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ACIST CVi®1 Contrast Delivery System: The ACIST CVi®1 Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The CVi®1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CVi@1 Syringe Kits are also indicated for single patient use with ACIST CVi® Contrast Delivery Systems. The ACIST CVi@1 Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent. ACIST CVi® Contrast Delivery System: The ACIST CVi® Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The ACIST CVi® Contrast Delivery System is specifically indicated for use in angiographic procedures for the delivery of ISOVUE (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of ten (10) hours. The Syringe Kit must be discarded after six (6) patient procedures. The Manifold Kit and AngioTouch Kit must be discarded after each patient procedure. The ACIST CVi® Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

The CVi/CVi1 System is designed to aid the physician in the controlled infusion of radiopaque contrast media. Radiographic imaging devices are used in conjunction with the delivery of contrast media to produce angiograms. Operating environments for the CVi/CVi1 System are catheterization and radiological laboratories. The CVi/CVi1 System contains a software-controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume via the ACIST provided consumable kits and a hospital provided angiographic patient catheter. The CVi/CVi1 System is also equipped to synchronize with commercially available X-ray imaging systems. The CVi/CVi1 System is used in interventional cardiology, radiology, and vascular surgical procedures. The CVi/CVi1 System device modification that is the subject of this 510k premarket notification is a material component change to the AngioTouch Hand Controller.

The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound in indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HD System.

The primary function of HDi System is to collect reflected ultrasonic (sound) waves from the Kodama catheter and render an intravascular image on the console touchscreen. The catheter emits sound energy from a transducer at the tip; sound waves reflected from the inner vascular tissues are received from the transducer and sent to the console where a high resolution, cross-sectional image is displayed on the touchscreen in real-time. The main devices are the Console, Patient Interface Module (PIM), Linear Translation System (LTS) (optional), and Kodama Catheter. The console houses hardware and software required to generate the energy used to excite the transducer in the Kodama catheter; it is the center of control and system architecture for how signals are acquired, processed, images constructed and presented, and overall power management and control of the PIM and LTS. The system digitally records case images, provides a review of recorded cases, and provides for the archival of recorded cases onto removable media. The handheld PIM provides the electromechanical interface between the catheter and the console. It also provides the mechanical interface to secure the catheter, as well as the mechanical energy to rotate the catheter's imaging assembly. The LTS device provides automated, controlled linear translation of the catheter by providing mechanical coupling to the PIM and to the catheter's telescoping anchor as the PIM is pulled back along the longitudinal axis. The coupling between the LTS and PIM and LTS to catheter is strictly mechanical. The LTS device allows the user to perform automatic pullbacks and can be controlled via touchscreen buttons on the console or the buttons on the LTS. Manual pullbacks may be performed with or without the LTS, making the use of the LTS optional to the user. The Kodama Catheter emits sound energy from its transducer at the distal tip, which is guided into the coronary and peripheral vasculature. The catheter can be operated at two different frequencies, 40MHz and/or 60MHz. The electrical energy from the catheter is transmitted, via the coaxial cable embedded in the drive cable, back to the HDi console for signal processing and image reconstruction.

The ACIST RXi System is indicated for obtaining intravascular pressurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System

The ACIST Navvus II MicroCatheter is a single-lumen monorail catheter designed to be used with standard 0.014 in (0.36 mm) guidewires in the arterial vasculature. The MicroCatheter is compatible with the ACIST RXi family of system hardware which includes the RXi System and RXi Mini. Features unique to each system are denoted specifically. The Navvus II MicroCatheter distal shaft is 26 cm in length with a pressure sensor located 5 mm from the distal tip. The elliptical distal shaft is 1.68 x 1.91F (0.020 in x 0.025 in) up to 10 mm from the distal tip; a maximum profile of 2.7F (0.036 in) occurs at the pressure sensor. The distal shaft smoothly tapers over the pressure sensor and down to the tip accepting the guidewire. A radiopaque marker band is located 2.5 mm from the distal tip. The shaft proximal to the monorail section is 2.4F, allowing use in 5F or larger guide catheters. Two white positioning markers are located at 80 cm and 100 cm from the distal tip. The pressure sensor on the catheter utilizes optical sensing technology. Both the optical pressure signal and information for auto calibration are transmitted from the catheter to the RXi hardware. The ACIST RXi System is designed to provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR) and resting Pd/Pa. FFR and resting Pd/Pa supplement the visual data provided by angiography and provides an assessment of the lesion severity. Measurement of FFR and resting Pd/Pa requires simultaneously monitoring the blood pressures proximal and distal to a lesion. The ACIST RXi System includes a single-use MicroCatheter with a pressure sensor for acquisition of the distal pressure. The proximal pressure is acquired via the guide catheter which is monitored by the ACIST RXi System via an interface to the hospital's hemodynamic monitor. Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressured at resting conditions. The physician may then use the resting Pd/Pa value, along with knowledge of patient history, medical expertise and clinical judgment to determine if an additional measurement of FFR during hyperemia or therapeutic intervention is indicated.

The ACIST|CVi®1 Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The CVi1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CV1 Syringe Kits are also indicated for single patient use with ACISTCVi® Contrast Delivery Systems. The ACIST|CVi®1 Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

The ACIST CVi1 Contrast Delivery System is designed to aid the physician in the controlled infusion of radiopaque contrast media. The CVi1® Contrast Delivery System contains a software controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume. The CVi1 Contrast Delivery System is used in conjunction with ACIST provided consumable kits: A1000/A1000V Syringe Kit, BT2000 Manifold Kit, and the AT-P AngioTouch Hand Controller Kit. The current submission introduces the A1000/A1000V Syringe Kit provided in the consumable kits. Changes are also introduced into software and labeling to address single patient use for the consumable kit. The CVi1 Contrast Delivery System is used in interventional cardiology, radiology, and vascular surgical procedures. The operating environments for the CVi1 Contrast Delivery System are catheterization or radiological laboratories. The CVi1 system is used in interventional cardiology, radiology, and vascular surgical procedures. Like the predicate CVi system, the CVi1 system is used in adults and pediatrics patient populations.

The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

The primary function of HDi System is to collect reflected ultrasonic (sound) waves from the Kodama catheter and render an intravascular image on the console touchscreen. The catheter emits sound energy from a transducer at the tip; sound waves reflected from the inner vascular tissues are received from the transducer and sent to the console where a high resolution, cross-sectional image is displayed on the touchscreen in real-time. The main devices are the Console, Patient Interface Module (PIM), Linear Translation System (LTS) (optional), and Kodama Catheter. The console houses hardware and software required to generate the energy used to excite the transducer in the Kodama catheter; it is the center of control and system architecture for how signals are acquired, processed, images constructed and presented, and overall power management and control of the PIM and LTS. The system digitally records case images, provides a review of recorded cases, and provides for the archival of recorded cases onto removable media. The handheld PIM provides the electromechanical interface between the catheter and the console. It also provides the mechanical interface to secure the catheter, as well as the mechanical energy to rotate the catheter's imaging assembly. The LTS device provides automated, controlled linear translation of the catheter by providing mechanical coupling to the PIM and to the catheter's telescoping anchor as the PIM is pulled back along the longitudinal axis. The coupling between the LTS and PIM and LTS to catheter is strictly mechanical. The LTS device allows the user to perform automatic pullbacks and can be controlled via touchscreen buttons on the console or the buttons on the LTS. Manual pullbacks may be performed with or without the LTS, making the use of the LTS optional to the user. The Kodama Catheter emits sound energy from its transducer at the distal tip, which is guided into the coronary and peripheral vasculature. The catheter can be operated at two different frequencies, 40MHz and/or 60MHz, depending on user preference. The catheter design includes an imaging assembly (with transducer, drive cable, coaxial cable, and rotor), sheath assembly (which includes the femoral marker and hydrophilic coating), telescope assembly, and catheter hub assembly. The electrical energy from the catheter is transmitted, via the transmission line embedded in the drive cable, back to the HDi console for signal processing and image reconstruction.

The ACIST|CVi® Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The ACIST CVi® Contrast Delivery System is specifically indicated for use in angiographic procedures for the delivery of ISOVUE (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of ten (10) hours. The Syringe Kit must be discarded after six (6) patient procedures. The Manifold Kit and AngioTouch Hand Controller Kit must be discarded after each patient procedure. The ACIST CVi® Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

The ACIST CVi® Contrast Delivery System is designed to aid the physician in the controlled infusion of radiopaque contrast media. The CVi Contrast Delivery System contains a software controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume. The CVi Contrast Delivery System is used in conjunction with ACIST provided consumable kits: A2000 Syringe Kit, BT2000 Manifold Kit, and the AT-P AngioTouch Hand Controller Kit, and a hospital provided angiographic patient catheter. The CVi Contrast Delivery System is used in interventional cardiology, radiology, and vascular surgical procedures. The operating environments for the CVi Contrast Delivery System are catheterization or radiological laboratories.

The ACIST HDi System is intended to be used for the intravascular ultrasound imaging assessment of coronary artery disease. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is a medical device for use by or on the order of a physician and is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The primary function of HDi System is to collect reflected ultrasonic (sound) waves from the Kodama catheter and render an intravascular image on the console touchscreen. The catheter emits sound energy from a transducer at the tip; sound waves reflected from the inner vascular tissues are received from the transducer and sent to the console where a high resolution, cross-sectional image is displayed on the touchscreen in real-time. The main devices are the Console, Patient Interface Module (PIM), Linear Translation System (LTS) (optional), and Kodama Catheter. The console houses hardware and software required to generate the energy used to excite the transducer in the Kodama catheter; it is the center of control and system architecture for how signals are acquired, processed, images constructed and presented, and overall power management and control of the PIM and LTS. The system digitally records case images, provides a review of recorded cases, and provides for the archival of recorded cases onto removable media The handheld PIM provides the electromechanical interface between the catheter and the console. It also provides the mechanical interface to secure the catheter, as well as the mechanical energy to rotate the catheter's imaging assembly. The LTS device provides automated, controlled linear translation of the catheter by providing mechanical coupling to the PIM and to the catheter's telescoping anchor as the PIM is pulled back along the longitudinal axis. The coupling between the LTS and PIM and LTS to catheter is strictly mechanical. The LTS device allows the user to perform automatic pullbacks and can be controlled via touchscreen buttons on the console or the buttons on the LTS. Manual pullbacks may be performed with or without the LTS, making the use of the LTS optional to the user. The Kodama Catheter emits sound energy from its transducer at the distal tip, which is guided into the coronary arteries of the heart. The catheter can be operated at two different frequencies, 40MHz and/or 60MHz, depending on user preference. The catheter design includes an imaging assembly (with transducer, drive cable, coaxial cable, and rotor), sheath assembly (which includes the femoral marker and hydrophilic coating), telescope assembly, and catheter hub assembly. The electrical energy from the catheter is transmitted, via the transmission line embedded in the drive cable, back to the HDi console for signal processing and image reconstruction.

The ACIST RXi Mini is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus Catheter is intended for use with the ACIST RXi Mini.

ACIST RXi Mini consists of a 1.) Navvus Interface, which receives the pressure signal sensed by the Navvus Catheter, and a 2.) Processing Unit, which converts the optical sensor pressure signal into an analog pressure signal that can be read by a third party hemodynamic system in real-time. These two hardware components are intended to be located on or around a patient bed, and multiple mounting options are available to accommodate different workflows. Both components contain software. The two modules are connected using the Navvus Interface cable, which contains both a fiber optic cable and an electrical signal (communication) cable. A hemodynamic cable is connected to the Processing Unit and is plugged into the appropriate channel programmed to accept the distal pressure in the hemodynamic system. The power cord is plugged into the Processing Unit and is then connected to the mains power source.

The Adagio™ Retracting ECG patient lead wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional.

The Adagio™ Retracting ECG Lead Wires are standard five lead wire set that incorporate retractors to facilitate the handling of the lead wires and are: • ANSI/AAMI EC 53: 1995 (R) 2001 Compliant • AAMI EC 13: 2002 (R) 2007 Color Code compliant

The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

The C2000 Automated Manifold Assembly Kit is the disposable patient contact intravenous tubing that attaches to Part A via a connector. This kit is contains the patient manifold, saline spike, 3-way pressure stopcock, high pressure line, and a syringe cap. This kit is designed to be connected to the users own pressure monitoring equipment to measure homodynamic waveform.