(354 days)
Not Found
Not Found
No
The description focuses on traditional image processing, 3D visualization, and manual user interaction for surgical planning and simulation. There is no mention of AI or ML techniques for tasks like automated segmentation, prediction, or decision support.
No
The device is described as a planning tool for surgery, radiotherapy, and radiosurgery, designed to assist medical professionals in visualizing and planning procedures, not to provide direct therapy.
No
Explanation: The "Intended Use / Indications for Use" section describes the device as a tool for "surgery planning" and for presenting "anatomical data for diagnostic and surgical planning," but it explicitly states that the module provides data for diagnostic and surgical planning. The primary function described is preparing for and assisting in stereotactic surgery, not making a diagnosis.
Yes
The description focuses entirely on software modules for planning and analysis using existing imaging data. There is no mention of any accompanying hardware components or hardware-specific functions.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "SURGERY PLANNING module" and related modules (BRAINMAP, FUNCTIONAL PLANNING). Its purpose is to assist in the planning and execution of stereotactic surgery, particularly in the brain. It uses imaging data (CT, MRI, etc.) to visualize anatomical structures, plan trajectories, and simulate procedures.
- No Sample Analysis: There is no mention of the device analyzing biological samples from the patient. Its input is imaging data, not biological specimens.
Therefore, the device falls under the category of medical imaging software or surgical planning software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SURGERY PLANNING module is a tool for pre- and introoporative stereotactic surgery planning based on stereotactic systems Multiple graphical display functions and 3-dimensional views of anatomical structures offer an effective and efficient means of presenting the anatomical data for diagnostic and surgical planning. The module provides possibilities to combine and process intage data sets from CT, MRI, Angiographic, and other imaging sources. 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 workstation with on-line calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach. Its modular design makes possible adaption to the user's special requirements,
BRACHYTHERAPY Itus module, hased on SURGERY PLANNING, is designed for computergraphic coloulation of isodoses from implantation of radioactive seeds, implanted at aven nositions within a turnor volume. The radioactive accoa are loaded into catheters that are implanted stereotactically. The computer software the isodose profiles in various views or in three dimensions prior to actual seed injuly not the catheters and the indivelling seeds can bo displayed in sceen contours, each perpendicular to the Uirection of the implanted catherers. The objective is to better tailor the dose distribution to the 3 dimensional volume of the turnor. The relevant implantation positions and other parameters can be printed out for a herdcopy documentation of what has been dulle.
The BRAINMAP module is a tool, which defines two and three-dimensional information about anatomical atructures of the human brain for pre- and intraveralive playming of stereotactic procedures.. These contours are defined and described by Tslairach/Tournoux and/or Schaltenbrand/Wahren based broin allasses. The user is provided with information about the various functional and anotomical areas of the brain. These positions of the structures have to be correlated with every patients brain data. The conclation is delined by a procedure defined by Talatach Tournoux. Using their prid system to divide the brain in porticular areas, the program will be able to provide maticliny data for different patient data. BrainMAP may be used alono or in conjunction with neurosurgcry, radiotheropy and radiosurgery planning systems.
The FUNCTIONAL PLANNING Module is a tool based on SURGERY PLANNING , which gives wor three rimensional online information of a stereotactical surgical instrument (clectrodco) 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 nasition and orientation relative to the patient of his surgical instrument to perfuring sumulation and treatment on brain structures or to a preplanned trajectory .
The software is capable of displaying the trajectory and functional aroas of the brain baced on BRAINMAP online on the screen and recording the stimulations by storing positions of the electrodes.
The FUNCTIONAL PLANNING module is intended to be used with patients where measurement, stimulation and placement of electrodes in the brain (pallidotomy) are part of 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.
Product codes (comma separated list FDA assigned to the subject device)
HAW, KXK
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, Angiographic, PET, SPECT
Anatomical Site
Human brain, tumor volume
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Neurosurgery
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.
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of three human figures. The figures are represented by three curved lines that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1999
Mr. Rainer Birkenbach Executive Vice President Brainlab USA. Inc. 3100 Hansen Way Building 4A. Mailstop E233 Palo Alto, California 94304
K983410 Re: Trade Name: @TARGET Regulatory Class: II Product Code: HAW and KXK Dated: June 21, 1999 Received: June 24, 1999
Dear Mr. Birkenbach:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Rainer Birkenbach
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Page | 1 | of | 2 |
|---|---|---|---|
| ------ | --- | ---- | --- |
510(k) Number (if known):
983410
I Device Name:
@Targot
Indications For Use:
SURGERY PLANNING
The SURGERY PLANNING module is a tool for pre- and introoporative stereotactic surgery planning based on stereotactic systems Multiple graphical display functions and 3-dimensional views of anatomical structures offer an effective and efficient means of presenting the anatomical data for diagnostic and surgical planning. The module provides possibilities to combine and process intage data sets from CT, MRI, Angiographic, and other imaging sources. 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 workstation with on-line calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach. Its modular design makes possible adaption to the user's special requirements,
(p.L.o.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801, 109)
OR
Over-The-Counter Usc
(Optional Forum I-2-96)
collef
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K983410
3
Page ંદ of __ 2
| 510(k) Number (if known): | K983410 |
|---|---|
| Device Name: | @Target |
BRACHYTHERAPY
Itus module, hased on SURGERY PLANNING, is designed for computergraphic coloulation of isodoses from implantation of radioactive seeds, implanted at aven nositions within a turnor volume. The radioactive accoa are loaded into catheters that are implanted stereotactically. The computer software the isodose profiles in various views or in three dimensions prior to actual seed injuly not the catheters and the indivelling seeds can bo displayed in sceen contours, each perpendicular to the Uirection of the implanted catherers. The objective is to better tailor the dose distribution to the 3 dimensional volume of the turnor. The relevant implantation positions and other parameters can be printed out for a herdcopy documentation of what has been dulle.
BRAINMAP
The BRAINMAP module is a tool, which defines two and three-dimensional information about anatomical atructures of the human brain for pre- and intraveralive playming of stereotactic procedures.. These contours are defined and described by Tslairach/Tournoux and/or Schaltenbrand/Wahren based broin allasses. The user is provided with information about the various functional and anotomical areas of the brain. These positions of the structures have to be correlated with every patients brain data. The conclation is delined by a procedure defined by Talatach Tournoux. Using their prid system to divide the brain in porticular areas, the program will be able to provide maticliny data for different patient data. BrainMAP may be used alono or in conjunction with neurosurgcry, radiotheropy and radiosurgery planning systems.
FUNCTIONAL PLANNING
The FUNCTIONAL PLANNING Module is a tool based on SURGERY PLANNING , which gives wor three rimensional online information of a stereotactical surgical instrument (clectrodco) 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 nasition and orientation relative to the patient of his surgical instrument to perfuring sumulation and treatment on brain structures or to a preplanned trajectory .
I he software is capable of displaying the trajectory and functional aroas of the brain baced on BRAINMAP online on the screen and recording the stimulations by storing positions of the electrodes.
The FUNCTIONAL PLANNING module is intended to be used with patients where measurement, stimulation and placement of electrodes in the brain (pallidotomy) are part of 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.
bicolleto
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983410
GESHIT SEITEN 03
Prescription Use
(Per 21 CFR 801.109)