(119 days)
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Not Found
No
The summary describes a device for reviewing and visualizing DICOM data with image manipulation tools, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as being for "reviewing purposes only" and "not capable to generate new or modified RT plan data," indicating it does not directly treat or diagnose.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Bridge-RT is intended for reviewing purposes only and is not capable to generate new or modified RT plan data." A diagnostic device typically generates data or provides analysis to inform a diagnosis, whereas this device is for review and assessment of existing data.
Yes
The description explicitly states "The software provides..." and details its function as a tool for reviewing and visualizing DICOM data, without mentioning any accompanying hardware components or their function. The intended use is purely software-based data review.
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.
- Bridge-RT's Intended Use: The intended use of Bridge-RT is for reviewing and assessing DICOM based datasets (images and related data) generated by medical imaging devices. It is used for visualization and manipulation of these images for review purposes in a radiotherapy environment.
- No mention of biological samples: The description does not mention the analysis of any biological samples from a patient.
Therefore, Bridge-RT falls under the category of a medical device used for image review and analysis, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
MUJJ
Device Description
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Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
RT-STRUCT, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET.
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Qualified specialist / Radiotherapy environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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
1
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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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Page 14 of 27
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