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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 ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea. The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patent Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

The ELITATM Femtosecond Laser System is an ophthalmic laser for corneal surgical operation. The system accurately cuts cornea tissue through a high pulse repetition rate and ultra-fast scanner to place pulses tightly next to each other, generating a continuous cutting surface. The system is controlled by the graphical user interface and software real-time controls. The optical delivery system determines a 3-dimensional position in the cornea at which the laser focuses. When the laser is emitted, the energy delivered is sufficient to photo-disrupt a small volume of tissue. The process of cutting involves repetitively setting a focus point and translating the laser cutting line generated by the resonant scanner. The ELITATM Femtosecond Laser System is a CDRH Class IV laser per 21 CFR 1040.10 and 1040.11 due to intentional laser exposure of the eye.

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are nearsighted (hyperopic) and may have 1.00D or less of astigmatism that does not interfere with visual acuity. ACUVUE® OASYS MAX 1-DAY Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism. ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and may have 0.75D or less of astigmatism that does not interfere with visual acuity. ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism. The lenses are to be prescribed for daily disposable wear. Therefore, no cleaning or disinfection is required. Lenses should be discarded upon removal.

The subject device is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date a 2-year shelf-life has been established. The subject device is made of a silicone hydrogel material containing an internal wetting agent. The lens is tinted using Reactive Blue 247. A benzotriazole UV absorbing monomer is used to block UV radiation in combination with a novel fused tricyclic chromophore that also blocks UV radiation and reduces transmittance in the range from 380 nm to 450 mm.

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 VERITAS(TM) Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the user to configure the system to meet their surgical requirements. The VERITAS(TM) Advanced Infusion Pack or VERITAS(TM) Advanced Fluidics Pack contains the manifold (cassette) and Tubing Assembly and is intended to perform irrigation during anterior segment cataract surgery. It is used with the VERITAS(TM) Vision System. The VERITAS(TM) Pack is sterilized using ethylene oxide and is designed for single use only.

The VERITAS™ Vision System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) ophthalmic surgery. The device uses ultrasonic energy via finely modulated pulses of energy, interrupted by brief cooling periods, to emulsify and extractous lens. This allows the system to achieve full ultrasound cutting efficiency while introducing less energy to the eye, which reduces risk of thermal damage. The VERITAS™ System performs phacoemulsification, diathermy, irrigation/aspiration, and vitrectomy functions, and is a peristaltic system with a graphic user interface that has updated technology and hardware to meet current electrical and material safety standards. The VERITAS™ Vision System consists of components that are used to perform cataract surgery, which include the 1) System Console, 2) Wireless Remote Control, 3) Advanced Foot Pedal and 4) Single-Use Fluidics Pack or Single-Use Infusion Pack 5) Swivel Handpiece 6) Hardware 7) Software. The VERITAS™ Advanced Infusion Pack or VERITAS™ Advanced Fluidics Pack contains the manifold (cassette) and Tubing Assembly and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the VERITAS™ Vision System. The VERITAS™ Pack is sterilized using ethylene oxide and is designed for single use only.

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.

The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may need up to 4.00 of ADD power and have 0.75D or less of astigmatism. The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism. Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2 weeks (14 days).

The subject device is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. The subject device is made of a silicone hydrogel material containing an internal wetting agent. The lens is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 315 nm to 380 nm for the entire power range.

The UNFOLDER Vitan™ Inserter, Model DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.

The UNFOLDER Vitan™ Inserter, Model DK9000, is an autoclavable, reusable titanium intraocular lens (IOL) inserter or handpiece that is designed for use in combination with the SmartLOAD™ Delivery Technology (P980040/S095) to fold and assist in the insertion of a J&J Vision acrylic one-piece IOL into the eye following cataract extraction. The IOL is provided preloaded in the disposable polypropylene cartridge and is snapped into the inserter. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye. The SmartLOAD™ Delivery Technology cartidge is designed to eliminate the need for the IOL to be loaded into the cartridge to provide a sterile, controlled, and convenient method of efficiently delivering J&J Vision acrylic onepiece lenses into the eye during cataract surgery.

The COMPACT INTUITIV™ System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The COMPACT INTUITIV™ System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) surgery. The device is used to emulsify and extract a cataractous lens. The COMPACT INTUITIV™ is a mid-tier peristaltic system with a graphic-user that has updated technology and hardware to meet current electrical and material safety standards. The currently cleared COMPACT INTUITIV™ consists of the System Console, the Wireless Remote Control, the Open-Toe Foot Pedal, and the Single-Use Fluidics Pack, Model OPO80. The closed-toe foot pedal is equivalent to the currently cleared open-toe foot pedal for use with the COMPACT INTUITIV" system. The closed-toe foot pedal provides similar functionality as the opentoe foot pedal. Both open-toe and closed-toe foot pedals contain three-programmable switches, and the closed-toe device incorporates a programmable treadle. Both open and closed toe foot pedals provide tactile feedback to the user. The switches and treadle on the foot pedal can be programmed to access features on the COMPACT INTUITIV™ System Console based on the surgeon's preference.