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510(k) Data Aggregation

    K Number
    K180704
    Device Name
    SonoSite iViz Ultrasound System
    Manufacturer
    FUJIFILM SonoSite, Inc.
    Date Cleared
    2018-04-13

    (25 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    K162045,K133454,K162288
    Why did this record match?
    Reference Devices :

    K162045, K133454, K162288

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include:

    Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic

    Device Description

    The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the FUJIFILM SonoSite iViz Ultrasound System. The purpose of this document is to demonstrate that the iViz Ultrasound System is substantially equivalent to legally marketed predicate devices.

    Here's an analysis of the acceptance criteria and the study information as requested:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, image quality scores) for the device's diagnostic capabilities. Instead, the "acceptance criteria" are implied through the comparisons to predicate devices and adherence to recognized standards.

    The primary method to demonstrate acceptance is through substantial equivalence to existing, legally marketed predicate devices by showing comparable:

    • Intended Use
    • Indications for Use
    • Technological Characteristics
    • Safety and Effectiveness (via non-clinical testing)

    Below is a table summarizing the general "acceptance criteria" (implicitly by comparison to predicates and standards) and the device's reported performance (by asserting compliance and equivalence).

    Acceptance Criteria (Implicit)Reported Device Performance
    Intended Use Equivalence: Device intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, comparable to predicate devices.The SonoSite iViz Ultrasound System has the same intended use as the predicate devices: "a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis."
    Indications for Use Equivalence: Device supported clinical applications align with or expand upon those of predicate devices.The SonoSite iViz Ultrasound System and its various transducers (L38v/10-5 MHz, P21v/5-1 MHz, C60v/5-2 MHz, L25v/13-6 MHz) cover a range of clinical applications including Fetal, Abdominal, Pediatric, Small Organ, Musculo-skeletal, Cardiac Adult/Pediatric, Peripheral vessel, and Ophthalmic. Many of these are "P" (previously cleared) from identified predicate devices (K162288, K133454, K162045, K152983), and some are "N" (new indications) for specific transducers. The document asserts these are consistent with predicates.
    Technological Characteristics Equivalence: Fundamental scientific technology, transducer types, frequency ranges, and modes of operation are comparable to predicate devices.The SonoSite iViz Ultrasound System employs the "same fundamental scientific technology" as the SonoSite iViz, Edge, and Edge II Ultrasound systems (Track 3 devices). Comparison tables (Pg 9) detail comparable transducer types (Linear Array, Phased Array, Curved Array), frequency ranges (1.0 - 13.0 MHz), and modes of operation (B-mode, M-mode, Color Power Doppler, SonoHD3 Noise Reduction, etc.), with some differences noted (e.g., PW and CW Doppler not available on iViz but available on older Edge models).
    Safety and Effectiveness: Compliance with recognized electrical, thermal, mechanical, EMC, cleaning/disinfection, biocompatibility, and acoustic output standards.The iViz Ultrasound System was evaluated for electrical, thermal, mechanical, and EMC safety, cleaning/disinfection, biocompatibility, and acoustic output. It was found to conform to applicable mandatory medical device safety standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, IEC 62359, ISO 14971, NEMA UD 2-2004). Quality assurance processes were also followed.
    No new questions of safety or effectiveness are raised.The conclusion explicitly states that "FUJIFILM SonoSite, Inc. believes that the iViz Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices."

    Study Proving Acceptance Criteria:

    The document states: "The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."

    Instead, the determination of substantial equivalence is based on non-clinical tests and a comparison of technological characteristics and intended uses with identified predicate devices.

    2. Sample Size Used for the Test Set and Data Provenance:

    No clinical test set was used, as no clinical studies were deemed necessary. The acceptance was based on non-clinical testing and comparison to predicates.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

    Not applicable, as no clinical test set requiring expert ground truth was utilized.

    4. Adjudication Method for the Test Set:

    Not applicable, as no clinical test set requiring adjudication was utilized.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool for interpretation by human readers. The document makes no mention of AI assistance.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    Not applicable. The device is a diagnostic ultrasound system, operated by a qualified physician or healthcare professional. It is not a standalone algorithm.

    7. The Type of Ground Truth Used:

    For the non-clinical tests (e.g., electrical, thermal, EMC, acoustic output), the "ground truth" would be the specifications and requirements defined by the referenced industry standards (e.g., IEC 60601 series, ISO 10993, NEMA UD 2-2004). The device's performance against these standards served as the "ground truth" for non-clinical acceptance.

    8. The Sample Size for the Training Set:

    Not applicable. The document does not describe the development of an AI model or algorithm that would require a "training set."

    9. How the Ground Truth for the Training Set Was Established:

    Not applicable, as there was no mention of a training set for an AI model.

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