(70 days)
No
The document does not mention AI, ML, or any related terms, and the described functionalities are standard for medical image viewing and manipulation systems.
No
Explanation: The device is intended for the display, manipulation, and visualization of medical images, and explicitly states it is "not intended for primary image diagnosis." While it can assist with "navigation planning" and export "basic treatment plans," its primary function is image viewing and processing, not direct therapy or treatment.
No
The "Intended Use / Indications for Use" explicitly states, "It is not intended for primary image diagnosis". While it displays medical images and has manipulation functions, it is specified not for diagnosis.
No
The device description explicitly states it consists of two high-resolution monitors, touch panels, an integrated PC, and physical interfaces for external media (CD, DVD, USB), indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, 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 Digital Lightbox is described as a system for displaying and manipulating medical images. It works with images acquired from imaging modalities (like CT, MRI, etc.), not with biological samples.
- Intended Use: The intended use explicitly states it's for displaying medical images, transferring them, and performing image manipulation and visualization. It does not mention any analysis of biological samples.
Therefore, the function and intended use of the Digital Lightbox clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Digital Lightbox is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
Product codes
LLZ
Device Description
Digital Lightbox is a medical image viewing device consisting of two high-resolution monitors controlled through touch panels with an integrated PC. It features an Ethernet connection for retrieving medical images through a computer network. Further, the device can read images from CD, DVD or USB drives through external interfaces. The device software is compatible with the DICOM standard and allows basic image manipulation, 3D visualization (reconstructions and volume rendering), basic measurements, multi-modality image fusion and object and trajectory creation. Basic treatment plans can be exported to BrainLAB navigation systems. The device software integrates a web browser and remote access software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
iPlan (K053127), Digital Lightbox (K080608)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
510 (k) Summary of Safety and Effectiveness for Digital Lightbox
Manufacturer:
Address:
DEC 1 1 2009
BrainLAB AG Kapellenstrasse 12 85622 Feldkirchen Germany +49 89 99 15 68 0 Phone: Fax: +49 89 99 15 68 33
Contact Person:
.
November 19, 2009
Mr. Alexander Schwiersch
Summary Date:
DEC 0 3-2009
FDA CDRH DMC
Received
Device Name:
Tradè name:
Digital Lightbox
Common/Classification Digital Lightbox, BrainLAB system, image processing, radiological Name: LLZ Product Code: Regulation Number 21 CRF §892.2050
Predicate Devices:
iPlan (K053127)
-
HAW Product Code: -Requlation Number: 21 CFR 882.4560 -
Digital Lightbox (K080608) -
Product Code: - LLZ -21 CRF §892.2050 -Regulation Number:
Device Classification Name: System, image processing, radiological Regulatory Class: Class II
Intended Use:
The Digital Lightbox is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
1
Device Description:
Digital Lightbox is a medical image viewing device consisting of two high-resolution monitors controlled through touch panels with an integrated PC. It features an Ethernet connection for retrieving medical images through a computer network. Further, the device can read images from CD, DVD or USB drives through external interfaces. The device software is compatible with the DICOM standard and allows basic image manipulation, 3D visualization (reconstructions and volume rendering), basic measurements, multi-modality image fusion and object and trajectory creation. Basic treatment plans can be exported to BrainLAB navigation systems. The device software integrates a web browser and remote access software.
Substantial equivalence:
Digital Lightbox has been verified and validated according to BrainLAB procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510 (K) application was found to be substantially equivalent with the predicate devices iPlan (K053127) and Digital Lightbox (K080608).
Technical Characteristics:
The technical characteristics are equivalent to the predicate device Digital Lightbox (K080608), except for the new functionality 3D visualization and basic surgical planning including object and trajectory creation and plan export to navigation systems. This new functionality is equivalent to the corresponding features in the predicate device iPlan (K053127).
The Digital Lightbox conforms to the DICOM standard.
Documentation:
The reason for this submission is a change in intended use of the previously submitted Digital Lightbox (K080608). This 510(k) submission contains documentation only for features in the product Digital Lightbox that were not included in the previously submitted Digital Lightbox (K080608).
The risk analysis contains only risks identified due to the changes in software and intended use. Further, as all changes apply to software only, this submission contains documentation of the software only. The Digital Lightbox hardware is unchanged and is not affected by the changes in intended use.
2
Image /page/2/Picture/0 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 perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DEC 1 1 2009
Mr. Alexander Schwiersch Regulatory Affairs Manager BrainLAB AG Kapellenstrasse 12 Feldkirchen. 85622 GERMANY
Re: K093117
Trade/Device Name: Digital Lightbox Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system. Regulatory Class: II Product Code: LLZ Dated: November 27, 2009 Received: December 3, 2009
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, 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 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
3
Page 2 -
Enclosure
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/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/Resourcesfor You/Industry/default.htm.
Singerely yours
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
: K093117
510(k) Number (if known):
Device Name: Digital Lightbox
Indications For Use:
The Digital Lightbox is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
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)
Colin R. Pollard
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 : of