KOSMOS

K193518 · EchoNous, Inc. · IYN · Mar 26, 2020 · Radiology

Device Facts

• Record ID: K193518
• Device Name: KOSMOS
• Applicant: EchoNous, Inc.
• Product Code: IYN · Radiology
• Decision Date: Mar 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

KOSMOS is intended to be used by qualified and trained healthcare professionals in the clinical assessment of the cardiac and pulmonary systems and the abdomen by acquiring, processing, displaying, measuring, and storing 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, Peripheral Vascular, and Image Guidance for Needle/Catheter Placement - Modes of Operation: B-mode, M-mode, Color Doppler, Combined Modes of B+M and B+CD, 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 handheld diagnostic system comprising a tablet and a cable-connected probe. The probe integrates an ultrasound transducer, microphones for digital auscultation (DA), and a 3-lead single-channel ECG interface. The device acquires synchronized ultrasound images, DA sounds, and ECG waveforms. The tablet displays these inputs, allowing clinicians to perform measurements and store data. Used in clinical care and medical education settings, the device is operated by healthcare professionals. The system supports Wi-Fi for data archival but does not require it for operation. By providing time-synchronized multimodal data, KOSMOS assists clinicians in focused assessments and clinical diagnosis, potentially improving diagnostic efficiency and patient management.

Clinical Evidence

No clinical data was required to support the determination of substantial equivalence. Bench testing only.

Technological Characteristics

System includes a tablet and probe. Probe materials: RTV silicone 664 (lens), Polysulfone (housing), RTV silicone 832 (joint). ECG leadwires: Thermoplastic urethane. Ultrasound: Phased array, 1.5–4.5 MHz, B/M-mode, Color Doppler, Harmonic Imaging. DA: 12.7 kHz sampling, 50–600 Hz filter, 20 dB analog gain. Connectivity: Wi-Fi (802.11 b/g/n/ac), DICOM. Power: Mains/rechargeable Li-ion battery. IP ratings: Tablet IP22, Probe IPX7.

Indications for Use

Indicated for qualified healthcare professionals to assess cardiac, pulmonary, and abdominal systems in adult and pediatric patients. Used for ultrasound imaging, ECG rhythm monitoring, and digital auscultation. Contraindications not specified.

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

• GE Vscan Extend (K180995)
• Eko Duo Model E5 (K170874)

Submission Summary (Full Text)

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March 26, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

EchoNous, Inc. % Ms. Trish Liau Regulatory Affairs Manager 8310 154th Avenue NE, Bldg B., Suite 200 REDMOND WA 98052

Re: K193518

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: February 29, 2020 Received: March 3, 2020

Dear Ms. Liau:

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/cfpmp/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); 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

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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 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-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) K193518

Device Name KOSMOS

Indications for Use (Describe)

KOSMOS is intended to be used by qualified and trained healthcare professionals in the clinical assessment of the cardiac and pulmonary systems and the abdomen by acquiring, displaying, measuring, and storing 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, Peripheral Vascular, and Image Guidance for Needle/Catheter Placement
- . Modes of Operation: B-mode, Color Doppler, Combined Modes of B+M and B+CD, 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 (Select one or both, as applicable) | <span> <span style="padding-right: 20px;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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## K193518

#### 1. Submitter

EchoNous, Inc. 8310 154th Ave NE Bldg B. Ste 200 Redmond, WA 98052 USA

#### 2. Contact Person

Trish Liau Regulatory Affairs Manager Telephone: [phone] E-mail: patricia.liau(@echonous.com

#### 3. Date Prepared

December 17, 2019

- 4. Device / Marketing Trade Name KOSMOS (subject to change)
#### ર. Common / Usual Name

Diagnostic ultrasound system with integrated electronic stethoscope and electrocardiograph

#### 6. Classification

Regulatory Device Class: II Classification Panel: Radiology, Cardiovascular

| 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

Primary predicate device: GE Vscan Extend (K180995); Product Code: IYN, IYO, ITX Secondary predicate device: Eko Duo Model E5 (K170874); Product Code: DQD, DPS

#### 8. Device Description

KOSMOS consists of a tablet and probe, which connects to the tablet via a cable. Its accessories include a power charger, ECG cable, and binaural headset. KOSMOS can operate on battery or while connected to mains.

The probe face houses an ultrasound transducer and sealed microphones for auscultation. The tablet can display clinical and patient data information including the display of ultrasound images, auscultation and ECG waveforms, and patient data/reports. The

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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.

The tablet can be positioned on a flat surface close to the patient while the user holds the probe with one hand to scan the patient. The user's other hand is then free to interact with the tablet using its touchscreen and buttons. The user can also hold the tablet in one hand and the probe in the other hand to scan the patient.

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 the probe in a time-synchronized manner.

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 II, or Lead III waveforms. One end of the 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 usersupplied clip-style electrodes affixed to the patient using the standard RA/LA/LL configuration.

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

KOSMOS is intended to be used by qualified and trained healthcare professionals in the clinical assessment of the cardiac and pulmonary systems and the abdomen by acquiring. processing, displaying, measuring, and storing 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, Peripheral Vascular, and Image Guidance for Needle/Catheter Placement
- Modes of Operation: B-mode, M-mode, Color Doppler, Combined Modes of B+M ● and B+CD, 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)

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### 10. Basis for Substantial Equivalence

KOSMOS is substantially equivalent to its predicate devices with regards to intended use, technological characteristics, and safety and effectiveness. A comparison table is provided below.

| Feature | KOSMOS System<br>(This 510(k) submission) | GE Vscan Extend Ultrasound<br>System (K180995) | Eko Duo Model E5<br>(K170874) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | KOSMOS is intended to be used<br>by qualified and trained healthcare<br>professionals in the clinical<br>assessment of the cardiac and<br>pulmonary systems and the<br>abdomen by acquiring, processing,<br>displaying, measuring, and storing<br>synchronized ultrasound images,<br>electrocardiogram (ECG) rhythms,<br>and digital auscultation (DA)<br>sounds and waveforms.<br><br>With respect to its ultrasound<br>imaging capabilities, KOSMOS is<br>a general purpose diagnostic<br>ultrasound system used in the<br>following clinical applications and<br>modes of operation:<br>• Clinical Applications: Cardiac,<br>Thoracic/Lung, Abdominal,<br>Peripheral Vascular, and Image<br>Guidance for Needle/Catheter<br>Placement<br>• Modes of Operation: B-mode,<br>M-mode, Color Doppler,<br>Combined Modes of B+M and<br>B+CD, and Harmonic Imaging<br><br>KOSMOS is intended to be used<br>in clinical care and medical<br>education settings on adult and<br>pediatric patient populations.<br><br>The device is non-invasive,<br>reusable, and intended to be used<br>on one patient at a time.<br><br>Type of Use: Prescription Use<br>(Part 21 CFR 801 Subpart D) | Vscan Extend is a general purpose<br>diagnostic ultrasound imaging<br>system for use by qualified and<br>trained healthcare professionals<br>enabling visualization and<br>measurement of anatomical<br>structures and fluid. Its pocket-<br>sized portability and simplified<br>user interface enables integration<br>into examination and training<br>sessions indoors and in other<br>environments described in the user<br>manual. The information can be<br>used for basic/focused assessments<br>and adjunctively with other<br>medical data for clinical diagnosis<br>purposes during routine, periodic<br>monitoring, and triage.<br><br>With the phased array transducer<br>on the sector probe, the specific<br>clinical applications and exam<br>types include: Cardiac;<br>Abdominal; Renal; OB/GYN;<br>Urology; Fetal, Evaluation of<br>Presence of Fluid; Imaging<br>Guidance for Needle/Catheter<br>Placement (e.g. paracentesis,<br>pericardiocentesis, thoracentesis,<br>amniocentesis); Peripheral<br>Vascular Imaging (e.g. arteries<br>and veins); Thoracic/Lung (e.g.<br>pleural motion/sliding, line<br>artifacts); Adult Cephalic; and<br>Pediatrics.<br><br>With the addition of the linear<br>array transducer on the single dual<br>headed probe solution, the specific<br>clinical applications and exam<br>types are expanded to include:<br>Peripheral vascular imaging (e.g.<br>lower extremity, carotid);<br>Procedure Guidance for Arterial or<br>Venous Vessels (e.g. central lines,<br>upper extremity); Small Organs<br>(e.g. thyroid); Musculoskeletal<br>(Long Bone; Hip, shoulder, elbow<br>and Knee Joints); Evaluation of<br>Presence of Fluid; Thoracic/Lung<br>(e.g. pleural motion/sliding, line<br>artifacts); and Pediatrics.<br><br>Type of Use: Prescription Use<br>(Part 21 CFR 801 Subpart D) | The Eko Model E5 System is<br>intended to be used by healthcare<br>professionals to electronically<br>amplify, filter, and transfer body<br>sounds and single-channel<br>electrocardiogram (ECG)<br>waveforms. The Eko Model E5<br>System also displays ECG<br>waveforms and phonocardiogram<br>waveforms on the accompanying<br>mobile application for storage and<br>sharing (when prescribed or used<br>under the care of a physician). It<br>can be used to record heart sounds<br>and cardiac murmurs, bruits,<br>respiratory sounds, and abdominal<br>sounds during physical<br>examination in normal patients or<br>those with suspected diseases of<br>the cardiac, vascular, pulmonary,<br>or abdominal organ systems. The<br>device can be used on adults and<br>pediatrics.<br><br>The data offered by the device is<br>only significant when used in<br>conjunction with physician over<br>read as well as consideration of<br>other relevant patient data.<br><br>The device should not be used on<br>infants weighing less than 10kg.<br><br>Type of Use: Prescription Use (Part<br>21 CFR 801 Subpart D) |
| Feature | KOSMOS System<br>(This 510(k) submission) | GE Vscan Extend Ultrasound<br>System (K180995) | Eko Duo Model E5<br>(K170874) |
| | Ultrasound Substantial Equivalence (Technological Characteristics) | | |
| Transducer Types | Phased Array | Phased Array<br>Linear Array | |
| Clinical<br>Applications | Phased Transducer:<br>Anatomy/ Region of Interest:<br>Abdominal<br>Pediatric<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral Vascular<br>Thoracic/Lung<br><br>Interventional Guidance:<br>Nonvascular | Phased Transducer (only):<br>Anatomy/ Region of Interest:<br>Fetal – OB/GYN<br>Abdominal<br>Pediatric<br>Adult Cephalic<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral Vascular<br>Thoracic/Pleural<br><br>Interventional Guidance:<br>Nonvascular | |
| Transducer<br>Frequency | 1.5 – 4.5 MHz | 1.7 – 3.8 MHz | |
| Modes of<br>Operation | 2D / B-mode<br>M-mode<br>Color Doppler<br>Combination Modes<br>Harmonic Imaging | 2D / B-mode<br>Color Doppler<br>Combination Modes<br>Harmonic Imaging | |
| PW Doppler | Not available | Not available | Not available |
| CW Doppler | Not available | Not available | Not available |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
| | DA and ECG Substantial Equivalence (Technological Characteristics) | | |
| DA Pickup<br>Sensor and<br>Processing | Audio microphone + digital signal<br>processing<br>Sampling Rate: 12.7 kHz | | Audio microphone + digital signal<br>processing<br>Sampling Rate: 4000 Hz |
| DA Filter Modes | Heart/Midrange (50 – 600 Hz) | | Diaphragm (100 – 500 Hz), Bell<br>(20 – 200 Hz, Midrange (50 – 500<br>Hz), Extended ((20 - 2000 Hz) |
| DA Sound<br>Amplification | Analog gain: 20 dB; Digital gain:<br>user adjustable up to 25 dB | | Amplifies up to 60x |
| DA Volume<br>Control | Yes; 15 volume steps available | | Yes; 12 volume setti…