CONSULTIVA REPORT STATION, MODEL RS-1

K031248 · Miramedica, Inc. · LLZ · Jun 20, 2003 · Radiology

Device Facts

• Record ID: K031248
• Device Name: CONSULTIVA REPORT STATION, MODEL RS-1
• Applicant: Miramedica, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Consultiva™ Report Station is a software application intended to be used to display low resolution, non-diagnostic medical images with annotations such as regions-of-interest or CAD marks.

Device Story

Consultiva™ Report Station is a Windows-based software application; inputs include digitized medical images and pre-existing CAD results/annotations from hard disk storage. Device displays images at reduced resolution and fixed size; overlays CAD marks or regions-of-interest onto images; provides UI for image initiation and CAD report printing. Used in clinical settings; operated by healthcare professionals. Device does not perform diagnostic analysis; serves as a visualization tool for non-diagnostic images and CAD results. Benefits include streamlined review of CAD-annotated images.

Clinical Evidence

No clinical data. Bench testing only; verification procedures with pass/fail criteria were performed to ensure the software met specified requirements.

Technological Characteristics

Windows-based software application; functions as a radiological image processing system (21 CFR 892.2050). Features include image display at reduced resolution, image enlargement, and CAD result overlay. Standalone software architecture.

Indications for Use

Indicated for the display of low-resolution, non-diagnostic medical images with annotations, including regions-of-interest or CAD marks.

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

• Coronis 3MP Medical Flat Panel Display System (K013922)
• IMPAX Workstations (K022292)
• ImageChecker CT Workstation (K023003)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo for Mira Medica. The logo consists of a stylized symbol resembling a flame or a strand of hair, positioned above the text "Mira Medica". The text is in a simple, sans-serif font and appears to be slightly blurred.

K031248

#### 510(k) Summary E

| Submitter's Name: | MiraMedica, Inc. |
|-------------------------------|--------------------------------------------------------------------|
| Submitter's Address: | 15466 Los Gatos Blvd., Suite 109 PMB #171, Los Gatos,<br>CA, 95032 |
| Submitter's Telephone: | [phone] |
| Contact Name: | Wido Menhardt |
| Date Summary was<br>Prepared: | April 11, 2003 |
| Trade or Proprietary Name: | Consultiva™ Report Station (RS) |
| Common or Usual Name: | System, Image Processing, Radiological |
| Classification Name: | Picture archiving and communications system (21 CFR<br>892. 2050) |

| Predicate Devices: | Device Name | 510(k) Number |
|--------------------|--------------------------------------------------|---------------|
| | Coronis 3MP Medical Flat Panel<br>Display System | K013922 |
| | IMPAX Workstations | K022292 |
| | ImageChecker CT Workstation | K023003 |

## Description of the Device and Summary of the Technological Characteristics:

The Consultiva™ Report Station (RS) is a Windows-based program that gathers digitized medical images from a specified location on hard disk, and displays those images on a monitor, with Computer Aided Detection (CAD) results (or other annotations) overlaid on top of the images. The RS provides a User Interface (UI) that allows the user to initiate the display of the images . The RS also provides the capability to print a CAD report.

The primary data sources for this system include the low resolution digital images and the CAD results. The visualization of CAD and images requires no explicit requirements for user manipulation of the data (zoom, pan, window level, etc). The visualization features of the RS include:

- The ability to display medical images at a reduced resolution and fixed size. .
- . The ability to enlarge an image.
- The ability to display the CAD results as an overlay over the displayed digitized images. .

#### Indications for Use:

{1}------------------------------------------------

The Consultiva™ Report Station is a software application intended to be used to display low resolution, non-diagnostic medical images with annotations such as regions-of-interest or CAD marks.

# Substantial Equivalence:

The RS is similar to predicate devices such as the R2 Technology ImageChecker CT Workstation, Agfa IMPAX Diagnostic Display Station, and BARCO Coronis 3MP Medical Flat Panel Display System.

### Testing:

Various tests of the software will be done to verify system specifications are being performed. Verification procedures with pass/fail criteria were developed to ensure that the product met all the specified requirements.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2003

Wido Menhardt, Ph.D. General Manager and Chief Technical Officer Miramedica, Inc. 15466 Los Gatos Blvd. Suite 109, PMB#171 LOS GATOS CA 95032

Re: K031248

Trade/Device Name: Consultiva™ Report Station Model RS-1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: April 15, 2003 Received: April 29, 2003

Dear Dr. Menhardt:

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 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); 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.

{3}------------------------------------------------

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

Page 2

{4}------------------------------------------------

# D Indications for Use Statement

Ver/ 3 = 4:24:96 Applicant: MiraMedica, Inc. 510(k) Number (if known): _r = 3 12 48

Device Name: Consultiva™ Report Station Indications For Use:

The Consultiva™ Report Station is a software application intended to be used to display low resolution, non-diagnostic medical images with annotations such as regions-of-interest or CAD marks.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Symm

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number

631248

Prescription Use
per 21 CFR 801.109

Over the Counter Use