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.

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

AI/ML Overview

The provided text is a 510(k) premarket notification for the KOSMOS device. It details the device's technical specifications and its comparison to predicate devices to demonstrate substantial equivalence, but it does not contain a study proving the device meets specific acceptance criteria based on clinical performance data.

Section 12 explicitly states: "An assessment of clinical performance data for KOSMOS was not required to support a determination of substantial equivalence." This means that the FDA did not require clinical study data to clear this device for market, and therefore, the document does not include information about acceptance criteria for clinical performance, the reported device performance against those criteria, or details regarding the design and execution of such a clinical study.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study details.
Standalone performance details.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This information is typically found in clinical study reports, which are
not present in this 510(k) summary given the FDA's "not required" determination for clinical performance data in this instance. The substantial equivalence determination was based on technological characteristics and safety data, as detailed in Section 10 and 11 of the provided document.

Summary

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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 (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)

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

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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.

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 UltrasoundSystem (K180995)	Eko Duo Model E5(K170874)
Intended Use /Indications forUse	KOSMOS is intended to be usedby qualified and trained healthcareprofessionals in the clinicalassessment of the cardiac andpulmonary systems and theabdomen by acquiring, processing,displaying, measuring, and storingsynchronized ultrasound images,electrocardiogram (ECG) rhythms,and digital auscultation (DA)sounds and waveforms.With respect to its ultrasoundimaging capabilities, KOSMOS isa general purpose diagnosticultrasound system used in thefollowing clinical applications andmodes of operation:• Clinical Applications: Cardiac,Thoracic/Lung, Abdominal,Peripheral Vascular, and ImageGuidance for Needle/CatheterPlacement• Modes of Operation: B-mode,M-mode, Color Doppler,Combined Modes of B+M andB+CD, and Harmonic ImagingKOSMOS is intended to be usedin clinical care and medicaleducation settings on adult andpediatric patient populations.The device is non-invasive,reusable, and intended to be usedon one patient at a time.Type of Use: Prescription Use(Part 21 CFR 801 Subpart D)	Vscan Extend is a general purposediagnostic ultrasound imagingsystem for use by qualified andtrained healthcare professionalsenabling visualization andmeasurement of anatomicalstructures and fluid. Its pocket-sized portability and simplifieduser interface enables integrationinto examination and trainingsessions indoors and in otherenvironments described in the usermanual. The information can beused for basic/focused assessmentsand adjunctively with othermedical data for clinical diagnosispurposes during routine, periodicmonitoring, and triage.With the phased array transduceron the sector probe, the specificclinical applications and examtypes include: Cardiac;Abdominal; Renal; OB/GYN;Urology; Fetal, Evaluation ofPresence of Fluid; ImagingGuidance for Needle/CatheterPlacement (e.g. paracentesis,pericardiocentesis, thoracentesis,amniocentesis); PeripheralVascular Imaging (e.g. arteriesand veins); Thoracic/Lung (e.g.pleural motion/sliding, lineartifacts); Adult Cephalic; andPediatrics.With the addition of the lineararray transducer on the single dualheaded probe solution, the specificclinical applications and examtypes are expanded to include:Peripheral vascular imaging (e.g.lower extremity, carotid);Procedure Guidance for Arterial orVenous Vessels (e.g. central lines,upper extremity); Small Organs(e.g. thyroid); Musculoskeletal(Long Bone; Hip, shoulder, elbowand Knee Joints); Evaluation ofPresence of Fluid; Thoracic/Lung(e.g. pleural motion/sliding, lineartifacts); and Pediatrics.Type of Use: Prescription Use(Part 21 CFR 801 Subpart D)	The Eko Model E5 System isintended to be used by healthcareprofessionals to electronicallyamplify, filter, and transfer bodysounds and single-channelelectrocardiogram (ECG)waveforms. The Eko Model E5System also displays ECGwaveforms and phonocardiogramwaveforms on the accompanyingmobile application for storage andsharing (when prescribed or usedunder the care of a physician). Itcan be used to record heart soundsand cardiac murmurs, bruits,respiratory sounds, and abdominalsounds during physicalexamination in normal patients orthose with suspected diseases ofthe cardiac, vascular, pulmonary,or abdominal organ systems. Thedevice can be used on adults andpediatrics.The data offered by the device isonly significant when used inconjunction with physician overread as well as consideration ofother relevant patient data.The device should not be used oninfants weighing less than 10kg.Type of Use: Prescription Use (Part21 CFR 801 Subpart D)
Feature	KOSMOS System(This 510(k) submission)	GE Vscan Extend UltrasoundSystem (K180995)	Eko Duo Model E5(K170874)
	Ultrasound Substantial Equivalence (Technological Characteristics)
Transducer Types	Phased Array	Phased ArrayLinear Array
ClinicalApplications	Phased Transducer:Anatomy/ Region of Interest:AbdominalPediatricCardiac AdultCardiac PediatricPeripheral VascularThoracic/LungInterventional Guidance:Nonvascular	Phased Transducer (only):Anatomy/ Region of Interest:Fetal – OB/GYNAbdominalPediatricAdult CephalicCardiac AdultCardiac PediatricPeripheral VascularThoracic/PleuralInterventional Guidance:Nonvascular
TransducerFrequency	1.5 – 4.5 MHz	1.7 – 3.8 MHz
Modes ofOperation	2D / B-modeM-modeColor DopplerCombination ModesHarmonic Imaging	2D / B-modeColor DopplerCombination ModesHarmonic 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 PickupSensor andProcessing	Audio microphone + digital signalprocessingSampling Rate: 12.7 kHz		Audio microphone + digital signalprocessingSampling Rate: 4000 Hz
DA Filter Modes	Heart/Midrange (50 – 600 Hz)		Diaphragm (100 – 500 Hz), Bell(20 – 200 Hz, Midrange (50 – 500Hz), Extended ((20 - 2000 Hz)
DA SoundAmplification	Analog gain: 20 dB; Digital gain:user adjustable up to 25 dB		Amplifies up to 60x
DA VolumeControl	Yes; 15 volume steps available		Yes; 12 volume settings
DA AmbientNoise Reduction	Yes		Yes
DA DirectListening	Sounds can be listened to in realtime using a digital-to-analogbinaural headset		Digital-only sound mode
ECG Non-ContinuousMonitoring Leads	3-lead, single-channel, user-supplied commercial electrodes		Single-channel, 2 stainless steelelectrodes
ECG AnatomicalSites	Chest (torso) and Leg		Chest
ECG Leadwiresand TrunkAssembly	Combines trunk cable and threeleadwires into a single, non-sterile,reusable assembly that forms aconduction channel fortransmitting signals from user-supplied clip-style electrodesaffixed to patient skin to theKosmos Torso (probe)		No
DA and ECGVisualization	Sounds and ECG waveforms canbe visualized and recorded on theKosmos Bridge (tablet) with orwithout an internet connection		Sounds and ECG tracings can bevisualized on a Bluetooth deviceusing the Eko App. The app can beused to visualize waveforms andtracings without an internetconnection; however an internetconnection is necessary to save thedata.
Feature	KOSMOS System(This 510(k) submission)	GE Vscan Extend UltrasoundSystem (K180995)	Eko Duo Model E5(K170874)
System Characteristics
Dimensions andWeight	Handheld tablet display unit(proprietary): 146 x 216 x 59 mm,657 gDisplay: 8"Probe: 150 x 56 x 35 mm, 260 g	Handheld tablet display unit(proprietary): 168 x 76 x 22 mm,321 gDisplay: 12.7 cm, 720 x 1280 pixels resolutionSector probe: 129 x 32 x 25 mm, 85 gDual probe: 129 x 39 x 38 mm, 120 g	Handheld Unit: 119 x 47 x 16 mmWeight: 208 g
Power Source	Mains and battery operated(rechargeable lithium ion battery)	Battery operated	Battery operated (rechargeablelithium ion battery)
Patient ContactMaterials	Probe Lens: RTV silicone 664Probe Housing: Polysulfone thermoplasticProbe Cemented Joint: RTV silicone 832ECG Leadwires: Thermoplastic urethane	Unknown (information notpublicly available); however,transducer material and otherpatient contact materials arebiocompatible	6061 machined aluminumenclosureHigh-impact ABS thermoplastic
Ingress Protection(IP) Rating	Tablet: IP22Probe: IPX7	Unit: IP33Probe: IPX7	IP55
DICOM	Yes	Yes	No
WirelessNetworking	Wireless networking (IEEE802.11 b/g/n/ac supported)	Wireless networking (IEEE802.11 b/g/n supported)	Wireless networking (Bluetooth4.0 low-energy)

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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

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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.

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.