(197 days)
Not Found
No
The document describes image alignment as "automatically" performed, but does not mention AI, ML, or any related technologies like neural networks or deep learning. The description focuses on traditional treatment planning algorithms and software functionalities.
No.
The device is a treatment planning software that assists in planning radiation treatment, not directly administering therapy itself.
No
BrainSCAN is a treatment planning system for radiation therapy, which focuses on generating treatment plans and simulating dose delivery, rather than diagnosing conditions.
Yes
The device is described as a "software program" and its description focuses entirely on its software functionalities for treatment planning and dose simulation. While it interacts with other systems (LINAC, archive/verification systems), the device itself is presented as a software product running on standard operating systems and processor platforms.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions." This describes a therapeutic planning system, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as "a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy." This aligns with a treatment planning system, not a diagnostic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or other materials for in vitro testing
The device is clearly a software tool used by healthcare professionals to plan and simulate radiation therapy, which is a treatment modality.
N/A
Intended Use / Indications for Use
BrainSCAN is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. BrainSCAN is the evolutionary successor of the predicate devices and is a treatment planning software specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from image viewing to quality assurance. BrainSCAN is developed for the Windows NT operating systems and is tested and released for Alpha and Intel processor platforms.
BrainSCAN is a stereotactic radiation treatment planning system with the same intended use as the commercially available BrainSCAN Radiosurgery and BrainSCAN Conformal RT modules. It is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be experienced and trained health professionals.
BrainSCAN is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions.
Product codes
90 MUJ
Device Description
BrainSCAN is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. BrainSCAN is the evolutionary successor of the predicate devices and is a treatment planning software specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from image viewing to quality assurance. BrainSCAN is developed for the Windows NT operating systems and is tested and released for Alpha and Intel processor platforms.
BrainSCAN incorporates all capabilities of the predicate devices and extends some of them. BrainSCAN allows aligning of two image sets of different imaging modalities automatically to obtain a common coordinate system for both. It allows defining a stereotactic coordinate system for treatment of extracranial lesions using the patient positioning system ExacTrac. To account for tissue inhomogeneities the possibility to calculate dose with a pencil beam algorithm is added. If the pencil beam algorithm is used it is possible to calculate the dose distribution of intensity modulated beams. BrainSCAN further extends the capabilities of the predicate devices to export treatment plans with the possibilities to export plans to the archive and verification system of Varian (VARiS) and to generate ASCII-files for the import into the archive and verification system of Impac (Lantis/Impac).
BrainSCAN is a stereotactic radiation treatment planning system that allows the 3D definition of objects based on patient images obtained from various imaging modalities. It offers several tools to the user to allow optimizing the dose distribution to spare healthy tissue and to escalate the dose in the planning target volume.
To summarize the additional features:
- Pencil beam dose calculation for increased accuracy in extracranial applications.
- Intensity modulated fields for optimized dose distribution shaping.
- Stereotactic coordinate system for the whole body in conjunction with ExacTrac.
- Automatic image fusion to superimpose two image sets from different imaging modalities.
- Treatment plan export to VARiS, the record and verify system of Varian.
- Treatment plan export to LANTIS and Impac, the record and verify system(s) of Impac.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
various imaging modalities
Anatomical Site
cranial, head and neck, and extracranial lesions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
experienced and trained health professionals.
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)
The different subsystems of the BrainSCAN software have been thoroughly tested on subsystem level and an extensive integration test of the submodules was performed. Numerous tests that were derived from a complete risk analysis and assessment have been performed as well. Dosimetric as well as cross checks with other treatment planning systems have been performed to verify the implementation and performance of the pencil beam algorithm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) Summary of Safety and Effectiveness JUL 1 3 2000 for BrainSCAN
K994413
Page 1 of 42
Brain AV
1. Company
| Address: | BrainLAB AG
Ammerthalstr. 8
85551 Heimstetten
Germany |
|---------------------------------------|------------------------------------------------------------------------|
| Contact Person:
Telephone:
Fax: | Stefan Vilsmeier, President
+49 (89) 991568-0
+49 (89) 991568-33 |
| Date Prepared: | December 21, 1999 |
Device Name 2.
| Trade name: | BrainSCAN XL, BrainSCAN Classic, Novalis Treatment Planning |
|---|---|
| Common name: | BrainSCAN |
| Current version number: | 5.0 |
| Classification name: | X-ray radiation therapy system (per 21CFR892.5900) |
Predicate Devices: 3.
BrainSCAN Radiosurgery Module (K920879) BrainSCAN Conformal RT Module (K971367)
Device Description 4.
BrainSCAN is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. BrainSCAN is the evolutionary successor of the predicate devices and is a treatment planning software specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from image viewing to quality assurance. BrainSCAN is developed for the Windows NT operating systems and is tested and released for Alpha and Intel processor platforms.
BrainSCAN incorporates all capabilities of the predicate devices and extends some of them. BrainSCAN allows aligning of two image sets of different imaging modalities automatically to obtain a common coordinate system for both. It allows defining a stereotactic coordinate system for treatment of extracranial lesions using the patient positioning system ExacTrac. To account for tissue inhomogeneities the possibility to calculate dose with a pencil beam algorithm is added. If the pencil beam algorithm is used it is possible to calculate the dose distribution of intensity modulated beams. BrainSCAN further extends the capabilities of the predicate devices to export treatment plans with the possibilities to export plans to the archive and verification system of Varian (VARiS) and to generate ASCII-files for the import into the archive and verification system of Impac (Lantis/Impac).
Intended Use 5.
BrainSCAN is a stereotactic radiation treatment planning system with the same intended use as the commercially available BrainSCAN Radiosurgery and BrainSCAN Conformal RT modules. It is intended for use in stereotactic, conformal, computer planned, LINAC based radia
1
tion treatment of cranial, head and neck, and extracranial lesions. It is intended to be experienced and trained health professionals.
General Safety And Effectiveness 6.
The different subsystems of the BrainSCAN software have been thoroughly tested on subsystem level and an extensive integration test of the submodules was performed. Numerous tests that were derived from a complete risk analysis and assessment have been performed as well. Dosimetric as well as cross checks with other treatment planning systems have been performed to verify the implementation and performance of the pencil beam algorithm. The training and installation session provides assurance that the user understands all aspects of the BrainSCAN system: mechanical, computer and software, plus its intended functionality.
Technological Characteristics 7.
The information and testing provided in this submission clearly describes the technological characteristics of the BrainSCAN modifications and additional features and demonstrates that BrainSCAN is substantially equivalent to the commercially available predecessors BrainSCAN Radiosurgery Module and BrainSCAN Conformal RT Module.
BrainSCAN is a stereotactic radiation treatment planning system that allows the 3D definition of objects based on patient images obtained from various imaging modalities. It offers several tools to the user to allow optimizing the dose distribution to spare healthy tissue and to escalate the dose in the planning target volume.
To summarize the additional features:
- Pencil beam dose calculation for increased accuracy in extracranial applications .
- Intensity modulated fields for optimized dose distribution shaping .
- Stereotactic coordinate system for the whole body in conjunction with ExacTrac .
- Automatic image fusion to superimpose two image sets from different imaging modalities .
- Treatment plan export to VARiS, the record and verify system of Varian .
- Treatment plan export to LANTIS and Impac, the record and verify system(s) of Impac .
Substantial Equivalence 8.
Documentation was provided which demonstrated the BrainSCAN software to be substantially equivalent to its predecessor versions BrainSCAN Radiosurgery Module and BrainSCAN Conformal RT Module.
Patient Relevant Safety Information 9.
The predecessor devices of BrainSCAN have been used in over a hundred installations worldwide and thousands of patients have safely been treated using the predicate devices of BrainSCAN in clinics like the University of California, Los Angeles. All new features were introduced to improve the resulting quality of the treatment plans further and to enhance the possibilities the oncologist has to develop strategies for radiation treatment.
All treatment plans generated with BrainSCAN have to be approved by signature of a radiation physicist and a physician, normally a radiation oncologist, prior to treatment. This ensures that the plan is correct from the point of view of the physician with his medical background and the point of view of the physicist with his radiation physics background.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2000
Claus Promberger Project Manager BrainLab AG AmmerthalstraBe 8 855551 Heimstetten Germany
Dear Mr. Promberger:
Re:
K994413 BrainScan (X-ray Radiation Therapy System) Dated: April 20, 2000 Received: April 24, 2000 Regulatory class: II 21 CFR 892.5050/Procode: 90 MUJ
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have reviewed your Occlon of re(y notications for use stated in the enclosure) to legally marketed predicate devices device is substantially equivalent (for the enactment date of the Medical Device Amendments, or to devices that manked in interstate ochinnovo provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, nave been recolability in accorative will controls provisions of the Act. The general controls provisions of the Act include manse the device, sollyce to the general provided in the proctice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to il your device is data: 1000 are regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Such additional controls: Excelling major regalations as umes compliance with the Current Good Manufacturing Practice r ars oo oo oo. 7 Juliolantany of the Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and requirements, as occions, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with that, through periodic as may result in addition, FDA may publish further announcements concerning your device in the Ever Tease note: this response to your premarket notification submission does not affect any obligation you might the reductions 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of r rith letter will allow 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 xites il you done specific device for your bornes of Compliance at (301) 594-4591. 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, auroning of your don't not of hours collection" (21CFR 807.97). Other general information on your responsibilities under the millerians by relocition 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/dsma/dsmamain.html".
Sincerely yours,
uson. Hetet.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
Page 1 of 1
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K994413 |
| Device Name: | Brain Scan |
Indications For Use:
BrainSCAN is a stereotactic radiation treatment planning system that is intended for use in
tersial BrainSCAN is a Stereotacal radiation deather. prailiting as a suitition treatment of cranial, head and neck, and extracranial lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
. .
(Optional Format 1-2-96)
,
David A. Snythm
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices ાંદી (
510(k) Number __