(58 days)
OnQ rts software is stand-alone software that provides a means of visualizing and comparing medical image data from multiple DICOM compliant imaging modality devices. It is used for the display, evaluation, co-registration and fusion of medical images, contour of anatomical structures and radiation therapy dose distributions to aid in radiation therapy planning, diagnostic radiology, oncology and other medical specialties. Note: The software is not for use with digital mammography
OnQ rts® is a stand-alone medical imaging software program that imports DICOM images from different modalities and provides imaging tools to visualise, compare, contour, co-register medical images, anatomical structures and radiation therapy dose distributions. These procedures are performed by manual, semi-automatic techniques which extract anatomical information for image contouring and analysis from the DICOM data. The system can operate as a single workstation or with multiple workstations, with one of them being the server networked with multiple clients and remotely via Citrix® terminal services. OnQrts is not intended for use with hand-held mobile devices.
OnQ rts software includes the import and export of DICOM data securely via a network connection. The imported images, from different modalities, are processed to provide a clinical picture of the anatomy and corresponding radiation therapy doses. OnQrts co-registers images together, using rigid image registration (RIR) and elastic/deformable image registration (DIR) or a combination of both. These images can display imported or generated contours (anatomical and dose) overlaid onto the fused images.
OnQ rts contouring can be performed manually or .automatically from a library of user defined or prepared pre-contoured CT cases. The library atlas files act as a template that is then mapped to the patients' anatomy. The contours are reviewed and approved before export, e.g. to radiotherapy planning software. OnQrts can import radiation therapy treatment planning data (dose and dose distributions) which can then be displayed for review, radiation therapy dose comparison and analysis. The software provides contour companson tools using a range of comparison metrics that highlight variations between VOIs in terms of size, shape and location. OnQ rts is not a radiation therapy treatment planning system and can only display and evaluate dose plan information generated from radiation therapy equipment.
The provided text describes the 510(k) summary for the OnQ rts® imaging software. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify quantitative acceptance criteria or a dedicated performance study with specific metrics like sensitivity, specificity, accuracy, or dice scores. Instead, the "acceptance criteria" appear to be met through demonstrating substantial equivalence to predicate devices via non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets product requirements (features and technical characteristics equivalent to predicate devices) | "Test Plans were written and executed internally which validate that OnQ rts meets the product requirements. The product requirements include equivalent features and technical characteristics as the predicate device and the test results confirmed that OnQ rts is substantially equivalent to the predicate device." |
| Software performs appropriately | "These results concluded that the software performed appropriately and the testing included confirmation of image fusion, atlas based segmentation, auto contouring, 4D contouring, analysis tools (DVH), adaptive re-planning (dose mapping), integration and display of radiation therapy doses." |
| As safe, as effective, and performs as well or better than predicate devices | "This concludes that OnQ rts is as safe, as effective and performs as well or better than the predicate device." and "Based on the defined technical characteristics and the non-clinical testing that was performed it is determined that OnQ rts is as safe, as effective and performs as well or better than the predicate device and is therefore substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the context of clinical performance evaluation. The "test plans" mentioned are for internal non-clinical validation. No patient data provenance (country of origin, retrospective/prospective) is provided, as no clinical testing was performed for substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical test set with expert-established ground truth was reported.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with adjudication was reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was reported. This device is described as a standalone imaging software with manual/semi-automatic contouring capabilities, not explicitly an AI-assisted tool in the context of improving human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document focuses on the software's functionality as a standalone tool that aids in clinical tasks. It mentions "auto contouring" and "atlas based segmentation" which implies algorithmic components, but no performance metrics for these features in isolation are provided in the summary. The overall evaluation is for the software system, not solely an algorithm's standalone diagnostic performance against a ground truth.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" was implicitly based on the expected behavior and accuracy of the implemented features, likely compared against predefined computational or functional specifications rather than clinical ground truth (e.g., pathology, expert consensus on patient images).
8. The Sample Size for the Training Set
Not applicable. The document does not describe a training set for a machine learning model in the conventional sense. The "library atlas files" mentioned for auto contouring act as a template, but the size or nature of this "training" data isn't specified in terms of machine learning training.
9. How the Ground Truth for the Training Set was Established
Not applicable. No specific training set for a machine learning model is described in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for "OSL Y ONCOLOGY SYSTEMS LIMITED". The logo consists of the letters "OSL" in a stylized font, with each letter appearing on a separate black square. To the right of the letters is a sine wave. The words "Y ONCOLOGY SYSTEMS LIMITED" are printed below the letters.
Oncology Systems Limited
14 Longbow Professional Centre, Longbow Close SHREWSBURY SHROPSHIRE SY1 3GZ UNITED KINGDOM
Phone: (+44)1743-462694 (+44)1743-462695 Fax:
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92
Date: November 13th , 2012
Submitter of 510(k):
Company name: 510k number: Address:
Oncology Systems Ltd. K123357 14 Longbow Professional Centre, Longbow Close SHREWSBURY SHROPSHIRE SY1 3GZ UNITED KINGDOM (+44)1743-462694 (+44)1743-462695 Carl Walker Service and Quality Manager
Device Name:
Correspondent:
Phone:
Fax:
Trade/Proprietary Name: Common/Usual Name: Classification Classification Name:
OnQ rts® RTS Imaging Software Class II Medical charged-particle radiation therapy system. (21 CFR 892.5050 · Product Code: MUJ) Picture Archiving and communications system (21 CFR 892.2050, Product Code LLZ)
Legally Marketed Device(s)
Our modified device is based on the legally marketed device cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| MIM Software Inc | Mobile MIM | K103785 |
| MIM Software Inc | Mobile MIM (RT) | K112930 |
FDA Response 11/2012
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Device description:
OnQ rts® is a stand-alone medical imaging software program that imports DICOM images from different modalities and provides imaging tools to visualise, compare, contour, co-register medical images, anatomical structures and radiation therapy dose distributions. These procedures are performed by manual, semi-automatic techniques which extract anatomical information for image contouring and analysis from the DICOM data. The system can operate as a single workstation or with multiple workstations, with one of them being the server networked with multiple clients and remotely via Citrix® terminal services. OnQrts is not intended for use with hand-held mobile devices
OnQ rts software includes the import and export of DICOM data securely via a network connection. The imported images, from different modalities, are processed to provide a clinical picture of the anatomy and corresponding radiation therapy doses. OnQrts co-registers images together, using rigid image registration (RIR) and elastic/deformable image registration (DIR) or a combination of both. These images can display imported or generated contours (anatomical and dose) overlaid onto the fused images.
OnQ rts contouring can be performed manually or .automatically from a library of user defined or prepared pre-contoured CT cases. The library atlas files act as a template that is then mapped to the patients' anatomy. The contours are reviewed and approved before export, e.g. to radiotherapy planning software. OnQrts can import radiation therapy treatment planning data (dose and dose distributions) which can then be displayed for review, radiation therapy dose comparison and analysis. The software provides contour companson tools using a range of comparison metrics that highlight variations between VOIs in terms of size, shape and location. OnQ rts is not a radiation therapy treatment planning system and can only display and evaluate dose plan information generated from radiation therapy equipment.
Intended use:
OnQ rts software is stand-alone software that provides a means of visualizing and comparing medical image data from multiple DICOM compliant imaging modality devices. It is used for the display, evaluation, co-registration and fusion of medical images, contour of anatomical structures and radiation therapy dose distributions to aid in radiation therapy planning, diagnostic radiology, oncology and other medical specialties. Note: the software is not for use with digital mammography.
Summary of the Technical Characteristics
OnQ rts and the predicate devices have the same technical characteristics which include a software product that imports DICOM images and data for registration, display, evaluation and analysis. This data includes different modality images, contours and radiation dose information. These similarities in design and technology are the basis and reason for substantial equivalence of OnQ rts to the legally marketed predicate devices.
Summary of Non- clinical testing
Test Plans were written and executed internally which validate that OnQ rts meets the product requirements. The product requirements include equivalent features and technical characteristics as the predicate device and the test results confirmed that OnQ rts is substantially equivalent to the predicate device. This submission includes the comprehensive system test plan, the passifail results and a summary of test results. These results concluded that the software performed appropriately and the testing included confirmation of image fusion, atlas based segmentation, auto contouring, 4D contouring, analysis tools (DVH), adaptive re-
FDA Response 11/2012
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planning (dose mapping), integration and display of radiation therapy doses. The same features and technical characteristics are demonstrated in the legally marketed predicate device. This concludes that OnQ rts is as safe, as effective and performs as well or better than the predicate device.
Summary of Clinical testing
Clinical testing was not required to demonstrate substantial equivalence.
Conclusion
Based on the defined technical characteristics and the non-clinical testing that was performed it is determined that OnQ rts is as safe, as effective and performs as well or better than the predicate device and is therefore substantially equivalent.
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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, interconnected shapes that resemble human figures. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 28, 2012
Ms. Lu Anne Johnson c/o Capamed, Inc. Oncology Systems Limited 1917 29 3/4 Ave RICE LAKE WI 54868
Re: K123357
Trade/Device Name: OnQ rts Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ, LLZ Dated: October 24, 2012 Received: October 31, 2012
Dear Ms. Johnson:
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
Janine M. Morris 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): K123357
Device Name: OnQ rts
Indications For Use:
OnQ rts software is stand-alone software that provides a means of visualizing and comparing medical image data from multiple DICOM compliant imaging modality devices. It is used for the display, evaluation, co-registration and fusion of medical images, contour of anatomical structures and radiation therapy dose distributions to aid in radiation therapy planning, diagnostic radiology, oncology and other medical specialties.
Note: The software is not for use with digital mammography
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
Michael D. O'Hara
Page 1 of
(Division Sign Off)
Division of Radiological Health
Office of In Vitro
61004 K123352
§ 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.