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510(k) Data Aggregation

    K Number
    K193620
    Device Name
    OptoMonitor 3
    Manufacturer
    Opsens Inc.
    Date Cleared
    2020-06-18

    (175 days)

    Product Code
    DXO
    Regulation Number
    870.2870
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K192340
    Why did this record match?
    Reference Devices :

    K192340

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

    To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or any interventional procedures.

    Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease.

    Device Description

    The proposed OptoMonitor 3 is a new version of the OptoMonitor System. This device and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires.

    The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components and device functionalities are equivalent to that of the previous generation OptoMonitor (K192340 (cleared on 12/12/2019).

    The device is a non-sterile, non-patient contact device.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the OptoMonitor 3 device, which is an updated version of the OptoMonitor System. The submission aims to establish substantial equivalence to a predicate device (K192340).

    Here's an analysis of the acceptance criteria and study information, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document presents a comparison table between the proposed OptoMonitor 3 and its predicate device, OptoMonitor (K192340), rather than explicitly listing acceptance criteria with reported performance for a new study. However, the "Technological Characteristics" section of the table effectively serves as a list of performance parameters with implied acceptance criteria being "Same" as the predicate device.

    Performance ParameterAcceptance Criteria (Implied: Same as Predicate)Reported Device Performance (OptoMonitor 3)
    Pressure Range-30 to 300 mmHg-30 to 300 mmHg
    Pressure Accuracy+/- 1 mmHg plus +/- 1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg)+/- 1 mmHg plus +/- 1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg)
    Thermal Zero Shift
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