(91 days)
The OPTIS™ Software with Dragonfly™ DUO or Dragonfly™ OPTIS™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ DUO or Dragonfly ™ OPTIS™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ DUO or Dragonfly™ OPTIS™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS™ Software will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
The Metallic Stent Optimization SW E.4 is an OCT system software that allows update of the current software version of ILUMIEN OPTIS (K150878), OPTIS Mobile System (K152120) and OPTIS Integrated OCT Systems (K151286) on the field for the Stent Optimization Tool features. The Metallic Stent Optimization SW E.4 is also compatible with flush catheters compatible with the above mentioned OCT systems (Dragonfly OPTIS and Dragonfly DUO catheters).
The OCT system software is used to control the OCT imaging engine in order to acquire OCT images, it is used to make measurements based on acquired OCT images, it is used to maintain a database of OCT images and data, and it is used to review previously acquired OCT images and data.
The OCT System software is also used to control the Aortic (AO) and PressureWire (PW) USB receivers to collect and store pressure waveform data for computing Fractional Flow Reserve (FFR). Similar to the OCT images, the FFR waveforms are stored in the database and are available for later review.
The OPTIS™ Metallic Stent Optimization E.4 SW software runs on 64-bit Microsoft Windows 7 Embedded Operating System only. The software also contains Intel JPEG Library, Microsoft MPEG-4 Video Codec, Microsoft Video 1 codec, AMD FirePro V4900 Display Adapter Driver, Intel 82579LM/82583V Gigabit Ethernet Controller Driver, Microsoft Foundation Class Library, Active Template Library, Microsoft Standard C++ Library, LEADTOOLS Medical Imaging Suite SDK, Microsoft SQL Server Express 2008 Service Pack 2 (SP2), Open Inventor Library, Haru PDF Library, IDEA Video Driver, iWRAP Bluetooth Stack and Intel Integrated Performance Primitives commercial off the shelf (COTS) software.
The E.4 software introduces the following new features:
- . 3D Flythrough, 3D Bifurcation (Bifurcation Visualization)- Enhance assessment of ostium geometry with optimized 3D views
- Cross Frame Angio (Stent Roadmap) Display stent roadmap with . OCT/angiography coregistrations
- Stent Display (Quantification of Stent Strut Apposition, Metallic Stent . Visualization) and 3D Display Options (Guide Wire Detection, Side Branch Detection) - Provide intra-procedural guidance by automatic detection and 3D visualization of BMS struts, side branches, and guidewires
The provided text (K160878) describes the OPTIS™ Metallic Stent Optimization E.4 SW, an upgrade to Lightlab Imaging's OCT system software. It details the device's enhanced features, indications for use, and a general statement about performance testing, but it does not include a detailed study proving the device meets specific acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions 2 through 9 regarding a specific study's details like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set information.
The document only states the following regarding performance:
- Performance Testing: "The OPTIS™ Metallic Stent Optimization E.4 SW has been developed and tested in compliance with IEC 62304: 2006 and DICOM Standard: 2015b. Software verification and validation was conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements. Design verification and validation was also performed in compliance with internal design control procedures. The results of this testing conclude the OPTIS™ Metallic Stent Optimization E.4 SW is determined to be safe and effective and is substantially equivalent to the predicate OPTIS Mobile System software."
This is a general statement of compliance and outcome, not a detailed report of a study with specific acceptance criteria and measured numerical performance.
§ 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.