# K020631: IPLAN

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Sep 9, 2002 after 194 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983410 (1999). 4 ancestors in all.
343 later devices descend from it; 5 cite it directly.
3 of 348 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003589: Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent, Brainlab AG (2001) Summary page 1.
- K010602: Vectorvision Hip, Brainlab AG (2001) Summary page 1.
- K010612: Vectorvision Knee, Brainlab AG (2001) Summary page 1.
- K983410: @ Target, Brainlab AG (1999) Summary page 1.

## Most influential descendants
- K040050: Instatrak System with Multiple Dataset Navigation, Model IT3500 (2004), 280 descendants of its own
- K053610: Abaris (2006), 278 descendants of its own
- K121498: Percunav (2012), 222 descendants of its own
- K132304: Epiq Diagnostic Ultrasound System (2013), 211 descendants of its own
- K160807: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2016), 100 descendants of its own

## 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 Stsreotactic Surgery: -Suraery 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 far diagnostic and surgical planning. Computer-graphic simulation in vanous views of a chosen probe path can help prevent probe intersections with unwanted, critical structures or vasseis, 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 optimizlng 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 Talairacflournoux andfar SchaltenbranWahren based brain atlases. The user is provided &ith information about the position of the various functional and anatamical areas of the brain. These positions of the structures have to be carrelated with every patients brain data. The correlation is defined by a procedure defined by TalairacNTournoux. 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 FunctionalPlanning 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 rkmstruction planes based on patient lrnages (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 tmjectoly 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 w'&h patients where rneesurement, 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) includinq - 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 systtilrn t o 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 B 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. Exampte procedures include but are not limited to: - Cranial procedures - Spine procedures - ENT procedures - Hip procedures - Knee procedures

Source page: https://510kreport.com/device/K020631
Methodology: https://510kreport.com/methodology