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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 PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3.x.

The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the CARTO® 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 Fr guiding sheath. This deflectable catheter consists of multiple 3 Fr spines on the distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO® 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the CARTO® 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.

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.

These Systems are intended for the following: Hooks, Plate/Rods, Plates, Rods and Screws When intended to provide stabilization as an adjunct to fusion of the cervical junction (occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon, OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft for the following: · Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) - · Spondylolisthesis - · Spinal stenosis - Fracture/dislocation - Atlantoaxial fracture with instability - Occipitocervical dislocation - · Revision of previous cervical spine surgery - Tumor When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only. Hooks and Rods The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars The rods, clamps, screws, nuts, variable axis screws and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine. The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector. The Synthes System can be linked to the DePuy EXPEDIUM 5.5 Titanium Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods. Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12) or lumbar spine.

The tapered rods are intended to create a single construct by linking system components that receive different rod diameters. These rods are manufactured from titaniumaluminum-niobium (Ti-6Al-7Nb (TAN)). These rods taper from a diameter of 3.5 mm or 4.0 mm to a diameter of 5.5 mm and are both 500 mm in length. The Synthes Synapse System is a hook, rod and pedicle screw spinal system intended to provide posterior stabilization of the upper spine (C1-T3) as an adjunct to fusion in skeletally mature patients. This system consists of multiple components manufactured from either titanium aluminum niobium (Ti-6Al-7Nb (TAN)) or commercially pure grade 4 Titanium and include rods (straight, tapered and curved), plate/rods, hooks, clamps, screws, nuts, variable axis screws, locking screws, transconnector clamps, transverse bars, parallel connectors and variable axis/top loading transconnectors. These system components are implanted using Class I general surgical instruments. A complete occipital-cervical-thoracic construct can be created by using components from the previously cleared Synthes CerviFix System, Synthes Axon System, and Synthes OC Fusion System. When combined with the Synthes Universal Spinal System (including Matrix) using parallel connectors or tapered rods, constructs can extend from the occiput to the lower spine.

Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction Hip: Capsular Repair, Acetabular Labral Repair

The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM (composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture (UHMWPE braided suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The Permacord suture is a non-absorbable suture that conforms to USP except for oversized diameter. The device is provided as sterile; the device is for single patient use only.

The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.

The proposed device is a cortical fixation system composed of titanium button, adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leading suture (UHMWPE and green Polyester (PET) co-braid) and training suture (green PET). Length of the suture loops is adjustable to the desired length. The proposed device provides a fixation in cruciate ligament reconstructive surgery. The device is provided as sterile for single patient use only.

The Healix Advance Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder Rotator Cuff . . Biceps Tenodesis

The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5 mm Healix Advance Knotless PEEK Anchor is manufactured from PEEK (Polyetheretherketone) material.

ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.

Orthocord® Suture is a synthetic, sterile, braided, composite suture composed of dyed (D&C Violet #2 or D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.