(84 days)
Not Found
No
The summary describes standard radiological viewing software with image manipulation capabilities, but there is no mention of AI, ML, or related concepts. The performance studies described are general software testing, not specific to AI/ML model validation.
No
The "Intended Use" section clearly states "ShowCase is diagnostic quality radiological viewing software." and does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states "ShowCase is diagnostic quality radiological viewing software," directly indicating its diagnostic purpose.
Yes
The device description explicitly states "ShowCase is diagnostic quality radiological viewing software" and the entire description focuses on software functionalities (receive, store, display, manipulate medical images). There is no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states that ShowCase is "diagnostic quality radiological viewing software" used to "receive, store, display and manipulate medical images and associated clinical data." This focuses on the display and manipulation of medical images, which are typically generated by imaging modalities (like X-ray, CT, MRI, etc.).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. ShowCase does not perform any such tests on biological samples.
- Device Description: The description reiterates the function of viewing and manipulating medical images, not analyzing biological samples.
- Lack of IVD-Specific Information: The document lacks any mention of biological samples, assays, reagents, or any other elements typically associated with IVD devices.
Therefore, ShowCase falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ShowCase is diagnostic quality radiological viewing software. ShowCase can be used to receive, store, display and manipulate medical images and associated clinical data. This device is not intended for diagnosis of lossy compressed images.
Product codes
LLZ
Device Description
ShowCase is diagnostic quality radiological viewing software. ShowCase can be used to receive, store, display and manipulate medical images and associated clinical data. This device is not intended for diagnosis of lossy compressed images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Extensive testing of the software package has been performed by programmers, nonprogrammers and by potential customers.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K082135
Page 1 of 3
SECTION 2 -- SHOWCASE- Summary Information for 510k
1 -Submitted by:
Trillium Technology, Inc 448 Fifth Street Ann Arbor, MI 48103-4837
OCT 2 1 2008
Official Correspondent: Gary Allsebrook Regulatory Management Services regman10@comcast.net Email: 510-276-2648 Phone: Address: 16303 Panoramic Way San Leandro, CA USA 94578-1116
Company Contact Person:
Sandra Simon Operations Director Phone: 734-213-5975 FAX: 734-527-6198 Email: ssimon@trillech.com
- SHOWCASE® 2-Proprietary Name:
Common/ Usual Name:
Soft-copy reading system
Classification: Classification Name
Device Class Classification Panel CRF Section Product Code
Picture Archiving and Communications System (PACS) Class II Radiology CFR 892.2050 LLZ
Substantial Equivalence Predicate Devices: 3-
Substantial Equivalence
ShowCase is substantially equivalent to the following devices:
| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance
Date | Product
Code |
|-------------------------------------------------------------------------------------|------------------|-------------------|-----------------|
| eFilm™ Workstation with Modules,
eFilm Medical Inc.
(became Merge eMed, Inc.) | K020995 | 04/12/2002 | LLZ |
1
K082135
Page 2 of 3
| syngo® Ultrasound Workplace,
Siemens Medical Systems USA, Inc.
| Ultrasound Division | K060992 | 04/28/2006 | LLZ |
|---|---|---|---|
| Volcano s5i Family of Imaging Systems, | |||
| Volcano Corporation | K061215 | 08/10/2006 | LLZ |
5- Device Description
ShowCase is diagnostic quality radiological viewing software. ShowCase can be used to receive, store, display and manipulate medical images and associated clinical data. This device is not intended for diagnosis of lossy compressed images.
6- Software Development
Trillium Technology certifies that ShowCase software is designed, developed, tested and validated according to written procedures. These procedures identify the individuals within the organization responsible for developing and approving products pecifications, codinq v erification and validation testing. The software developed for this product provides diagnostic quality images and associated information to the intended users.
7 - Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Devices
ShowCase®, eFilm® Workstation and syngo® Ultrasound Workplace are all available as "software only" workplaces that run under Microsoft Windows® operating systems on readily available computer hardware. All applications indude image and structured report viewing and a seto f imaging measurements and manipulation tools. All three are DICOM compliant systems capable of receiving and storing images and moving imaging studies using DICOM Query/Retrieve.
ShowCase includes some of the ultrasound specific functionality of the syngo Ultrasound Workplace including stress echo displays and Doppler measurement tools.
ShowCase is a more basic level product than the predicate devices and has a smaller overall feature set. ShowCase has no advanced diagnostic modules.
The Volcano s5i family of products is a set of intravascular ultrasound acquisition products that have only one feature in common with ShowCase. The s5i acquisition device includes an interactive display of both the radial and longitudinal views of an IVUS image set, with a 360 degree cursor on the radial view that matches it to the
Section 2- 2
2
K0821353 of 3
page
longitudinal view. This is referred to as the In-line Digital Display (ILD). ShowCase also provides the ILD image playback option for intravascular ultrasound pullback image sets.
8- Safety and Effectiveness
General Safety and Effectiveness Concerns:
ShowCase Workstation labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
The hardware components specified (and optionally supplied) are all "off the shelf" computer components.
The device does not contact the patient, nor does it control any life sustaining devices. Thus, the "Level ofC oncern" for the ShowCase Workstation is "minor".
8- Validation and Effectiveness
Extensive testing of the software package has been performed by programmers, nonprogrammers and by potential customers.
9- Conclusion as to Substantial Equivalence
ShowCase Workstation has Indications for Use and a Target Population similar to the predicate devices, eFilm Workstation with Modules (K020995) and syngo Ultrasound Workplace (K060992). Any differences between the ShowCase Workstation software and the equivalent devices have no significant influence on safety or effectiveness. Therefore, ShowCase Workstation raises no new issues of safety or effectiveness from its predicate devices.
Andria B Simon
Sandra Simon Operations Director / Owner
14 - Oct - 2008 Date
Section 2- 3
3
Image /page/3/Picture/0 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of an abstract human figure with three wavy lines extending from its arm. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Trillium Technology, Inc. % Mr. Gary Allsebrook Consultant Regulatoy Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116
Re: K082135 Trade/Device Name: ShowCase® Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulation Name: Picture archiving and communications system
Regulation Cl Regulatory Class: II Product Code: LLZ Dated: July 27, 2008 Received: July 29, 2008
Dear Mr. Allsebrook:
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.
OCT 2 1 2008
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.
4
Page 2
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jaque M. Zhang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K082135
Device Name:Sh owCase®
Indications for Use:
..............................................................................................................................................................................
ShowCase is diagnostic quality radiological viewing software. ShowCase can be used to receive, store, display and manipulate medical images and associated clinical data. This device is not intended for diagnosis of lossy compressed images.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | Over-The-Counter Use |
| (21 CFR 801 Subpart C) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and | |
| Radiological Devices | |
| 510(k) Number | K082135 |