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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 ENSEAL X1 Curved Jaw and ENSEAL X1 Straight Jaw Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are indicated for use during open or laparoscopic surgery. Indications for use include open and laparoscopic general surgical procedures (including bowel resections, gynecology, gastric, urologic and thoracic surgical procedures) where vessel ligation (sealing and cutting), division of lymphatics, tissue grasping and dissection is performed. The devices can be used on vessels and vascular bundles up to and including 7 mm in diameter.

The ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers are intended to cut and seal vessels, and to cut, grasp, and dissect tissue during surgery. The ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers are sterile, single-patient-use surgical instruments used to coagulate and transect vessels up to and including 7 mm in diameter, tissue, and/or vascular bundles. These devices are for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. The ENSEAL™ X1 Curved and Straight JawTissue Sealers have separate seal and cut capabilities. The lower jaw of the ENSEAL™ X1 Curved and Straight Jaw Tissue Sealers can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL™ X 1 Curved and Straight Jaw Tissue Sealer instruments are designed for use exclusively with the Ethicon Generator G11(GEN11). software version 2016-1 or later, or other compatible Ethicon generators. Refer to the Ethicon Generator's Manual for more information.

The IRIS Thermocoagulator and Digital Colposcope is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in selecting areas for biopsy and diagnosing as needed for a colposcopy exam.

The Liger Medical IRIS Thermocoagulator and Digital Colposcope is a portable thermal coagulator with integral colposcope that provides assistance for clinician examination of the cervix as well as utilizes a heated probe to ablate human tissue. It is specifically designed for use in resource-limited settings. The colposcope and thermal ablation modes can be used separately from each other. The device is a handheld, portable, battery-operated, ablator with an LCD display and optical camera to assist diagnosis and treatment, in a safe, effective, easy to use package with sufficient battery life to sustain work for 4 hours. Thermal coagulation can be used in hospital and non-hospital professional healthcare locations. The IRIS colposcope/thermal ablation device is not intended on into the vaginal canal during colposcopic examination. The camera remains outside the vaginal cavity and functions comparably to a standard non-invasive colposcope in terms of providing magnified visual assistance to the clinician. There is no patient contact during the colposcopic examination. Contact between the clinician and the device is mitigated through good clinical practice of wearing protective gloves, limiting contact to intact skin protected by operating gloves. The thermal ablation probe, which is reusable and provided non-sterile, is designed to perform low-power destruction of human tissue with high temperatures by tissue contact with an electrically heated probe tip. The biocompatibility of the probe materials conforms to all recommended endpoints per FDA's guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for limited duration mucosal membrane contact.

The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tisue bundles is performed (e.g. bowel resections, hysterectomies, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). The devices can be used on vessels up to and bundles as large as will fit in the jaws of the instruments. The ENSEAL X1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The ENSEAL X1 Tissue Sealer instrument is a sterile. single patient use surgical instrument to coagulate and transect vessels up to and including 7 mm in diameter, tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. The ENSEAL X1 Tissue Sealer has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot pedal is pressed. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.

The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tisue bundles is performed (e.g. bowel resections, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). The devices can be used on vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instruments. The ENSEAL X1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The ENSEAL X1 Tissue Sealer instrument is a sterile, single patient use surgical instrument to coagulate and transect vessels up to and including 7mm in diameter, tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. The ENSEAL X1 Tissue Sealer has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.

HARMONIC 1100 Shears: The HARMONIC 1100 Shears instrument is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis. Ethicon Generator G11: The Generator G11 provides radiofrequency power to drive ENSEAL electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive HARMONIC ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. ENSEAL and HARMONIC instruments, when used with the Generator G11, have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

HARMONIC 1100 Shears: The HARMONIC 1100 Shears are sterile, single-patient use devices for the dissection, grasping, coagulation, and cutting of soft tissue between the blade and clamp arm. The device consists of an ergonomic grip housing assembly with two-hand control buttons: 1) Energy button for power levels 1-5, and 2) Energy with Advanced Hemostasis button for large vessel sealing. The device is available in two shaft lengths (20 cm and 36 cm), and both device shafts can be rotated continuously to facilitate visualization and access to targeted tissue. An integrated audible and tactile mechanism in the grip housing indicates full trigger closures. The device has a clamp arm and coated curved blade that is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The Energy button is indicated for vessels up to 5 mm in diameter. When the Energy button is used, cutting speed is the fastest. The Energy with Advanced Hemostasis button is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy with Advanced Hemostasis button is used, cutting speed is reduced and hemostasis is maximized. The device utilizes Adaptive Tissue Technology (the technological characteristics of which were first cleared under K120729 on May 17, 2012 and incorporated into multiple Ethicon devices). This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output, as well as provide audible feedback to the user as appropriate. The HARMONIC 1100 Shears are designed for use exclusively with the Ethicon Generator 11 (GEN11), last cleared under K160554 on September 9, 2016. Generator G11: The Generator G11 supplies energy to the HARMONIC® and ENSEAL® surgical instruments. The generator uses a touchscreen display interface and has a unique receptacle port that accepts either a HARMONIC or an ENSEAL instrument. Connectors (HGA11 for HARMONIC and EGA11 for ENSEAL) are used to enable the generator to power legacy instruments. All ENSEAL and HARMONIC devices compatible with the generator and provided by Ethicon and authorized manufacturers undergo an extensive verification and validation process. The Ethicon Endo-Surgery Generator G11 System is not designed to operate unauthorized devices. Such use is not in accordance with the design and use parameters, instructions and guidelines for the product.

Indications for Use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two models, one for ABF01-F and the other for lock functions, ABF01-L. The two models are same except for lock function. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, plastic and reconstructive, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tissue bundles is performed (e.g. bowel resections, hysterectomies, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). The devices can be used on vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instruments. The ENSEAL X 1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures

The ENSEAL X1 Tissue Sealer, Curved Jaw Articulating instrument is a sterile, single patient use surgical instrument to coagulate and transect vessels up to and including 7 mm in diameter, tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable iaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The instrument shaft, normally in the straight position, can be articulated using the articulation wheel to gain additional access to tissue and facilitate additional angles across tissue and/or vascular bundles. The jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. The ENSEAL X1 Tissue Sealer, Curved Jaw Articulating has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer, Curved Jaw Articulating instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.

The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, plastic and reconstructive, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tissue bundles is performed (e.g. bowel resections, hysterectomies, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). The devices can be used on vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instruments. The ENSEAL X1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The ENSEAL X1 Tissue Sealer instrument is a sterile, single patient use surgical instrument to coagulate and transect vessels up to and including 7 mm in diameter, tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The ENSEAL X1 Tissue Sealer has a curved jaw and a straight jaw configuration. The jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. The ENSEAL X1 Tissue Sealer has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.

The Enseal® X1 Large Jaw Tissue Sealer instrument is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. It is a bipolar instrument for use with the Ethicon Generator G11 (GEN11). It is intended for use during open surgery to cut and seal vessels, cut, grasp, and dissect tissue during surgery. Indications for use include open general, gynecological, thoracic, and vascular procedures. These procedures include hysterectomies. Nissen fundoplication. adhesiolysis, oophorectomies, etc. The devices can be used on vessels (arteries, veins, pulmonary vasculature, lymphatics) up to and including 7 mm and tissue bundles. The Enseal® X1 Curved Large Jaw instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures. The efficacy of the Enseal® X1 Curved Large Jaw instrument for the indication of contraceptive tubal coagulation (permanent female sterilization) has not been evaluated and is unknown. The design of the EnSeal® Tissue Sealing Device is significantly different from bipolar designs that are marketed for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the procedure and failure rates may not be comparable.

The Enseal® X1 Large Jaw Tissue Sealer device is a sterile, single patient use surgical instrument used to coagulate and transect vessels up to and including 7 mm in diameter, tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The curved jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. Bipolar energy is delivered when the seal button (blue button) or MIN foot pedal is pressed. Pressing the cut button advances the knife the length of the jaws to cut the targeted tissue. It should be noted that this device has independent seal and cut capabilities. The power cord is permanently attached to the device and connects the instrument directly to the Generator 11. The Enseal® X1 Large Jaw Tissue Sealer device is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.