LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023713
    Device Name
    SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
    Manufacturer
    SONTRA MEDICAL INC.
    Date Cleared
    2004-01-28

    (450 days)

    Product Code
    KRC
    Regulation Number
    870.2370
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K782079
    Why did this record match?
    Product Code :

    KRC

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

    The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System is intended to be used for preparation of intact skin to lower skin impedance. The supplied electrodes are intended to be used for ECG monitoring.

    Device Description

    The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System consists of a microprocessor controlled ultrasonic skin prep generator, a reusable handpiece, a reusable handheld contact electrode, coupling media and ECG electrodes used for ultrasonically treating intact skin in order to lower the skin impedance for the application of ECG electrodes for monitoring heart rates.

    AI/ML Overview

    The provided document is a 510(k) summary for the Sontra Medical Corporation's SonoPrep™ Impedance Diagnostics (IDx) system. This document is a premarket notification to establish substantial equivalence to a legally marketed predicate device, rather than a detailed study report with specific acceptance criteria and performance metrics typically found in clinical trials for new drug or device approvals.

    Therefore, the information about acceptance criteria and detailed study results is very limited in this document. Based on the provided text, here's what can be extracted:

    1. A table of acceptance criteria and the reported device performance:

    The document does not explicitly state numerical acceptance criteria in a table format. However, it implies that the device's performance was evaluated against the predicate device (Quinton, Inc. QuikPrep Electrode System, K782079) regarding ECG waveform morphology, long-term impedance, and safety (skin irritation).

    Acceptance Criteria (Implied)Reported Device Performance
    Comparable ECG waveform morphology to predicate deviceClinical studies showed no difference in ECG waveform morphology as compared to the predicate device.
    Comparable long-term impedance to predicate deviceClinical studies showed no difference in long-term impedance as compared to the predicate device.
    Acceptable safety profile (e.g., minimal adverse events)Some patients developed redness at the treated sites which resolved within 24 hours and required no further follow-up treatment.
    Ability to lower skin impedance for ECG monitoringDemonstrates that the SonoPrep IDx reduced skin monitoring. (This statement appears fragmented and likely refers to reducing skin impedance.)

    2. Sample size used for the test set and the data provenance:

    • Sample Size: Not explicitly stated. The document only mentions "Clinical studies" and "Some patients."
    • Data Provenance: Not specified (e.g., country of origin). The document indicates "Clinical studies," suggesting prospective data collection. It does not mention retrospective data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    This information is not available in the provided text. The evaluation method described focuses on comparison to a predicate device and direct observation of physiological effects (ECG morphology, impedance, skin reaction), rather than expert-derived ground truth for diagnostic accuracy.

    4. Adjudication method for the test set:

    This information is not available in the provided text.

    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:

    This is not applicable to this device. The SonoPrep IDx System is for preparing skin for ECG monitoring, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

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

    This is not applicable to this device. The SonoPrep IDx System is a physical device that preconditions the skin, not an algorithm.

    7. The type of ground truth used:

    The ground truth or reference standard implicitly used for this device's performance evaluation was a comparison to a legally marketed predicate device (Quinton, Inc. QuikPrep Electrode System). The "ground truth" for showing effectiveness involved measuring physiological parameters (ECG waveform morphology, long-term impedance) and observing clinical outcomes (skin irritation) in patients treated with both the new device and the predicate.

    8. The sample size for the training set:

    There is no mention of a training set. This type of device (skin preparation for ECG) would typically involve clinical testing rather than machine learning training.

    9. How the ground truth for the training set was established:

    Since there is no mention of a training set, this information is not applicable.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1