(59 days)
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.
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.
This document describes the Sonavex EchoSure Diagnostic Ultrasound System, which is intended for clinical examinations of blood vessels marked with an EchoMark or EchoMark LP implant. The system provides measurements and information about blood flow and is intended for use by trained medical healthcare professionals in support of clinical diagnosis.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabulated format with corresponding performance metrics as would typically be seen for a new device claiming improved performance. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K173265, WinProbe UltraVision 2 Diagnostic Ultrasound System) by outlining similar technical characteristics and adherence to relevant safety and performance standards.
The table below summarizes key comparisons between the EchoSure and its predicate, acting as implicit "acceptance criteria" through comparative equivalence:
| Feature | Acceptance Criteria (Predicate Device K173265) | Reported Device Performance (EchoSure) |
|---|---|---|
| Intended Use | Clinical examinations of vessels for evaluating blood flow and echogenicity of soft tissue (thyroid, breast, testicles, peripheral vessel, abdominal, superficial muscular skeletal diagnosis). | Clinical examinations of blood vessels marked with EchoMark or EchoMark LP implants, providing blood flow measurements and information. (More limited scope than predicate) |
| Principle of Operation | Same fundamental scientific technologies | Same fundamental scientific technologies (B-mode and Color Flow Doppler-mode operations) |
| Power Supply Voltage | 90-264 V AC | 100 – 264 V AC |
| Power Supply Frequency | 50/60 Hz | 47-63 Hz |
| Installation & Use | Portable equipment, mobile with cart | Portable equipment, mobile with cart |
| Mode of Operation | Continuous operation | Continuous operation |
| Dimensions (WxHxD) | 400x50x250 mm | 400x55x250 mm |
| Weight | ~10 lbs (4.5 kg) | ~13 lbs (5.9 kg) |
| Operating Temperature | 0°C to 40°C | 0°C to 40°C |
| Operating Humidity | Not for high humidity | 0% - 90% relative humidity (Allows for higher humidity than predicate's implied acceptance) |
| Safety Classification | Class II, Type BF | Class II, Type BF |
| EMC Compliance | IEC 60601-1-2 | IEC 60601-1-2 |
| Acoustic Output Std. | IEC 61157 AIUM/NEMA UD-2 | IEC 61157 AIUM/NEMA UD-2 |
| Biocompatibility | ISO 10993-1 | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 (More extensive testing than predicate's implied acceptance) |
| Monitor Display | 15 inch LCD flat panel, 2800x1800 pixels | 15.6 inch IGZO, 3200x1800 pixels (Higher resolution than predicate) |
| General Imaging Mode | B, M, Color Flow Doppler, Shear, PW Doppler, E | B mode, Color Flow Doppler mode (More limited modes than predicate) |
| Scanning Method | Linear | Linear |
| Displayed Depth | 20 mm to 300 mm | 10 mm – 80 mm (More limited depth range) |
| Gray Scales | 256 | 256 |
| TGC | 8 segments | 8 segments |
| Probe Type | Linear (L14-4) | Linear (4DML12-5) |
| Probe Freq. Bandwidth | 5 - 15 MHz | 5 – 12 MHz (More limited bandwidth than predicate) |
| Probe # Elements | 256 | 192 |
| Probe Modes | B, E, M, CFD, PWD | B and CFD (More limited modes than predicate) |
| Mechanical Index (MI) | 0.82 | 0.8 |
| ISPTA (mW/cm²) | 75 | 106 |
| Pr (MPa) | 2.142 | 2.75 |
| Frequency (MHz) | 7.55 | 6.85 |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Clinical studies are not required to support equivalence for these conventional ultrasound systems." This implies that there was no specific clinical test set used for the EchoSure device itself to prove its performance in human subjects, beyond the non-clinical safety and performance data. The FDA clearance is based on substantial equivalence to a predicate device and adherence to recognized standards.
Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable as no clinical studies were performed for this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
As no clinical test set was required or performed for direct evaluation of the EchoSure device's performance in a clinical setting, there's no information about experts establishing ground truth for a test set. The submission relies on the established safety and performance of the predicate device and compliance with standards.
4. Adjudication Method for the Test Set:
Since a clinical test set was not used to evaluate device performance, an adjudication method for a test set is not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No MRMC comparative effectiveness study was done, as confirmed by the statement "Clinical studies are not required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The EchoSure is a diagnostic ultrasound system, not an algorithm-only device. Its performance is intrinsically tied to human operation and interpretation. Therefore, a "standalone algorithm only" performance study is not applicable in this context. The document emphasizes its use "by trained medical health care professionals."
7. The type of ground truth used:
Given the reliance on substantial equivalence and non-clinical testing, the "ground truth" for the EchoSure's clearance is primarily based on:
- Compliance with recognized electrical, mechanical, safety, EMC, acoustic output, and biocompatibility standards (e.g., ISO 10993, IEC 60601 series). These standards serve as the "ground truth" for ensuring the device meets fundamental safety and engineering performance requirements.
- Demonstrated performance specifications during bench testing. These tests confirm that risk controls were properly implemented, design outputs meet design inputs, and the device is suitable for its intended use within a laboratory/engineering context.
8. The sample size for the training set:
The EchoSure is a conventional diagnostic ultrasound system, not an AI/ML-driven device that requires a "training set" in the machine learning sense. Therefore, information about a training set sample size is not applicable.
9. How the ground truth for the training set was established:
As the device does not utilize a machine learning algorithm requiring a training set, this question is not applicable.
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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 (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
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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) | |
|---|---|
| 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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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 200Baltimore, MD 21224 |
| Primary ContactPerson: | Michelle ZwernemannDirector of Quality & OperationsSonavex, Inc.2835 O'Donnell Street, Suite 200Baltimore, MD 21224Phone: (443) 862-3223Email: mzwernemann@sonavex.com |
| Secondary ContactPerson: | David NarrowChief Executive OfficerSonavex, Inc.2835 O'Donnell Street, Suite 200Baltimore, MD 21224Phone: (443) 862-2003Email: dnarrow@sonavex.com |
| Trade Name: | EchoSure |
| Common Name: | Diagnostic Ultrasound System |
| Classification Names: | Ultrasound Pulsed Echo Imaging System, 21 CFR 8921560, Product Code IYO |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570,Product Code ITX | |
| Ultrasound Pulsed Doppler Imaging System, 21 CFR892.1550, Product Code IYN | |
| Device Classification: | Class II |
| Product Codes: | IYO, ITX, IYN |
| Predicate Device: | K173265, WinProbe UltraVision 2 Diagnostic UltrasoundSystem |
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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 DiagnosticUltrasound System(K173265) | |
|---|---|---|
| Description | EchoSure is a portablediagnostic ultrasoundsystem that enables aclinician to evaluate bloodflow in vessels.EchoSure functions wellwithin the operationalperformance specificationsof the UltraVision 2.0platform for B-mode andColor Flow Doppler-modeoperations. | The UltraVision is a portableDiagnostic UltrasoundSystem, which applies thelatest technologies toproduce optimal images.The system facilitates aworkflow from imageacquisition through toarchival in a standardDICOM interface to theclinics PACS system.Various image parameteradjustments, dual, high-resolution displays andcustom probes are |
| Indications for Use | The EchoSure diagnosticultrasound system and itstransducers are intended foruse in clinical examinationsof vessels. The systemprovides measurements andinformation about blood flow.The system is intended foruse by trained medicalhealth care professionals insupport of clinical diagnosis. | configured to provide clearand stable images. Itoperates in B, M, Color FlowDoppler, Shear Mode, PWDoppler Mode, and E Mode.The various uses ofUltraVision 2.0 includeevaluation of blood vessels,as seen in EchoSure.This diagnostic ultrasoundsystem and its transducersare indented for use inclinical examinations toevaluate differences in theechogenicity of soft tissue ofsmall parts in adult patients,(thyroid, breast, andtesticles) and for peripheralvessel, abdominal andsuperficial muscular skeletaldiagnosis. |
| Power Supply | ||
| Voltage | 100 – 264 V AC (powersupply label) | 90-264 V AC (as listed insubmission) |
| Frequency | 47-63 Hz (power supplylabel) | 50/60 Hz (as listed insubmission) |
| OperationalCharacteristics | ||
| Installation anduse | Portable equipment. Mobilewhen installed in mobile cart | Portable equipment. Mobilewhen installed in mobile cart |
| Mode ofoperation | Continuous operation | Continuous operation |
| Physical Specifications | ||
| Dimensions | 400 mm (W) x 55 mm (H) x250 mm (D) | 400 mm (W) x 50 mm (H) x250 mm (D) |
| Weight | 5.9 kg (~13lbs) | 4.5 kg (~10lbs) |
| Temperature | ||
| Operating | 0°C to 40°C | 0°C to 40°C |
| Transport/Storage | Equipment should not besubject to excessivetemperatures duringtransportation/storage | Equipment should not besubject to excessivetemperatures duringtransportation/storage |
| Relative Humidity | ||
| Operating | 0% - 90% relative humidity | Equipment should not beused in locations of highhumidity |
| Transport/Storage | 0% - 90% relative humidity | Equipment should not beused in locations of highhumidity |
| Safety Classifications | ||
| Type ofprotectionagainst electricshock | Class II | Class II |
| Degree ofprotectionagainst electricshock | Type BF | Type BF |
| Degree of safetyof application inthe presence ofa flammable gas | Equipment not to be used inthe presence of a flammablegas | Equipment not to be used inthe presence of a flammablegas |
| Compliance withelectrical, mechanicaland safety standards | Complies with the standard:ES60601-1 / IEC 60601-1IEC 60601-2-37 | Complies with the standard:IEC 60601-1IEC 60601-2-37 |
| EMC Compliance withstandards | Complies with the standard:IEC 60601-1-2 | Complies with the standard:IEC 60601-1-2 |
| Acoustic outputevaluation | Complies with the standard:IEC 61157 AIUM/NEMA UD-2, Acoustic OutputMeasurement Standard forDiagnostic Ultrasound | Complies with the standard:IEC 61157 AIUM/NEMA UD-2, Acoustic OutputMeasurement Standard forDiagnostic Ultrasound |
| BiocompatibilityEvaluation | Complies with the standard:ISO 10993-1 | Complies with the standard:ISO 10993-1 |
| Disinfection | Probe: .55% OrthoPhthalaldehyde, 2.4%Glutaraldehyde | Probe: .55% OrthoPhthalaldehyde, 2.4%Glutaraldehyde |
| Specifications | ||
| Monitor | 15.6 inch IGZO 3200 x 1800pixel image displayRefresh Rate: 60 HzAspect Ratio: 16x9 | 15 inch display LCD flatpanel display with 2800 x1800 pixels |
| General ImagingMode | B mode, Color Flow Dopplermode | B mode, M mode, E mode,Color Flow Doppler mode,Shear mode |
| ScanningMethod | Linear | Linear |
| Focus number | Max = 4 | Max = 4 |
| Peripheral Devicessupported | ||
| 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 modeparameters | Gain, Depth, TGC,Frequency | Gain, Depth, TGC,Frequency |
| Color FlowDoppler Mode | Transmit Frequency, Gain,Pulsed repetition frequency | Transmit Frequency, Gain,Persistence, Pulsedrepetition frequency,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 Probe4DML12-5 | Predicate ProbeL14-4 | |
|---|---|---|
| Type | Linear | Linear |
| FrequencyBandwidth | 5 – 12 MHz | 5 - 15 MHz |
| Applications | • Vascular | • Breast• Testes• Thyroid• Musculoskeletal• Peripheral Vessel• Abdominal |
| Number ofelements | 192 | 256 |
| Modes of operation | B and CFD | B, E, M, CFD, PWD |
| Array footprint | 55 mm | 52 mm |
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| Acoustic outputdisplay 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.
§ 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.