CI: (96.1 to 97.3) |
| | Multi-Device | 97.9<br>95% CI: (97.5 to 98.3) |
| Heart rate | | |
| Metric | Dataset | Test result |
| MAE | America | 0.482 bpm<br>95% CI: (0.418 to 0.557) |
| | Multi-Device | 0.389 bpm<br>95% CI: (0.346 to 0.430) |

- Biocompatibility 12. Not Applicable (Standalone Software) Testing:
13. 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 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 trial was not required to demonstrate the safety and<br>effectiveness of the device. Bench testing mentioned in the<br>Performance section was done using clinically collected data. |
| 17. | Statement of<br>Substantial<br>Equivalence: | Stethophone Pro and the predicates have the same intended use and<br>similar indications, technological characteristics, and principles of<br>operation, and were assessed on similar performance metrics with the<br>comparable results. The minor differences do not present different<br>questions of safety or effectiveness than the predicate device. Extensive<br>performance testing was conducted for both acoustics and heart sound<br>analysis algorithms. Performance data demonstrates that Stethophone<br>Pro is as safe and effective as the predicate devices. Thus,<br>Stethophone Pro is substantially equivalent to the predicate devices.<br>The minor differences in indications do not introduce a new intended<br>use 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.