(31 days)
Not Found
No
The document describes standard image management, viewing, and manipulation features typical of a PACS or image viewer, without mentioning any AI or ML capabilities.
No
This device is designed for diagnostic image management, archiving, and processing, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic image management" and that "reviewed images can be used as an element for diagnosis."
Yes
The device is described as a "Web-based medical image and workflow management system" and "software development process," focusing on image viewing, manipulation, and management in a diagnostic imaging setting. There is no mention of proprietary hardware components included with the device.
Based on the provided information, the KIKA Imaging Lab is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- KIKA Imaging Lab's Function: The KIKA Imaging Lab is a system for managing, viewing, processing, and archiving medical images (ultrasound, CT, MRI, X-ray). It works with images generated by other diagnostic devices, not with biological specimens.
- Intended Use: The intended use clearly states it's for "diagnostic image management, archiving, annotation, acceptance, transfer, display, storage, image processing..." and that reviewed images can be used as "an element for diagnosis" when interpreted by a physician. This reinforces its role as a tool for handling and presenting diagnostic images, not for performing the diagnostic test itself on a specimen.
Therefore, the KIKA Imaging Lab falls under the category of medical image management and processing software, not an IVD.
N/A
Intended Use / Indications for Use
KIKA Imaging Lab is intended to be used for diagnostic image management, archiving, annotation, acceptance, transfer, display, storage, image processing of diagnostic ultrasound, CD, MRI, and X-ray images, including manipulation, compression and quantification of images.
The KIKA Imaging Lab brings is typically used in web data sharing domains, especially in clinical trial management, post marketing surveillance, adverse event management, tele-expertise or telemedicine.
When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The KIKA Imaging Lab is a Web-based medical image and workflow management system that allows reviewing, manipulating, interpreting, archiving and interchanging medical multi-modality image in the DICOM format. The functions of this workflow management system provide image viewing and manipulation in a diagnostic imaging setting. KIKA Imaging Lab Viewer is a secured web communication platform, to handle image management needs between all users of web clinical trials (investigators, experts, data managers etc.). The investigator may upload images from a CD source to a web based patient database, add annotations, adjusts display of images, scroll all the images of a DICOM series, and show cine playbacks.
Images are stored in a DICOM 3.0 compliant format using various different standard compression methods. Parameters and measurements are saved into a file attached to the image on the remote server. The original image is never altered.
The expert can then review images in a DICOM browser interface, retrieve images to local hard disc, do measurements (calibration, distance, area, angle) and display images in double view layout useful to compare images from different visits or series.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
diagnostic ultrasound, CD, MRI, and X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
typically used in web data sharing domains, especially in clinical trial management, post marketing surveillance, adverse event management, tele-expertise or telemedicine. When interpreted by a trained physician
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The KIKA Imaging Lab Viewer is tested according to the specifications that are documented in a Verification and Validation Test Description and Plan. Testing is part of KIKA Medical's software development process as described in KIKA Medical's Standard Operating Procedure 2.1.01SOP.en: Software Development Life Cycle. In all instances, the KIKA Imaging Lab Viewer functioned as intended and was all tests and validations observed as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
0
11051127
JUN 3 - 2005
510(k) SUMMARY
KIKA Medical's KIKA Imaging Lab Viewer
Date Prepared:
Submitted by:
Contact Name:
Contact Email:
Contact Telephone:
Contact Fax:
Device Trade Name:
Device Common Name:
Regulation Number: Device Classification: Name:
Predicate Device: Predicate Device Manufacture: Predicate Device 510(k) Number: Date Received: Decision Date : Decision: Panel Code Device Reviewed by: Panel Code Device Classified by: Product Code: Regulation Number: Device Classification:
April 14, 2005
KIKA Medical, Inc 6 Beacon Street, Suite 220 Boston, MA 02108
John J. Talarico
+1(617)619-9990 ext 3
+1(617)557-3136
KIKA Imaging Lab Viewer
Picture Archiving Communications System (PACS)
892.2050 Class II Image Processing System
eFilm™ Workstation™ with Modules eFilm Medical, Inc. K020995
Substantially Equivalent
LLZ 892.2050 Class II
Device Description:
The KIKA Imaging Lab is a Web-based medical image and workflow management system that allows reviewing, manipulating, interpreting, archiving and interchanging medical multi-modality image in the DICOM
1
format. The functions of this workflow management system provide image viewing and manipulation in a diagnostic imaging setting. KIKA Imaging Lab Viewer is a secured web communication platform, to handle image management needs between all users of web clinical trials (investigators, experts, data managers etc.). The investigator may upload images from a CD source to a web based patient database, add annotations, adjusts display of images, scroll all the images of a DICOM series, and show cine playbacks.
Images are stored in a DICOM 3.0 compliant format using various different standard compression methods. Parameters and measurements are saved into a file attached to the image on the remote server. The original image is never altered.
The expert can then review images in a DICOM browser interface, retrieve images to local hard disc, do measurements (calibration, distance, area, angle) and display images in double view layout useful to compare images from different visits or series.
Indications for Use
KIKA Imaging Lab is intended to be used for diagnostic image management. archiving, annotation, acceptance, transfer, display, storage, image processing of diagnostic ultrasound, CD, MRI, and X-rav images, including manipulation, compression and quantification of images.
The KIKA Imaging Lab is typically used in web data sharing domains. especially in clinical trial management, post marketing surveillance, adverse event management, tele-expertise or telemedicine.
When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.
Technological Characteristics
The KIKA Imaging Lab Viewer is a stand alone product or plug-in module that can be used on more than one platform and can be fully integrated into a host web server solution. Minimum requirements are the use of an Internet Web Browser and a broadband Internet connection with a Pentium-based or equivalent personal computer.
The system allows for digital image processing and measurement capability.
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Testing
The KIKA Imaging Lab Viewer is tested according to the specifications that are documented in a Verification and Validation Test Description and Plan. Testing is part of KIKA Medical's software development process as described in KIKA Medical's Standard Operating Procedure 2.1.01SOP.en: Software Development Life Cycle. In all instances, the KIKA Imaging Lab Viewer functioned as intended and was all tests and validations observed as expected.
Substantial Equivalence
The KIKA Imaging Lab Viewer is as safe and effective as the UltrPro PACs and e-Film with Modules. The KIKA Imaging Lab Viewer has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between KIKA Imaging Lab, the UltrPro PACs and E-Film Workstation raise no new issues of safety or effectiveness. Performance Data demonstrate that the KIKA Imaging Lab Viewer is as safe and effective as the UltrPro PACs and E-Film Workstation. Thus, the KIKA Imaging Lab Viewer is substantially equivalent.
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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular seal with the words "Department of Health & Human Services" written around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, with three bars running across the eagle's body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050
JUN 3 - 2005
John J. Talarico c/o Howard M. Holstein, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. WASHINGTON DC 20004
Re: K051127
Trade/Device Name: KIKA Imaging Lab Viewer Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 24, 2005 Received: May 3, 2005
Dear Mr. Talarico:
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 (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, 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I mb letter wification. The FDA finding of substantial equivalence of your device to a legally premarket notificate 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 If you doin't openits as a ne of the following numbers, based on the regulation number 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 Act 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/industry/support/index.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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Indications for Use Statement
510(k) Number (if known): K051127
Device Name: KIKA Imaging Lab Viewer
Indications for Use:
KIKA Imaging Lab is intended to be used for diagnostic image management, archiving, annotation, acceptance, transfer, display, storage, image processing of diagnostic ultrasound, CD, MRI, and X-ray images, including manipulation, compression and quantification of images.
The KIKA Imaging Lab brings is typically used in web data sharing domains, especially in clinical trial management, post marketing surveillance, adverse event management, tele-expertise or telemedicine.
When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ra.C.Pelles
Division Sianand Radiological Dev 510k) Numb
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