(63 days)
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No
The document describes a software application for displaying medical images and CAD results, but there is no mention of AI or ML being used within the Consultiva™ Report Station itself. The CAD results are presented as input data, implying the AI/ML processing happens elsewhere.
No
The device is a software application for displaying non-diagnostic medical images and CAD results, not for treating or diagnosing medical conditions itself. It's a display system, not a therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states that the software is intended to display "non-diagnostic medical images."
Yes
The device is described as a "software application" and a "Windows-based program" that displays and overlays information on existing digital images. While it interacts with images and potentially CAD results (which could be generated by other systems), the description focuses solely on the software's functionality for display and reporting, without mentioning any proprietary hardware components or hardware-specific validation. The predicate devices listed include display systems and workstations, but the description of the subject device itself is limited to the software's capabilities.
Based on the provided information, the Consultiva™ Report Station is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for displaying "low resolution, non-diagnostic medical images." IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device is focused on displaying existing images and annotations, not analyzing biological samples.
- Device Description: The description reinforces that it's a software application for gathering, displaying, and overlaying information on medical images. It doesn't mention any interaction with biological specimens or laboratory procedures.
- Lack of IVD-Specific Information: The document lacks any information typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Performance metrics related to biological analysis (sensitivity, specificity in the context of detecting biomarkers, etc.)
- Predicate Devices: The predicate devices listed (Medical Flat Panel Display System, Workstations, CT Workstation) are all related to medical imaging display and processing, not in vitro diagnostics.
In summary, the Consultiva™ Report Station is a medical imaging software application designed for displaying and reporting on existing medical images and associated annotations. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
90 LLZ
Device Description
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. .
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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.
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 was | |
| 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 |
-
- |
| Predicate Devices: | Device Name | 510(k) Number |
|---|---|---|
| Coronis 3MP Medical Flat Panel | ||
| 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 | (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
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