EchoSure Diagnostic Ultrasound System

K190039 · Sonavex, Inc. · IYO · Mar 8, 2019 · Radiology

Device Facts

• Record ID: K190039
• Device Name: EchoSure Diagnostic Ultrasound System
• Applicant: Sonavex, Inc.
• Product Code: IYO · Radiology
• Decision Date: Mar 8, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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.

Device Story

EchoSure is a portable diagnostic ultrasound system used by trained medical professionals in clinical settings to evaluate blood flow in vessels marked with EchoMark or EchoMark LP implants. The system utilizes a custom 4D linear probe (192 elements) to acquire ultrasound signals, which are processed to generate B-mode and Color Flow Doppler images. These images and flow measurements are displayed on a 15.6-inch high-resolution monitor to assist clinicians in diagnosis. The device operates via continuous ultrasound imaging, providing real-time visual feedback of the marked vasculature. By enabling visualization and measurement of blood flow in the presence of the implant, the device supports clinical decision-making regarding vascular health and implant monitoring.

Clinical Evidence

Bench testing only. No clinical data was required. Performance was validated through compliance with AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, and acoustic output standards (IEC 61157, AIUM/NEMA UD-2). Biocompatibility of the probe was confirmed per ISO 10993-1, -5, -10, and -11.

Technological Characteristics

Portable diagnostic ultrasound system; B-mode and Color Flow Doppler; 15.6-inch IGZO display (3200x1800); 4D linear probe (5-12 MHz, 192 elements). Electrical safety: IEC 60601-1, IEC 60601-2-37. EMC: IEC 60601-1-2. Biocompatibility: ISO 10993-1. Disinfection: Ortho-Phthalaldehyde/Glutaraldehyde. Power: 100-264V AC.

Indications for Use

Indicated for clinical examination of blood vessels marked with EchoMark or EchoMark LP implants in adult patients. Intended for use by trained medical healthcare professionals for blood flow measurement and clinical diagnosis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• WinProbe UltraVision 2 Diagnostic Ultrasound System (K173265)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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.<br>2835 O'Donnell Street, Suite 200<br>Baltimore, MD 21224 |
| Primary Contact<br>Person: | Michelle Zwernemann<br>Director of Quality & Operations<br>Sonavex, Inc.<br>2835 O'Donnell Street, Suite 200<br>Baltimore, MD 21224<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact<br>Person: | David Narrow<br>Chief Executive Officer<br>Sonavex, Inc.<br>2835 O'Donnell Street, Suite 200<br>Baltimore, MD 21224<br>Phone: [phone]<br>Email: [e-mail] |
| Trade Name: | EchoSure |
| Common Name: | Diagnostic Ultrasound System |
| Classification Names: | Ultrasound Pulsed Echo Imaging System, 21 CFR 892<br>1560, Product Code IYO |
| | Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>Product Code ITX |
| | Ultrasound Pulsed Doppler Imaging System, 21 CFR<br>892.1550, Product Code IYN |
| Device Classification: | Class II |
| Product Codes: | IYO, ITX, IYN |
| Predicate Device: | K173265, WinProbe UltraVision 2 Diagnostic Ultrasound<br>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<br>Ultrasound System<br>(K173265) |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | EchoSure is a portable<br>diagnostic ultrasound<br>system that enables a<br>clinician to evaluate blood<br>flow in vessels.<br>EchoSure functions well<br>within the operational<br>performance specifications<br>of the UltraVision 2.0<br>platform for B-mode and<br>Color Flow Doppler-mode<br>operations. | The UltraVision is a portable<br>Diagnostic Ultrasound<br>System, which applies the<br>latest technologies to<br>produce optimal images.<br>The system facilitates a<br>workflow from image<br>acquisition through to<br>archival in a standard<br>DICOM interface to the<br>clinics PACS system.<br>Various image parameter<br>adjustments, dual, high-<br>resolution displays and<br>custom probes are |
| | | |
| Indications for Use | The EchoSure diagnostic<br>ultrasound system and its<br>transducers are intended for<br>use in clinical examinations<br>of vessels. The system<br>provides measurements and<br>information about blood flow.<br>The system is intended for<br>use by trained medical<br>health care professionals in<br>support of clinical diagnosis. | configured to provide clear<br>and stable images. It<br>operates in B, M, Color Flow<br>Doppler, Shear Mode, PW<br>Doppler Mode, and E Mode.<br>The various uses of<br>UltraVision 2.0 include<br>evaluation of blood vessels,<br>as seen in EchoSure.<br><br>This diagnostic ultrasound<br>system and its transducers<br>are indented for use in<br>clinical examinations to<br>evaluate differences in the<br>echogenicity of soft tissue of<br>small parts in adult patients,<br>(thyroid, breast, and<br>testicles) and for peripheral<br>vessel, abdominal and<br>superficial muscular skeletal<br>diagnosis. |
| Power Supply | | |
| Voltage | 100 – 264 V AC (power<br>supply label) | 90-264 V AC (as listed in<br>submission) |
| Frequency | 47-63 Hz (power supply<br>label) | 50/60 Hz (as listed in<br>submission) |
| Operational<br>Characteristics | | |
| Installation and<br>use | Portable equipment. Mobile<br>when installed in mobile cart | Portable equipment. Mobile<br>when installed in mobile cart |
| Mode of<br>operation | Continuous operation | Continuous operation |
| Physical Specifications | | |
| Dimensions | 400 mm (W) x 55 mm (H) x<br>250 mm (D) | 400 mm (W) x 50 mm (H) x<br>250 mm (D) |
| Weight | 5.9 kg (~13lbs) | 4.5 kg (~10lbs) |
| Temperature | | |
| Operating | 0°C to 40°C | 0°C to 40°C |
| Transport/<br>Storage | Equipment should not be<br>subject to excessive<br>temperatures during<br>transportation/storage | Equipment should not be<br>subject to excessive<br>temperatures during<br>transportation/storage |
| Relative Humidity | | |
| Operating | 0% - 90% relative humidity | Equipment should not be<br>used in locations of high<br>humidity |
| Transport/Stora<br>ge | 0% - 90% relative humidity | Equipment should not be<br>used in locations of high<br>humidity |
| Safety Classifications | | |
| Type of<br>protection<br>against electric<br>shock | Class II | Class II |
| Degree of<br>protection<br>against electric<br>shock | Type BF | Type BF |
| Degree of safety<br>of application in<br>the presence of<br>a flammable gas | Equipment not to be used in<br>the presence of a flammable<br>gas | Equipment not to be used in<br>the presence of a flammable<br>gas |
| Compliance with<br>electrical, mechanical<br>and safety standards | Complies with the standard:<br>ES60601-1 / IEC 60601-1<br>IEC 60601-2-37 | Complies with the standard:<br>IEC 60601-1<br>IEC 60601-2-37 |
| EMC Compliance with<br>standards | Complies with the standard:<br>IEC 60601-1-2 | Complies with the standard:<br>IEC 60601-1-2 |
| Acoustic output<br>evaluation | Complies with the standard:<br>IEC 61157 AIUM/NEMA UD-<br>2, Acoustic Output<br>Measurement Standard for<br>Diagnostic Ultrasound | Complies with the standard:<br>IEC 61157 AIUM/NEMA UD-<br>2, Acoustic Output<br>Measurement Standard for<br>Diagnostic Ultrasound |
| Biocompatibility<br>Evaluation | Complies with the standard:<br>ISO 10993-1 | Complies with the standard:<br>ISO 10993-1 |
| Disinfection | Probe: .55% Ortho<br>Phthalaldehyde, 2.4%<br>Glutaraldehyde | Probe: .55% Ortho<br>Phthalaldehyde, 2.4%<br>Glutaraldehyde |
| Specifications | | |
| Monitor | 15.6 inch IGZO 3200 x 1800<br>pixel image display<br>Refresh Rate: 60 Hz<br>Aspect Ratio: 16x9 | 15 inch display LCD flat<br>panel display with 2800 x<br>1800 pixels |
| General Imaging<br>Mode | B mode, Color Flow Doppler<br>mode | B mode, M mode, E mode,<br>Color Flow Doppler mode,<br>Shear mode |
| Scanning<br>Method | Linear | Linear |
| Focus number | Max = 4 | Max = 4 |
| Peripheral Devices<br>supported | | |
| Rolling Cart | EchoSure Roll Stand | TBD |
| Performance | | |
| Displayed depth | 10 mm – 80 mm | 20 mm to 300 mm |
| Gray scales | 256 | 256 |
| TGC | 8 segments | 8 segments |
| Image Adjustments | | |
| B mode<br>parameters | Gain, Depth, TGC,<br>Frequency | Gain, Depth, TGC,<br>Frequency |
| Color Flow<br>Doppler Mode | Transmit Frequency, Gain,<br>Pulsed repetition frequency | Transmit Frequency, Gain,<br>Persistence, Pulsed<br>repetition frequency,<br>Smoothing, Map |

# 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<br>4DML12-5 | Predicate Probe<br>L14-4 |
|------------------------|----------------------------|----------------------------------------------------------------------------------------------|
| Type | Linear | Linear |
| Frequency<br>Bandwidth | 5 – 12 MHz | 5 - 15 MHz |
| Applications | • Vascular | • Breast<br>• Testes<br>• Thyroid<br>• Musculoskeletal<br>• Peripheral Vessel<br>• Abdominal |
| Number of<br>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<br>display standard | Track 1 | Track 1 |
|-------------------------------------|---------|---------|
| Mechanical Index<br>(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.