DICOM Viewer

K153653 · Brainlab AG · LLZ · Apr 13, 2016 · Radiology

Device Facts

• Record ID: K153653
• Device Name: DICOM Viewer
• Applicant: Brainlab AG
• Product Code: LLZ · Radiology
• Decision Date: Apr 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

DICOM Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (MPR reconstructions and 3D volume rendering). It is not intended for primary image diagnosis or the review of mammographic images.

Device Story

Web-based software for viewing DICOM medical images and healthcare data; inputs include DICOM datasets, fiber objects, and image fusion data from other Brainlab applications. Operates on desktop PCs, tablets (Android/iPad), and touch-screen devices. Functions include image review, manipulation, basic measurements, multiplanar reconstruction (MPR), and 3D volume rendering. Used by physicians and clinical staff in ORs, hospital offices, or remote locations for surgical planning, board meetings, or expert consultation. Output is visual display of images/data to support clinical discussion; does not provide primary diagnosis. Benefits include improved access to patient data for surgical preparation and collaborative treatment planning.

Clinical Evidence

No clinical data. Evidence consists of non-clinical verification and validation, including formative usability testing, review of post-market complaint databases (MAUDE, BfArM, internal), and comparison of design specifications against predicate devices.

Technological Characteristics

Software-only device; web-based architecture. Supports DICOM standard. Features MPR and 3D volume rendering. Deployed on desktop PCs, tablets, and touch-screen devices. No hardware-dependent essential performance characteristics.

Indications for Use

Indicated for medical professionals (doctors, assistants, nursing staff) for non-diagnostic viewing of medical images and healthcare data. No specific patient population; not for primary diagnosis or mammography.

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

• Digital Lightbox (K093117)
• CONI (K130624)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 13, 2016

Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 Feldkirchen 85622 GERMANY

Re: K153653

Trade/Device Name: DICOM Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 2, 2016 Received: March 7, 2016

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K153653

Device Name

DICOM Viewer

Indications for Use (Describe)

DICOM Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (MPR reconstructions and 3D volume rendering).

It is not intended for primary image diagnosis or the review of mammographic images.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510 (K) SUMMARY DICOM VIEWER

IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92

| Manufacturer: | Brainlab AG<br>Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany |
|--------------------------------------|-------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 11/5/2015 |
| Device: | Image Viewer |
| Trade name: | DICOM Viewer |
| Device Classification<br>Regulation: | 892.2050 - Picture archiving and communications system |
| Regulatory Class: | Class II |
| Product Code: | LLZ - System, Image Processing, Radiological |
| Main Predicate Device: | Digital Lightbox (K093117) |
| Secondary Predicate<br>Device: | CONI (K130624) |

#### INTENDED USE: 1

DICOM Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (MPR reconstructions and 3D volume rendering).

It is not intended for primary image diagnosis or the review of mammographic images.

#### DEVICE DESCRIPTION: 2

The DICOM Viewer is software for web based viewing of DICOM data.

#### Operator profile

The device is generally used by medical professionals such as doctors, their assistants or nursing staff which are in need of displaying medical (DICOM) images and other healthcare data for non-diagnostic purposes.

#### Patient population

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The device is software which allows viewing of DICOM data. Hence there is no specific patient population.

### Intended use environment

The software is intended to be used:

- . in Operating Rooms
- in Office environments within hospitals or at any other location offering a computer
- at any location on tablet devices ●

### Operating principle

There are different operating principles:

- On desktop PCs the interaction with the software is mainly performed with mouse and/or kevboard
- -On touch screen PCs and on mobile devices the software is mainly used with a touch screen interface.

### Primary operating functions

Non-diagnostic viewing of medical images and other healthcare data in DICOM format.

#### Use scenarios

- A user wants to review DICOM data in an OR before or during a surgery in order to think about the procedure or to talk about the procedure with his colleagues.
- -A user wants to review DICOM data of patients in a reqular board meeting in order to discuss aspects of treatments with his colleaques
- -A user wants to review DICOM data of patients in a meeting where the participants are not in the same room in order to discuss aspects of treatments with his colleagues or to get the opinion of an external expert

#### Intended part of the body or type of tissue applied to or interacted with

The device is software only which allows viewing of DICOM data. Hence it does not interact with any body/tissue part and the viewing is not limited to any body/tissue part.

#### Essential performance characteristics

Image Viewer is essentially software for medical image visualization. A hardware shutdown, power failure or other hardware issue that makes the software inoperable does not cause harm. Hence, no unacceptable risk arises if the hardware loses performance. Therefore, the hardware does not have any essential performance characteristics.

The software risks were analyzed to find risks in the non-acceptable area. No risks have been identified in the non-acceptable area. Hence, no measures are considered essential performance characteristics. In summary, the Image Viewer software does not have any essential performance characteristics.

#### 6 SUBSTANTIAL EQUIVALENCE

DICOM Viewer has similar functionality, intended use, technological characteristics, and typical users as

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the predicate devices.

Both DICOM Viewer and the primary predicate device, Digital Lightbox (K093117) are used to display medical images including multiplanar reconstructions and 3D volume rendering, perform basic image manipulations and measurements, and load and visualize planning data as fusions, objects and trajectories. Both devices are Brainlab products, have been developed by the same R&D team and use the same software framework. Both DICOM Viewer and all two predicate devices (Digital Lightbox (K093117) and CONi (K130624)) are intended to view medical images.

In contrast to the primary predicate device. Digital Lightbox (K093117), the DICOM Viewer has a web frontend which is available on multiple devices (computers, Android tablets and iPads); whereas, the Digital Lightbox is accessible and running on a dedicated system only. However the other predicate device CONi (K130624) is also web-based software for viewing DICOM Images.

In addition the DICOM Viewer can display fiber objects generated by other Brainlab applications and align images sets and persist the align state. These enhancements in respect to the predicate devices do not affect the intended use, alter the fundamental technology of the primary predicate device, Digital Lightbox (K093117) nor do they introduce any new issues concerning safety and effectiveness.

#### 4 VERIFICATION/VALIDATION SUMMARY

### Verification

The verification of the System DICOM Viewer has been carried out thoroughly both at the top level and on underlying modules. The verification was done to demonstrate that the design specifications are met.

### Non-clinical validation

- . DICOM Viewer 2.2 and DICOM Viewer 3.0 are substantially equivalent regarding user group, use scenario, use related risks and the user interface being nearly identical. Thus safe use of the device can be posed on post-market evaluation for the DICOM Viewer 2.2.
- Validation contained reviews of the MAUDE, BfArM and Brainlab internal complaint databases ● regarding incidents of similar products including the DICOM Viewer 2.2. The search results did not result in any necessary actions for the DICOM Viewer.
- . The validation of the intended use, user needs and primary operating functions of the DICOM Viewer 3.0 is additionally covered by specific sections in the verification protocols.
- . Formative usability tests have been performed as listed in the Usability Evaluation Summary. The prototype is substantially equivalent with the user interface being nearly identical to the final device. Only bug fixes and minor improvements of the software with no effect on the results of the formative usability tests have been incorporated afterwards.

#### CONCLUSION 5

The comparison of the DICOM Viewer with the predicate devices using available labelling (Digital Lightbox K093117 and CONi K130624) and Brainlab internal specifications (Digital Lightbox K093117) shows that the DICOM Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate devices. Verification and validation activities ensure that the design specifications are met and that the DICOM Viewer does not introduce new issues concerning safety and effectiveness. Hence DICOM Viewer is substantial equivalent to the predicate devices.