(91 days)
The OPTISTM Mobile System with DragonflyTM DUO or DragonflyTM OPTISTM Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The DragonflyTM DUO or Dragonfly™ OPTISTM Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ DUO or DragonflyTM OPTISTM 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 OPTISTM Mobile System 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 OPTIS Mobile System is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. It includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the OPTIS Mobile System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety.
The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor.
The OPTIS Mobile System is comprised of the following main components:
- . A rapidly scanning laser engine
- A host computer with embedded application software ●
- A drive-motor and optical coupler (DOC) which connects to the imaging catheter ●
- A mobile console with monitors, keyboard and mouse housing laser engine and host computer, and connected to the DOC.
- An imaging catheter
- An optional Tableside Controller (TSC) ●
- o Video interfaces for interaction with the boom monitor and angiography system
The function of the Tableside Controller (TSC) is to provide tableside system control to the Physician. The TSC communicates with the console via wireless configuration or an optional wired configuration.
The OPTIS Mobile System can perform both OCT and FFR procedures, and is compatible with Dragonfly OPTIS, DUO and JP catheters and the PressureWire Aeris. The OPTIS Mobile system provides the ability to incorporate the angiography images into the GUI, which allows users to visualize the position of OCT image data on angiography images, tightening the linkage between anatomical assessment with OCT and subsequent therapeutic actions.
The provided text does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical or performance study would typically describe for a new AI/ML device. The document is an FDA 510(k) clearance letter and summary for the LightLab Imaging, Inc. OPTIS™ Mobile System, which is an ultrasonic pulsed echo imaging system, not an AI/ML device in the context of typical AI study requirements.
The performance testing mentioned is primarily related to:
- Electrical Safety and EMC: Compliance with standards like IEC 60601-1, IEC 60601-1-2.
- Software Verification and Validation: Compliance with IEC 62304 and FDA regulations.
- Laser Safety: Compliance with IEC 60825-1 and 21 CFR 1040.10.
- Usability Engineering: Compliance with IEC 62366 and IEC 60601-1-6.
- OCT Parameter and Hardware Testing: This is mentioned as part of design verification and validation, but specific acceptance criteria and results are not detailed.
The document asserts that "The results of this testing conclude the software has met these requirements" and "The results of this testing concludes the OPTIS Mobile System is determined to be safe and effective and is substantially equivalent to the ILUMIEN OPTIS predicate device." However, no specific performance metrics, sample sizes for test sets, ground truth methodology, or details of comparative effectiveness studies (like MRMC) are provided in the context of diagnostic accuracy, which would be typical for an AI/ML device.
Therefore, I cannot populate the requested table and answer many of the questions because the provided text does not contain this information. The device is cleared based on substantial equivalence to predicate devices, and the performance testing described is focused on safety, electromagnetic compatibility, software V&V, and basic system functionality, rather than detailed diagnostic accuracy metrics for an AI/ML algorithm.
§ 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.