Medtronic APSD150 Instructions for Use

Accurian™ Single-Use RF Probe M708348B805E Rev. C

2022-04-05

IMPORTANT INFORMATION ON THE ACCURIAN™ SINGLE-USE RF PROBE

Note: not all parts may be available in each geography.

PURPOSE

The intended purpose of the Accurian™ Single-Use RF Probe is the creation of radiofrequency lesions in nervous tissue.
Medtronic does not warrant use of instruments, accessories, or any component parts upon which repairs have been made or

attempted, except as performed by Medtronic or an authorized Medtronic repair representative. Implied warranties of
merchantability and fitness for a particular purpose or use are specifically excluded.

For US audiences only

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

DESCRIPTION

The Accurian™ Single-Use Radiofrequency (RF) Probe is supplied sterile for single use. The Accurian™ Single-Use RF Probe
(sterile, single use) comprises an active electrode for RF energy delivery, a handle, and a standard connector hub with a 7-pin
connector. It is inserted through an Accurian™ RF Cannula and positioned using fluoroscopy or ultrasound. It delivers
radiofrequency (RF) through the active tip of the Accurian™ RF Cannula. A thermocouple in the probe measures electrode
temperature throughout the procedure. See Figure 1 for more details.

DEVICE LIFETIME

Each device in this bundle is intended to be a single-use disposable device, designed to be used once only and then discarded.
The duration of contact of the device with tissue is limited and is expected to never exceed 24 hours. Each device should not be
reused, resterilized, reprocessed, reconditioned, refurbished, repaired, or modified in any way to enable further use.

Surgeon note: although the surgeon is the learned intermediary between the company and patient, the important medical
information in this document should be conveyed to the patient.

INDICATIONS

The Accurian™ Single-Use RF Probe is intended for the creation of radiofrequency lesions in nervous tissue.

CONTRAINDICATIONS

The use of the Accurian™ Single-Use RF Probe is contraindicated in patients with systemic infection or local infection in area of
the procedure.

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.

▪ Check the compatibility and safety of other physiological monitoring and electrical apparatus to be used on the patient while

operating the Accurian™ RF Ablation System.

▪ If the patient has a spinal cord, deep brain, or other stimulator, contact the manufacturer to determine if the stimulator needs

to be in the OFF position.

▪ This procedure should be reconsidered in patients with any prior neurological deficit.
▪ The Accurian™ Single-Use RF Probe is a single use device. It 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. Refer to the ASRA guidelines
for recommendations on anti-coagulant use in combination with pain procedures.

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

for patient feedback. The use of general anesthesia is not recommended.

▪ 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 Accurian™ 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 Accurian™ RF Ablation System, the surgeon should have specific training, experience, and thorough

familiarity with the use and application of this product.

▪ Do not remove or withdraw the device while energy delivery is ongoing. There is a rare potential for localized skin burns if

the RF lesion is formed in insufficient subcutaneous tissue (<15mm) or within 15mm of a shallow metal implant.

▪ Use standard electrosurgical cautions when using the Accurian™ RF Ablation System in the vicinity of nerves and nerve

roots.

▪ Do not touch the electrode tip while power is being applied.
▪ Ablation must be performed under fluoroscopic or ultrasonic guidance. Do not perform ablation without imaging as it can

result in severe injury to the patient.

▪ When using this device, the Accurian™ Single-Use RF Probe must be positioned such that when ablation is performed per

the lesion size graph (Figure 3) or lesion size equation (Equation 1), vessel and non-targeted nerve roots are beyond the
ablation zone. Failure to consider the lesion size can result in severe injury to the patient.

PRECAUTIONS

Do not attempt to use the Accurian™ Single-Use RF Probe before thoroughly reading the accompanying Instructions for Use
(IFU), and the IFU for the Accurian™ RF Generator and the dispersive electrode.

▪ Only surgeons familiar with RF lesion techniques should use the Accurian™ Single-Use RF Probe.
▪ Use care when handling the devices.
▪ Disconnect the Accurian™ Single-Use RF Probe from the Accurian™ Standard Connector Hub by pulling the connector, not

the cable.

▪ Handle the Accurian™ Single-Use RF Probe safely when it is in use due to electric currents and the hot electrode.
▪ Do not kink the Accurian™ Single-Use RF Probe as this may make it difficult to insert into the cannula or otherwise impair

the function of the electrode.

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

ADVERSE EVENTS

The Accurian™ Single-Use RF Probe is used with other components of the Accurian™ 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. Potential complications include but are not limited to:

▪ 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.

▪ Infection including deep or superficial wound infection.
▪ Increased pain.
▪ Visceral injury.
▪ Failure of technique.

INSPECTION PRIOR TO USE

Prior to using the device, inspect the packaging to ensure the package has not been damaged and sterility has not been
compromised. Do not use the device if the package is damaged or defective.

EQUIPMENT

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

Accessory/Applied Parts Part Classification Part number

1. Accurian™ RF Generator with Desk Stand N/A AG1000

2. Accurian™ Standard Connector Hub N/A APH100

3. Accurian™ Single-Use RF Probe Type CF (Defibrillation Proof Applied Part) APSDXXX

4. Accurian™ RF Cannula Type CF AC00XX

The ValleyLab™ dispersive electrode E7507 has been validated for use with this system.

DIRECTIONS FOR USE

Assemble all the equipment required for the procedure. Set up the Accurian™ RF Generator as directed in its Instructions for
Use (IFU). Connect the Accurian™ Standard Connector Hub and the dispersive electrode to the Accurian™ RF Generator as
described in its corresponding Instructions for Use (IFU). Figure 2 is a schematic representation of the connections of the
system.

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.

Accurian™ RF Cannula (supplied separately)

Follow the Instructions for Use (IFU) provided with the cannula to position it into the desired ablation site. Ensure the cannula tip
is in the correct position using fluoroscopy or ultrasound. Remove the stylet to create an access channel for the probe.

Accurian™ Single-Use RF Probe

1. Connect the Accurian™ Single-Use RF Probe(s) to the 7-pin connector on the Accurian™ Standard Connector Hub.

2. The Sensory Stimulation mode will be automatically selected in the Accurian™ RF Generator upon successful detection of a

valid Accurian™ Single-Use RF Probe. Set advanced settings and the parameters for RF delivery in the Generator as
described in the Accurian™ RF Generator IFU.

3. Using radiographic imaging or ultrasound, confirm the tip of the Accurian™ RF Cannula is in the desired location. If the
cannula position needs to be adjusted, ensure that either the Accurian™ Single Use RF Probe or the accompanying stylet is
inserted into the Cannula prior to moving the Cannula position.

4. Insert the Accurian™ Single-Use RF Probe(s) into the tissue through the Accurian™ RF Cannula(e), ensuring the probe
handle is pushed fully into the cannula. Never force the probe in if significant resistance is felt.

5. Using fluoroscopic or ultrasonic imaging, ensure the tip of the Accurian™ RF Cannula is in the desired location.

6. Perform the procedure as described in the Accurian™ RF Generator Instructions for Use (IFU). The procedure comprises

sensory and motor stimulation and RF delivery, either via Lesion Mode for thermal ablation, or Pulsed Mode for Pulsed RF
procedures.

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 probe(s) and cannula(e) and discard as biohazards. Discard the dispersive electrode appropriately.
Disconnect the Accurian™ Standard Connector Hub from the Generator. Follow standard hospital techniques to handle
reusable items.

DEVICE MODELS

The stainless steel probe models in the Accurian™ Single-Use RF Probe range are as follows:

▪ 50mm length, compatible with 50mm long 16G-22G cannula
▪ 100mm length, compatible with 100mm long 16G-22G cannula
▪ 150mm length, compatible with 150mm long 16G-22G cannula

PACKAGING

Devices are supplied sterile. Packages for each of the components should be intact upon receipt. Once the seal on the sterile
package has been broken, the product should not be re-sterilized. Damaged or unintentionally opened sterile packages should
not be used and should be returned to Medtronic. Contact Medtronic for return information.

VISUAL INSPECTION

Visually inspect all sterile barrier packaging before use. If the integrity of the sterile barrier has been compromised, do not use
the product. Visually inspect the device before use. If the device is damaged, do not use the product. Contact Medtronic for
return information.

MRI INFORMATION

Medtronic instruments and accessories are not intended to be used in the magnetic resonance (MR) environment. As such,
Medtronic instruments and accessories were not evaluated for safety and compatibility in the MR environment. Therefore, safety
of Medtronic instruments and accessories in the MR environment is unknown.

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.
Patients in the European Union experiencing a serious incident in relation to the device should contact Medtronic and the

competent authority of the Member State in which they are established.

STERILIZATION

Devices are supplied in sterile form. The Accurian™ Single-Use RF Probes are sterilized with ethylene oxide.

HOW SUPPLIED

The Accurian™ Single-Use RF probes 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 should be stored in the 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

No temperature measurement
OR
Inaccurate, erratic, or sluggish
temperature reading

▪ Ensure all connections are made.
▪ Check for an error message on the generator.
▪ Ensure devices are dry and at room temperature. If devices are not at room

temperature, wait until they have reached temperature and retry.

Problem Troubleshooting

▪ Visually inspect the probe or probe cable for damage. If problem persists,

discontinue use.

Probe Connector does not fit in
Probe Plug-in

Probe is not recognized by
Accurian™ RF Generator

Damage is observed to handle,
connector, or any part of the probe

▪ Check that the connector's keys are lined up in the proper orientation.
▪ Check that the Connector hub is the Accurian™ Standard Connector hub.
▪ Ensure the connectors are clean and unobstructed.

▪ Check that the Connector hub is the Accurian™ Standard Connector hub.
▪ Check that the connector is not damaged.
▪ Check that the Accurian™ Single-Use RF Probe has not been used before.

Do not use. Discard immediately.

FURTHER INFORMATION

Recommended directions for use (surgical operative techniques) are available at no charge upon request. If further information
is required, contact Medtronic.

After the EUDAMED website is launched, the Summary of Safety and Clinical Performance (SSCP) can be found at https://
ec.europa.eu/tools/eudamed.

©2022 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Figure 1: Device components

Legend (See Figure 1)

A Thermocouple
BElectrode
C Handle

Figure 2: Diagram of system connections

Legend (See Figure 2)

1 Accurian™ RF Generator
2 Accurian™ Standard Connector Hub
3 Accurian™ Single-Use RF Probe
4 Dispersive Electrode (Not included)

LESION SIZE

The size of a RF lesion is affected by the exposed surface area of the active tip (both the active tip length and cannula
diameter), the Set Temperature, and the Procedural Time (excluding the Ramp Time). Typical lesion size graphs over time are
shown for an 18G cannula at a Set Temperature of 80°C in Figure 3. The value of the Y coordinate for the graph on the left
represents lesion length (mm). The value for the Y coordinate for the graph on the right represents lesion width (mm).

Figure 3: Lesion size (Y) graph for an 18 G cannula at a Set Temperature of 80°C and Procedural time (X)

Y

XX

Y

To estimate the length (L) and Width (W) of lesion for any Probe, the following equations may be used:

Equation 1: Lesion size equations

L =-7.95 + 0.86D + 0.89A + 0.14T + 0.75t
W =-8.47 + 1.40D + 0.28A + 0.14T + 0.88t

Where A is the Cannula Active Tip Length in millimeter, D is the Cannula Diameter in millimeter, T is the Set Temperature in
degree C, and t is the Procedural Time (excluding the Ramp Time) in minute.

These equations are valid within the following ranges for the factors:

D = 16G (1.65mm), 18G (1.27mm), 20G (0.91mm), and 22G (0.72mm)
A = 5 and 10mm
T = 70, 80, and 90°C
t = 1, 2, and 3 min

Medtronic Sofamor Danek USA, Inc.

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

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

Authorized representative in the European Community/
European Union

Importer

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

This device complies with applicable European Union
regulations and directives.

For US audiences only

Manufacturer

Date of manufacture

Batch code

Use-by date

Catalogue number

Do not re-use

Do not use if package is damaged and consult instructions
for use

Keep away from sunlight

Do not resterilize

Sterilized using ethylene oxide

-20 °C

50°C

Temperature limit -20°C to 50°C

Non pyrogenic

Serial Number

Consult instructions for use at this website.

Medical device

*Single sterile barrier system

Double sterile barrier system

Single sterile barrier system with protective packaging
inside

Single sterile barrier system with protective packaging
outside

*Single barrier packaging systems may not contain a
sterile barrier system symbol. Per ISO 11607-1, a symbol
is only required if more than one barrier is present.