WayPoint™ Implant and Surgical Kits

Directions For Use

L011-68 (Rev E0, 2018-07-18)

Contains directions for the following products:

66-WP-BKS, 66-WP-IKS, 66-WP-SKS

FHC, Inc.1201 Main StreetBowdoin, ME 04287 USAFax: +1-207-666-8292www.fh-co.com

FHC Europe (TERMOBIT PROD srl)42A Barbu Vacarescu Str, 3rd FlBucharest 020281 Sector 2 Romania

FHC Latin AmericaCalle 6 Sur Cra 43 A-200Edificio LUGO Oficina 1406Medellín-Colombia

24 hour technical service:1-800-326-2905 (US & Can)+1-207-666-8190

www.fh-co.com

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Table of Contents:

Indications for use, Intended use, and Other devices required

Symbol Key

Storage

Warnings and Cautions

Inventory

Illustrative Procedure:

Implant Procedure

Scanning

Surgical Procedure

Track Selection

Track Offsetting Chart

4

4

4

5

6

7

7

8

9

11

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Symbol Key

WARNING / Caution, consult instructions for important cautionary information.

Consult the instructions for use.

In reference to “Rx only” symbol; this applies to USA audiences only

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

Indicates the catalogue number so that the medical device can be identified.

Indicates the manufacturer’s batch code so that the batch or lot can be identified.

The date after which the medical device is not to be used.

Authorized Representative in the European Community

European Conformity. This device fully complies with MDD Directive 93/42/EEC and legal responsibilities as a manufacturer are with FHC, Inc., 1201 Main Street, Bowdoin, ME 04287 USA.

medical device that should not be used if the package has been damaged or opened.

Do not re-use; intended for one use on a single patient, during a single procedure.

Medical device that is not to be resterilized.

Medical device that has been sterilized using ethylene oxide.

Indications for use:The WayPoint™ Implant and Surgical Kits are intended for use in neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Intended use:The WayPoint™ Implant Kit is intended for use by medical personnel under the direction of a neurosurgeon in a clinical or operating room, to place WayPoint™ fiducial anchors used to build a microTargeting™ stereotactic platform for one or more trajectories of a neurosurgical procedure.

The WayPoint™ Surgical Kits are intended for use by a neurosurgeon in an operating room to attach a microTargeting™ stereotactic platform to previously implanted fiducial anchors, and provide fixtures to position a microTargeting™ drive or other stereotactic de-vice along the planned trajectory or at fixed offsets.

Other devices required:• Compatible navigation software, such as WayPoint™ Navigator

• Patient specific microTargeting™ Platform built using fiducial anchor locations and desired trajectory

• Stereotactic device compatible with surgical kit positioners, such as microTargeting™ STar™ Drive

Storage:Store the WayPoint™ Implant and Surgical Kits at normal room temperatures between 0°C (32°F) and 40°C (104°F). Do not exceed 104°F for long-term storage. Relative humidity should not exceed 95%.

MR Unsafe- an item that is known to pose hazards in all MRI enviroments.

MR Safe- the item poses NO known hazards in all MR environments

MR Conditional-an item that has been demonstrated to pose no known hazard in specicied MRI enviroments with specified conditions of use.

Medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

Telephone number

MR

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Warnings and Cautions:

WARNING: Do not drill or install anchors in bone that is less than 4.5mm thick, or in bone that is weakened or diseased.

WARNING: Do not use anchors that exhibit any sign of looseness. Replace anchors and rescan if necessary.

WARNING: Do not allow WayPoint™ Anchors to remain implanted for more than 28 days.

WARNING: Do not overtighten screws or anchors as this could result in targeting errors.

WARNING: Complete kit is labeled MR Unsafe because it contains some MR Unsafe components. Refer to inventory section for MRI status of individual components.

WARNING: Avoid trajectories close to parallel to the ground as this can cause accuracy errors due to flexing of the plastic hubs and positioners.

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

CAUTION: Sterilized by ethylene oxide

CAUTION: Sterile Medical Device - Do NOT resterilize

CAUTION: Do not use the contents if there is any evidence of damage to the package or package seal that could compromise sterility.

CAUTION: WayPoint™ Implant and Surgical Kits are for single use only. Do not reuse. Cleaning or reuse may affect the structural integrity and/or function of the device.These devices are difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused.

CAUTION: For the most secure fit of the WayPoint™ Anchors, advance drill and driver tools as perpendicular to the skull as possible, and do not permit them to ‘wobble’ during advancement.

CAUTION: Avoid over tightening anchors as this can strip bone, or otherwise damage components.

CAUTION: Instruct the patient to avoid situations that could affect or disrupt the implanted anchors and to be cautious about infection.

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Inventory:

Combo Driver 5mm Fiducial Anchors

Anchor WrenchPilot Drill Driver

66-WP-SKS: Surgical Kit

Burr Hole Marker

Burr Hole Marker Bushing

Offset Positioner

Center Positioner

Standoffs

Anchor Wrench

Thumb-knobs

Standoff Wrench

Entry Offset Hub

Center Hub

Target Offset Hub

66-WP-BKS: Simultaneous Bilateral Kit

Offset Positioner

Center Positioner

WayPoint™ Implant Kit: 66-WP-IKS

MR

WayPoint™ Surgical Kits: 66-WP-SKS & 66-WP-BKS

Combo Driver

MR MR

MR

MR MR MR MR MR MR

MR MR

Entry Offset Hub

Center Hub

Target Offset Hub

MR MR MR

Removable Combo

Driver Bit

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Illustrative Procedure:

Implant Procedure

1. Follow aseptic technique throughout. The implant procedure does not need to be done in an OR setting.

2. Mark the intended anchor points on the patient’s scalp.

• Proper placement of the fiducial anchors is important to generate optimal platform geometry. The Fiducial Placement Template DFU (L011-40-05) describes ideal anchor locations for each DBS platform model that can be easily measured using the disposable fiducial placement template.

3. Using local anesthesia, for each anchor installation:

• Create a 10-15mm incision through scalp and muscle tissue and scrape the pericranium from the anchor site.

• Use the Pilot Drill Driver to create a pilot hole, particularly if the patient’s bone is dense or if the surgeon encounters any difficulty fully seating the anchors.

• Secure the combination driver to the anchor preloaded in the wrench.

• Install the anchor in the skull with a clockwise rotation of the wrench and combination driver.

a b c

~10mm

Note: The Combination driver bit can be removed and used with the Osteomed Power Driver (68-OM-SD). Pull the bit from the driver handle then insert into the Osteomed power Driver. Note that the collar bit will be approximately 10mm below the power driver when fully inserted.

~10mm

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• Use the wrench to support the anchor while twisting the driver counterclockwise out of the anchor.

• Inspect the attachment of the anchor to the skull. Anchors must be tight. Replace stripped anchors in a new location. Note that if anchors are not fully seated in the skull, they should be tightened by hand with the hex wrench.

• Close each anchor wound over the anchor.

• Repeat this process for all remaining anchors.

4. Scan the patient (see next section).

5. Once scans have been checked to ensure that all anchors are displayed properly, patient may be released.

Scanning

WayPoint™ Anchors are CT visible. The patient’s head must be kept immobile while being scanned.

CT Scan requirements:

• Contiguous slices; no gaps between slices

• No overlapping slices

• Slice thickness no greater than 1.25mm

• Pixel size less than 1mm (0.5 to 0.8mm for best results)

• Gantry tilt angle of zero

Non-clinical testing demonstrated that the WayPoint™ Anchors are MR Conditional. A patient with this device can be scanned safely, immediately after placement under the following conditions:

MR Scan requirements:

• Static magnetic field of 3-Tesla or less

• Maximum spatial gradient magnetic field of 720-Gauss/cm or less

• Refer to WayPoint™ Anchor/Locator Implantation Kit DFU (L011-40) for detailed MRI safety information on the WayPoint™ Anchors

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the WayPoint™ Anchor. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

a b c

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Surgical Procedure

1. Attach and handtighten standoffs to anchors.

2. Attach platform to standoffs with thumbknobs.

3. Attach the center hub to the platform using 2 screws at 90 degrees apart. Make sure the hub is completely seated in the platform. The hub will sit approximately 1/8” above the top surface of the platform.

4. Use the burr hole entry marker with burr hole bushing and mark the skin and skull, then remove.

a b

a b

a b c d

WARNING: Do not overtighten thumbknobs. Only turn an additional 1/4 turn after contacting mating surface.

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5. Remove platform and drill burr hole.

6. Reattach platform.

7. Attach center drive positioner to center hub with tab oriented 45°, 90°, or 135° relative to screw. Make sure positioner is completely seated in the hub.

8. Attach drive to positioner and secure following drive instructions.

9. Perform MER and implant lead.

10. Remove drive from positioner, then remove platform.

11. Use the standoff wrench to support the standoff while twisting the driver clockwise to secure it to the standoff. Turn standoff wrench counterclockwise to remove standoff.

12. Use the anchor wrench to support the anchor while twisting the driver clockwise to secure it to the anchor. Turn anchor wrench counterclockwise to remove anchor.

a b c

a b c d

a b c d

13. Dispose of kit parts according to Hospital protocol.

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3.5

3.0

2.12 2.0

1.41 1.0 .71

3.5

3.0

2.12 2.0

1.41 1.0 .71

3.5

3.0

2.12

2.

0 1.

41

1.0

.71

3.5

3.0

2.12

2.

0 1.

41

1.0

.71

Track Selection:Center positioner (9 distinct tracks): Center track on target. Four parallel tracks with 2mm offset, ‘+’ configuration, using positions A, C, E and G. Four parallel tracks with 2mm offset, ‘x’ configuration, using positions B, D, F and H.

Examples:

Center Positioner, ‘+’ configuration, using any of positions A, C, E or G, indicated by the black dots in the offsetting chart below.

Center Positioner, ‘X’ configuration, using any of positions B, D, F or H, indicated by the red dots in the offsetting chart.

3mm offset positioner (40 distinct tracks): Five parallel tracks with 2mm offset, center track offset 3mm from origin, in eight configurations using positions A-H.

Examples:

3mm Offset Positioner in the ‘G’ position, indicated by the dark blue dots in the offsetting chart.

3mm Offset Positioner in the ‘B’ position, indicated by the magenta dots in the offsetting chart.

Offsets beyond the 10mm range of the positioner may be reached with the target offset hub.

Track Offsetting Chart

WARNING: The target offset hub creates a new trajectory with target area orthogonally offset 6mm from the original at the microelectrode tip depth when the physical drive reads 30mm. For platforms with T<>30, the offset of 0.69mm per 10mm of drive travel may be used to determine position at target depth.

WARNING: The entry offset hub creates a new trajectory which is orthogonally offset 3mm from original at approximate entry depth, and coincides with the original at the microelectrode tip depth when the physical drive reads 30mm. For platforms with T<>30, the offset of 0.34mm per 10mm of drive travel may be used to determine position at target depth.