VIRTUE

K111833 · Diagnosoft, Inc. · LLZ · Sep 21, 2011 · Radiology

Device Facts

• Record ID: K111833
• Device Name: VIRTUE
• Applicant: Diagnosoft, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Virtue software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.

Device Story

Virtue is software for Windows-based operating systems; functions as a Picture Archiving and Communication System (PACS) component. Inputs: DICOM-formatted MR or CT image data from scanners or archives. Processing: software performs image viewing, manipulation, and quantification. Outputs: processed images for clinical review, printing, or communication. Used in clinical settings by healthcare professionals to assist in diagnostic workflows. Benefits: facilitates visualization and quantitative analysis of cardiac MR/CT images to support clinical decision-making.

Clinical Evidence

Bench testing only. Software performance testing demonstrated that the device fulfills prospectively defined performance criteria and meets user needs.

Technological Characteristics

Software-based PACS; runs on Windows operating systems. Supports DICOM standard for image data. Functions include viewing, manipulation, communication, printing, and quantification of CT/MRI images.

Indications for Use

Indicated for viewing, manipulating, communicating, printing, and quantifying medical image data (CT or MRI) received from scanning devices or archives.

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

• Philips Easy Vision Workstation Release 6 (K023137)
• Harp 2.06 (K100352)

Submission Summary (Full Text)

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# K111833

#### 5. 510(K) SUMMARY

# Diagnosoft, Inc. Virtue (per 21CFR 807.92)

### SEP 2 1 2011

#### 1. SUBMITTER/510(K) HOLDER

Diagnosoft, Inc. 6501 Weston Parkway Suite 125 Cary, NC 27513

| Contact Person: | Firas BenAchour |
|-----------------|-----------------|
| Telephone: | 919-677-8100 |
| Fax: | 919-882-1815 |

June 23, 2011 Date Prepared:

#### 2. DEVICE NAME

Proprietary Name: Virtue Classification Name: Picture archiving and communications system

#### 3. PREDICATE DEVICE

- · Philips Easy Vision Workstation Release 6 marketed by Philips Medical Systems, K023137
- · Harp 2.06 marketed by Diagnosoft, Inc., K100352

#### 4. DEVICE DESCRIPTION

The Diagnosoft Virtue is software that runs on Windows-based operating systems to view and analyze MR images of the heart in DICOM format.

#### 5. INTENDED USE

The Virtue software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.

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## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The characteristics of the Virtue are substantially equivalent to the following current legally marketed predicate devices based on intended use, typical clinical use, and operational and fundamental technological characteristics.

- · Philips Easy Vision Workstation Release 6 marketed by Philips Medical Systems, K023137
- · Harp 2.06 marketed by Diagnosoft, Inc., K100352

A detailed side-by-side comparison of the Virtue with the identified predicate device is provided in the substantial equivalence discussion in this premarket notification.

### 7. PERFORMANCE TESTING

Testing of the Virtue software has demonstrated that the device fulfills prospective defined performance criteria and that the device meets the user needs.

### 8. CONCLUSION

Based on the similarities in indication for use, design, functional, and operational features the Virtue has demonstrated substantial equivalence to the listed legally marketed predicate device and any differences do not affect the product's safety or effectiveness.

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Public Health Service

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

Diagnosoft, Inc. % Mr. Jeffrey Roberts Medical Device Consultants 40 Plain Street NORTH ATTLEBORO MA 02760

SEP 2 1 2011

Re: K111833

Trade/Device Name: Virtue Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: H Product Code: LLZ Dated: June 23, 2011 Received: June 28, 2011

Dear Mr. Roberts:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

ff 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/cdrl/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. 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 4.

510(k) Number (if known): Not yet assigned

Device Name: Virtue

Indications for Use:

The Virtue software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.

Prescription Use _X (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 Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devic Office of In Vitro Diagnostic Device Evaluation and

510K K111833

Diagnosoft, Inc. Virtue, Traditional 510(k)