K Number

Device Name

IPLAN

Manufacturer

BRAINLAB AG

Date Cleared

2011-06-03

(359 days)

Product Code

HAW

Regulation Number

882.4560

Intended Use

iPlan's indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g. with stereotactic image guided surgery or other devices for further processing and visualization. Example procedures include but are not limited to: - Planning and simulation of cranial surgical procedures such as tumor resection, shunt placement, minimal-invasive stereotactic interventions, biopsy, trajectory planning for stimulation and electrode recording - ENT procedures such as sinus surgery, tumor surgery - - Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning - iPlan View is an application which is intended to be used for reviewing existing treatment plans

Device Description

Following planning sub-modules are available in the functional applications: Load and Import, View and Adjustment, Registration Points, ACPC Localization, Localization, Image Fusion, Object Creation, Advanced Object Planning, BOLD MRI mapping, Fiber Tracking, Trajectory planning, Stereotactic planning, Electrode recording, Save and Export.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K053127

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard medical image processing and planning tools, but there is no mention of AI or ML algorithms, training data, or performance metrics typically associated with AI/ML devices.

Therapeutic

No.
The device is for viewing, planning, and documenting medical imaging, which is a diagnostic/planning function, not a therapeutic one. Its output is used with other devices for further processing and visualization or stereotactic image-guided surgery, indicating it supports therapy rather than performing it.

Diagnostic

Explanation: The device is described as being for "viewing, presentation and documentation of medical imaging" and "planning and simulation of surgical procedures." While it processes medical images, its stated purpose is pre-operative planning and visualization, not making a diagnosis or providing diagnostic information directly.

SaMD (Software as a Medical Device)

The device description and intended use clearly indicate that iPlan is a software application used for planning and processing medical images. However, the description also mentions that the output can be used with "stereotactic image guided surgery or other devices for further processing and visualization." This implies that the software is intended to be used in conjunction with hardware devices, making it part of a larger system rather than a standalone software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The description of iPlan clearly states its purpose is for the viewing, presentation, documentation, and planning of medical imaging. It processes and analyzes images already acquired from the patient (CT, MRI, PET, SPECT). It does not perform tests on biological samples.
Intended Use: The intended use focuses on surgical planning and visualization based on imaging data, not on analyzing biological samples for diagnostic purposes.

Therefore, iPlan falls under the category of medical imaging software or surgical planning software, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Example procedures include but are not limited to:

Planning and simulation of cranial surgical procedures such as tumor resection, shunt placement, minimal-invasive stereotactic interventions, biopsy, trajectory planning for stimulation and electrode recording
ENT procedures such as sinus surgery, tumor surgery -
Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning
iPlan View is an application which is intended to be used for reviewing existing treatment plans

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

HAW

Device Description

Following planning sub-modules are available in the functional applications:

#	Sub-module	Changed *)	iPlan Cranial	iPlan ENT	iPlan Stereotaxy	iPlan Spine	iPlan View
1	Load and Import	yes	X	X	X	X	X
2	View and Adjustment	yes	X	X		X	X
3	Registration Points	yes	X	X	X	X
4	ACPC Localization	yes			X
5	Localization	yes			X
6	Image Fusion	yes	X	X	X	X	X
7	Object Creation	yes	X	X	X	X
8	Advanced Object Planning	yes	X	X
9	BOLD MRI mapping	yes	X		X
10	Fiber Tracking	yes	X		X
11	Trajectory planning	yes	X	X		X
12	Stereotactic planning	yes			X
13	Electrode recording	yes			X
14	Save and Export	yes	X	X	X	X

The iPlan software can be used on a dedicated Brainlab system or other platforms with defined minimum requirements.

The iPlan software can be mainly used in combination with the Brainlab devices: iPlan Net, Digital Lightbox, VectorVision navigation, Kolibri navigation.

Description of sub-modules:

#	Sub-module	Description
1	Load and Import	Load existing treatment data from different data sources, Import patient data from DICOM or other archive types, manage (delete/copy/move) patient folders
2	View and Adjustment	Review patient data in various reconstructions or overlay, side-by-side comparison of different modalities, aligning the data set orientation, import or export screenshot images
3	Registration Points	Automatic detection of CT or MR registration markers for navigation, manual placement of markers and anatomical landmarks
4	ACPC Localization	This planning task allows the definition of AC/PC coordinate system
5	Localization	Assign a localizer frame for CT or MRI localization Perform automatic detection of localizer rods
6	Image Fusion	Align available image sets automatically, manually or using landmarks for various combinations of images sets and modalities such as CT, MRI, PET and SPECT. Visual verification of alignment.
7	Object Creation	Outline anatomical structures using manual or automatic segmentation methods. Advanced manipulation for 3D objects with scaling, logical operations and object splitting. Volumetric measurements based on the created 3D objects
8	Advanced Object Planning	Mirror and split segmented structures
9	BOLD MRI mapping	Processing of blood oxygen level dependent (BOLD) MRI data Definition of block design functional task, calculation of activation areas based on BOLD MRI data, time series view for activation signal, creation of 3D objects from activation areas
10	Fiber Tracking	Processing of diffusion tensor imaging (DTI) using various ways to define and combine seed regions of interest. Definition of multiple fiber bundles and creation of 3D objects from fiber bundles. Volumetric measurements and detailed fiber information
11	Trajectory planning	Plan pathways for surgical instruments or resection, definition of entry, target points and diameter for trajectories
12	Stereotactic planning	Planning of stereotactic trajectories Usage of AC/PC coordinates and Schaltenbrandt-Wahren atlas Calculation of stereotactic arc settings for planned trajectories
13	Electrode recording	Planning of parallel electrode tracks Enter and display microelectrode recording and stimulation results, display information stepwise along tracks
14	Save and Export	Save the current treatment plan to the patient folder Export the results to the navigation, as DICOM or STL format

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, MRI, PET, SPECT, Diffusion Tensor Imaging (DTI), BOLD MRI

Anatomical Site

Cranial, ENT, Spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Typical users of iPlan are medical professionals, including but not limited to surgeons and radiologists.

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)

On different levels of development (module, subsystem, system) specific bench and integration tests were conducted. Internal standards were tested and documented as conformance report, environment compatibility and interfaces. Compatibility with previous version and comparable workflows to predicate devices were documented in corresponding review protocols.

Side-by-side comparison testing of the new version of iPlan with it's predicate device was conducted to determine substantial equivalences of the new version of iPlan with it's predicate version.

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.

K053127

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

K101627

JUN - 3 2011

510 (k) Summary of Safety and Effectiveness for iPlan

Manufacturer:

| Address: | Brainlab AG
Kapellenstrasse 12
85622 Feldkirchen
Germany |
|------------|-------------------------------------------------------------------|
| | Phone: +49 89 99 15 68 0 |
| | Fax: +49 89 99 15 68 33 |
| Submitter: | Mr. Rainer Birkenbach |

Contact Person: Mr. Alexander Schwiersch

Summary Date: April 21, 2011

Device Name:

| Trade name: | iPlan Cranial, iPlan Stereotaxy
iPlan ENT, iPlan Spine, iPlan View |
|-----------------------------|-----------------------------------------------------------------------|
| Common/Classification Name: | Planning System, Stereotactic Instrument |

Predicate Device:

iPlan (K053127)

Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II

Indications For Use:

Example procedures include but are not limited to:

Planning and simulation of cranial surgical procedures such as tumor resection, shunt placement, minimal-invasive stereotactic interventions, biopsy, trajectory planning for stimulation and electrode recording
ENT procedures such as sinus surgery, tumor surgery -
Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning
iPlan View is an application which is intended to be used for reviewing existing treatment plans

Typical users of iPlan are medical professionals, including but not limited to surgeons and radiologists.

Device Description

Following planning sub-modules are available in the functional applications:

| # | Sub-module | Changed
*) | iPlan
Cranial | iPlan
ENT | iPlan
Stereotaxy | iPlan
Spine | iPlan
View |
|----|-----------------------------|---------------|------------------|--------------|---------------------|----------------|---------------|
| 1 | Load and Import | yes | X | X | X | X | X |
| 2 | View and Adjustment | yes | X | X | | X | X |
| 3 | Registration Points | yes | X | X | X | X | |
| 4 | ACPC Localization | yes | | | X | | |
| 5 | Localization | yes | | | X | | |
| 6 | Image Fusion | yes | X | X | X | X | X |
| 7 | Object Creation | yes | X | X | X | X | |
| 8 | Advanced Object
Planning | yes | X | X | | | |
| 9 | BOLD MRI mapping | yes | X | | X | | |
| 10 | Fiber Tracking | yes | X | | X | | |
| 11 | Trajectory planning | yes | X | X | | X | |
| 12 | Stereotactic planning | yes | | | X | | |
| 13 | Electrode recording | yes | | | X | | |
| 14 | Save and Export | yes | X | X | X | X | |

*) changed compared to previous iPlan version

Description of sub-modules:

#	Sub-module	Description
1	Load and Import	Load existing treatment data from different data sources, Import patient data from DICOM or other archive types, manage (delete/copy/move) patient folders
2	View and Adjustment	Review patient data in various reconstructions or overlay, side-by-side comparison of different modalities, aligning the data set orientation, import or export screenshot images
3	Registration Points	Automatic detection of CT or MR registration markers for navigation, manual placement of markers and anatomical landmarks
4	ACPC Localization	This planning task allows the definition of AC/PC coordinate system
5	Localization	Assign a localizer frame for CT or MRI localization
Perform automatic detection of localizer rods
6	Image Fusion	Align available image sets automatically, manually or
using landmarks for various combinations of images sets
and modalities such as CT, MRI, PET and SPECT.
Visual verification of alignment.
7	Object Creation	Outline anatomical structures using manual or automatic
segmentation methods. Advanced manipulation for 3D
objects with scaling, logical operations and object
splitting.
Volumetric measurements based on the created 3D
objects
8	Advanced Object Planning	Mirror and split segmented structures
9	BOLD MRI mapping	Processing of blood oxygen level dependent (BOLD) MRI
data
Definition of block design functional task, calculation of
activation areas based on BOLD MRI data, time series
view for activation signal, creation of 3D objects from
activation areas
10	Fiber Tracking	Processing of diffusion tensor imaging (DTI) using various
ways to define and combine seed regions of interest.
Definition of multiple fiber bundles and creation of 3D
objects from fiber bundles.
Volumetric measurements and detailed fiber information
11	Trajectory planning	Plan pathways for surgical instruments or resection,
definition of entry, target points and diameter for
trajectories
12	Stereotactic planning	Planning of stereotactic trajectories
Usage of AC/PC coordinates and Schaltenbrandt-Wahren
atlas
Calculation of stereotactic arc settings for planned
trajectories
13	Electrode recording	Planning of parallel electrode tracks
Enter and display microelectrode recording and
stimulation results, display information stepwise along
tracks
14	Save and Export	Save the current treatment plan to the patient folder
Export the results to the navigation, as DICOM or STL
format

The iPlan software can be used on a dedicated Brainlab system or other platforms with defined minimum requirements.

The iPlan software can be mainly used in combination with the Brainlab devices: iPlan Net, Digital Lightbox, VectorVision navigation, Kolibri navigation.

K101627

Application performance testing

Side-by-side comparison testing of the new version of iPlan with it's predicate device was conducted to determine substantial equivalences of the new version of iPlan with it's predicate version.

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is composed of three curved lines, and below it are three wavy lines, possibly representing water.

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

JUN - 3 2011

BrainLab AG c/o Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 Feldkirchen Germany 85622

Re: K101627

Trade/Device Name: iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan Spine, iPlan View Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 13, 2011 Received: May 25, 2011

Dear Mr. Schwiersch:

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. Iisting 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Q. Ci. Tim, m/

Malvina B. Evdelman. M.E Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

K101627

Indications for Use

510(k) Number (if known):

Device Name: iPlan

Indications For Use:

Example procedures include but are not limited to:

Planning and simulation of cranial surgical procedures such as tumor resection, " shunt placement, minimal-invasive stereotactic interventions, biopsy, planning and simulation of trajectories for stimulation and electrode recording
ENT procedures such as sinus surgery, tumor surgery -
Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning
iPlan View is an application which is intended to be used for reviewing existing treatment plans

Typical users of iPlan are medical professionals, including but not limited to surgeons and radiologists.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tion Use

er 21 CFR 801.109)

(Division/Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Throat Devices

Division of
Nose and Throat Devices

510(k) Number

Page