(224 days)
No
The description focuses on standard image processing techniques and visualization tools, with no mention of AI or ML algorithms.
No
A therapeutic device is one that treats a disease or condition. This device is described as software that assists radiologists in analyzing medical images for screening and diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis."
Yes
The device description explicitly states that z3D is a "software package" and a "software application" designed to be distributed as a "plug-in for OEM imaging systems, PACS, workstations, or embedded in software applications cleared for use in medical imaging." It performs image processing and analysis on existing digital images. There is no mention of any accompanying hardware component that is part of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that z3D Contrast Acuity is a post-processing, productivity software package designed to assist radiologists in the analysis of medical images (CT, MR, X-Ray, PET, Nuclear Medicine). It manipulates and enhances existing image data.
- No mention of biological samples: There is no indication that this software interacts with or analyzes any biological samples from a patient.
Therefore, since the device operates on medical images and not biological samples, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
z3D Contrast Acuity (z3D) version 2.1 is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The software displays the temporal variation in dynamic data as a surface map that enhances visualization of pixel intensity and time/intensity changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay over the selected image.
z3D may perform additional functions to aid in the analysis and viewing of dynamic studies, including registration of serial MR and CT acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 3D, segmentation of tissues, multiplanar and oblique reformats, maximum intensity projections, image averaging, subtraction and blinking of images acquired at different time points to help visualize enhancement.
z3D also may be used to perform post-processing analysis of multi-modality, digital images, including MR, CT, X-Ray, PET, and Nuclear Medicine images. The software analysis tools may be applied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections.
The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of z3D analysis. The z3D software is contraindicated for automated sole interpretation of digital mammography images.
Product codes
90-LLZ, LLZ
Device Description
z3D Contrast acuity (z3D) Version 2.1 is a software package designed to assist the radiologist in interpretation of multi-modality, digital radiology images, including dynamic CT and MR image data sets. The software applies standard 2D and 3D image processing techniques on a pixel-by-pixel basis to analyze grayscale data and perform visual enhancement of user-selected images. The software may be applied to image subtractions, reformatted images, multiplanar reformats, and Maximum Intensity Projections (MIP). Single or multi-slice data sets may be used as input.
The software consists of several modes that can be enabled or disabled depending upon the specific configuration purchased/implemented. These modes include 2D image review, 2D mass morphology, 3D mass characterization.
The results of the analysis are displayed as a surface man, parametric map, Maximum Intensity Projection (MIP), subtraction, registered subtraction, or 3D display that enhances visualization of pixel intensity data provided by the image. The results may be displayed in grayscale enhancement or as a color overlay. The software includes standard workflow tools that allow the radiologist to manipulate, rotate and fly-through images for enhanced visualization of the digital output. Additionally, the software package allows the radiologist to visually inspect time sensitive contrast agent intensity curves and to make mass measurements.
The software application consists of proprietary software developed by Clario and is a Windows 2000/XP, DICOM-compatible platform. The software is designed to be distributed as a plug-in for OEM imaging systems, PACS, workstations, or embedded in software applications cleared for use in medical imaging.
The z3D user interface is designed to follow typical workflow patterns to process, review, and analyze digital images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dynamic CT, MR, X-Ray, PET, Nuclear Medicine
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
KOSUI96
SEP - 5 2008
510(k) Summary 4
In accordance with the requirements addressed by the Safe Medical Devices Act of 1990, this Attachment provides the 510(k) Summary of Safety and Effectiveness information to support the determination of substantial equivalence to currently-marketed predicate devices.
A Certification is also included herein.
Original 510(k) PreMarket Notification Clario Medical Imaging, Inc.
1
510(k) Summary/Statement Certification
Re: 510(k) Premarket Notification: z3D Contrast Acuity
CHECK ONLY ONE:
X
-
510(k) Summary. Attached is a summary of safety and effectiveness information upon which an equivalence determination could be based.
-
510(k) Statement. I certify that in my capacity as
Chief Executive Officer
Clario Medical Imaging, Inc. of
(company)
I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
Chris Wood CEO
Date
*(Premarket Notification [510(k)] Number)
Original 510(k) ProMarket Notification Clario Medical Imaging, Inc.
z3D Contrast Aculty
· * For a new submission, leave the 510(k) number blank.
2
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87 (h).
1. Identification of Submitter:
Submitter: Address:
Phone: Fax:
Clario Medical Imaging, Inc. 1924 1st Avenue, Suite 4W Seattle, WA 98101 206-448-2212 206-441-3226
Contact: Title: Phone:
Fax:
Chris Wood Chief Executive Officer 206-448-2212 206-441-3226
Date Prepared:
2. Identification of Product:
| Trade Name: | z3D Contrast Acuity |
|---|---|
| Common Name: | Picture Archiving and Communications System |
| Regulation Number: | 892.2050 |
| Classification Name: | Radiological Image Processing System |
| Product Cone: | 90-LLZ |
| Regulatory Class: | Class II |
Manufacturer:
Clario Medical Imaging, Inc. 1924 18t Avenue, Suite 4W Seattle, WA 98101
3
3. Marketed Devices
z3D Contrast Acuity Version 2.1 is substantially equivalent to the legally marketed predicate devices listed below:
Model: Manufacturer: 510(k) Number: MedIQ Clario Medical Imagining, Inc. K052963
Model: Manufacturer: 510(k) Number: CADstream Version 4.0 Confirma, Inc. K043216
Original 510(k) PreMarket Notification Clarlo Medical Imaging, Inc.
16
4
4. Device Description
z3D Contrast acuity (z3D) Version 2.1 is a software package designed to assist the radiologist in interpretation of multi-modality, digital radiology images, including dynamic CT and MR image data sets. The software applies standard 2D and 3D image processing techniques on a pixel-bypixel basis to analyze grayscale data and perform visual enhancement of user-selected images. The software may be applied to image subtractions, reformatted images, multiplanar reformats, and Maximum Intensity Projections (MIP). Single or multi-slice data sets may be used as input.
The software consists of several modes that can be enabled or disabled depending upon the specific configuration purchased/implemented. These modes include 2D image review, 2D mass morphology, 3D mass characterization.
The results of the analysis are displayed as a surface man, parametric map, Maximum Intensity Projection (MIP), subtraction, registered subtraction, or 3D display that enhances visualization of pixel intensity data provided by the image. The results may be displayed in grayscale enhancement or as a color overlay. The software includes standard workflow tools that allow the radiologist to manipulate, rotate and fly-through images for enhanced visualization of the digital output. Additionally, the software package allows the radiologist to visually inspect time sensitive contrast agent intensity curves and to make mass measurements.
The software application consists of proprietary software developed by Clario and is a Windows 2000/XP, DICOM-compatible platform. The software is designed to be distributed as a plug-in for OEM imaging systems, PACS, workstations, or embedded in software applications cleared for use in medical imaging.
The z3D user interface is designed to follow typical workflow patterns to process, review, and analyze digital images.
5. Indications for Use
z3D Contrast Acuity (z3D) version 2.1 is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
5
changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay on the selected image.
z3D may perform additional functions to aid in the analysis and viewing of dynamic studies. including registration of serial MR and CT acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 3D, segmentation of tissues, multiplanar and oblique reformats, maximum intensity projections, image averaging, subtraction and blinking of images acquired at different time points to help visualize enhancement.
z3D also may be used to perform post-processing analysis of multi-modality, digital images, including MR, CT, X-Ray, PET, and Nuclear Medicine images. The software analysis tools may be applied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections.
The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of z3D analysis. The z3D software is contraindicated for automated sole interpretation of digital mammography images.
6. Comparison with Predicate Devices
Clario Medical Imaging, Inc. believes that the product described in this Submission is substantially equivalent to a combination of the MedIQ/K052963 and CADstream/K043216 devices.
z3D and the cited predicate devices are designed to assist radiologists in analyzing pixel intensity data from multi-modality, digital images and performing post-processing analysis of selected images using standard software techniques. The output of these software packages is intended to provide supplemental information and enhanced visual analysis of the digital images selected by the user for processing.
The Clario software product, MedIQ, and the Confirma software product, CADstream, perform post-processing analysis of dynamic CT and/or MR images to enhance the radiologist's visual interpretation of time/intensity changes observed in temporal data sets obtained during the administration
6
The Clario software product, MedIQ, and the Confirma software product, CADstream, perform post-processing analysis of dynamic CT and/or MR images to enhance the radiologist's visual interpretation of time/intensity changes observed in temporal data sets obtained during the administration of contrast agents. The output is displayed as curves or color parametric images from user-specified processing of algorithms.
The Clario software product MedIQ provides functional features that are equivalent to z3D, allowing the user to view and manipulate images in 3D in real time, and to provide 3D surface shading of selected images.
The Confirma software product, CADstream, provides the functional feature that allows the user to make measurements on images.
The cited predicate devices allow easy selection, review, processing, archiving, printing and media interchange of multi-modality images from a variety of diagnostic imaging systems.
19
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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2008
Mr. Chris Wood CEO Clario Medical Imaging, Inc. 1924 18t Avenue, Suite 4W SEATTLE WA 98101
Re: K080196
Trade/Device Name: z3D Contrast Acuity Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 12, 2008 Received: August 14, 2008
Dear Mr. Wood:
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.
8
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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,
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
9
| Indications for Use | |
|---|---|
| 510(k) Number: | To be assigned by FDA |
| Device Name: | z3D Contrast Acuity |
Z3D Contrast Acuity (z3D) version 2.1 is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The software displays the temporal variation in dynamic data as a surface map that enhances visualization of pixel intensity and time/intensity changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay overlay over the selected image.
z3D may perform additional functions to aid in the analysis and viewing of dynamic studies, including registration of serial MR and CT acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 310. segmentation of tissues, multiplanar and oblique reformats, maximum intensity projections, image, averaging, subtraction and blinking of images acquired at different time noints to help visualize enhancement.
23D also may be used to perform post-processing analysis of multi-modality, digital images, including MR, CT, X-Ray, PET, and Nuclear Medicine images. The software analysis tools may be anplied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections.
The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of z3D analysis. The z3D software is contraindicated for automated sole interpretation of digital mammography images.
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Page 1 of 1 | |||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of Reproductive, Abdominal and Radiological Devices | |||
| Original 510(k) PreMarket Notification | |||
| Clario Medical Imaging, Inc. | 510(k) Number | K080196 | 12 |
z3D Contrast Acuity 2.1