ONQ RTS

K123357 · Oncology Systems, Inc. · MUJ · Dec 28, 2012 · Radiology

Device Facts

• Record ID: K123357
• Device Name: ONQ RTS
• Applicant: Oncology Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Dec 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

OnQ rts is stand-alone medical imaging software for clinical use by oncology and radiology professionals. It imports DICOM images from various modalities; provides tools for visualization, comparison, contouring, and co-registration of anatomical structures and radiation therapy dose distributions. System supports single or networked workstations, including remote access via Citrix. Core functions include rigid and elastic/deformable image registration (RIR/DIR) and image fusion. Contouring is performed manually or automatically via atlas-based mapping from pre-contoured CT libraries. Software imports radiation therapy treatment planning data for review and dose comparison; provides contour comparison metrics (size, shape, location). Output assists clinicians in radiation therapy planning and diagnostic evaluation. Not a treatment planning system; cannot generate dose plans. Benefits include improved workflow for image analysis and dose distribution review.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only. Internal validation confirmed system requirements, including image fusion, atlas-based segmentation, auto-contouring, 4D contouring, DVH analysis, and dose mapping.

Technological Characteristics

Stand-alone software; DICOM compliant; supports rigid and elastic/deformable image registration (RIR/DIR); atlas-based segmentation; networked architecture (server-client/Citrix); non-mobile device.

Indications for Use

Indicated for use in radiation therapy planning, diagnostic radiology, oncology, and other medical specialties to visualize, evaluate, co-register, and fuse medical images and contour anatomical structures and radiation therapy dose distributions. Not for use with digital mammography.

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.

Predicate Devices

• Mobile MIM (K103785)
• Mobile MIM (RT) (K112930)

Submission Summary (Full 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: [phone] ([phone] 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 ([phone] ([phone] 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

K123357

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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 [phone] or [phone] 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

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(Division Sign Off)

Division of Radiological Health

Office of In Vitro

61004 K123352