Indications, safety, and warnings for Intracept Intraosseous Nerve Ablation System

Relievant RF Generator

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 change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

Intracept Intraosseous Nerve Ablation System

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 change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

Relievant RF Generator

The use of this product is contraindicated for:

• Patients with implantable pulse generators (e.g., pacemakers, defibrillators) or other electronic implants.
• Situations where unintended tissue damage may result, based on the clinical assessment by the physician.
• Application with electrosurgical instruments NOT tested and specified for use with the Relievant RFG.

Intracept Intraosseous Nerve Ablation System

Use of the Intracept Intraosseous Nerve Ablation System is contraindicated in:

• Patients with severe cardiac or pulmonary compromise
• Patients with active implantable pulse generators (e.g. pacemakers, defibrillators)
• Patients where the targeted ablation zone is < 10 mm away from a sensitive structure not intended to be ablated, including the vertebral foramen (spinal canal)
• Patients with active systemic infection or local infection in the area to be treated
• Patients who are pregnant
• Skeletally immature patients (generally ≤ 18 years of age)

Relievant RF Generator

Please read this manual and follow its instructions carefully. Warnings, Cautions, and Notes carry special meanings and should be carefully reviewed:

Warnings indicate risks to the safety of the patient or the user of the device. Failure to follow warnings may result in injury to the patient or user.

Note: Notes provide special information to clarify instructions or present additional useful information.

To avoid potential serious injury to the user and the patient and/or damage to this device, the user must obey the warnings and cautions listed in the sections that follow.

General Warnings and Cautions

• Federal law (USA) restricts this device to use by, or on order of, a physician.
• Attempt no internal repairs or adjustments not specifically detailed in this manual. Refer any readjustments, modifications, and/or repairs to Relievant Medsystems or its authorized representatives.
• Pay close attention to the care and cleaning instructions in this manual. Failure to follow these instructions may result in product damage.
• Install this device in a room that complies with all locally applicable requirements (including and not limited to IEC, CEC, and NEC) for safety and electromagnetic compatibility of high-frequency electrical surgical equipment.
• DO NOT use the Relievant RFG on patients with implantable pulse generators (e.g., pacemakers, defibrillators) or other electronic device implants. Doing so could lead to electromagnetic interference and possible death.
• No modification of this equipment is allowed.
• To avoid the risk of electric shock, the equipment must be connected only to a supply mains with protective earth.
• Failure of the RFG could result in an unintended increase in output power.
• Minor neuromuscular stimulation is possible when arcs between the ACTIVE ELECTRODE and tissue occur. The generator has been designed to minimize the possibility of neuromuscular stimulation.
• Operator may choose to use smoke-plume extraction apparatus, though the indicated procedure is unlikely to produce noticeable smoke.
• The RF Generator is for use WITHOUT a neutral electrode (i.e., a grounding pad).
• The separable AC power cord is provided as a means of emergency shutdown and disconnection from the power source. DO NOT position the Relievant RFG in a way that is difficult to disconnect the AC power cord.
• Discontinue use if inaccurate, erratic or sluggish temperature readings are observed. Use of damaged equipment may cause patient injury.

Fire and Explosion Warnings

• DO NOT use this device in the presence of flammable anesthetics, other flammable gases or objects, near flammable fluids such as skin prepping agents and tinctures, or oxidizing agents. Observe appropriate fire precautions at all times.
• To prevent the risk of explosion, DO NOT use this device in oxygen-enriched atmospheres, nitrous oxide (N2O) atmospheres, or in the presence of other oxidizing agents. Ensure that oxygen connections are not leaking.
• Electrosurgical components may remain hot following activation. To prevent combustion, keep all electrosurgical equipment away from flammable materials.
• To prevent the risk of fire, DO NOT replace the Relievant RFG fuses. If it is suspected that fuses are damaged, contact Relievant Medsystems for repair.
• There is a danger of ignition of endogenous gases (e.g., cotton and gauze saturated with oxygen may be ignited by sparks produced during normal use of the RFG).

Prior to Surgery Warnings

• The Relievant RFG should be used by a qualified physician who has complete knowledge of the use of this equipment and awareness of the risks associated with electrosurgical procedures.
• The Relievant RFG should be used by a physician experienced in electrosurgical practices and techniques.
• The user of the Relievant RFG should read this manual thoroughly and be familiar with its contents prior to operating the equipment.
• Use only electrosurgical instruments specified for use with the Relievant RFG.
• Carefully unpack the unit and ensure that all Relievant RFG components are accounted for and remain undamaged from shipment. Inspect the power cable for any damage to insulation. If damage to any component is detected, the Relievant RFG should not be used. Contact Relievant Medsystems for repair.
• To prevent the risk of electrical shock, ensure the proper connection of the primary power cord of the Relievant RFG to a grounded receptacle. To prevent the risk of electric shock, DO NOT use extension cords or adapter plugs.
• DO NOT wrap electrosurgical instrument cables around metal objects; the induction of hazardous currents may result.
• Position the electrosurgical instrument cables to avoid contact with the patient, electrodes, cables, and any other electrical leads that may provide paths for high frequency current.
• Position the Relievant RFG such that the fan directs the flow of air away from the patient.
• When the Relievant RFG and physiological monitoring equipment are used simultaneously on a patient, position any monitoring electrodes as far as possible from the surgical electrodes. Monitoring equipment using high frequency, current limiting devices is recommended. Needle monitoring electrodes are not recommended.
• The Relievant RFG should be positioned for an unobstructed view of the Relievant RFG display by the user.
• The Relievant RFG should be positioned between the AC wall outlet and the patient, leaving enough slack in the power cord to connect to the AC wall outlet and slack in the electrosurgical instrument cable allowing placement in the patient.
• Prior to connecting an electrosurgical instrument to the Relievant RFG or placing an electrosurgical instrument within the patient, power on the Relievant RFG and allow it to complete the power-on self-test.
• RF energy is activated and remains active with a single push and release of the RF Start/Pause Button. The RF Start/Pause Button does not need to be continuously depressed to keep RF energy active.
• Prior to operation, visually inspect the Probe for physical damage, obvious cracks in insulation or loose parts.

Warnings During Surgery

• To prevent the risk of shock, DO NOT allow the patient to come into contact with grounded metal objects or objects that have an appreciable capacitance to the earth, such as a surgical table frame or instrument table.
• When the Relievant RFG is activated, the conducted and radiated electrical fields may interfere with other electrical medical equipment. Provide as much possible distance between the Relievant RFG and other electronic medical equipment.
• Remove electrosurgical instruments from the surgical site and place them away from metallic objects when not in use. Attachments should be separated from other electrosurgical equipment to avoid inadvertent electrical coupling between devices. Inadvertent activation may cause user/patient injury and/or product damage.
• Keep the ends of electrosurgical instrument connectors, power cord connectors, and Relievant RFG receptacles away from all fluids.
• DO NOT touch any accessible parts (electrodes, knobs, buttons, grips, cables, and connectors) and the PATIENT simultaneously, except for electrosurgical instruments specified for use with the Relievant RFG.
• DO NOT activate the RF energy delivery until the electrosurgical instrument is properly positioned in the patient.
• DO NOT touch the electrodes on electrosurgical instruments during RF energy delivery. Superficial skin burns to the patient or user could occur.
• DO NOT allow the electrodes on electrosurgical instruments to come into contact with a metal instrument or surface during energy delivery. Superficial skin burns to the patient or user could occur.
• Keep the activation indicator lights, display, and speaker in field of view and hearing at all times during activation. The display, lights, and sounds are important safety features.
• DO NOT obstruct the fan, and avoid contact with the fan (located on the back panel of the Relievant RFG).
• If the Relievant RFG malfunctions, discontinue its use immediately and contact a Relievant Medsystems representative.
• During use, users should wear standard surgical gloves to help reduce the risk of electric shock.
• The Relievant RF Generator is MR Unsafe. Do not bring the device into an MR environment. The device must not be used in an MR environment.

After Surgery Warnings

• DO NOT use flammable agents for cleaning and disinfecting the Relievant RFG.
• DO NOT remove the cover of the Relievant RFG; this could cause electric shock and product damage. Refer servicing to qualified personnel.
• There are no user-serviceable parts inside the Relievant RFG. Units requiring repair should be returned to Relievant Medsystems.
• Before inspecting fuses, disconnect the Relievant RFG from the AC wall outlet.
• DO NOT disassemble the Relievant RFG. This will void the warranty and may cause serious injury to the operator or damage to the unit. If any problems are not resolved by the instructions in “Troubleshooting,” contact a Relievant Medsystems representative for further instructions.
• The USB communication data port on the back panel of the Relievant RFG is to be used only by Relievant Medsystems designated personnel. The metal plate covering the data ports shall be removed only by Relievant Medsystems designated personnel.
• DO NOT connect any cables or electrosurgical instruments to the Relievant RFG that are not specified by Relievant Medsystems. Doing so could potentially damage the system or cause injury.
• See “Technical Information” for Warnings related to Electromagnetic Compatibility.

Start-up Procedure

• The Relievant RF Generator (“Relievant RFG”) is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System. DO NOT connect any equipment not specified in this manual; unexpected results or serious injury may occur.
• Be sure that no liquid is present between connections to the Relievant RFG and the RF Probe. Connection of wet accessories may lead to electric shock or electrical short.
• To avoid the risk of electric shock, this equipment must be connected only to a supply mains with protective earth.
• Use only the power cable and electrosurgical instruments supplied by Relievant with the Relievant RFG.
• Using other cables or electrosurgical instruments may result in increased electromagnetic emissions and/or decreased electromagnetic immunity of the Relievant RFG.
• The Relievant RFG is not a sterile device and should not enter the sterile field.
• DO NOT obstruct the fan, and avoid contact with the fan (located on the back panel of the Relievant RFG).

Power-off

Should emergency shutdown become necessary, power off the Relievant RFG as described above. As an added safety measure, the Relievant RFG can be powered off by the AC Power Switch or by detaching the power cord from either end.

Routine Maintenance

No modification of this equipment is allowed.

EMC Compatibility

The Relievant RFG is intended for use by healthcare professionals only. This system may cause radio interference and disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the Relievant RFG or shielding the location. Interference with electronic medical equipment such as monitors and imaging systems is usually resolved or minimized by rearranging the cables such that the unit cables DO NOT overlap with the cables from the monitoring equipment.

Intracept Intraosseous Nerve Ablation System

• Do not use if package is opened or damaged as product integrity and/or sterility may be compromised.
• Do not use after the expiration date has passed as product integrity and/or sterility may be compromised.
• Do not re-sterilize or reuse. Re-sterilization or reuse may result in cross contamination, patient infection, or device malfunction.
• Reconditioning, refurbishing, repair or modification of the device to enable further use is prohibited.
• Do not use this product if you have not been properly trained in its use. Physicians using the device should be familiar with the physiology and pathology of the selected anatomy to be treated and be trained in the performance of the chosen surgical technique. Improper surgical use and technique may lead to suboptimal clinical outcomes.
• Read and understand the Instructions For Use (“IFU”) completely prior to use.
• The Intracept System must be used with the Relievant Medsystems RF Generator in order to provide the required treatment parameters.
• Failure of the RFG could result in an unintended increase of output power to the Probe.
• The Intracept RF Probe may interfere and adversely influence the operation of other electronic equipment.

The Intracept System is contraindicated for targeted treatment sites < 10 mm from boundary of the vertebral

Please read this manual and follow its instructions carefully. Warnings, Cautions, and Notes carry special meanings and should be carefully reviewed:

Cautions indicate risks to the equipment. Failure to follow cautions may result in product damage.

Note: Notes provide special information to clarify instructions or present additional useful information.

To avoid potential serious injury to the user and the patient and/or damage to this device, the user must obey the warnings and cautions listed in the sections that follow.

Intracept Intraosseous Nerve Ablation System

• The Intracept Access Instruments and the Intracept RF Probe are single patient use only. The Introducer Cannula, Diamond Stylet, Bevel Stylet, J-Stylet, Straight Stylet, Drill, and Probe may be used to treat up to a maximum of four (4) vertebrae (L3, L4, L5, S1) on a single patient, while the Curved Cannula may only be used on one (1) vertebra on a single patient.
• As with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the Instruments or Probe. Excessive force can result in product failure.
• Prior to the procedure, CT or MRI imaging must be utilized to help define the desired treatment site and define working anatomical landmarks that can be used for mapping access to the treatment site.
• The device should be manipulated only while under fluoroscopic or CT observation.
• DO NOT use this device in the presence of flammable anesthetics, other flammable gases or objects, near flammable fluids such as skin prepping agents and tinctures, or oxidizing agents. Observe appropriate fire precautions at all times. There is a risk of pooling of flammable solutions under the patient or in body depressions and cavities.
• Fluids pooled in the body depressions and cavities of the patient should be mopped up before RFG is used.
• There is a danger of ignition of endogenous gases (e.g., cotton and gauze saturated with oxygen may be ignited by sparks produced during normal use of the RFG).
• Operator may choose to use smoke-plume extraction apparatus, though the indicated procedure is unlikely to produce noticeable smoke.
• The Probe is for use WITHOUT a neutral electrode (i.e., a grounding pad).
• Discontinue use if inaccurate, erratic or sluggish temperature readings are observed. Use of damaged equipment may cause patient injury.
• Prior to operation, visually inspect the Probe and RFG for physical damage, obvious cracks in insulation or loose parts.
• During power delivery, the cable should not come in direct contact with the patient’s skin or other patient leads.
• Safety and effectiveness in patients with conditions that are associated with poor bone quality such as osteoporosis have not been established.

Fluoroscopic or CT imaging must be utilized frequently throughout the procedure to ensure proper entry and placement of the Instruments and Probe. Improper entry and placement of the devices may result in patient injury and/or sub-optimal clinical treatment effects. 

Care should be taken when removing the J-Stylet to prevent blood/tissue from ejecting from the tip of the J-Stylet as it comes free of the Curved Cannula. In addition to rotating the J-Stylet 180 degrees as it is removed, gauze may be placed over the slot in the Curved Cannula handle to prevent this action.

In the event of inadvertent advancement of the Introducer Cannula during deployment of the Curved Cannula Assembly, care must be taken to prevent potential further device damage. This can occur if mallet strikes continue to be delivered when the Gear Wheel is in contact with the Introducer Cannula. This scenario can create a condition in which the Introducer Cannula advances along its straight trajectory, while the Curved Cannula is held in the bone along its curved trajectory. This can lead to the creation of a kink in the Curved Cannula material. If it is suspected that this occurred, or if retraction of the Curved Cannula is difficult, it is recommended that Introducer Cannula and Curved Cannula be removed as a single unit, rather than retracting the Curved Cannula by itself.

Both Anterior-Posterior (A-P) and lateral imaging should be reviewed to ensure that the Probe is positioned so that its tip transects the basivertebral foramen at the target treatment site, while remaining ≥ 10 mm from the boundary of the vertebral body, or other sensitive structures not intended to be ablated. Unintended damage to tissue can occur, with potential harm to the patient, if advanced beyond this target site.

Do not remove or withdraw the Probe while energy is being delivered, due to risk of burn, injury, or incomplete tissue ablation.

Relievant RF Generator

Adverse events potentially associated with use of this device include: Electric Shock to the user or patient.

Intracept Intraosseous Nerve Ablation System

Adverse events potentially associated with use of this device include:

• Nerve injury including puncture of the spinal cord or nerve roots potentially resulting in radiculopathy, paresis or paralysis
• Breakage, slippage, misuse or mishandling of Instruments or Probe, such as on sharp edges, may cause burns or injury to the patient or operative personnel
• Unintended puncture wounds including vascular puncture and dural tear
• Embolism of fat, thrombus or other materials resulting in symptomatic pulmonary embolism or other clinical sequelae
• Deep or superficial wound infection
• Hemorrhage
• Hematoma
• Pneumothorax
• Pedicle or vertebral body fracture