MEDCOM RT-VIEWER SYSTEM

K100056 · Medcom GmbH · MUJ · May 7, 2010 · Radiology

Device Facts

• Record ID: K100056
• Device Name: MEDCOM RT-VIEWER SYSTEM
• Applicant: Medcom GmbH
• Product Code: MUJ · Radiology
• Decision Date: May 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Bridge-RT is a Medical Device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCT, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET. The software provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM-RT related datasets including the geometrical super imposition of 3D plan data. Bridge-RT is intended for reviewing purposes only and is not capable to generate new or modified RT plan data.

Device Story

Bridge-RT 2.0 is a software-based DICOM viewer for radiotherapy environments. Input: DICOM-formatted datasets (RT-STRUCT, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR, PET). Operation: Loads and displays medical imaging and radiotherapy planning data; provides visualization and manipulation tools for review, presentation, and comparison; performs geometrical superimposition of 3D plan data. Output: Visual display of datasets and superimpositions. Used by qualified radiotherapy specialists in clinical settings. Clinical impact: Facilitates review and assessment of existing radiotherapy plans and images; does not generate or modify treatment plans. Benefit: Enables clinicians to visualize and compare complex radiotherapy data for assessment purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based DICOM viewer; supports standard DICOM-RT data formats (RT-STRUCT, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR, PET). Features include visualization, image manipulation, and 3D plan superimposition. Operates as a standalone software application for review purposes.

Indications for Use

Indicated for use by qualified radiotherapy specialists to review, assess, and compare DICOM-based radiotherapy datasets (RT-STRUCT, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR, PET) via visualization and image manipulation tools, including 3D plan superimposition. Not for generating or modifying RT plan data.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The words are arranged in a single line. There is a small arrow pointing to the right on the left side of the text.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Roon1 - WO66-G609 Silver Spring, MD 20993-0002

MAY - 7 2010

Mr. Stefan Walter Quality Manager MedCom GmbH Rundeturmstrasse 12 Darmstadt, Hessen, 64283 GERMANY

Re: K100056

Trade/Device Name: Bridge-RT 2.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJJ Dated: April 27, 2010 Received: April 29, 2010

Dear Mr. Walter:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Donald J. Trump

Donald J. St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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VIII. Indications for Use Statement

510(k) Number (if known): K100056

Device Name: Bridge-RT 2.0

Indications for use:

Bridge-RT is a Medical Device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCT, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET.

The software provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM-RT related datasets including the geometrical super imposition of 3D plan data.

Bridge-RT is intended for reviewing purposes only and is not capable to generate new or modified RT plan data.

## Prescription Use (Part 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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert Beaton
(Division Sign-Off)

Division of Radiological Dev Division of Radiological Bevice Evantation and Safety Office of In

510K