MIRADA XD

K101228 · Mirada Medical, Ltd. · LLZ · Jun 23, 2010 · Radiology

Device Facts

• Record ID: K101228
• Device Name: MIRADA XD
• Applicant: Mirada Medical, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jun 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists. Mirada XD is a software application intended to display and visualize 2D & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include, CT, MR, PET, SPECT and planar NM. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets. Mirada XD allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The result of the registration operation can assist the user in assessing changes in image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly. Mirada XD provides a number of tools such as rulers and region of interests, which are intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up. Mirada XD allows the user to define, transform and export regions of interest structures in DICOM format including RT format for use in radiation therapy planning systems.

Device Story

Mirada XD is a software application for multi-modal medical image visualization and analysis; inputs include DICOM 3.0 compliant datasets (CT, MR, PET, SPECT, planar NM). The device performs automatic and manual image registration to fuse anatomical and functional data; provides measurement tools (rulers, ROI) and SUV calculations; enables report generation and export of ROI structures (RTSS format) for radiation therapy planning. Used in clinical settings by radiologists, nuclear medicine physicians, and physicists. Output facilitates comparison of image data, assessment of lesions, and treatment response monitoring; assists clinicians in interpreting combined information that would otherwise be viewed disjointedly.

Clinical Evidence

Bench testing only. Verification and validation performed in compliance with ISO 13485:2003 and DICOM standards. Testing included performance, functional, and algorithmic assessments to confirm device meets user needs and requirements.

Technological Characteristics

Software application for workstation deployment; supports DICOM 3.0 standard; enables 2D/3D rendering, image registration, and SUV calculation. Compliant with ISO 13485:2003. Connectivity via computer networks.

Indications for Use

Indicated for use by trained medical professionals (radiologists, nuclear medicine physicians, physicists) to display, visualize, process, and register 2D/3D multi-modal medical images (CT, MR, PET, SPECT, planar NM) for clinical assessment, lesion evaluation, treatment response monitoring, and radiation therapy planning.

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

• MiM 4.1 (SEASTAR) (K071964)
• Syngo TrueD Software (K091373)
• XELERIS 3 PROCESSING AND REVIEW WORKSTATION (K093982)
• RTist (KO33955)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

| Date of summary: | 23 March 2010 |
|--------------------------|---------------------------------------------------------------------------------------|
| Submitter's name: | Mirada Medical Ltd |
| Submitter's address: | Innovation House, Mill Street, Oxford, OX2 0JX, United Kingdom |
| Submitter's contact: | Gwilym Owen |
| Telephone number: | [phone] |
| Device Proprietary Name: | Mirada XD |
| Device Common Name(s): | XD4/ XD3 (NM)/XD3 NM Edition/XD3 |
| Classification Name: | Class II: Picture Archiving and Communications System<br>(892.2050) Product Code: LLZ |

Mirada XD is Substantially Equivalent to the following Legally Marketed devices:

| 510(k) Number | Trade Name | Manufacturer |
|---------------|------------------------------------------------|------------------------------------|
| K071964 | MiM 4.1 (SEASTAR) | MIMvista Corp. |
| K091373 | Syngo TrueD Software | Siemens Medical Solutions USA, Inc |
| K093982 | XELERIS 3 PROCESSING AND<br>REVIEW WORKSTATION | GE Healthcare |
| KO33955 | RTist | Mirada Solutions Ltd |

# 1.1.1 Intended Use

Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists.

Mirada XD is a software application intended to display and visualize 2D & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include, CT, MR, PET, SPECT and planar NM. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.

Mirada XD allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The result of the registration operation can assist the user in assessing changes in

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Image /page/1/Picture/1 description: The image shows the words "MIRADA medical" in a stylized font. The word "MIRADA" is in all caps and is larger than the word "medical", which is in lowercase. The font is blocky and has a slightly futuristic look.

image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly.

Mirada XD provides a number of tools such as rulers and region of interests, which are intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up.

Mirada XD allows the user to define, transform and export regions of interest structures in DICOM format including RT format for use in radiation therapy planning systems.

#### 1.1.2 Device Description

Mirada XD is a software application for displaying and visualizing 2D & 3D multi-modal medical image data such as CT, MR, PET, SPECT and planar NM. Mirada XD runs on a workstation with color monitor(s), keyboard, mouse and optional CD-RW. Mirada XD is designed to enable rendering, reviewing, storing, printing and distribution of DICOM 3.0 compliant datasets and reports within the system and/or across computer networks.

Mirada XD enables automatic and manual registration of combinations of anatomical and functional images that can be displayed with fused and non-fused displays to facilitate the comparison of image data by the user.

Mirada XD provides a number of tools such as rulers and region of interests through SUV calculation for the assessment of regions of an image to support a clinical workflow. Mirada XD also allows users to define, transform, store and export regions of interest structures in DICOM format including RTSS format for use in radiation therapy planning systems.

## 1.1.3 Testing

Mirada XD is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that Mirada XD meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate devices.

Verification and Validation for Mirada XD has been carried out in compliance with the requirements of ISO 13485:2003 and in adherence to the DICOM standard.

In conclusion, performance testing demonstrates that Mirada XD is substantially equivalent to, and performs at least as safely and effectively as the listed predicate devices. Mirada XD meets requirements for safety and effectiveness and does not introduce any new potential safety risks.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping, curved lines, possibly representing a stylized caduceus or a similar emblem associated with health and medicine.

Public Health Service

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

Mirada Medical, Ltd. Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

JUN 2 8 2010

Re: K101228

Trade/Device Name: Mirada XD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 3, 2010 Received: June 4, 2010

Dear Mr. Job:

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/ReportalProblem/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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# Indications for Use Form

K101228 510(k) Number (if known):

Device Name: Mirada XD

### Indications for Use:

Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists.

Mirada XD is a software application intended to display and visualize 2D & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include, CT, MR, PET, SPECT and planar NM. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.

Mirada XD allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The result of the registration operation can assist the user in assessing changes in image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly.

Mirada XD provides a number of tools such as rulers and region of interests, which are intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up.

Mirada XD allows the user to define, transform and export regions of interest structures in DICOM format including RT format for use in radiation therapy planning systems.

Prescription Use X (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 Becker

Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101228

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Copyright © Mirada Medical Ltd, 2010