Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a multi-modal diagnostic device (ultrasound, ECG, auscultation) with image processing capabilities, but there is no mention of AI, ML, or any related technologies in the provided text. The performance studies section also indicates that clinical performance data was not required for substantial equivalence, which is often a requirement for devices incorporating AI/ML algorithms that provide diagnostic or interpretive outputs.

Therapeutic

No.
The device is described as a "general purpose diagnostic ultrasound system" and its intended use is for "assessment" via acquiring, displaying, measuring, and storing various physiological data. It does not provide any form of therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "With respect to its ultrasound imaging capabilities, KOSMOS is a general purpose diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description clearly states that KOSMOS consists of a tablet and probe, which are hardware components. It also includes accessories like an ECG cable and binaural headset. While software is involved in processing and displaying data, the device is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the KOSMOS device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens from the human body. The definition of an IVD involves testing samples like blood, urine, or tissue outside the body to provide information about a person's health.
KOSMOS is used for direct patient assessment. The intended use clearly states that KOSMOS is used for the clinical assessment of the cardiac and pulmonary systems and the abdomen by acquiring data directly from the patient through ultrasound, ECG, and digital auscultation.
The device description confirms direct patient interaction. The probe is applied to the patient's body to acquire the data.

Therefore, KOSMOS falls under the category of a medical device used for diagnostic imaging and physiological monitoring, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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, 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.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX, DQD, DPS

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 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 user-supplied clip-style electrodes affixed to the patient using the standard RA/LA/LL configuration.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiac, Thoracic/Lung, Abdominal, Peripheral Vascular

Indicated Patient Age Range

Adult and pediatric patient populations.

Intended User / Care Setting

Qualified and trained healthcare professionals in clinical care and medical education settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

An assessment of clinical performance data for KOSMOS was not required to support a determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

0

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------

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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: (425) 402-4044 E-mail: patricia.liau(@echonous.com

3. Date Prepared

December 17, 2019

1. 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

4

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
(This 510(k) submission) | GE Vscan Extend Ultrasound
System (K180995) | Eko Duo Model E5
(K170874) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) | Vscan Extend is a general purpose
diagnostic ultrasound imaging
system for use by qualified and
trained healthcare professionals
enabling visualization and
measurement of anatomical
structures and fluid. Its pocket-
sized portability and simplified
user interface enables integration
into examination and training
sessions indoors and in other
environments described in the user
manual. The information can be
used for basic/focused assessments
and adjunctively with other
medical data for clinical diagnosis
purposes during routine, periodic
monitoring, and triage.

With the phased array transducer
on the sector probe, the specific
clinical applications and exam
types include: Cardiac;
Abdominal; Renal; OB/GYN;
Urology; Fetal, Evaluation of
Presence of Fluid; Imaging
Guidance for Needle/Catheter
Placement (e.g. paracentesis,
pericardiocentesis, thoracentesis,
amniocentesis); Peripheral
Vascular Imaging (e.g. arteries
and veins); Thoracic/Lung (e.g.
pleural motion/sliding, line
artifacts); Adult Cephalic; and
Pediatrics.

With the addition of the linear
array transducer on the single dual
headed probe solution, the specific
clinical applications and exam
types are expanded to include:
Peripheral vascular imaging (e.g.
lower extremity, carotid);
Procedure Guidance for Arterial or
Venous Vessels (e.g. central lines,
upper extremity); Small Organs
(e.g. thyroid); Musculoskeletal
(Long Bone; Hip, shoulder, elbow
and Knee Joints); Evaluation of
Presence of Fluid; Thoracic/Lung
(e.g. pleural motion/sliding, line
artifacts); and Pediatrics.

Type of Use: Prescription Use
(Part 21 CFR 801 Subpart D) | The Eko Model E5 System is
intended to be used by healthcare
professionals to electronically
amplify, filter, and transfer body
sounds and single-channel
electrocardiogram (ECG)
waveforms. The Eko Model E5
System also displays ECG
waveforms and phonocardiogram
waveforms on the accompanying
mobile application for storage and
sharing (when prescribed or used
under the care of a physician). It
can be used to record heart sounds
and cardiac murmurs, bruits,
respiratory sounds, and abdominal
sounds during physical
examination in normal patients or
those with suspected diseases of
the cardiac, vascular, pulmonary,
or abdominal organ systems. The
device can be used on adults and
pediatrics.

The data offered by the device is
only significant when used in
conjunction with physician over
read as well as consideration of
other relevant patient data.

The device should not be used on
infants weighing less than 10kg.

Interventional Guidance:
Nonvascular | Phased Transducer (only):
Anatomy/ Region of Interest:
Fetal – OB/GYN
Abdominal
Pediatric
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Peripheral Vascular
Thoracic/Pleural

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Non-Clinical Performance Data 11.

KOSMOS has been designed and evaluated to comply with the following applicable FDArecognized consensus standards. All verification and validation testing for KOSMOS confirms that product specifications are met and are equivalent in design and technological and performance characteristics as the predicate devices.

ANSI AAMI ES60601-1:2005/(R)2012 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, ● C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
ANSI AAMI IEC 60601-2-27:2011(R)2016 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (limited set of test requirements)
ANSI AAMI EC53:2013 ECG Trunk Cables And Patient Leadwires (limited set of test ● requirements)
ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ANSI AAMI IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering ● to medical devices
IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment Part 2-37: Particular ● requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related

8

to medical diagnostic ultrasonic fields

ANSI AAMI IEC 62304:2006/A1:2016 Medical device software Software life cycle processes . [Including Amendment 1 (2016)]
. ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical devices -Applications of risk management to medical devices

12. Clinical Performance Data

An assessment of clinical performance data for KOSMOS was not required to support a determination of substantial equivalence.

13. Conclusion

EchoNous, Inc. considers KOSMOS to be substantially equivalent to its predicate devices with regards to intended use, technological and performance characteristics, and safety and effectiveness.