(122 days)
Not Found
No
The document describes image processing, fusion, and segmentation, which are common in medical imaging software, but it does not mention AI, ML, or any related terms like deep learning or neural networks. The focus is on traditional image processing and planning tools.
No
The device is described as software used for preparing and presenting patient and image data for the creation of treatment plans and image-guided surgery, not for directly treating a condition.
No
The device is described as "Image Guided Surgery system intended to be an intraoperative image guided localization system" and for "creation of treatment plans," indicating it is a surgical planning and guidance system used during treatment, not a device for diagnosing medical conditions.
Yes
The device description and intended use clearly define the product as software ("iPlan! Cranial software," "this application provides functions"). While it interacts with other BrainLAB medical devices (which are likely hardware), the submitted 510(k) summary focuses solely on the software's functionality for image processing, planning, and data preparation. There is no mention of hardware components being part of the device being cleared.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device's Intended Use: The intended use of iPlan! and iPlan! FiberTracking is to prepare and present patient and image data from imaging modalities (CT, MR, X-ray) for the purpose of surgical planning and image-guided surgery. It processes existing medical images of the patient's anatomy.
- No Specimen Examination: The device does not involve the collection, preparation, or examination of specimens taken from the human body. It works with images of the human body.
Therefore, while it is a medical device used in the context of patient care, its function falls under surgical planning and image guidance, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro), including
- image preparation -
- image fusion
- image segmentation -
where the result is used for the creation of treatment plans for Stereotactic Surgery:
- Surgery Planning
The Surgery Planning is a tool for pre- and intraoperative stereotactic surgery planning based on stereotactic systems. Multiple graphical display functions and 3-dimensional views of anatomical structures offer effective and efficient means of presenting the anatomical data for diagnostic and surgical planning. Computer-graphic simulation in various views of a chosen probe path can help prevent probe intersections with unwanted, critical structures or vessels.
The surgeon can interactively change a probe path simulation through the image slices in the software with on-line calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach.
- BrainMAP
The BrainMAP module is a tool, which defines two and three-dimensional information about anatomical structures of the human brain for pre- and intraoperative planning of stereotactic procedures. These contours are defined and described by Talairach/Tournoux and/or Schaltenbrand/Wahren based brain atlases.
The user is provided with information about the position of the various functional and anatomical areas of the brain. These positions of the structures have to be correlated with every patients brain data. The correlation is defined by a procedure defined by Talairach/Tournoux. Using their grid system to divide the brain in particular areas, the program will be able to provide matching data for different patient data. BrainMAP may be used alone or in conjunction with neurosurgery.
- Functional Planning
The Functional Planning is based on Surgery Planning, which gives two- and three dimensional online information of a stereotactical surgical instrument (electrodes) for a neurosurgical functional treatment using a stereotactic arc. The user is provided with information by numerical results and by various displays and reconstruction planes based on patient images (CT, MRI, PET, SPECT) about the position and orientation relative to the patient of his surgical instrument to perform stimulation and treatment on brain structures or to a preplanned trajectory.
The software is capable of displaying the trajectory and functional areas of the brain based on BrainMAP online on the screen and recording the stimulations by storing positions of the electrodes.
The Functional Planning is intended to be used with patients where measurement, stimulation and placement of electrodes in the brain (pallidotomy) are part of the treatment. The stereotactic arc system is useful for placing these electrodes or using the instruments during the treatment and in the planning phases of the functional treatment.
In addition iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro) including
- image preparation -
- image fusion
- image segmentation -
where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for:
Image Guided Surgery
BrainLAB's Image Guided Surgery system is intended to be an intraoperative image guided localization system to enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.
Example procedures include but are not limited to:
- Cranial procedures
- -Spine procedures
- -ENT procedures
Additional Indications For Use:
iPlan! FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where this medical device is used for image guided surgery.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
iPlan! FiberTracking is developed to enhance functionality of iPlan! Cranial software with the import and planning of diffusion tensor images (DTI). Additional to the basic functions of iPlan! (viewing, drawing, image fusion and planning) this application provides functions for the import and display MRI anisotropic data, image processing of the DTI data and the display of the calculated fiber tracts.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT, X-ray (Fluoro), PET, SPECT
Anatomical Site
Brain, skull, long bone, vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
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
§ 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).
0
04/703
510 (k) Summary of Safety and Effectiveness for iPlan! FiberTracking
OCT 2 2 2004
Manufacturer:
| Address: | BrainLAB AG
Ammerthalstrasse 8
85551 Heimstetten
Germany
Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 33 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Rainer Birkenbach |
Summary Date: May 27, 2004
Device Name: iPlan!
The existent iPlan! Planning System should be amended with the subsystem Fiber Tracking.
iPlan!
Planning System/Stereotaxic Instrument Common/Classification Name:
Predicate Device:
iPlan! (K020631)
Trade name:
Device Classification Name: Instrument, Stereotaxic Requlatory Class: Class II
Intended Use:
iPlan! FiberTracking's indication for use is to prepare and present patient and image data based on MBI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where his medical device is used for image guided surgery.
Device Description:
iPlan! FiberTracking is developed to enhance functionality of iPlan! Cranial software with the import and planning of diffusion tensor images (DTI). Additional to the basic functions of iPlan! (viewing, drawing, image fusion and planning) this application provides functions for the import and display MRI anisotropic data, image processing of the DTI data and the display of the calculated fiber tracts.
Substantial equivalence:
iPlan! has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device iPlan! (K020631).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2004
Mr. Rainer Birkenbach BrainLAB, AG Ammerthalstrasse 8 85551 Heimstetten Germany
Re: K041703 Trade/Device Name: iPlan! Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: October 8, 2004 Received: October 12, 2004
Dear Mr. Birkenbach:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Mr. Rainer Birkenbach
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K041703 510(k) Number (if known):
iPlan! Device Name:
Indications For Use:
iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro), including
- image preparation -
- image fusion
- image segmentation -
where the result is used for the creation of treatment plans for Stereotactic Surgery:
- Surgerv Planning
The Surgery Planning is a tool for pre- and intraoperative stereotactic surgery planning based on stereotactic systems. Multiple graphical display functions and 3-dimensional views of anatomical structures offer effective and efficient means of presenting the anatomical data for diagnostic and surgical planning. Computer-graphic simulation in various views of a chosen probe path can help prevent probe intersections with unwanted, critical structures or vessels.
The surgeon can interactively change a probe path simulation through the image slices in the software with on-line calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach.
- BrainMAP
The BrainMAP module is a tool, which defines two and three-dimensional information about anatomical structures of the human brain for pre- and intraoperative planning of stereotactic procedures. These contours are defined and described by
Talairach/Tournoux and/or Schaltenbrand/Wahren based brain atlases.
The user is provided with information about the position of the various functional and anatomical areas of the brain. These positions of the structures have to be correlated with every patients brain data. The correlation is defined by a procedure defined by Talairach/Tournoux. Using their grid system to divide the brain in particular areas, the program will be able to provide matching data for different patient data. BrainMAP may be used alone or in conjunction with neurosurgery.
- Functional Planning
The Functional Planning is based on Surgery Planning, which gives two- and three dimensional online information of a stereotactical surgical instrument (electrodes) for a neurosurqical functional treatment using a stereotactic arc. The user is provided with information by numerical results and by various displays and reconstruction planes based on patient images (CT, MRI, PET, SPECT) about the position and orientation relative to the patient of his surgical instrument to perform stimulation and treatment on brain structures or to a preplanned trajectory .
Page 1 of 3
4
The software is capable of displaying the trajectory and functional areas of the brain based on BrainMAP online on the screen and recording the stimulations by storing positions of the electrodes.
The Functional Planning is intended to be used with patients where measurement, stimulation and placement of electrodes in the brain (pallidotomy) are part of the treatment. The stereotactic arc system is useful for placing these electrodes or using the instruments during the treatment and in the planning phases of the functional treatment.
In addition iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro) including
- image preparation -
- image fusion
- image segmentation -
where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for:
Image Guided Surgerv
BrainLAB's Image Guided Surgery system is intended to be an intraoperative image guided localization system to enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or verfebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.
Example procedures include but are not limited to:
- Cranial procedures ー
- -Spine procedures
- -ENT procedures
Additional Indications For Use:
iPlan! FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where this medical device is used for image guided surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Muriam C. Provost
Page 2 of 3
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
510(k) Number K041703