(231 days)
Not Found
No
The description focuses on image digitization, archiving, and basic quality checks, with no mention of AI/ML algorithms for image analysis or interpretation.
No.
The device facilitates the digitization and archiving of medical images and performs quality control checks; it does not directly treat or diagnose a disease or condition, which is characteristic of a therapeutic device.
No
The device is described as a software application that facilitates the digitization and archiving of medical images. It performs quality checks on images and digitizer performance, and can display status information (e.g., Pass or Fail), but it does not independently analyze medical images for diagnostic purposes. Its primary function is to process and store images, which can then be used by medical professionals for diagnosis.
No
The device is described as a Windows-based program that interfaces with a commercial digitizer. While the core functionality is software, it explicitly requires and interacts with a hardware component (the digitizer) to acquire data, making it a system that includes both software and hardware.
Based on the provided information, the Consultiva™ Case Input Station is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the digitization and archiving of medical images from a digitizer. This process deals with imaging data, not biological samples or specimens from the human body.
- Device Description: The device description reinforces this by explaining its function as a software application that interfaces with a digitizer to capture and store digital images. It mentions quality control procedures related to digitizer performance and image quality, but these are focused on the technical aspects of image acquisition and storage, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Consultiva™ Case Input Station's function falls outside this scope.
N/A
Intended Use / Indications for Use
The Consultiva™ Case Input Station is a software application that facilitates the digitization of medical images from a commercial digitizer and archives the digital images. The Consultiva™ Case Input Station is intended for use by a technician under the supervision of a medical professional.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The Consultiva™ Case Input Station (CIS) is a Windows-based program that facilitates the digitization of medical images and saves these digital images to a specified location on hard disk. Although the CIS is a stand-alone system, it requires a digitizer to get data. The CIS interfaces with the digitizer through high level programming interfaces that allow the CIS to initiate scans and receive messages from the digitizer. The CIS provides a User Interface (UI) that allows the user to initiate scans and verify the completion of the scans (visually) as well as view error information.
The CIS can operate as a stand-alone system to collect medical images. It can also be the first step in a larger medical system. It interfaces with downstream products by sending and receiving messages. If configured in this mode, the CIS can display status information (e.g. Pass of Fail) to the user through the UI.
The CIS also provides some Quality Control (OC) procedures to verify digitizer performance. These procedures are initiated from the CIS UI and require specific test films to be digitized and processed. In the regular workflow, the CIS also implements some quality checks on each image to ensure that the image is of sufficient quality.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digitization of medical images from a commercial digitizer
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
a technician under the supervision of a medical professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Various tests of the software 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo for MiraMedica. The logo consists of a stylized graphic above the company name. The graphic appears to be a curved shape with vertical lines, possibly representing hair or a flame. The company name, "MiraMedica," is written in a simple, sans-serif font below the graphic.
Image /page/0/Picture/2 description: The image shows handwritten text that appears to be a document identifier and page number. The text "K031132" is written on the top line. Below that, the text "page 1 of 2" indicates that this is page 1 of a 2-page document.
Page E-1
510(k) Summary
| Submitter's Name: | MiraMedica, Inc. | |
|---|---|---|
| Submitter's Address: | 15466 Los Gatos Blvd., Suite 109-171, Los Gatos, CA, 95032 | |
| Submitter's Telephone: | (408) 858-0718 | |
| Contact Name: | Wido Menhardt | |
| Date Summary was Prepared: | April 04, 2003 | |
| Trade or Proprietary Name: | Consultiva™ Case Input Station | |
| Common or Usual Name: | System, Image Processing, Radiological | |
| Classification Name: | Picture Archiving and Communications System (21 CFR 892. 2050) | |
| Predicate Devices: | Device Name | 510(k) Number |
| ExpressSuite | K011049 | |
| ImagClear | K992467 | |
| IMPAX Workstations | K022292 |
Description of the Device and Summary of the Technological Characteristics:
The Consultiva™ Case Input Station (CIS) is a Windows-based program that facilitates the digitization of medical images and saves these digital images to a specified location on hard disk. Although the CIS is a stand-alone system, it requires a digitizer to get data. The CIS interfaces with the digitizer through high level programming interfaces that allow the CIS to initiate scans and receive messages from the digitizer. The CIS provides a User Interface (UI) that allows the user to initiate scans and verify the completion of the scans (visually) as well as view error information.
The CIS can operate as a stand-alone system to collect medical images. It can also be the first step in a larger medical system. It interfaces with downstream products by sending and receiving messages. If configured in this mode, the CIS can display status information (e.g. Pass of Fail) to the user through the UI.
The CIS also provides some Quality Control (OC) procedures to verify digitizer performance. These procedures are initiated from the CIS UI and require specific test films to be digitized and processed. In the regular workflow, the CIS also implements some quality checks on each image to ensure that the image is of sufficient quality.
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Page E-2
Image /page/1/Picture/1 description: The image shows the text "K031132 page 2 of 2" in a handwritten font. Below this text is a stylized graphic and the text "Arra Medica" in a smaller font. The text and graphic elements are arranged in a visually distinct manner.
Indications for Use:
The Consultiva™ Case Input Station is a software application that facilitates the digitization of medical images from a commercial digitizer and archives the digital images. The Consultiva™ Case Input Station is intended for use by a technician under the supervision of a medical professional.
Substantial Equivalence:
The Consultiva™ Case Input Station is similar to predicate devices such as the VIDAR ExpressSuite, Agfa IMPAX Workstation, and the Titan (formerly DBA) ImagClear. The intended use for the CIS and the predicate devices is for the digital acquisition and archiving of medical images. All of the devices operate on commercially available computer systems such as a Windows-based system and all interface with commercially available digitizers.
Testing:
Various tests of the software 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 2003
Wido Menhardt, Ph.D. General Manager, CAD Business Segment Eastman Kodak Company 100 Centry Center Court, Suite 600 SAN JOSE CA 95112
Re: K031132 Trade/Device Name: Consultiva™ Case Input Station Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: October 27, 2003 Received: October 30, 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 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, 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
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Image /page/4/Picture/0 description: The image shows a logo for a company called "MiraMedica". The logo consists of a stylized, abstract symbol above the company name. The symbol appears to be a curved shape, possibly representing a human form or a stylized letter. The text "MiraMedica" is written in a serif font, with the first letter of each word capitalized.
D Indications for Use Statement
| Ver/ 3 - 4/24/96 | |
|---|---|
| Applicant: MiraMedica, Inc. | |
| 510(k) Number (if known): | K031132 |
| Device Name: Consultiva™ Case Input Station | |
| Indications For Use: |
The Consultiva™ Case Input Station is a software application that facilitates the digitization of
medical images from a commercial digitizer and archives the digital images. The Consultiva™
Case Input Station is intended for use by a technician under the supervision of a medical
professional.
(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 Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K031132 |
|---|---|
| --------------- | --------- |
| Prescription Use per 21 CFR 801.109 | Over the Counter Use |
|---|---|
| ------------------------------------------------- | ---------------------- |
Consultiva™ Case Input Station 510(k) Application - CONFIDENTIAL