Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis beyond standard measurements). The description focuses on standard ultrasound technology and image processing adjustments.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its "Intended Use / Indications for Use" explicitly state it is for "clinical examinations" to provide "measurements and information about blood flow." There is no mention of treating or preventing diseases.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The EchoSure diagnostic ultrasound system... The system provides measurements and information about blood flow." and "The system is intended for use by trained medical health care professionals in support of clinical diagnosis." The "Device Description" also refers to it as a "portable diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system is comprised of the EchoSure Ultrasound, the EchoSure Application, and the EchoSure Probe, indicating the presence of hardware components (ultrasound system and probe) in addition to the software application. Furthermore, the performance studies section details biocompatibility and safety testing performed on the EchoSure Probe and electrical safety testing on the overall system, confirming the existence of hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the EchoSure diagnostic ultrasound system is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
EchoSure's Intended Use: The EchoSure system is used for "clinical examinations of blood vessels" in vivo (within the living body) using ultrasound. It provides measurements and information about blood flow directly from the patient.
Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens taken from the patient.

Therefore, the EchoSure system falls under the category of a diagnostic imaging device used for in vivo examination, not an IVD device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EchoSure diagnostic ultrasound system and its transducer are in clinical examinations of blood vessels that are marked with an EchoMark LP implant. The system provides measurements and information about blood flow.

The system is intended for use by trained medical health care professionals in support of clinical diagnosis.

Product codes

IYO, ITX, IYN

Device Description

EchoSure is a portable diagnostic ultrasound system which applies the latest technologies to produce optimal images and provide information about blood flow in vessels. Various image parameter adjustments, dual high-resolution displays, and a custom probe are configured to provide clear and stable images. The system operates in B-Mode and Color Flow Doppler Mode. EchoSure is comprised of the EchoSure Ultrasound, the EchoSure Application, and the EchoSure Probe.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic ultrasound imaging

Anatomical Site

blood vessels

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained medical health care professionals

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)

Non-clinical Safety and Performance Data:
All necessary testing has been performed for EchoSure to assure substantial equivalence to the predicate device and to demonstrate that the device performs as intended.

The following ISO 10993 biocompatibility and safety testing was performed on the EchoSure Probe. Results from the tests indicate that the device is non-toxic, nonsensitizing, non-mutagenic and non-irritating therefore biocompatible for its intended use:

ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity

Performance and safety testing, Bench: Successful completion of the following tests confirmed that risk controls were properly implemented, and design outputs meet design inputs and device is suitable for its intended use:

AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Capability - Requirements and tests.
IEC 60601-2-37:2015 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
Acoustic output testing per the FDA Guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound and Transducers" dated September 9, 2008, and Draft Guidance dated 2017, including IEC 61157 testing as required.

Clinical studies are not required to support equivalence for these conventional ultrasound systems. EchoSure is in conformance with the standards described above which are the same or equivalent to those performed on the predicate UltraVision 2 system. EchoSure met all specified criteria and did not raise new safety or performance questions and therefore support a finding of substantial equivalence.

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

Not Found

Predicate Device(s)

K173265

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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Image /page/0/Picture/0 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.

March 12, 2019

Sonavex, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K190039

Trade/Device Name: EchoSure Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX, IYN Dated: February 25, 2019 Received: February 26, 2019

Dear Mr. Job:

This letter corrects our substantially equivalent letter of March 8, 2019.

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

1

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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jeff Bolgeo

for Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

Device Name

EchoSure Diagnostic Ultrasound System

Indications for Use (Describe)

The EchoSure diagnostic ultrasound system and its transducer are in clinical examinations of blood vessels that are marked with an EchoMark LP implant. The system provides measurements and information about blood flow.

The system is intended for use by trained medical health care professionals in support of clinical diagnosis.

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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Diagnostic Ultrasound Indications for Use Table

EchoSure Diagnostic Ultrasound System System: Transducer: EchoSure Probe 4DML12-5

Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	N				N	N(B+Color)
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication;

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510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Date Prepared:	November 18, 2018
Applicant:	Sonavex, Inc.
2835 O'Donnell Street, Suite 200
Baltimore, MD 21224
Primary Contact
Person:	Michelle Zwernemann
Director of Quality & Operations
Sonavex, Inc.
2835 O'Donnell Street, Suite 200
Baltimore, MD 21224
Phone: (443) 862-3223
Email: mzwernemann@sonavex.com
Secondary Contact
Person:	David Narrow
Chief Executive Officer
Sonavex, Inc.
2835 O'Donnell Street, Suite 200
Baltimore, MD 21224
Phone: (443) 862-2003
Email: dnarrow@sonavex.com
Trade Name:	EchoSure
Common Name:	Diagnostic Ultrasound System
Classification Names:	Ultrasound Pulsed Echo Imaging System, 21 CFR 892
1560, Product Code IYO
	Diagnostic Ultrasound Transducer, 21 CFR 892.1570,
Product Code ITX
	Ultrasound Pulsed Doppler Imaging System, 21 CFR
892.1550, Product Code IYN
Device Classification:	Class II
Product Codes:	IYO, ITX, IYN
Predicate Device:	K173265, WinProbe UltraVision 2 Diagnostic Ultrasound
System

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Substantially Equivalent to:

EchoSure is substantially equivalent in intended use, principle of operation and technological characteristics to the UltraVision 2 Diagnostic Ultrasound System cleared under premarket notification K173265.

Description of the Device Subject to Premarket Notification:

EchoSure is a portable diagnostic ultrasound system which applies the latest technologies to produce optimal images and provide information about blood flow in vessels. Various image parameter adjustments, dual high-resolution displays, and a custom probe are configured to provide clear and stable images. The system operates in B-Mode and Color Flow Doppler Mode. EchoSure is comprised of the EchoSure Ultrasound, the EchoSure Application, and the EchoSure Probe.

Indications for Use:

The EchoSure diagnostic ultrasound system and its transducer are intended for use in clinical examinations of blood vessels that are marked with an EchoMark or EchoMark LP implant. The system provides measurements and information about blood flow.

The system is intended for use by trained medical health care professionals in support of clinical diagnosis.

Technical Characteristics Compared to Predicate Device:

EchoSure uses the same fundamental scientific technologies as the predicate device (K173265, WinProbe UltraVision 2 Diagnostic Ultrasound System). Table 1 compares EchoSure to the predicate device with respect to indications for use, and principles of operation for the determination of substantial equivalence.

| | EchoSure | UltraVision 2 Diagnostic
Ultrasound System
(K173265) |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | EchoSure is a portable
diagnostic ultrasound
system that enables a
clinician to evaluate blood
flow in vessels.
EchoSure functions well
within the operational
performance specifications
of the UltraVision 2.0
platform for B-mode and
Color Flow Doppler-mode
operations. | The UltraVision is a portable
Diagnostic Ultrasound
System, which applies the
latest technologies to
produce optimal images.
The system facilitates a
workflow from image
acquisition through to
archival in a standard
DICOM interface to the
clinics PACS system.
Various image parameter
adjustments, dual, high-
resolution displays and
custom probes are |
| | | |
| Indications for Use | The EchoSure diagnostic
ultrasound system and its
transducers are intended for
use in clinical examinations
of vessels. The system
provides measurements and
information about blood flow.
The system is intended for
use by trained medical
health care professionals in
support of clinical diagnosis. | configured to provide clear
and stable images. It
operates in B, M, Color Flow
Doppler, Shear Mode, PW
Doppler Mode, and E Mode.
The various uses of
UltraVision 2.0 include
evaluation of blood vessels,
as seen in EchoSure.

Table 1. Predicate Device Comparison

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Intended Use Comparison:

The intended use and clinical applications for EchoSure are the same or limited compared to the predicate device. Both systems are intended to be used with a conventional extracorporeal transducer. The EchoSure Probe is a 4D linear transducer specified for use with EchoSure. Comparison of the transducers is provided in Table 2:

			Table 2. Probe Comparison
--	--	--	---------------------------	--

| | EchoSure Probe
4DML12-5 | Predicate Probe
L14-4 |
|------------------------|----------------------------|----------------------------------------------------------------------------------------------|
| Type | Linear | Linear |
| Frequency
Bandwidth | 5 – 12 MHz | 5 - 15 MHz |
| Applications | • Vascular | • Breast
• Testes
• Thyroid
• Musculoskeletal
• Peripheral Vessel
• Abdominal |
| Number of
elements | 192 | 256 |
| Modes of operation | B and CFD | B, E, M, CFD, PWD |
| Array footprint | 55 mm | 52 mm |

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| Acoustic output

display standard	Track 1	Track 1
Mechanical Index
(MI)	0.8	0.82
ISPTA (mW/cm²)	106	75
Pr (MPa)	2.75	2.142
Frequency (MHz)	6.85	7.55

Non-clinical Safety and Performance Data:

All necessary testing has been performed for EchoSure to assure substantial equivalence to the predicate device and to demonstrate that the device performs as intended.

The following ISO 10993 biocompatibility and safety testing was performed on the EchoSure Probe. Results from the tests indicate that the device is non-toxic, nonsensitizing, non-mutagenic and non-irritating therefore biocompatible for its intended use:

ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity

Performance and safety testing, Bench: Successful completion of the following tests confirmed that risk controls were properly implemented, and design outputs meet design inputs and device is suitable for its intended use:

AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Capability - Requirements and tests.
IEC 60601-2-37:2015 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

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Acoustic output testing per the FDA Guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound and Transducers" dated September 9, 2008, and Draft Guidance dated 2017, including IEC 61157 testing as required.

Conclusion:

Clinical studies are not required to support equivalence for these conventional ultrasound systems. EchoSure is in conformance with the standards described above which are the same or equivalent to those performed on the predicate UltraVision 2 system. EchoSure met all specified criteria and did not raise new safety or performance questions and therefore support a finding of substantial equivalence.

Basis for Determination of Substantial Equivalence:

The Indication/Intended Use, the fundamental scientific technology, and differences between EchoSure and the predicate device do not raise new questions of safety and/or effectiveness. EchoSure has been determined to be substantially equivalent to the predicate device.