Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a surgical navigation system for planning and guidance, but there is no mention of AI or ML in the intended use, device description, or performance studies. The modifications are described as enhancing user comfort, look and feel, and simplifying/extending functions using the latest platform technology, which does not necessarily imply AI/ML.

Therapeutic

No.
The device is a surgical planning and intraoperative guidance system, supporting surgical procedures rather than directly treating a medical condition itself.

Diagnostic

No

This device is a surgical navigation and guidance system, not a diagnostic device. Its purpose is to assist in planning and providing intraoperative guidance for surgical procedures, it does not diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the software is a component of a larger system that includes a computer workstation, smart instruments, and accessories, indicating it is not a standalone software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Stryker Navigation System - CranialMap Neuro Module is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The description clearly states that this system is a "planning and intraoperative guidance system" used during surgical procedures. It uses imaging modalities (CT, MR, etc.) to help surgeons navigate within the patient's body.
Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is based on processing medical images and providing real-time guidance during surgery.

Therefore, the Stryker Navigation System - CranialMap Neuro Module falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Stryker Navigation System - CranialMap Neuro Module is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.

The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The system should be operated only by trained personnel such as surgeons and clinic staff. The CranialMap Neuro Navigation system supports, but is not limited to, the following surgical procedures:

. Cranial biopsies
Puncture of abscesses .
Craniotomies .
. Craniectomies
Resection of tumors and other lesions ●
. Removal of foreign objects
○ Skull base procedures
Transnasal neurosurgical procedures .
Transphenoidal pituitary surgery .
Shunt placement, including pediatric shunt placement .
Placement of electrodes for recording, stimulation and lesion generation .
. Endoscopic Sinus Surgery (ESS)
Intranasal procedures .
Ear implant procedures .
Craniofacial procedures .
. Skull reconstruction procedures
Orbital cavity reconstruction procedures .

Product codes (comma separated list FDA assigned to the subject device)

HAW

Device Description

The Stryker Navigation System - CranialMap Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified.

The CranialMap Neuro Module is the Stryker Navigation System for cranial surgeries as described in the indications for use statement.

The subject device is the Stryker Navigation Software - CranialMap Neuro which together with the Stryker Navigation Platform, Smart Instruments and Accessories forms the Stryker Navigation System - CranialMap Module. It is therefore regarded as a component of the Stryker Navigation System - CranialMap Neuro Module. The design modifications introduced with the Stryker Navigation Software CranialMap Neuro are intended to increase the user comfort, to enhance the look and feel of the software and to simplify and extend the provided functions using the latest system platform technology.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, CTA, MR, MRA, fMRI, PET, SPECT

Anatomical Site

Cranial

Indicated Patient Age Range

The indication for shunt placement includes pediatric shunt placement, implying an age range from pediatric to adult.

Intended User / Care Setting

Trained personnel such as surgeons and clinic staff.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing: Validation activities, including human factors validation testing, have been conducted to provide assurance that the device meets the performance requirements under its indications for use conditions. In addition, system software validation acc, to IEC 62304 "Medical device software -Software life cycle processes", have been performed to show that the device is safe and effective.

Clinical Testing: No clinical testing has been conducted.

Key Results: The conclusions drawn from the nonclinical tests demonstrate that the Stryker Navigation Application Software CranialMap Neuro performs as safely and effectively as the legally marketed device identified in chapter 3. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the Stryker Navigation System - CranialMap Neuro Module is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K062640

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).

Summary

0

KB1214

Image /page/0/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are closely spaced together, and the word appears to be a logo or brand name. There is a small superscript symbol after the "r" in "stryker".

Navigation

510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

1. Contact Details

| Applicant Name: | Stryker Leibinger GmbH & Co. KG - Navigation
Boetzinger Strasse 41
D-79111 Freiburg, Germany
Phone number: +49-761-4512 117
Fax number: +49-761-4512 49117 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 3007582679 |
| Name of Contact Person: | Lilian Eckert
lilian.eckert@stryker.com |
| Date prepared: | 12 September 2013 |

2. Device Name

Trade Name:	CranialMap Neuro
Common Name:	Navigation software for cranial surgeries
Classification Name:	Product Code	Device	Regulation Number	Class	Review Panel
	Primary Code:
HAW	Neurologic stereotaxic instrument	21 CFR §882.4560	II	Neurology

1

3. Legally Marketed Predicate Device

The legally marketed predicate device is the Cranial Module as cleared in K062640 Stryker Navigation System - Cranial Module.

510(k) Number	Product Code	Trade Name
K062640	HAW	iNtellect Cranial
iNtellect ENT	Stryker Leibinger GmbH &
Co. KG - Navigation
Boetzinger Strasse 41
D-79111 Freiburg,
Germany

4. Device Description

The Stryker Navigation System - CranialMap Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified.

The CranialMap Neuro Module is the Stryker Navigation System for cranial surgeries as described in the indications for use statement.

The subject device is the Stryker Navigation Software - CranialMap Neuro which together with the Stryker Navigation Platform, Smart Instruments and Accessories forms the Stryker Navigation System - CranialMap Module. It is therefore regarded as a component of the Stryker Navigation System - CranialMap Neuro Module. The design modifications introduced with the Stryker Navigation Software CranialMap Neuro are intended to increase the user comfort, to enhance the look and feel of the software and to simplify and extend the provided functions using the latest system platform technology.

2

5. Indications for use

The Stryker Navigation System - CranialMap Neuro Module is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as a planning and intraoperative quidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The system should be operated only by trained personnel such as surgeons and clinic staff. The CranialMap Neuro Navigation system supports, but is not limited to, the following surgical procedures:

. Cranial biopsies
Puncture of abscesses .
Craniotomies .
. Craniectomies
Resection of tumors and other lesions ●
. Removal of foreign objects
� Skull base procedures
Transnasal neurosurgical procedures .
Transphenoidal pituitary surgery .
Shunt placement, including pediatric shunt placement .
Placement of electrodes for recording, stimulation and lesion generation .
. Endoscopic Sinus Surgery (ESS)
Intranasal procedures .
Ear implant procedures .
Craniofacial procedures .
. Skull reconstruction procedures
Orbital cavity reconstruction procedures .

3

6. Substantial Equivalence Comparison

In summary, the indications for use of the modified Stryker CranialMap Neuro Module are identical to the predicate device Cranial Module. Furthermore, the technological characteristics of the modified CranialMap Neuro Application Software are substantially equivalent to the original Cranial Application Software. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the CranialMap Neuro Module is substantially equivalent to the predicate device.

The following table gives an overview of the substantial equivalence reflecting all modifications being made between the predicate device and the subject device.

| Topic | Predicate Device
iNtellect Cranial
Software | Subject Device
CranialMap Neuro
Software | Equivalence assessment |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | Refer to chapter 5
"Indications for use" | Refer to chapter 5
"Indications for use" | Identical
Identical, except for the
module name, titles and
the order of listed
indications for use. |
| Look of the
Software
User
Interface | Grey-style graphical
user interface on 4:3
screen ratio, one tab
per task concept from
left to right on top of
screen, image box with
image tools and task
panel on the right | Black-style graphical
user interface on 16:9
screen ratio, one tab
per task concept from
left to right on top of
screen, image box with
image tools and task
tablet on the right | Equivalent
Refreshed and touch-
enabled graphical user
interface on HD screen.
Changes are minor and do
not alter the way the
software performs nor
affect safety and
effectiveness of device. |
| Modes of
Operation | Software workflow
controlled by tabs from
left to right, registration
planning tab after
planning tab. | Software workflow
controlled by tabs from
left to right, registration
planning tab moved
before planning tab. | Equivalent
Modification improves the
ease of use of the
software and does not
negatively affect the safety
and effectiveness of the
proposed device. |
| Topic | Predicate Device
iNtellect Cranial
Software | Subject Device
CranialMap Neuro
Software | Equivalence assessment |
| Control
Mechanism | Mouse Keyboard Buttons on
navigated sterile
smart tools. | Mouse Virtual Keyboard Buttons on
navigated sterile
smart tools. IO-Tablet with touch
screen | Equivalent
The control mechanism
during surgery is identical.
The control mechanism
before surgery is
equivalent: mouse,
keyboard and touch
screen. |
| Operating
Principle | The iNtellect Cranial
software is installed on
the computer that is
part of the Navigation
system platform.
Images are imported in
DICOM format. | The CranialMap
software is installed on
the computer that is
part of the Navigation
system platform.
Images are imported in
DICOM format. | Identical
The operating principle on
the Stryker Platform is
unchanged. |
| Accuracy
Statement | Within the camera
working space, the
system has a mean
accuracy of 2 mm for
translation and 2° for
rotation. | Within the camera
working space, the
system has a mean
accuracy of 2 mm for
translation and 2° for
rotation. | Identical |
| Registration
Accuracy | The root mean square
value is displayed as
mean error of the
registration. | The root mean square
value is displayed as
mean error of the
registration. | Identical |
| Check for
Sustained
Accuracy
Intra-
operatively | Navigation instrument's
tip geometry check on
initialization of
instrument.
Intra-operative
interactive landmark
checks demanded by
the software, e.g.
during mandatory
registration
confirmation step. | Navigation instrument's
tip geometry check on
initialization of
instrument.
Intra-operative
interactive landmark
checks demanded by
the software, e.g.
during mandatory
registration
confirmation step. | Identical
An additional video
guidance how to check the
instrument's tip geometry
makes the device more
users friendly and does
not negatively affect the
safety and effectiveness of
the proposed device. |
| Topic | Predicate Device
iNtellect Cranial
Software | Subject Device
CranialMap Neuro
Software | Equivalence assessment |
| System Components | | | |
| Localization
Technology
and Working
Sphere | Infrared optical active
sensing technology:
Infrared light emitted by
diodes placed in a
known fashion on
instruments (trackers)
is sensed by a camera
array thus allowing for
computation of the
spatial information. | Infrared optical active
sensing technology:
Infrared light emitted by
diodes placed in a
known fashion on
instruments (trackers)
is sensed by a camera
array thus allowing for
computation of the
spatial information. | Identical
The Navigation Camera is
the same camera as used
for the predicate device. |
| Navigation
System
Platform | Stryker Navigation
System II - Cart,
Stryker eNlite:
• Stryker
Navigation
Camera
• Mouse,
Keyboard
• Stryker PC
Computer | Stryker Navigation
Platform:
• Stryker
Navigation
Camera
• IO-Tablet
• Stryker PC-3
Computer | Equivalent
The same navigation
camera and equivalent PC
based components are
used. The IO-tablet
interface to control the
application is a state-of-
the-art alternative to using
a mouse and keyboard for
user's convenience. |
| OR Display | Display properties:
• 4:3 LCD monitor
• 1280 x 1024 pixel
resolution
• 19" screen | Display properties:
• 16:9 LCD monitor
• 1980 x 1080 pixel
resolution
• 32" screen | Equivalent
The larger high resolution
display does not
negatively affect the safety
and effectiveness of the
subject device. |
| Smart
Instrument
Technology
(Trackers) | Active, battery
powered, wireless
instrumentation with bi-
directional IR-
communication and IR-
LEDs for tracking | Active, battery
powered, wireless
instrumentation with bi-
directional IR-
communication and IR-
LEDs for tracking | Identical
All smart instruments
supported by the predicate
device are supported by
the subject device as well. |
| Topic | Predicate Device
iNtellect Cranial
Software | Subject Device
CranialMap Neuro
Software | Equivalence assessment |
| Calibration of
Instrument
Dimensions | Workflow to calibrate
and validate the
navigated instruments
during the operation. | Workflow to calibrate
and validate the
navigated instruments
during the operation. | Identical |
| Disposable
Parts | Batteries for trackers,
registration markers,
Frameless Guide,
Patient Registration
and tracking mask. | Batteries for trackers,
registration markers,
Frameless Guide,
Patient Registration
and tracking mask. | Identical |
| Scanner
Interface
Technology
(to imaging
devices) | Magneto Optical Disk
CD, DVD, USB
Network connectivity
DICOM storage client | CD, DVD, USB
Network connectivity
DICOM storage client
DICOM query/retrieve | Equivalent
Modification to support
state-of-the-art scanner
interfaces. |
| Supported
imaging
modalities | CT, CTA
MR, MRA, fMRI
PET, SPECT | CT, CTA
MR, MRA, fMRI
PET. SPECT | Equivalent
More convenient image
modality correlation based
on DICOM frame-of-
reference ID supported. |
| Microscope
interfaces | Zeiss NC4,
Zeiss Pentero,
Leica M5xx,
Leica M720
microscope models | Zeiss NC4, Zeiss
Pentero, Zeiss
Pentero 900, Leica
M5xx
Leica M720
microscope models | Equivalent
The additional support of
the Zeiss Pentero 900
microscope is identical to
the Pentero microscope
except for a new
microscope ID. |
| Topic | Predicate Device
iNtellect Cranial
Software | Subject Device
CranialMap Neuro
Software | Equivalence assessment |
| | Operating System and Implementation Technology | | |
| Platform
Operating
System | Windows 2000
Windows XP | Windows XP | Equivalent
Higher version of Windows
operating system used. |
| Software
Implemen-
tation | C and C++
programming applying
object oriented analysis
and design methods,
Qt GUI design and up-
to-date continuous
integration and testing
tools in a Microsoft
development
environment. | C and C++
programming applying
object oriented analysis
and design methods,
Qt GUI design and up-
to-date continuous
integration and testing
tools in a Microsoft
development
environment. | Equivalent
Additional methods have
been applied to the
software development of
the subject device for
state-of-the-art software
quality, e.g. code
coverage measurements
and 100% code reviews. |
| Use of Off-
the-Shelf
(OTS)
Software | OTS software for
logging, visualization,
algorithms, 3D
graphics, multi-
threading, GUI
components, volume
rendering, multi-
modality matching,
backup on CD and cpp-
templates. | OTS software for
logging, visualization,
algorithms, 3D
graphics, multi-
threading, GUI
components, volume
rendering, multi-
modality matching,
backup on CD and cpp-
templates.
DICOM Tool Kit | Equivalent
For the CranialMap Neuro
Software the same Off-
the-Shelf software
components that have
already been used for the
predicate device are used
with updated versions
where appropriate.
The new DICOM
Query/Retrieve extension
is based on the DICOM
Tool Kit. |

4

5

6

7

:

8

| Topic | Predicate Device
iNtellect Cranial
Software | Subject Device
CranialMap Neuro
Software | Equivalence assessment |
|----------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CranialMap Neuro Modifications | | | |
| Touch
Screen
Functionality | No touch screen GUI operated via
Mouse input | Touch on IO-tablet
can be used
alternatively to
mouse control | Equivalent
Additional touch screen
functionality does not
negatively affect the safety
and effectiveness |
| LiveCam
System
Setup | System setup using
side and top view of
working sphere. | System setup using
side and top view of
working sphere. Additionally a
"localizer's eye" live
video view option. | Equivalent
The additional option using
the LiveCam does not
affect the performance or
the indications for use
of the subject device. |
| Collision
Zones | Segments and
annotations can be
defined | Segments and
annotations can be
defined Collision check
option for
segments,
annotations and
functional overlays
during navigation | Equivalent
An additional option for
audible and visual
feedback during
navigation is provided.
This modification does not
negatively affect safety
and effectiveness or
change the indications for
use of the subject device. |

9

| Topic | Predicate Device
iNtellect Cranial
Software | Subject Device
CranialMap Neuro
Software | Equivalence assessment |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image series
import and
handling | Anatomical and functional MRI data is imported as separate image series. The "identity correlation" feature is used to correlate functional data to the appropriate anatomical MRI series. The correctness of the image correlation must be confirmed during image import. | Functional MRI images are detected during image import as overlays of a related anatomical MRI image series automatically. System applies an "identity correlation" based on DICOM reference frame ID. The correctness of the image correlation must be confirmed during image import. Deletion of imported image series. | Equivalent
Simplification by reducing number of steps needed to correlate image modalities. Like in the predicate device the user must confirm the result.
For convenience an unintentionally imported image series can be removed.
The modification does not negatively affect the safety and effectiveness of the subject device. |
| 3D model
visualization | Advanced virtual surgical planning based on 3D DICOM data, e.g. a CT scanned implant possible. | Planning based on 3D model data, e.g. STL models is possible. The 3D models can be loaded and aligned with anatomical image data. | Equivalent
Advanced virtual planning is enhanced but no change of indications for use. Change does not negatively affect safety and effectiveness. |

10

| Topic | Predicate Device
iNtellect Cranial
Software | Subject Device
CranialMap Neuro
Software | Equivalence assessment |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Automatic
intra-
operative
mask (AIM)
registration | • Automatic mask
registration and
tracking based on
skin surface
extraction. | • Automatic mask
registration and
tracking based on
skin surface
extraction.

• The mask is
attached on the
patient during the
CT scan and AIM
registration is able
to detect the LED
positions of the
mask in the scan. | Equivalent
Additional mask
registration method using
a CT scan while the mask
is attached to the patient.
The established point-to-
point registration
algorithms are used. No
change of the indications
for use. Change does not
negatively affect safety
and effectiveness. |

7. Non-clinical Testing

Validation activities, including human factors validation testing, have been conducted to provide assurance that the device meets the performance requirements under its indications for use conditions. In addition, system software validation acc, to IEC 62304 "Medical device software -Software life cycle processes", have been performed to show that the device is safe and effective.

8. Clinical Testing

No clinical testing has been conducted.

9. Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the Stryker Navigation Application Software CranialMap Neuro performs as safely and effectively as the legally marketed device identified in chapter 3. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the Stryker Navigation System - CranialMap Neuro Module is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics.

11

Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 18, 2013

Stryker Corporate Ms. Lilian Eckert Boetzinger Str. 41 Freiburg, Baden-Wuerttemberg, GM 79111

Re: K131214

Trade/Device Name: Cranial Map Neuro Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: September 12, 2013 Received: September 16, 2013

Dear Ms. Eckert:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

12

Page 2 - Ms. Lilian Eckert

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

13

Indications for Use

510(k) Number (if known):

K131214

Device Name:

Stryker CranialMap Neuro Module

Indications For Use:

The Stryker Navigation System - CranialMap Neuro Module is a navigation surgical software module that, when used with a specific Styker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.

The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The system should be operated only by trained personnel such as surgeons and clinic staff.

The CranialMap Neuro Navigation system supports, but is not limited to, the following surgical procedures:

Cranial biopsies ●
Puncture of abscesses .
Craniotomies .
Craniectomies .
Resection of tumors and other lesions .
Removal of foreign objects .
Skull base procedures �
Transnasal neurosurgical procedures �
. Transphenoidal pituitary surgery
Shunt placement, including pediatric shunt placement .
Placement of electrodes for recording, stimulation and lesion generation �
Endoscopic Sinus Surgery (ESS) �
Intranasal procedures .
Ear implant procedures .
Craniofacial procedures .
Skull reconstruction procedures .
Orbital cavity reconstruction procedures .

14

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ・

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 2 of _ _ 2__