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The Mammotome AutoCore™ Single Insertion Core Biopsy System is indicated to obtain tissue samples from the breast or lymph nodes for diagnostic analysis of breast abnormalities. This instrument is for diagnostic use only and is not indicated for therapeutic use. The extent of a histologic abnormality cannot always be reliably determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benian, it is essential that the tissue marqins be examined for completeness of removal using standard surgical procedures.

The Mammotome AutoCore™ Single Insertion Core Biopsy System is an automated core needle biopsy system. It is a single insertion, multiple sample device that includes automated arming and automated sample collection. It is available in two gauge sizes (12G and 14G) and acquires soft tissue samples using a spring-loaded inner piercing stylet and outer cutting cannula in the probe needle.

This device is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

The device is intended to be used as a 24-month reusable patient return electrode for patients age 12 years and older. The Universal (model 0845) and Universal Plus (model 0847) have a single cord that connects to one generator. The Universal Dual (model 0846) and Universal Plus Dual (model 0848) have two cords that can connect to one or two generators. The Mega Soft Universal Patient Return Electrodes (ie. Mega Soft) are constructed of a layer of conductive material strain-relieved between an insulative polymer gel, and sealed between two layers of a thermal polyurethane plastic film. The thermal polyurethane plastic film and the contained polymer gel enveloping the conductive material is compressable but does not laterally move under pressure. The polymer acts as a dielectric protection and is encapsulated by a layer of urethane film. The dielectric protection remains between the thermal polyurethane plastic film and the conductive layer irrespective of pressure. A two-conductor cable connects the conductive layer of the device to a two-conductor DetachaCable™. The DetachaCable is connected to a standard monopolar ESU. The DetachaCable is available in a variety of configurations and lengths, designed to be compatible with the various compatible generators available on the market and was cleared under K080741 on 16 December 2008.

The HydroMARK™ Plus Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least six (6) weeks, and be permanently visible by x-ray and MRI.

The HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird, subject device) is a two-component marker that provides permanent marking of a breast biopsy or axillary lymph node biopsy site following a breast biopsy procedure. The implantable marker is made of a highly expandable solid cylinder of polymerized and desiccated hydrogel that has the permanent titanium marker embedded. Upon fluid contact (e.g., water, blood, etc.), the hydrogel material expands to an equilibrium point. Once the material hydrates, it is visible under ultrasound. Over time, the hydrogel is resorbed by the patient's body. The titanium wire is permanently visible under x-ray and MRI even after the hydrogel is resorbed. The HydroMARK™ Plus Breast Biopsy Site Marker is a permanent implant and is not intended to be removed unless the marked tissue requires surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is designed to fit into specified commercially available breast biopsy devices. During a breast biopsy procedure, the marker is deployed through a compatible introducer or by direct puncture into the biopsy cavity created by the breast biopsy device.

The LumiMARK™ Biopsy Site Marker is indicated to mark tissue associated with a percutaneous breast biopsy procedure, including axillary lymph nodes, and be permanently visible under ultrasound, x-ray, and MRI.

The LumiMARK™ Biopsy Site Marker implant component [subject device] is composed of a nitinol (nickel/titanium alloy) material versus HydroMARK™ Breast Biopsy Site Marker [predicate device] which is composed of titanium or stainless steel encapsulated in resorbable hydrogel. The marker is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that allows the marker to be inserted with direct puncture under ultrasound. The applicator system is of similar design and materials as the currently marketed Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device]. LumiMARK™ Biopsy Site Markers will be available in three different shapes. These permanently visible, implantable markers will allow the physician to identify different biopsied sites under ultrasound, x-ray, and MRI. A similar marker device commercialized by Devicor Medical Products, Inc. is already available (under K212158), and this HydroMARK™ Breast Biopsy Marker [predicate]. The deployment system used for the LumiMARK™ Biopsy Site Marker device [subject] will be similar to the HydroMARK™ Breast Biopsy Site Marker [predicate] delivery system with minor design changes to the plunger assembly and cannula. The nitinol markers will be intended for direct puncture or insertion through another introducer needle that is already in the breast or axillary lymph node.

HydroMARK™ Plus Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI

The HydroMARK™ Plus Breast Biopsy Site Marker contains a two-component implantable marker that provides permanent marking of a breast biopsy or axillary lymph node biopsy site following a breast biopsy procedure. The implantable marker is made of a highly expandable solid cylinder of polymerized and desiccated hydrogel that has the permanent titanium marker embedded. Upon fluid contact (e.g., water, blood, etc.), the hydrogel material expands to an equilibrium point. Once the material hydrates, it is visible under ultrasound. Over time, the hydrogel is resorbed by the patient's body. The titanium wire is permanently visible under x-ray and MRI even after the hydrogel is resorbed. The implantable component of the HydroMARK™ Plus Biopsy Site Marker is supplied preloaded in a sterile, disposable applicator that is designed to fit into specified commercially available breast biopsy devices. During a breast biopsy procedure, the marker is deployed through a compatible introducer or by direct puncture into the biopsy cavity created by the breast biopsy device.

The HydroMARK Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The HydroMARK Breast Biopsy Site Marker [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component, and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMARK Breast Biopsy Site Marker has a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium or Stainless Steel. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray, and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI.

The Ethicon Megadyne Electrosurgical Generator (ESU) is intended as a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

The Ethicon Megadyne TM Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.

The HydroMARK Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The HydroMARK Breast Biopsy Site Marker [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component, and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMARK Breast Biopsy Site Marker is a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium or Stainless Steel. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray, and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI.

The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood, and blood products. The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for power injection of contrast media. For power injection of contrast media, the maximium recommended infusion rate is 5 mL/s.

The TidalPort-AP™ has one port size (Standard) and one catheter size (9.6F Polyurethane). It is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The TidalPort-APTM is available as a standard profile totally implantable, titanium port-based design and is accessed perpendicularly to the skin like a typical, conventional access port. For the purpose of apheresis, high-flow procedures, it is accessed with using the FDA Cleared 16G or 18G high-flow, non-coring needle Tidal High-Flow Non-coring Needle (K151341). The TidalPort-APTM can also be used for routine vascular access infusion or withdrawal using Huber point needle. For power injection infusion procedures, the subject device can be accessed with a power injection rated needle to create a power-injectable system. The design of the TidalPort-AP™ utilizes a spherical reservoir and an elongated radius contoured septum to achieve the design purpose of creating a port with a smaller reservoir and less clearance volume. The TidalPort-APTM comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The TidalPort-AP™ and necessary kit components are provided sterile (EtO). The overall implanted port system consists of three primary components: the titanium port body with a silicone septum, an attachable radiopaque polyurethane catheter, and a catheter lock which secures the catheter to the port body stem. Once implanted, the method of accessing the subject TidalPort-APTM device is the exact same as the predicate TidalPort™ device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped port. Once the port is palpated, providing the location of the septum, the 16G or 18G high-flow needle (K151341) is inserted into the reservoir for apheresis procedure use. After the reservoir floor is reached, the stylet is unlocked and pulled back slightly, and the needle is once again advanced forward until contacting the reservoir floor again. The stylet is then completely removed, leaving the hollow cannula with luer lock fitting in place. After stylet removal, the cannula is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.

The Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. · The Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. · The Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Mammotome revolve EX System is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination. The Mammotome revolve EX System is comprised of three primary subsystems: - 1) a sterile, single-use Probe - 2) a reusable Holster, and - 3) a reusable control unit.