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The ETHICON™ Total Energy System is intended to supply energy to surgical devices. The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.

The subject device, The ETHICON™ Total Energy System, is an electrosurgical generator that integrates Advanced Energy (Advanced Bipolar and Ultrasonic) and Core Monopolar and Bipolar energy modalities into one system, the Ethicon Total Energy System. The subject device consists of two modules: the Communications Module (ETHCM and ETHUSC) and the Energy Module (ETHEM). Atop the Energy Module is the Communications Module and the User Screen. The Communications Module contains the power button and speakers, connects to the User Screen, distributes power to the system, and provides external interfaces for other connectivity to external devices including Ethernet and USB. One or two Energy Modules can be connected to the Communications Module. When two Energy Modules are connected, each Energy Module can independently power any of the energy modalities. This feature allows for simultaneous use of two surgical instruments in one system to support complex surgical procedures where two surgeons are operating on a patient at the same time. The User Screen features a touch-operable graphical user interface (GUI) for system settings adjustment, user profile management, and alarm troubleshooting. The ETHICON™ Total Energy System accessories include a cart for system transport, footswitches (single, double, round), and an output verification key. The cart provides a mobile platform with adjustable shelves and accessory storage. Additionally, the cart has custom features to create stability for the system including cut-outs on the top shelf for holding the rubber feet of a second module layers. Casters provide 360° mobility with locking tabs that lock to prevent unwanted cart movement. Footswitches may be used to control power delivery to connected instruments, enabling surgeons to activate the energy output hands-free. The different footswitches can be used for various energy modalities and instruments. Up to four footswitches can be connected to the Communications Module of the Ethicon Total Energy System at the same time. The footswitches are assigned to the desired instrument port via the User Screen GUI. Output Verification is a service mode of the system used to periodically confirm that the power outputs of each energy modality are within the required specifications. The Energy Output Verification Key is used by biomed/hospital facility servicing personnel to complete this process for annual maintenance on the Energy Module, with on-screen guidance to assist in this process. The ETHICON™ Total Energy System is compatible with Ethicon HARMONIC™, Ethicon ENSEAL™, and Ethicon MEGADYNE™ monopolar and bipolar instruments.

The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The 4x reprocessed Monarch Bronchoscope. MBR-000211-B. (hereafter referred to as "Proposed Device") is similar to the 2x reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Predicate Device"). The Original Monarch Bronchoscope. MBR-000211-A. (hereafter referred to as "Co-Predicate Device") cleared under K193534 is identical to the 2x reprocessed Monarch Bronchoscope ("Predicate Device"), cleared under K203614. Both device designs are controlled by Auris Health, Inc., throughout their total product lifecycle. The Monarch Bronchoscope is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that is either discarded or returned to Auris for reprocessing after clinical use. The original singleuse Monarch Bronchoscope was cleared for one clinical use under K193534. The reprocessed single-use (rSUD) Monarch Bronchoscope was cleared for two (2) clinical uses under K203614. This premarket notification intends to gain market clearance for a reprocessed single-use (rSUD) Monarch Bronchoscope that can be reprocessed up to three (3) times, for a total of four (4) clinical uses. Identical to the Predicate Device, the Reprocessed Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the Predicate Device.

The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Proposed Device") is identical to the Original Monarch Bronchoscope, MBR-000211-A, (hereafter referred to as "Predicate Device"), which is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that can be reprocessed up to one (1) time. The Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the predicate Monarch Platform bronchoscope.

Milagro Interference Screw (5x12, 6x12, 7x15, 8x15) The MILAGRO BR Interference Screws are designed to attach soft tissues to bone in Orthopedic surgical procedures for the following indications: Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation) Milagro Advance Interference Screw (7x23, 8x23, 9x23) The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures. Additionally, the 7, 8 and 9mm x 23mm screws are indicated for: medial and lateral ligament repart, medial patellofemoral ligament reconstruction (femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

The proposed devices are interference screws used for attachment of soft tissue to bone in Orthopedic surgeries. The proposed devices are cannulated, threaded interference screws, made of absorbable Biocryl® Rapide™ (composite of β-TCP and PLGA copolymer). The devices are provided as sterile (EtO), and are for single patient use only. There is no accessory accompanied with the devices. Manual Orthopedic instruments such as tap and driver are used for screw insertion. Instruments are classified as LXH: Orthopedic Manual Surgical Instruments, Class I Exempt device, regulated per 21 CFR 888.4540. No new instrumentation is developed for the purpose of this submission.

The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/ interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.

The ELITECROSS™ Support Catheter is a single-use, 5F sheath-compatible sterile catheter designed to provide additional support to the distal portion of ancillary diagnostic/interventional devices, including the FRONTRUNNER® XP CTO Catheter, as well as to deliver saline or contrast medium. After crossing the occlusion with the ancillary device, the ELITECROSS™ may be used to facilitate placing a guide wire across the occlusion. The ELITECROSS™ Support Catheter device is a single lumen torqueable tube containing a full-length PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating on the distal 40 cm of the catheter body. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The ELITECROSS™ Support Catheter will be available in various configurations and several lengths. The ELITECROSS™ Support Catheter is provided sterile (by EO) and intended for single use only.

The OUTBACK Elite Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The OUTBACK Elite Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.

The OUTBACK® Elite Re-Entry Catheter is a single-use device designed to facilitate placement and positioning of guidewires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The OUTBACK® Elite Re-Entry Catheter is supplied sterile and is available in two useable lengths.

The Micro Guide Catheter ELITE accessory is to be used with the Frontrumer® CTO Catheter. The Frontrumer® CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

The Micro Guide Catheter ELITE is a 6F sheath compatible catheter designed to navigate and place guidewires in the peripheral vasculature and to provide additional support for the Frontrunner® CTO Catheter. The Frontrunner® CTO Catheter is indicated to facilitate the intraluminal placement of conventional guidewires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Micro Guide Catheter ELITE is a single lumen torqueable tube containing a PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The Micro Guide Catheter ELITE is available in various configurations and several lengths. The Micro Guide Catheter ELITE is provided sterile (by EO) and is intended for single use only.

The Healix Ti Anchor is intended for: - Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction - Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair - Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair - Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction - Hip: Capsular Repair, Acetabular Labral Repair

The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. The Healix Ti Anchors are manufactured of Titanium material. Permacord suture is non-absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only.

The VAPR® ARCTIC™ Suction Electrode for use with the VAPR VUE® RF System is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the hip.

The VAPR® ARCTIC™ Electrode is a single use, one-piece bipolar suction articulating electrode for use in arthroscopic surgery of the hip. The electrode has a hand-controlled articulating tip to improve access and suction capabilities. This will enhance the efficiency of the electrode and extend the utility of the system by assisting in the removal of bubbles and debris created during activation within the operating site. The ARCTIC Electrode has been designed to facilitate access and control the delivery of RF energy to the joint space. The plug of the ARCTIC Electrode is designed to fit the VAPR VUE® generator socket only. It has an internal identification capacitor code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be run only off the VAPR VUE electrosurgical generator at pre-determined default settings specific for the device.