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510(k) Data Aggregation

    K Number
    K152991
    Device Name
    OptoWire Deux
    Manufacturer
    OPSENS
    Date Cleared
    2016-02-11

    (121 days)

    Product Code
    DQX,DXO
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K142598
    Why did this record match?
    Device Name :

    OptoWire Deux

    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 other any interventional procedures. Blood pressurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.

    Device Description

    The OptoWire Deux is a hybrid Nitinol/Stainless Steel pressure sensing guidewire that is a steerable guidewire with an optical pressure sensor mounted proximal to the 3.5 cm long radio opaque tip. The OptoWire Deux is for use in combination with Opsens' OptoMonitor system for blood pressure measurement. The OptoWire Deux has a diameter of 0.014" (0.36 mm) and an effective length of 175 cm. The OptoWire Deux is supplied preconnected to the OptoWire cable along with a torque device. The OptoWire cable is unique to each OptoWire and it must be used conjunctionally with the OptoWire supplied in the same tray. OptoWire Deux is supplied sterile, non-pyrogenic and is intended for single use only. The changes described in this special 510k device modification only affect the OptoWire. There are no change to the OptoMonitor device included in the cleared systems K142598.

    AI/ML Overview

    The Opsens OptoWire Deux pressure guidewire is designed to measure blood pressure in coronary and peripheral vessels during diagnostic angiography and interventional procedures, providing hemodynamic information such as fractional flow reserve (FFR). The device is a hybrid Nitinol/Stainless Steel steerable guidewire with an optical pressure sensor.

    Here's a breakdown of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document primarily focuses on demonstrating substantial equivalence to a predicate device (OptoWire One, K142598) through verification and validation tests rather than explicitly stating acceptance criteria and numerical performance for all aspects. However, some key performance specifications are listed and implicitly serve as acceptance criteria for functionality.

    CharacteristicAcceptance Criteria (from predicate device spec)Reported Device Performance (OptoWire Deux)
    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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