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COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only AVANOS* and Diros RF Probes and accessories, such as Cooled / Standard RF Pain Management Probes, Cannulas, and Introducers. Use of the CRG System is limited to the indications cleared under these devices and accessories.

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

The Racz Neurostat RF Generator is intended for lesioning of neural tissue. It is indicated for use in the peripheral nervous system. It is to be used with Epimed RF probes and cannula.

The Racz Neruostat RF Generator is a touchscreen controlled Radio Frequency (RF) Generator used to lesion neural tissue for pain management. It has 4 outputs for delivering RF from a single source into the patient, it includes functions for nerve stimulation (Sensory and Motor), Continuous Thermal RF Lesioning, Pulsed RF Lesioning and Pulsed Dose RF Lesioning. The RF Energy is transmitted via each individual probe and a Neutral Electrode when in monopolar mode; or between probes when running in bipolar mode. The device will monitor the patient's impedance, probe temperature, along with the voltage and current of the RF Energy during a procedure.

The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

The OneRF™ Ablation System components consist of the: - Radiofrequency (RF) Generator and Accessories - Generator Interface Cable (GIC), Cart and Foot Pedal (optional) - sEEG-RF Probe (with Universal Cable Assembly) and Ablation Accessories - Temperature Accessory, Spacer Tubes, Stylet and RF Connector Box The OneRF™ Ablation System uses radiofrequency ablation to create lesion (s) in an area of nervous tissue that the neurosurgeon has identified for ablation. This is accomplished by diagnostically locating the area to ablate using the implanted Stereoelectroencephalography (sEEG). Once the area of ablation is located, the generator and ablation accessories are taken to the patient with implanted sEEG(s). The sEEG(s) now function as an sEEG-RF Probe for RF ablation. To perform the ablation the Temperature Accessory (TA) is inserted into the sEEG-RF Probe to the predetermined electrode contact location using the specified spacer tube. A stylet may be used to ensure the lumen is patent prior to inserting the TA. The universal cable assembly remains attached to the sEEG-RF Probe while its cables are disconnected from the diagnostic head box. One (monopolar) or two (bipolar) cables from the universal cable assembly are inserted into the radiofrequency connector box (RFCB) depending on the contact area(s) to be ablated. The TA is also connected to the RFCB is attached to the Generator Interface Cable which is attached to the Generator. Temperature and time are used to create lesion (s).

Intended for use for lesioning of neural tissue and for pain management. It is indicated for use in the peripheral nervous system. The APEX 6 is to be used with LCCS electrodes and cannulae and Conmed Thermogard Dispersive Electrodes.

The RF Innovations APEX 6 is a desktop RF lesioning generator which is used for the lesioning of neural tissue. The APEX 6 is a multi-lesioning, 6 channel portable generator that can provide continuous or pulsed RF output at 460 kHz, and monopolar or dual electrode modes. The device includes sensory and motor stimulation functions to fine tune electrode placement for procedures. Based on performance testing the device is designed to connect to LCCS FDA cleared lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures. Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface as well as self-diagnostics, calibration checks, and recordkeeping functions.

This disposable electrosurgical return electrode with conductive adhesive gel is used in monopolar electrosurgical procedures for adult patients.

The Abbott Medical Grounding Pad is a dispersive electrode that is designed for use in monopolar electrosurgical procedures in adult patients. It is a single-use, non-sterile and disposable device. The Abbott Medical Grounding Pad is compatible with the lonicRF™ Generator and provides a path for radiofrequency (RF) energy produced at an RF electrode to return to the generator. The Abbott Medical Grounding Pad consists of a grounding pad component (also called a neutral electrode, dispersive electrode or return electrode) and an attached cable. The grounding pad component includes a conductive aluminum foil layer which acts as the neutral electrode that connects back to the generator. The aluminum foil layer is covered with a conductive hydrogel adhesive which is covered with a protective liner while it is packaged.

The lonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is an aid in the management of pain in the nervous system. Examples include, facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures.

The Abbott IonicRF™ Generator is a desktop radiofrequency (RF) lesioning generator, which is intended for lesioning of neural tissue in the peripheral nervous system as an aid in the management of pain. The generator is portable and can be placed on a level surface using the countertop stand or mounted to a compatible roll stand using the optional pole mount. The IonicRF™ Generator is a multi-lesioning, 4 channel portable generator that can provide continuous or pulsed RF output at 460 KHz, monopolar or dual electrode modes, and a Simplicity™ mode for large lesion creation. The generator includes sensory and motor stimulation functions to fine-tune electrode placement before procedures are performed. The generator is also designed to be compatible with all existing Abbott electrodes and cannulas. Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface, and recordkeeping functions. The user interface controls all functions of the generator. The generator incudes a dial on the front for control of stimulation level during stimulation and motor testing. The IonicRF™ Generator can be set on a flat surface or mounted on a pole with the accessory pole mount bracket. The IonicRF™ Generator can be used with previously cleared Abbott RF Electrodes (K011387, K111576), and Cannula/Introducers (K042375, K000073) used with the predicate device.

COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.

The COOLIEF* Radiofrequency Generator (CRG) System uses controlled radiofrequency energy to generate heat that is used to create lesions in neurological tissues or to coagulate and decompress disc material to treat symptomatic patients with contained herniated discs. The following components of the predicate Pain Management Generator-TD (K072478), which must be used together, have been modified and are the subject of this 510(k): a) COOLIEF* Radiofrequency Generator (CRG), b) COOLIEF* Quad Pump Unit (QPU), and c) COOLIEF* Therapy Cables.

The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of sterile, single-use components: - . The Intracept Access Instruments include introducers, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation. - The Intracept RF Probe conducts RF energy to the target location. To obtain the energy needed for tissue ablation, the Intracept RF Probe is used with the Relievant RFG. The Intracept System technique uses RF ablation of the basivertebral nerve for relief of chronic low back pain and involves a two-step process. First, utilizing the Access Instruments, based on a minimally invasive, transpedicular or extrapedicular approach, a cannula and stylets are placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. The RF Probe is then placed into this channel at the terminus of the basivertebral foramen and controlled RF energy is delivered to ablate the basivertebral nerve. This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue.

The Polaris RF Ablation System includes the following components: 1. Polaris Radiofrequency Generator and Desk Stand 2. Polaris Pump, Pump Cable and Desk Stand 3. Polaris Standard Connector Hub / Polaris Cooled Connector Hub 4. Polaris Footswitch 5. Polaris Cooled RF Probe Kit: i. Polaris Cooled RF Ablation Probe ii. Polaris Tube Kit iii. Polaris Introducer 6. Polaris Single-Use RF Probe 7. Polaris Reusable RF Probe 8. Polaris RF Cannula The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue. The system is designed to deliver controlled RF energy from the Polaris RF Generator to target tissues via the Polaris RF Probes for standard RF procedures or Polaris Cooled RF Probes for cooled RF procedures. RF energy is applied based on the configured RF generator settings to create the desired lesions in the target tissue. The generator also delivers low frequency stimulation pulses during procedures. During standard RF procedures, the Polaris RF Probe is used with a compatible Polaris RF Cannula to enable RF energy delivery via the active electrode to the target tissues. During cooled RF procedures with Polaris Cooled RF Probes, the system integrates a cooling mechanism by internally circulating water through the probes using the Polaris Pump Unit. This cooling results in minimal charring of the surrounding tissue and also prevents tissue from adhering to the electrodes. This allows for larger and more consistent ablation volumes to be achieved.

The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

The Relievant RFG is a universal AC powered, microcontrolled, bipolar RF generator intended to deliver RF energy to a targeted site. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System are used with the Relievant RFG.