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Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance. - . Prostate - Biopsy and minimally invasive puncture - . Surgical (Prostate) - Biopsy and minimally invasive puncture

The TP Pivot Pro™ needle guide is a tool for performing freehanded transperineal prostate biopsies, taking advantage of the transperineal path to sample regions of the prostate including the difficult to reach anterior zone. Used in conjunction with an ultrasound probe, users visualize suspect target areas of the prostate, plan and position an access site, and obtain specimens from a precise point in the prostate.

This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers. Transvaginal - Diagnostic ultrasound needle / instrument quided procedures such as tissue biopsy. fluid aspiration, catheter placement, treatment, and oocyte retrieval. Transrectal - Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.

The VitroPRO disposable endocavity needle guides are devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. They can be utilized for various types of procedures from tissue biopsy and fluid aspirations to instrument placements and oocyte harvesting.

This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers. - Transvaginal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy fluid aspiration, catheter placement, treatment, and oocyte retrieval. - Transrectal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.

The disposable endocavity needle guides are devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. They can be utilized for various types of procedures from tissue biopsy and fluid aspirations to instrument placements and oocyte harvesting.

The cover is intended as a microbial barrier between the patient and medical imaging equipment. The transducer covers are used for all body sizes in sterile and non-sterile fields and for the following applications. - · Abdominal Diagnostic imaging and minimally invasive puncture procedures. - · Small Parts Diagnostic imaging and minimally invasive puncture procedures. - · Regional Anesthesia Minimally invasive puncture procedures. - · Vascular Access Vessel identification and catheter placement. - · Surgical Diagnostic imaging and puncture procedures. - · Transesophageal Diagnostic imaging and monitoring of heart chamber, valves and vessels. - · Transrectal Diagnostic imaging and minimally invasive puncture procedures. - · Transvaginal Diagnostic imaging and minimally invasive puncture procedures When conducting an ultrasound procedure, place an appropriate amount of gel inside cover and/or on transducer face.

The CIV-Clear cover is a microbial barrier for use during ultrasound procedures. The cover is offered in sterile and non-sterile configurations in a variety of sizes to function with different equipment. The material has been tested and proven to be a viral barrier for microbes 27 nanometers and larger in size.

The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. Device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The device is not intended for use with patients under 12 years of age.

The Breastboard and Overhead Arm Positioner are used to position the patient during external beam radiation therapy. The Breastboard is comprised of a Base, Back Support, and Bottom Stop. The Base serves as the foundation of the assembly and provides a mounting surface for the Back Support, Angle Supports, and the Bottom Stop. The inferior end of the Back Support is mounted to the Base while the superior end of the Back Support is raised/lowered as needed for patient setup using Low Angle Supports. The Bottom Stop is located near the inferior end of the Base and prevents the patient from sliding down the Board. The Low Angle Support is used to position the Back Support at 5°, 7.5°, 10°, 12.5°, and 15° angles. Features on the High Angle Support receive the cutouts on the Low Angle Support and hold the angular position of the Support. The High Angle Support is used to position the Back Support at 17.5°, 20°, 22.5°, and 25° angles. Features on the Base receive the cutouts on the High Angle Support and hold the angular position of the Support. A Lock provides a method of locking the Back Support to the Base at 0° to facilitate easier handling and storage of the Breastboard. The Overhead Arm Positioner provides support for the patient's arms above the head and is attached to the Back Support via a locking assembly. The Overhead Arm Positioner adjusts longitudinally on the Back Support to accommodate a variety of patient sizes. A Hand Grip is mounted on the Overhead Arm Positioner and the location of the Hand Grip is adjustable longitudinally. A Head Support rests on a recessed area of the Overhead Arm Positioner and provides a cushion for positioning of the head of the patient. The Head Support can also be mounted directly on the Breastboard. A Thermoplastic Frame may also be mounted to the Overhead Arm Positioner to enable attachment of a thermoplastic mask for additional patient support. The Breastboard and Overhead Arm Positioner can also be used for supporting and elevating patients undergoing treatment who cannot lay down flat on the table due to their habitus. The Breastboard and Overhead Arm Positioner are reusable devices that are provided nonsterile.

The Envision cover and Envision pad are intended as a microbial barrier between the patient and medical imaging electronics. The Envision cover and Envision pad are used, without the need for ultrasound coupling gel, in adult and pediatric patients, for diagnostic ultrasound imaging, in sterile fields, that currently use an ultrasound coupling gel or fluid alone or in combination with a protective transducer cover, including ultrasound guided venous access, ultrasound imaging over surgical wounds, during transcutaneous biopsy; for intraoperative, endocavity, or transcutaneous imaging procedures; or to enhance acoustic coupling to difficult geometries.

The Envision Ultrasound pad and Envision Ultrasound cover (Envision) are microbial barriers for use during ultrasound procedures. The Envision device contains a coating that facilitates the acoustic coupling between the patient and ultrasound equipment without the need for traditionally ultrasound gel. This enables the clean transmission of sound waves between the transducer and patient without the mess of gels. The Envision Ultrasound pad is comprised of four layers. The first layer is a crack and peel release liner that is removed by the customer to expose the adhesive layer (second layer) that sticks to the patient or the transducer within the cover. The third layer is a film carrier layer to hold the adhesive and coating layers together. The final layer is the coating layer, which is the acoustic couplant layer and is activated by using hydrating media, such as saline. The Envision pad is sold as both a standalone pad and also sold as an integrated ultrasound cover (cover). The cover is a traditional CIVCO ultrasound cover, where one end of the cover is cut out, and the Envision pad, cut down to size, is sealed to the cover at the location of the cut out.

1. Solstice™ SRS Immobilization System (when used with customizable cushion): The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition. including Computed Tomography (CT), to support treatment planning. 2. Solstice™ SRS Immobilization System (when used with headrest): The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning. 3. Solstat™ Immobilization System & Solstice™ Thermoplastic Mask: The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.

The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to 10º in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeters. The provider can correct the patient position for simulation and treatments by tilting the device. The Static Head Fixation (Solstat) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and cannot be tilted. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can reproduce the patient position to under 3 millimeters within a treatment cycle. The Open-Face Thermoplastic mask is comprised of a thermoplastic mask bonded with a frame. The frame has five swivel clamps that allow secure attachment onto either the Solstice or Solstat device. When heated, the thermoplastic mask can be formed around the patient anatomy and allows the Region of Interest (ROI) to be capture by camera systems, allowing Surface Guided Radiation Therapy to occur via camera systems. The same mask will be used throughout the course of the treatment. The Open-Face style mask is ideal for Surface Guided Radiation Therapy (SGRT) via camera systems. The Solstice Immobilization device and Solstat Immobilization device are reusable devices that are provided non-sterile. Solstat and Solstice thermoplastic are single-patient reusable and is provided non-sterile and manufactured of non-magnetic materials. The devices are used in a healthcare facility/hospital. All devices are intended to be used on adult and pediatric patients.

General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Cushions, Cushions, and Accessories. The following are other positioning devices: Head. Neck. and Shoulders Device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions. Support Garments: The device is indicated to aid in supporting adolescents undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age. Breast Positioning Devices: The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.

The CIVCO Positioning and Immobilization devices have been used for many years and were previously cleared under other 510(k) is to have these identical Class II products cleared for use in Proton Therapy environment. The Head, Neck, and Shoulder Devices are used to treat cancer of the head, neck, brain and spine. Organs that are located in these anatomical regions are applicable. The General Positioning Devices are used to treat cancer of the spine, thorax, breast, abdomen, pelvis and prostate. Organs that are located in these anatomical regions are applicable. The Support Garments are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable. The Breast Positioning Devices are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable. The devices are intended for therapeutic treatment (including proton, photon, and electron beam therapy) and diagnostics (including CT and MR as indicated). The devices will be used in a variety of types of external beam radiation therapy including Intensity Modulated Proton Therapy (IMPT), Intensity Modulated Radiation Therapy (IMRT), Pencil Beam Proton Therapy (PBPT), Image Guided Radiation Therapy (IGRT), Volumetric Modulated Arc Therapy (VMAT), Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Stereotactic Body Radiation Therapy (SBRT), and Craniospinal Treatment. The intended users of the devices are radiation oncology therapists, medical physicists, and oncologists. The provider selects the appropriate equipment based on a patient's individual clinical goals and unique constraints. Thermoplastic mask, AccuForm Cushion, and Support Garment devices are single patient use. All devices are non-powered and static. The subject devices are reusable or disposable as provided in product labeling, provided non-sterile, and are used in a healthcare facility/hospital. The devices are labeled for MR safety, as applicable.

For the ASTRA TEE® - The ASTRA TEE® automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants. For the ASTRA VR™ - The ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal/endorectal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

The ASTRA Product Family of automated reprocessors are floor standing electromechanical lab equipment that facilitate high-level liquid disinfection of ultrasound probes that have been enzymatically pre-cleaned.

The system provides guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients.

The ultrasound guidance system is used during diagnostic or therapeutic procedures to assist the clinician in placing an interventional device in a targeted anatomical location. The quidance system consists of a quide, gauge inserts, and may include a bracket. The guide attaches to the OEM ultrasound transducer via a VerzaLink™ locating feature either on the customized bracket (Figure 1) or on the OEM ultrasound transducer housing (Figure 2). The guide is secured to the locating feature using a locking mechanism. The angle of the quide adjusts within a 37° range by moving the angle selector grip proximally or distally on the quide. The angle is secured into place at the desired position using a locking mechanism. The guide receives the gauge inserts. The gauge inserts are provided on a gauge insert tree in sizes ranging from 12F to 25G. Rotation of a quick-release tab on the gauge insert enables the guide and OEM ultrasound transducer to be removed while leaving the interventional instrument in place. The guide and gauge inserts are provided sterile, and are intended for single-use. The bracket is provided non-sterile and is reusable.