Medtronic OCP115 Instructions for Use

OsteoCool™ RF Ablation Probe Kit M708348B507E Rev. D

2019-01-23

IMPORTANT INFORMATION ON THE OSTEOCOOL™ RF ABLATION PROBE KIT

Carefully read all instructions prior to use. Observe all contraindications, warnings, and precautions noted in these instructions.
Failure to do so may result in patient complications.

FOR US AUDIENCES ONLY

Caution: federal law (USA) restricts this device to sale by or on the order of a physician.

DEVICE DESCRIPTION

The OsteoCool™ RF Ablation Probe Kit (sterile, single use) is available in two kit configurations. The single kit includes one
OsteoCool™ RF Ablation Probe and one OsteoCool™ Tube Kit. The double kit includes two OsteoCool™ RF Ablation Probes
and two OsteoCool™ Tube Kits.

The OsteoCool™ RF Ablation Probe (sterile, single use) comprises an electrically insulated shaft, an active electrode, and a
return electrode for RF energy delivery, a handle, tubes with luer locks and a cable with an 8-pin connector. It is inserted
through an Introducer (not supplied) into bone. Sterile water circulates internally to cool the probe while it delivers
radiofrequency (RF). A thermocouple in the probe measures cooled electrode temperature throughout the procedure.

The OsteoCool™ Tube Kit (Sterile, single use, non-body contact) comprises a burette and flexible tubing fitted with luer locks for
connection to the OsteoCool™ Probe. It is used for closed-loop circulation of sterile water through an OsteoCool™ RF Ablation
Probe. It includes a burette and tubing.

INDICATIONS FOR USE

The OsteoCool™ RF Ablation Probe Kit, in combination with other components of the OsteoCool™ RF Ablation System, is
intended for:

▪ Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
▪ Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic

lesions involving bone in patients who have failed or are not candidates for standard therapy.

▪ Ablation of benign bone tumors such as osteoid osteoma.

CONTRAINDICATIONS

Use of the OsteoCool™ RF Ablation System device is contraindicated in vertebral body levels C1-C7.

WARNINGS

▪ Do not use in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified

professional (e.g. cardiologist). A possible hazard exists because interference with the action of the electronic implant may
occur, or the implant may be damaged.

▪ The OsteoCool™ RF Ablation Probe Kit contains single use devices. They should not be re-sterilized or re-used. Reuse can

cause the patient injury and/or the communication of infectious disease(s) from one patient to another.

▪ Take appropriate precautions for patients with blood coagulation disorders, anticoagulant use, neurological deficit, or

systemic infection or local infection in area of the procedure.

▪ The procedure is to be performed with minimal to moderate sedation to allow the patient to remain in a communicative state

for patient feedback.

▪ Adequate measures must be taken to minimize x-ray exposure while using fluoroscopy. This exposure can result in acute

radiation injury as well as increased risk for somatic and genetic effects.

▪ Do not modify the equipment as this may compromise safety and efficacy.
▪ When the OsteoCool™ RF Generator is activated, electrical fields may interfere with other electrical medical equipment.
▪ During power delivery, the patient should not be allowed to come in contact with grounded metal surfaces.
▪ Discontinue use if inaccurate, erratic, or sluggish temperature readings are observed. Use of damaged equipment may

cause patient injury.

▪ For safe use of the OsteoCool™ RF Ablation System, the physician should have specific training, experience, and through

familiarity with the use and application of this product.

▪ Do not ablate in painful osteoporotic vertebra without tumor.
▪ Do not use the device in fractures due to prostatic cancer or other osteoblastic metastases to the spine.

▪ Do not use the products in dense (sclerotic) bone including traumatic high energy fracture as device damage resulting in

patient injury may occur.

▪ Do not use this device in patients without metastatic malignant lesions in bone or in the vertebral body.
▪ When using this device in the vertebral body, do not use this device in patients with multiple myeloma, solitary

plasmacytoma, or primary malignant lesions in the index vertebra.

▪ Do not use this device in more than one vertebral body.
▪ Do not touch the electrode tip while power is being applied.
▪ Do not withdraw the OsteoCool™ RF Ablation Probe while power is being applied to ablate lesions.
▪ Use standard electrosurgical cautions when using the OsteoCool™ RF Ablation System in the vicinity of nerves and nerve

roots.

▪ Ablation must be performed under fluoroscopic guidance. Do not perform ablation without imaging as it will result in severe

injury to the patient.

▪ When using this device in the vertebral body, the OsteoCool™ RF Ablation Probe must be positioned within the vertebral

body such that when ablation is performed per the thermal distribution graphs, nerves and nerve roots are beyond the
ablation zone. Failure to follow the thermal distribution graphs will result in severe injury to the patient.

▪ Precautions during ablation near organ surface or near vasculature – Due to the non-homogenous conduction and

convection of heat in this anatomy, shapes of ablations performed on tissue that is near the organ surface or near
vasculature may not be spherical. Careful planning should be done for targets that require ablation in these locations.

▪ Any application or procedure that alters tissue perfusion and affects temperature elevation should be monitored carefully.
▪ High power settings can cause local desiccation of tissue, which can impede the ability to produce expected ablations. Set

power as low as possible for intended purpose. Follow manufacturer’s guidelines of time at temperature for ablation
generation. If the recommended times and temperatures are not achieved there can be no assurance that the desired
ablation volume has been created. Standard techniques for evaluation (e.g. CT or MRI) should be used to determine the
actual extent of all ablations.

▪ It is important to carefully evaluate all candidates for this procedure for evidence of impending fracture, particularly in

weight-bearing bone. Do not perform RF ablation of metastases in weight-bearing bone with evidence of impending
fracture. Note: Pathologic fracture is more prevalent and serious in long bone.

▪ It is important to carefully evaluate all candidates for this procedure for proximity of the metastasis to critical structures.

Ensure that device placement is at least 1cm away from the structures not intended for ablation. Proximity to nerve
structures is particularly critical. Serious complications such as incontinence can occur if these critical structures are
damaged during the RF ablation procedure.

▪ The durability of pain relief after using this device to ablate painful bone metastases has not been established.

PRECAUTIONS

Do not attempt to use the OsteoCool™ RF Ablation Probe Kit before thoroughly reading the accompanying Instructions for Use
and the user manual for the OsteoCool™ RF Generator.

▪ Only physicians familiar with RF lesion techniques should use the OsteoCool™ RF Ablation Probe Kit components.
▪ Do not modify the kit components, including bending and removing insulation.
▪ Use care when handling the devices.
▪ Proper sterile techniques must be used when assembling and filling the OsteoCool™ Tube Kit. Do not place the lid down on

a non-sterile surface.

OsteoCool™ RF Ablation Probe

▪ The OsteoCool™ Tube Kit should never be disconnected from the OsteoCool™ RF Ablation Probe when RF delivery is in

progress. The lumen of the tube kit should not be obstructed in any way during the procedure, as this will stop cooling of the
probe.

▪ Disconnect the OsteoCool™ RF Ablation Probe by pulling the connector, not the cable.
▪ Handle the OsteoCool™ RF Ablation Probe safely when it is in use due to electric currents and the hot tip.
▪ Do not bend the OsteoCool™ RF Ablation Probe as this may damage the insulation.
▪ Do not remove or withdraw the OsteoCool™ RF Ablation Probe while energy is being delivered to ablate lesions.
▪ While inserting the OsteoCool™ RF Ablation Probe through the Introducer watch the fluoroscope for any buckling. Do not

attempt to further insert the probe if any buckling is observed or significant resistance is felt.

▪ Do not move the Introducer when the OsteoCool™ RF Ablation Probe is in it. If repositioning is needed, retract the probe

from the introducer and then reposition the introducer with the stylet inserted.

▪ The physician must determine, assess, and communicate to each individual patient all foreseeable risks of the RF

procedure.

▪ The “Temperature” displayed on the generator while in “Ablate” refers to the cooled electrode temperature and not the

hottest tissue temperature.

Introducer (not supplied)

Introducers must be 13 Gauge or larger, and have a length such that the proximal electrode on the probe is extended at least
5mm beyond the distal margin of the introducer.

OsteoCool™ Tube Kit

▪ The OsteoCool™ Tube Kit is for use with a single OsteoCool™ RF Ablation Probe.

▪ Care must be taken to ensure all luer fittings are secure to prevent leaking. Do not disconnect luer fittings while the pump is

running.

▪ Arrange equipment to minimize tubing tripping hazards.
▪ Do not complete cooled RF lesion procedures if water is not circulating through the Tube Kit, water is leaking, or air bubbles

are seen in the tubing. Immediately stop the procedure and correct circulation before restarting the procedure.

▪ Do not pinch the tubing of the OsteoCool™ Tube Kit.

ADVERSE EVENTS

The OsteoCool™ RF Ablation Probe Kit is used with other components of the OsteoCool™ RF Ablation System in RF lesion
procedures. Adverse events associated with the use of this device are similar to those indicated for medicated and anesthetic
methods utilized in other surgical procedures.

▪ As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur.
▪ Nerve injury including thermal injury, puncture of the spinal cord or nerve roots potentially results in radiculopathy, paresis,

and paralysis.

▪ Pulmonary embolism.
▪ Hemothorax or pneumothorax.
▪ Infection including deep or superficial would infection.
▪ Unintended puncture wound including vascular puncture and dural tear.
▪ Hemorrhage.
▪ Hematoma.
▪ Pain.

PATIENT SELECTION CRITERIA

Candidates suitable for RF ablation procedures with the OsteoCool™ RF Ablation System include:

▪ Patients experiencing significant pain from metastases involving bone.
▪ Patients with localized pain resulting from not more than two sites of metastatic disease.
▪ Patients that do not have evidence of impending fracture.

Patients should be examined prior to the RF ablation procedure to determine the focal site(s) of pain. The following should be
used to help guide therapy and define the area that is intended for RF ablation:

▪ Location of most significant pain.
▪ Pre-operative image scans to correlate with the patient physical exam and patient symptoms.
▪ The extent of bone surrounding the tumor(s) to aid in selecting ablation parameters.

The size, shape, and location of the metastatic lesion in the patient will determine the number of ablations required.
Per the Indications for Use, the device is intended for:

▪ Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
▪ Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic

lesions involving bone in patients who have failed or are not candidates for standard therapy.

Standard therapy is defined per relevant medical society guidelines on treatment of metastatic lesions involving bone. For
guidance, please refer to applicable medical society guidelines.

INSPECTION PRIOR TO USE

Prior to using the devices inspect the packaging to ensure the package has not been damaged and sterility has not been
compromised. Do not use damaged or defective equipment in the procedure.

EQUIPMENT

The Osteocool™ RF Ablation Probe is for use in Osteocool™ RF procedures performed in specialized clinical settings. The
equipment in the OsteoCool™ RF Ablation System is as follows (Figure 2):

1. OsteoCool™ RF Generator.

2. OsteoCool™ Pump Unit and OsteoCool™ Pump Cable.

3. OsteoCool™ Connector Hub.

4. OsteoCool™ Cart or OsteoCool™ Desk Stand (not shown).

5. OsteoCool™ RF Ablation Probe Kit (consisting of the OsteoCool™ RF Ablation Probe and OsteoCool™ RF Ablation Tube

Kit).

a. Luer Locks - for connection of Tube Kits to OsteoCool™ Probe.

b. Sterile water injection port.

c. 70ml Mark.

d. Burette Reservoir.

6. OsteoCool™ Independent Thermocouple Kit
a. OsteoCool™ Independent Thermocouple.

b. OsteoCool™ Independent Thermocouple Introducer.

DIRECTIONS FOR USE

Assemble all the equipment required for the procedure. Set up the OsteoCool™ RF Generator and the OsteoCool™ Pump Unit,
as directed in their Instructions for Use. Connect the OsteoCool™ Connector Hub to the OsteoCool™ RF Generator as
described in its corresponding Instructions for Use. Figure 1 is a schematic representation of the connections of the system.
Figure 2 is a schematic representation of the Tube Kit.

Open the package in the sterile field using appropriate sterile techniques. Inspect the devices visually to make sure there is no
damage to them. Do not perform the procedure with any damaged equipment.

1. Place the burette into the burette holder on the side of the OsteoCool™ Pump Unit (Figure 3).

2. Fill the burette with room temperature sterile water. Use sterile handling techniques. Fill the burette to the 70mL mark.

Burette can be filled by injecting sterile water through a port in the lid, or by temporarily removing the lid and pouring in
sterile water (Figure 4).

Warning: be sure to fill the burette to the 70ml mark. Not filling the burette to the 70mL mark will result in an inadequate
supply of water for circulation.

Use only sterile room temperature water.
Ensure the lid is secured to the body of the burette after filling.

3. Place the thick-walled tubing coming out of the bottom of the burette into the pump head of the OsteoCool™ Pump Unit.

Place the tubing in the channels of the L-shaped bracket to ensure the tubing is not obstructed while closing the pump
head. Close the lid on the pump head to clamp down on the tubing (Figure 5).

4. Remove the caps on the male and female luer locks. Connect the appropriate luer lock to the corresponding luer lock on the

probe (Figure 6). Do not over-tighten the connection.

Caution: Connect one OsteoCool™ Tube Kit to one OsteoCool™ RF Ablation Probe.

5. At the end of the procedure, discard the OsteoCool™ Tube Kit appropriately.

Introducer (not supplied)

Follow the Instructions for Use provided with the Introducer to position it into the desired ablation site. Remove the stylet to
create an access channel for the Probe.

OsteoCool™ RF Ablation Probe

1. Insert the OsteoCool™ RF Ablation Probe(s) into the tissue through the introducer(s), ensuring the probe handle is pushed

fully into the introducer handle. Never force the probe in if significant resistance is felt.

2. Using radiographic imaging, ensure the radiopaque marker on the OsteoCool™ RF Ablation Probe is extended 5mm

beyond the distal margin of the introducer.

3. Connect the OsteoCool™ RF Ablation Probe to the OsteoCool™ Tube Kit.

4. Connect the 33-pin connector of the OsteoCool™ Connector Hub into the OsteoCool™ RF Generator. Connect the probe(s)

to the 8-pin connector on the OsteoCool™ Connector Hub.

5. The Ablate mode will be automatically selected in the OsteoCool™ RF Generator upon successful detection of a valid

probe. Set procedure settings and the parameters for RF delivery in the Generator as described in its Instructions for Use.

6. Perform the procedure as described in the Generator Instructions for Use. The procedure comprises pre-cooling, treatment

and optional retract stages.

Note: Other than reproduction of their usual referred pain or irritation due to probe introduction, monitor the patient for
unexpected symptoms that may indicate, for example, spinal cord or nerve root irritation. If these indications are suspected
discontinue energy delivery.

7. After treatment remove the probes and the introducer and discard as biohazards. Disconnect the OsteoCool™ Connector

Hub from the generator. Follow standard hospital techniques to handle reusable items.

Note: Maintain a minimum distance of 4mm between the probe and other metal objects.

Ablation Size and Shape

The OsteoCool™ RF Ablation System utilizes temperature-based control, which automatically controls the RF power delivery to
maintain a target temperature. The maximum allowable power limit is set through the software at 20W.

The minimum recommended ablation time is 6.5 minutes for a 7mm active tip, 7.5 minutes for a 10mm active tip, 11.5 minutes
for a 15mm active tip, and 15 minutes for a 20mm active tip. In order to enhance the likelihood of a complete ablation,
procedures should be performed for the recommended ablation time.

Figures 7 and 8 provide a general reference for the expected lesion growth profiles for a 10mm active tip probe using a target
temperature of 70°C.

In some cases, the lesion will only be partially destroyed. Standard evaluative techniques (e.g. CT or MRI) should be used to
determine the actual extent of the ablation. The final determination of the success of lesion destruction can only be made by
imaging studies shortly following the procedure and during long-term follow-up.

Table 1 provides a range of ablation zone dimensions which can be achieved by the OsteoCool™ RF Ablation System at
different Treatment Settings.

Overlapping Ablations

The OsteoCool™ RF Ablation Probe may be used to create multiple overlapping ablations if the desired ablation volume is
greater than that created by a single ablation. At the physician’s discretion, any method can be used that creates sufficient
overlap between the single ablation volumes to cover the desired tissue for ablation. Satisfactory overlap of the ablation
volumes can be confirmed using standard imaging techniques such as CT or MRI. With the OsteoCool™ RF Ablation System,
the most commonly used method is to overlap the individual prolate ellipsoid lesions to create a larger cylinder-shaped lesion. In
this case, ablations are repeated along a single axis, overlapping each ablation by approximately one-third the length of the
adjacent ablation, as shown in Figure 9.

The following steps can be followed for repositioning of the OsteoCool™ RF Ablation Probe prior to each subsequent ablation:

1. Retract the OsteoCool™ RF Ablation Probe and the Introducer together so the distal tip of probe is now at the location of

the radiopaque marker band of the previous lesion.

2. Reposition the OsteoCool™ RF Ablation Probe and the Introducer and confirm its position under fluoroscopic guidance. The

OsteoCool™ RF Ablation Probe’s radiopaque marker band provides a reference for the active tip location.

3. Activate RF energy delivery to the OsteoCool™ RF Ablation Probe.

4. Repeat steps 1 to 3 as required.

When the target tissue size or shape is such that a single cylinder is not enough to encompass the lesion, cylinders can be
overlapped as well.

Complete Ablations

The RF ablation procedures should be performed according to the recommended ablation times to enhance the likelihood of a
complete ablation. To determine the extent of ablation following RFA therapy, standard imaging studies should be used (e.g. CT
or MRI) following the procedure and during regular long-term follow up.

This device has only been studied in a cadaver model on lumbar vertebra.

STERILIZATION

Devices are supplied in sterile form. The OsteoCool™ RF Ablation Kits are sterilized with ethylene oxide.

HOW SUPPLIED

The OsteoCool™ RF Ablation Kits are supplied sterile in peel-open packaging. In the event of damage to the sterile packaging,
do not use and notify the manufacturer.

STORAGE

The probe and tube kit should be stored in their original shipping materials. Proper care should be taken to ensure the
instruments will not be damaged. The devices should be stored in a cool dry environment.

TROUBLESHOOTING

PROBLEM TROUBLESHOOTING

▪ Ensure all connections are made

No temperature measurement
or
Inaccurate, erratic or sluggish
temperature reading

▪ Probe to Connector Hub
▪ Connector Hub to the generator

▪ Generator to power outlet
▪ Check for an error message on the generator
▪ Visually inspect the probe or cable for damage. Ensure devices are dry and at room

temperature. If problem persists discontinue use.

▪ Stop the procedure immediately.

Water does not flow through the
probe and tube kit

▪ Check the luer lock connections to ensure the tube kit is connected to the probe.
▪ Check the pump to ensure the lid is not open.
▪ Check generator for any error messages.

Probe Connector does not fit in
Probe Plug-in

Damage to Insulation on probe or
introducer

▪ Check that the connector's keys are lined up in the proper orientation.
▪ Ensure the connectors are clean and unobstructed.

Do not use. Discard immediately.

▪ Ensure the tube kit is correctly connected to the probe.

Water is not circulating through
tubing during pre-cooling, on and
post-cooling states.

Water is not dripping into the burette. Check to see if water is running down the wall of the burette.
The lid of the burette cannot be

removed.

▪ Ensure the Tube Kit has been correctly placed in the pump head.
▪ Ensure the burette reservoir has been filled.
▪ Visually inspect the tube kit tubing and joints for leaks and occlusions.
▪ Ensure the pump tubing (thick-walled tubing that is coming directly out of the bottom

port of the burette) is placed in the pump head.

Inject sterile water through the port of the lid, rather than removing the lid.

PROBLEM TROUBLESHOOTING

Tube Kit breaks, is leaking, or is

Immediately discard the tube kit.

occluded.

FURTHER INFORMATION

For further information, contact Medtronic.

LIMITATION OF LIABILITY

In no event shall Medtronic be liable for any direct, indirect, incidental, consequential, or exemplary damages arising out of or in
connection with the OsteoCool™ RF Ablation Kit based upon breach of contract (including breach of warranty).

©2019 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Figure 1: Diagram of system connections

OSTEOCOOL

OSTEOCOOL

RADIOFREQUENCY

GENERATOR

OSTEOCOOL
PUMP CABLE

OSTEOCOOL

PERISTALTIC PUMP

CONNECTOR HUB

OSTEOCOOL

TUBE KIT

OSTEOCOOL

TUBE KIT

Optional Second Set

OSTEOCOOL

THERMOCOUPLE

OSTEOCOOL
RF ABLATION

PROBE

OSTEOCOOL
RF ABLATION

OSTEOCOOL

THERMOCOUPLE

PROBE

Figure 2: Diagram of Tube Kit

Tube Kit

Luer Locks - for connection of
Tube Kits to OsteoCool Probe

Figure 3: Place burette into burette holder.

Sterile water injection port

70ml Mark

Burette

Reservoir

Figure 4: Fill the burette.

Figure 5: Install tubing into Pump Unit.

Figure 6: Connect tubing to RF Ablation Probe.

Figure 7: Lesion length growth profile over time

Lesion Length (mm)

10mm Active Tip Lesion Length

Set Temp 50°C Set Temp 70°C Set Temp 90°C

Time ( minu tes)

Figure 8: Lesion width growth profile over time

10mm Active Tip Lesion Width

Lesion Width (mm)

Set Temp 50°C Set Temp 70°C Set Temp 90°C

Time (minutes)

Table 1: Soft Tissue Ablation Zone Sizes with the Corresponding Treatment Setting

Ablation Zone Size Treatment Setting

Length (mm) Width (mm) Active Electrode Length (mm) Duration (min) Set Temperature (°C) Number of Overlap

10 8 7 6.5 70 N/A
14 10 10 4 70 N/A
20 11 10 4 70 1
24 10 10 4 70 2
28 11 10 4 70 3
15 14 10 7.5 70 N/A
20 14 10 7.5 70 1
24 15 10 7.5 70 2
28 13 10 7.5 70 3
20 18 15 11.5 70 N/A
24 19 20 10 70 N/A
31 19 20 10 70 1
29 22 20 15 70 N/A

Figure 9: Cylinder Multiple Ablation Technique

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

50 °C

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.

Manufacturer

Batch code

Use-by date

Catalogue number

Caution, Consult Accompanying Documents

Do not re-use

Do not use if package is damaged

Keep away from sunlight

Sterilized using ethylene oxide

Upper temperature limit 50°C

Non pyrogenic

Consult instructions for use at this website.