Kosmos

K212100 · EchoNous, Inc. · IYN · Aug 6, 2021 · Radiology

Device Facts

• Record ID: K212100
• Device Name: Kosmos
• Applicant: EchoNous, Inc.
• Product Code: IYN · Radiology
• Decision Date: Aug 6, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms. With respect to its ultrasound imaging capabilities, Kosmos is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular/Peripheral Vascular, Musculoskeletal, and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block) Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed-Wave (PW) Doppler, Continuous-Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging Kosmos is intended to be used in clinical care and medical education settings on adult and pediatric patient populations. The device is non-invasive, reusable, and intended to be used on one patient at a time.

Device Story

Kosmos is a diagnostic ultrasound system comprising a tablet (Kosmos Bridge or Android device) and a probe (Kosmos Torso, Torso-One, or Lexsa). The system acquires ultrasound images, ECG rhythms (via 3-lead single-channel cable), and digital auscultation sounds. Inputs are processed and displayed on the tablet; the system provides synchronized visualization of ultrasound, ECG, and DA waveforms. Used by healthcare professionals in clinical or educational settings for diagnostic assessment and interventional guidance. The device aids clinicians in real-time visualization and measurement of anatomical structures and fluid flow, supporting clinical decision-making. Benefits include portable, multi-modal diagnostic capability for focused assessments.

Clinical Evidence

No clinical data required; substantial equivalence supported by non-clinical performance data, laboratory reports, and internal testing.

Technological Characteristics

System includes tablet display and phased/linear array probes. Materials are biocompatible. Connectivity via Wi-Fi/Bluetooth. Power: Mains/rechargeable Li-ion battery. IP22 (tablet), IPX7 (probes). Software lifecycle per IEC 62304. Standards: IEC 60601-1, 60601-1-2, 60601-2-37, ISO 10993-1, ISO 14971, IEC 62366-1, IEC 62359, NEMA UD 2, AAMI EC53.

Indications for Use

Indicated for qualified healthcare professionals to perform clinical assessments in cardiac, thoracic/lung, abdominal, vascular/peripheral vascular, musculoskeletal, and interventional guidance (needle/catheter placement, fluid drainage, nerve block) using ultrasound, ECG, and digital auscultation. Used on adult and pediatric populations in clinical care and medical education settings.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Kosmos (K193518)

Reference Devices

• Vscan Air (K202035)

Submission Summary (Full Text)

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August 6, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

EchoNous, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114

Re: K212100

Trade/Device Name: Kosmos Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, DQD, DPS Dated: July 3, 2021 Received: July 6, 2021

Dear Prithul Bom:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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 (QS) 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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K212100

Device Name Kosmos

#### Indications for Use (Describe)

Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.

With respect to its ultrasound imaging capabilities, Kosmos is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation:

· Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal, and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block) · Modes of Operation: B-mode, Color Doppler, Pulsed-Wave (PW) Doppler, Continuous-Wave (CW) Doppler, Combined Modes of B+M. and B+CD. B+PW. B+CW. and Harmonic Imaging

Kosmos is intended to be used in clinical care and medical education settings on adult and pediations.

The device is non-invasive, reusable, and intended to be used on one patient at a time.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(k) Summary

As required by 21, CFR Section 807.92

## 1. Submitter

EchoNous, Inc. 8310 154th Ave NE Building B, Suite 200 Redmond, WA 98052 USA

## 2. Contact Person

Carly Hom Manager, RA/QA Telephone: [phone] E-mail: [e-mail]

# 3. Date Prepared

August 4, 2021

## 4. Device / Marketing Trade Name

Kosmos

## 5. Common / Usual Name

Diagnostic ultrasound system with integrated electronic stethoscope and electrocardiograph

## 6. Classification

Regulatory Device Class: II Classification Panel: Radiology, Cardiovascular

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| Classification Name | 21 CFR Number | Product Code |
|------------------------------------------|---------------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
| Electronic Stethoscope | 870.1875 | DQD |
| Electrocardiograph | 870.2340 | DPS |

## 7. Predicate Devices

Predicate device: Kosmos (K193518); Product Code: IYN, IYO, ITX, DOD, DPS Reference device: Vscan Air (K202035); Product Code: IYN, IYO, ITX

## 8. Device Description

Kosmos consists of a tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the user) and probe (i.e., Kosmos Torso, Torso-One, or Lexsa), which connects to the tablet via a cable. Additional components include the ECG Patient Cable and Binaural Headset for use with Kosmos Torso only. Kosmos can operate on battery or while connected to mains, when used as either handheld device or mounted to the mobile stand (i.e., AI Station 2).

The probe face houses an ultrasound transducer and sealed microphones for auscultation (Kosmos Torso only).

The tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the customer) displays clinical and patient data information including the display of ultrasound images, auscultation and ECG waveforms (when connected to Kosmos Torso), and patient data/reports. The tablet also includes speakers for sounds associated with system control and feedback. Additionally, the tablet offers a means of user control with its touchscreen display and buttons.

Although its intended operation is not dependent on Wi-Fi, Kosmos supports Wi-Fi connectivity for:

- patient data archival,
- updating the embedded Kosmos Software (Kosmos Bridge configurations only), or ●
- downloading or updating the Kosmos Software Application from the Google Play Store ● (Kosmos On Android configuration only)

Kosmos' ECG capability provides a timing reference with respect to the cardiac cycle as compared with both ultrasound imaging and digital auscultation. Ultrasound imaging, ECG, and DA are all integrated into Kosmos Torso in a time-synchronized manner.

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Kosmos' 3-lead single-channel ECG allows for the acquisition and display of a single ECG waveform (lead), which can be any one of the Lead I, or Lead III waveforms. One end of Kosmos' ECG cable connects to the probe via a custom-designed magnetic connector. The other end has three (3) RA/LA/LL leadwires to be connected to user-supplied clip-style electrodes affixed to the patient using the standard RA/LA/LL configuration.

Kosmos is an FDA-cleared medical device: however, the new AI-assisted EF Workflow and Trio tool are not yet cleared by the FDA. Instead, EchoNous is following the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020 for this new feature.

#### 9. Intended Use / Indications for Use

Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.

With respect to its ultrasound imaging capabilities, Kosmos is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation:

- Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular/Peripheral Vascular, Musculoskeletal, and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block)
- . Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed-Wave (PW) Doppler, Continuous-Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging

Kosmos is intended to be used in clinical care and medical education settings on adult and pediatric patient populations.

The device is non-invasive, reusable, and intended to be used on one patient at a time.

Type of Use: Prescription Use (Part 21 CFR 801 Subpart D)

## 10. Basis for Substantial Equivalence

Kosmos is substantially equivalent to its predicate device with regards to intended use. technological characteristics, and safety and effectiveness. A comparison between the subject device, predicate device, and reference device are provided in the table below.

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| Feature | Subject Device:<br>Kosmos (This 510(k)<br>Submission) | Predicate Device:<br>Kosmos (K193518) | Reference Device:<br>Vscan Air (K202035) | Comparison |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use / Indications for Use | Kosmos is intended to be<br>used by qualified and<br>trained healthcare<br>professionals in the<br>clinical assessment for<br>the following clinical<br>applications by acquiring,<br>processing, displaying,<br>measuring, and storing<br>ultrasound images, or<br>synchronized ultrasound<br>images,<br>electrocardiogram (ECG)<br>rhythms, and digital<br>auscultation (DA) sounds<br>and waveforms.<br><br>With respect to its<br>ultrasound imaging<br>capabilities, Kosmos is a<br>general purpose<br>diagnostic ultrasound<br>system used in the<br>following clinical<br>applications and modes<br>of operation:<br>Clinical Applications:<br>Cardiac,<br>Thoracic/Lung,<br>Abdominal,<br>Vascular/Peripheral<br>Vascular,<br>Musculoskeletal, and<br>interventional<br>guidance (includes<br>needle/catheter<br>placement, fluid<br>drainage, and nerve<br>block) Modes of Operation:<br>B-mode, M-mode,<br>Color Doppler,<br>Pulsed-Wave (PW)<br>Doppler,<br>Continuous-Wave<br>(CW) Doppler,<br>Combined Modes of<br>B+M, and B+CD,<br>B+PW, B+CW, and<br>Harmonic Imaging | Kosmos is intended to be<br>used by qualified and<br>trained healthcare<br>professionals in the clinical<br>assessment of the cardiac<br>and pulmonary systems and<br>the abdomen by acquiring,<br>processing, displaying,<br>measuring, and storing<br>synchronized ultrasound<br>images, electrocardiogram<br>(ECG) rhythms, and digital<br>auscultation (DA) sounds<br>and waveforms.<br><br>With respect to its<br>ultrasound imaging<br>capabilities, Kosmos is a<br>general purpose diagnostic<br>ultrasound system used in<br>the following clinical<br>applications and modes of<br>operation:<br>Clinical Applications:<br>Cardiac,<br>Thoracic/Lung,<br>Abdominal, Peripheral<br>Vascular, and Image<br>Guidance for<br>Needle/Catheter<br>Placement Modes of Operation:<br>B-mode, M-mode,<br>Color Doppler,<br>Combined Modes of<br>B+M and B+CD, and<br>Harmonic Imaging | Vscan Air is a battery-<br>operated software-based<br>general-purpose<br>ultrasound imaging<br>system for use by<br>qualified and trained<br>healthcare professionals<br>or practitioners that are<br>legally authorized or<br>licensed by law in the<br>country, state or other<br>local municipality in<br>which he or she practices.<br>The users may or may not<br>be working under<br>supervision or authority<br>of a physician. Users may<br>also include medical<br>students working under<br>the supervision or<br>authority of a physician<br>during their education /<br>training. The device is<br>enabling visualization and<br>measurement of<br>anatomical structures and<br>fluid including blood<br>flow.<br><br>Vscan Air's pocket-sized<br>portability and simplified<br>user interface enables<br>integration into training<br>sessions and examinations<br>in professional healthcare<br>facilities (ex. Hospital,<br>clinic, medical office),<br>home environment,<br>road/air ambulance and<br>other environments as<br>described in the user<br>manual. The information<br>can be used for<br>basic/focused assessments<br>and adjunctively with<br>other medical data for<br>clinical diagnosis<br>purposes during routine,<br>periodic follow-up, and<br>triage.<br><br>Vscan Air supports Black/<br>white (B-mode), Color<br>flow (Color doppler),<br>Combined (B + Color<br>Doppler) and Harmonic<br>imaging modes with both<br>the curved and linear | Addition of the following<br>Clinical Applications:<br>Vascular Musculoskeletal Fluid Drainage Nerve Block Addition of the following<br>modes of operation:<br>Pulsed-Wave (PW) Doppler Continuous-Wave<br>(CW) Doppler Combined Modes of<br>B+PW and B+CW |
| | Kosmos is intended to be<br>used in clinical care and<br>medical education<br>settings on adult and<br>pediatric patient<br>populations. | Kosmos is intended to be<br>used in clinical care and<br>medical education settings<br>on adult and pediatric<br>patient populations. The<br>device is non-invasive,<br>reusable, and intended to<br>be used on one patient at a<br>time.<br><br>Type of Use: Prescription<br>Use (Part 21 CFR 801<br>Subpart D) | | |
| Feature | Subject Device:<br>Kosmos (This 510(k) Submission) | Predicate Device:<br>Kosmos (K193518) | Reference Device:<br>Vscan Air (K202035) | Comparison |
| | The device is non-invasive, reusable, and intended to be used on one patient at a time.<br><br>Type of Use:<br>Prescription Use (Part 21 CFR 801 Subpart D) | | array transducers.<br><br>With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional), pediatrics, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).<br><br>With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, ophthalmic, pediatrics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).<br><br>Type of Use: Prescription Use (Part 21 CFR 801 Subpart D) | |
| Ultrasound Substantial Equivalence (Technological Characteristics) | | | | |
| Transducer Types | Phased Array Linear Array | Phased Array | Curved Array Linear Array | Addition of Linear Array Transducer |
| Feature | Subject Device:<br>Kosmos (This 510(k)<br>Submission) | Predicate Device:<br>Kosmos (K193518) | Reference Device:<br>Vscan Air (K202035) | Comparison |
| Clinical<br>Applications | Phased Array<br>Transducer:<br>Anatomy/ Region of<br>Interest:<br>AbdominalPediatricCardiac AdultCardiac PediatricPeripheral VascularThoracic/Lung<br>Interventional Guidance:<br>Nonvascular<br>Linear Array<br>Transducer:<br>Anatomy/ Region of<br>Interest:<br>Vascular/Peripheral<br>VascularMusculoskeletal<br>Interventional guidance<br>Needle/catheter<br>placementFluid drainageNerve block | Phased Array<br>Transducer:<br>Anatomy/ Region of<br>Interest:<br>AbdominalPediatricCardiac AdultCardiac PediatricPeripheral VascularThoracic/Lung<br>Interventional Guidance:<br>Nonvascular | Linear Array<br>Transducer:<br>Anatomy/ Region of<br>Interest:<br>Vascular/peripheral<br>vascularMusculoskeletal<br>(conventional and<br>superficial)Small organsThoracic/lungOphthalmicPediatricsNeonatal cephalic<br>Interventional guidance<br>Free hand<br>needle/catheter<br>placementFluid drainageNerve blockVascular access and<br>biopsy | Remains unchanged<br><br>Addition of Linear Array<br>Transducer Clinical<br>Applications |
| Transducer<br>Frequency | Phased Array<br>Transducer:<br>1.5 - 4.5 MHz with center<br>frequency 3Hz<br><br>Linear Array<br>Transducer:<br>4-11 MHz with center<br>frequency 7.5 MHz | Phased Array<br>Transducer:<br>1.5 - 4.5 MHz with center<br>frequency 3Hz | Linear Array<br>Transducer :<br>3-12 MHz with center<br>frequency of 7.7 MHz | Remains unchanged<br><br>Addition of technological<br>characteristics for Linear<br>Array Transducer |
| Modes of<br>Operation | Phased Array<br>Transducer:<br>B-modeM-modeColor Doppler | Phased Array<br>Transducer:<br>B-modeM-modeColor Doppler | | Addition of the following<br>modes of operation:<br>Pulsed-Wave (PW)<br>DopplerContinuous-Wave |
| Feature | Subject Device:<br>Kosmos (This 510(k)<br>Submission) | Predicate Device:<br>Kosmos (K193518) | Reference Device:<br>Vscan Air (K202035) | Comparison |
| | Pulsed-Wave (PW) Doppler Continuous-Wave (CW) Doppler Combined Modes:<br>B+M, B+CD,<br>B+PW, and B+CW Harmonic Imaging | Combination Modes:<br>B+M, B+CD Harmonic Imaging | | (CW) Doppler<br>Combined Modes:<br>B+PW and B+CW |
| | Linear Array<br>Transducer:<br>B-mode | | Linear Array<br>Transducer:<br>B-mode Color Doppler Combined Modes of<br>B + CD Harmonic Imaging | Addition of Linear Array<br>Transducer B-mode |
| 510(k) Track | Phased Array<br>Transducer:<br>Track 3 | Phased Array<br>Transducer:<br>Track 3 | | Remains unchanged |
| | Linear Array<br>Transducer:<br>Track 3 | | Linear Array<br>Transducer:<br>Track 3 | Remains unchanged |
| | DA (Digital Auscultation) and ECG Substantial Equivalence (Technological Characteristics) | | | |
| DA Pickup<br>Sensor and<br>Processing | Audio microphone +<br>digital signal processing<br>Sampling Rate: 12.7 kHz…