DIGITAL LIGHTBOX

K080608 · Brainlab AG · LLZ · Apr 17, 2008 · Radiology

Device Facts

• Record ID: K080608
• Device Name: DIGITAL LIGHTBOX
• Applicant: Brainlab AG
• Product Code: LLZ · Radiology
• Decision Date: Apr 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Digital Lightbox is a system intended for the retrieval and display of medical images from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, 3D reconstruction, basic measurements, and multi-modality image fusion. It is not intended for primary image diagnosis or the review of mammographic images.

Device Story

Digital Lightbox is a medical image viewing system; consists of two high-resolution monitors, touch panels, and integrated PC. Inputs: medical images via Ethernet (PACS/servers) or removable media (CD/DVD/USB). Processing: software performs image manipulation, 3D reconstruction, basic measurements, and multi-modality image fusion. Output: displayed images on monitors. Used in clinical settings; operated by healthcare professionals. Provides visualization tools to assist clinicians in reviewing medical images; not for primary diagnosis. Benefits: facilitates efficient access and review of multi-modality imaging data.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System consists of two high-resolution monitors, touch panels, and integrated PC. Connectivity via Ethernet and external interfaces (CD, DVD, USB). Software supports DICOM standard, 3D reconstruction, and multi-modality image fusion. Includes web browser and remote access software.

Indications for Use

Indicated for retrieval and display of medical images from PACS, file servers, or removable media for clinical review. Not for primary diagnosis or mammographic image review.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• iPlan (K053127)
• iPlan Hip Templating (K042543)
• DGSCOPE, RELEASE 1.0 (K070397)

Submission Summary (Full Text)

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K080608.

APR 1 7 2008

# 510 (k) Summary of Safety and Effectiveness for Digital Lightbox

#### Manufacturer:

| Address: | BrainLAB AG<br>Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany | | | | | |
|-----------------|-------------------------------------------------------------------|--------------------|--|--|--|--|
| | Phone: | [phone] | | | | |
| | Fax: | [phone] | | | | |
| Contact Person: | Mr. Per Persson | | | | | |
| Summary Date: | November 13, 2007 | | | | | |

## Device Name:

Trade name:

Digital Lightbox

Common/Classification Name:

Digital Lightbox, BrainLAB system, image processing, radiological

## Predicate Devices:

iPlan (K 053127) iPlan Hip Templating (K 042543) DGSCOPE, RELEASE 1.0 (K 070397)

Device Classification Name: System, image processing, radiological Requlatory Class: Class II

## Intended Use:

The Digital Lightbox is a system intended for the retrieval and display of medical images from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, 3D reconstruction, basic measurements, and multi-modality image fusion. It is not intended for primary image diagnosis or the review of mammographic images.

## 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 reconstruction, basic measurements and multi-modality image fusion. The device software integrates a web browser and remote access software.

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#### 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 (K 053127), iPlan Hip Templating (K 042543) and DGSCOPE, RELEASE 1.0 (K 070397).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 7 2008

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Kapellenstraße 12 85622 Feldkirchen GERMANY

Re: K080608

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: February 22, 2008 Received: March 4, 2008

#### 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.

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#### Page 2

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 aftthe 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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance pt one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Deporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name: Digital Lightbox

Indications For Use:

The Digital Lightbox is a system intended for the retrieval and display of medical images from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, 3D reconstruction, basic measurements, and multi-modality image fusion. 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)

Ami M. Whay

(Division Sign Division of Reproductive, Abdomina Radiological Devi 510(k) Number

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