M-VU VIEWER STATION

K060451 · Vucomp, Inc. · LLZ · Mar 22, 2006 · Radiology

Device Facts

• Record ID: K060451
• Device Name: M-VU VIEWER STATION
• Applicant: Vucomp, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The M-Vu™ Viewer Station is intended to be used to display low resolution, non-diagnostic, medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks.

Device Story

M-Vu Viewer Station is a computer-based system for displaying digitized, low-resolution radiographic images and pre-computed CAD annotations. Input consists of image data and CAD results downloaded via Ethernet from an M-Vu CAD Station. System features include customizable hanging protocols, patient ID toggling, CAD mark toggling, magnification of regions-of-interest, and printed report generation. Operated by radiologists or technicians in clinical settings to support mammogram review. Output is visual display on an integrated LCD monitor. Device serves as a viewing aid; does not perform diagnostic analysis itself. Benefits include convenient, customizable review of pre-computed CAD findings.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, including software validation and verification.

Technological Characteristics

Computer-based system with integrated LCD display and bar code reader. Connectivity via Ethernet network. Software-based image display and annotation management. No specific material standards or energy sources beyond standard commercial computing hardware described.

Indications for Use

Indicated for use by radiologists or technicians to display low-resolution, non-diagnostic medical images and pre-computed CAD annotations for review of screening or diagnostic mammograms.

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

• Second Look® Viewer (K042697)

Submission Summary (Full Text)

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# 510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:________________________________________________________________________________________________________________________________________________

## Submitter's Identification: 1.

VuComp, Inc. 6509 Windcrest Drive, Suite 160 Plano, Texas 75024

Contact: Mr. Stuart Barab Tel: [phone] (Ext.121) email: [e-mail]

Date Summary Prepared: January 27, 2006

# 2. Vame of the Device:

M-Vu " Viewer Station

#### 3. Predicate Device Information:

Second Look® Viewer, K#042697, ICAD, Inc., Beaver Creek, Ohio

### 4. Device Description:

The M-Vu™ Viewer Station is a computer-based system that displays digitized. low-resolution, radiographic information. The system is typically used to support a radiologist's review of screening and/or diagnostic mammograms. The system has two main functional components: a commercially available computer with an integrated LCD display and an attached bar code reader. The computer is connected to the M-Vu™ CAD Station via an Ethernet network to download selected radiographic images and Computer-Aided Detection (CAD) results or other annotations. The Viewer Station serves no other purpose than providing convenient viewer support.

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The Viewer Station has built-in menu-driven options to allow the technician or radiologist to customize the system in several ways. Among these ways are:

- 1. The Viewer Station image display can be changed to match the hanging protocol preferred by the reviewing radiologist.
- 2. The patient ID information can be toggled on or off.
- 3. The CAD Marks can be toggled on or off.
- 4. The marked regions-of-interest can be magnified two levels.
- 5. The user can request printed reports with or without CAD results shown.

#### 5. Intended Use:

The M-Vu™ Viewer Station is intended to be used to display low resolution, nondiagnostic medical images with annotations such as pre-computed regions of interest or pre-computed CAD marks.

#### 6. Comparison to Predicate Devices:

Similarities and Differences are as follows:

- The predicate device uses a touch screen display to allow user interface to . the system. The M-Vu device uses a mouse instead. Both are standard user interface applications and represent no functional difference between the devices.
- Both devices offer a magnify feature. The predicate device allows the user to . select images using the touch screen and the M-Vu device uses a mouse.
- The predicate device allows direct printing on screen to a network printer. The . M-Vu device allows printing over the network to a M-Vu CAD Station printer and the user can select to have the CAD results superimposed on the low resolution image or not.
- The predicate device allows the user to view pre-computed ultrasound � results. The M-Vu device does not offer this feature.

In summary, both the subject and predicate devices are the same or very similar in significant aspects including the intended use of the devices,

#### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the M-VuT™ Viewer Station device in the intended environment of use is supported by testing that was conducted for safety and performance, including software validation and verification testing. Results of the testing revealed that the M-Vu™ Viewer Station is substantially equivalent to the predicate device.

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# 8. Discussion of Clinical Tests Performed:

Not applicable

# ல் Conclusions:

The M-VuTM Viewer Station device has the identical intended use and similar characteristics as the predicate device. Moreover, software testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the M-VuTM Viewer Station device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is rendered in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VuComp, Inc. % Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd. Suite 200 GREAT NECK NY 11021

Re: K060451

MAR 2 2 2006

Trade/Device Name: M-VuTM Viewer Station Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ

Dated: February 10, 2006 Received: February 21, 2006

Dear Ms. Goldstein-Falk:

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 (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 cither class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 FFA may publish further announcements concerning your device in the Federal Register.

Please be advised that FI)A '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 is requirements, including, but not limited to registration and listing (21 CFR Part 807) valueling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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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 logal|| 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 Part 801), please contact the Office of Compliance at one of the following numbers, bassd on the regulation numer at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Actrist (the Division of Small Manufacturers, International and Consumer Assistance at its toll-five number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. Brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit B

Indications for Use

Page __ 1 __ of __ 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: M-Vu™ Viewer Station

Indications For Use:

The M-Vu™ Viewer Station is intended to be used to display low resolution, non-diagnostic, medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks.

Prescription Use _ X (Per 21 CFR 801 Subpart D)

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)

David R. Segura
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________