(63 days)
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.
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. .
Here's a breakdown of the acceptance criteria and study information for the Consultiva™ Report Station (RS), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the Consultiva™ Report Station's performance, nor does it provide quantitative results of the device's performance against such criteria. The "Testing" section broadly mentions: "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." This indicates that internal testing was conducted, but the details of the criteria and results are not included in this summary.
Therefore, a table cannot be constructed from the given information in the requested format.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the documentation. The submission focuses on the functionality of the display software rather than the performance of a diagnostic algorithm based on a specific dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. As the device is for displaying images and CAD results, and not itself a diagnostic algorithm, the concept of "ground truth for a test set" in the context of diagnostic accuracy is not directly applicable to its stated function in this submission.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in the provided document. The device is described as a display system for CAD results, not a CAD system itself, nor is it intended to directly improve human reader performance in a controlled study scenario as part of this submission. The submission is focused on the display capabilities of the software.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was not performed or reported as the Consultiva™ Report Station (RS) is a software application intended to display medical images and annotations (including CAD marks), not to generate diagnostic interpretations independently. It acts as a viewer for outputs from other systems (like CAD results).
7. Type of Ground Truth Used
The concept of "ground truth" as it relates to diagnostic accuracy is not applicable to the Consultiva™ Report Station (RS) as presented in this document. Its purpose is to display images and existing CAD marks/annotations, not to make a diagnosis or directly generate those annotations. The "primary data sources" mentioned are "low resolution digital images and the CAD results," implying it relies on information from other sources.
8. Sample Size for the Training Set
This information is not provided. The device is a display software, not an AI/CAD algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the Consultiva™ Report Station (RS) is a display software and does not involve AI model training.
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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.
510(k) Summary E
| Submitter's Name: | MiraMedica, Inc. |
|---|---|
| Submitter's Address: | 15466 Los Gatos Blvd., Suite 109 PMB #171, Los Gatos,CA, 95032 |
| Submitter's Telephone: | (408) 858-0718 |
| Contact Name: | Wido Menhardt |
| Date Summary wasPrepared: | 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 CFR892. 2050) |
| Predicate Devices: | Device Name | 510(k) Number |
|---|---|---|
| Coronis 3MP Medical Flat PanelDisplay 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:
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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.
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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.
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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 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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).