(17 days)
No
The summary describes standard image processing and 3D rendering tools, and explicitly states that AI, DNN, or ML were "Not Found" in the document.
No
The device is described as software for 3D visualization and analysis of DICOM image data to facilitate planning, not to directly treat a condition.
No
This device is intended for visualization and analysis of medical images to facilitate surgical and non-surgical therapy planning, not for diagnosing medical conditions. While it processes medical images, its "Intended Use" focuses on planning, not diagnosis.
Yes
The device description explicitly states "Kuvia3D is a software system" and is supported on an "off-the-shelf personal computer system platform running the Microsoft Windows operating system." It processes existing DICOM image data and does not include any proprietary hardware components.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Kuvia3D's Function: Kuvia3D processes and visualizes medical image data (DICOM images from modalities like MRI or CT). It does not analyze biological samples taken from the body. Its purpose is to aid in the planning of surgical and non-surgical therapies based on anatomical visualization.
The description clearly indicates that Kuvia3D works with existing medical images, not with biological specimens. Therefore, it falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Kuvia3D software is intended for the display and analysis of DICOM image data to facilitate 3D visualization of joint anatomy for planning surgical and non-surgical therapies.
Product codes
LLZ
Device Description
Kuvia3D is a software system used to display, analyze and generate three-dimensional visualizations of DICOM image data. The software is supported on an off-the-shelf personal computer system platform running the Microsoft Windows operating system. The user will transfer medical image data to the Kuvia3D system from a DICOM image system (such as a PACS) and proceed to use Kuvia3D's viewing and segmentation tools to segment the image data as desired. Once the user has completed segmenting the image data, they can convert the segmented region to a 3D rendered surface and adjust the view of the segmented anatomy as desired. Linear measurements may be taken in the 2D image as well as the 3D surface rendering. Screen captures of the 3D surface rendering window may be saved as derivative images and appended to the imaging study, or transferred to other DICOM image systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM image data
Anatomical Site
Joint anatomy, adult articular knee cartilage
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use only. A physician, providing ample opportunity for competent human intervention, reviews images, generates/corrects segmentations as necessary and reviews information generated by Kuvia3D.
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
Nonclinical software testing was conducted under simulated use conditions. Predefined acceptance criteria were met and demonstrate that the device is as safe and effective as the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
4QImaging, LLC Dba Qmetrics Technologies % Mr. Edward Schreyer CEO 1250 Pittsford-Victor Road Suite 110, Bldg. 200 PITTSFORD NY 14534
Re: K161559
Trade/Device Name: Kuvia3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 2, 2016 Received: June 6, 2016
Dear Mr. Schreyer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
June 23, 2016
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161559
Device Name Kuvia3D
Indications for Use (Describe)
Kuvia3D software is intended for the display and analysis of DICOM image data to facilitate 3D visualization of joint anatomy for planning surgical and non-surgical therapies.
Type of Use (Select one or both, as applicable)
| Residential Use (Part 91, SFB 901, Subject Property) |
|---|
| On-Site Commercial Use (SFB 901, Subject Property) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Qmetrics Technologies. The logo consists of a red sun-like graphic on the left, followed by the word "Qmetrics" in red and black. Below "Qmetrics" is the word "TECHNOLOGIES" in gray.
Summary of Safety and Effectiveness
| Device Name: | Kuvia3D |
|---|---|
| Date Prepared: | May 24, 2016 |
| Submitter: | Qmetrics Technologies |
| 1250 Pittsford-Victor Rd. | |
| Suite 110, Bldg. 200 | |
| Pittsford, NY 14534 | |
| Contact: | Edward Schreyer |
| Edward.schreyer@qmetricstech.com | |
| Phone: +1 585 301-4300 x141 | |
| Fax: +1 585 270-4686 |
Device Classification:
| Trade Name | Kuvia3D® |
|---|---|
| Common Name | Picture Archiving and Communications System (PACS) |
| Device Classification Name | System, Image Processing, Radiological |
| Device Class | Class II |
| Regulation | 892.2050 |
| Product Code | LLZ |
| Classification Panel | Radiology |
Predicate/Reference Devices:
| Predicate Device | Reference Device | Reference Device | |
|---|---|---|---|
| Trade Name | 3D-DOCTOR | ClearCanvas | |
| RIS/PACS | RTVue XR | ||
| Device Class | Class II | Class II | Class II |
| Common Name | System, Image | ||
| Processing, | |||
| Radiological | System, Image | ||
| Processing, | |||
| Radiological | Optical Coherence | ||
| Tomography (OCT) | |||
| 510(k) | |||
| Submitter/Holder | Able Software | ||
| 5 Appletree Lane | ClearCanvas, Inc. | ||
| 439 University | Optovue, Inc. | ||
| 45531 Northport |
4
Image /page/4/Picture/0 description: The image is a logo for Qmetrics Technologies. The logo has a red graphic on the left side that looks like a sun with rays coming out of it. To the right of the graphic is the word "Qmetrics" in red and black lettering. Below the word "Qmetrics" is the word "TECHNOLOGIES" in smaller, gray lettering.
| | Lexington, MA
02420-2406 | Ave., Suite 1920
Toronto, ON M5G
1Y8 | Loop West
Fremont, CA 94538 |
|----------------------|-----------------------------|--------------------------------------------|--------------------------------|
| 510(k) Number | K003746 | K110332 | K120238 |
| Regulation Number | 21 CFR 892.2050 | 892.2050 | 21 CFR 886.1570 |
| Product Code | 90 LLZ | 90 LLZ | HLI |
| Classification Panel | Radiology | Radiology | Opthalmic |
Intended Use:
Kuvia3D software is intended for the display and analysis of DICOM image data to facilitate 3D visualization of joint anatomy for planning surgical and non-surgical therapies.
Kuvia3D is indicated for Prescription Use only.
Device Description:
Kuvia3D is a software system used to display, analyze and generate three-dimensional visualizations of DICOM image data. The software is supported on an off-the-shelf personal computer system platform running the Microsoft Windows operating system. The user will transfer medical image data to the Kuvia3D system from a DICOM image system (such as a PACS) and proceed to use Kuvia3D's viewing and segmentation tools to segment the image data as desired. Once the user has completed segmenting the image data, they can convert the segmented region to a 3D rendered surface and adjust the view of the segmented anatomy as desired. Linear measurements may be taken in the 2D image as well as the 3D surface rendering. Screen captures of the 3D surface rendering window mav be saved as derivative images and appended to the imaging study, or transferred to other DICOM image systems.
Major Functions performed by Kuvia3D:
- . Exchange of medical image data in DICOM standard format between the Kuvia3D system and DICOM-compatible imaging systems, such as MRI or CT scanners or PACS systems.
- Storage of image data
- Exchange of DICOM image data with other Kuvia3D systems
- . Multi-planar image display, including 3D rendering display
- Segmentation of image data, including editing of object boundaries.
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Image /page/5/Picture/0 description: The image shows the logo for Qmetrics Technologies. The logo has a red graphic on the left side that looks like a sun with rays coming out of it. To the right of the graphic is the word "Qmetrics" in black font, with the "Q" in red. Below the word "Qmetrics" is the word "TECHNOLOGIES" in a smaller, gray font.
- . Analysis of image data, including linear length.
- . 3D display of adult articular knee cartilage as segmented, color-coded by thickness.
Technical Characteristics:
Kuvia3D is a stand-alone software package used on general-purpose hardware meeting the minimum requirements specified in the labeling/documentation. It is based upon standard Microsoft™ technology. Use of Kuvia3D does not involve patient contact, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, reviews images, generates/corrects segmentations as necessary and reviews information generated by Kuvia3D. The intended use and general technological characteristics of Kuvia3D are the same as those of the predicate device; a reference device has been included to demonstrate that certain technical characteristics absent from the predicate but present in Kuvia3D are common with a more recently cleared device in the product code LLZ.
| Feature | Kuvia3D
(Subject
Device) | 3D-Doctor
(Predicate
Device) | ClearCanvas
(Reference
Device) | RTVue XR
(Reference
Device) |
|-----------------------------------------------------------------------------------------------|--------------------------------|------------------------------------|--------------------------------------|-----------------------------------|
| Intended Use | | | | |
| Storage and exchange of DICOM
medical images | Yes | No | Yes | No |
| Display and analysis of images | Yes | Yes | Yes | Yes |
| 3D rendering and display of
images | Yes | Yes | No | Yes |
| Specific Functionality | | | | |
| Query/import/send/receive image
data per DICOM file transfer
standards | Yes | No | Yes | No |
| Store image data locally | Yes | Yes | Yes | Yes |
| Feature | Kuvia3D
(Subject
Device) | 3D-Doctor
(Predicate
Device) | ClearCanvas
(Reference
Device) | RTVue XR
(Reference
Device) |
| Features to search, display and
select image data based on
DICOM header tag information | Yes | No | Yes | No |
| Display 2D image data, including
multi-planar views | Yes | Yes | Yes | No |
| Display 3D image data | Yes | Yes | No | Yes |
| Adjust display of image data,
including zoom/scale,
window/level. | Yes | Yes | Yes | Yes |
| Segment selected regions of
interest | Yes | Yes | No | No |
| Analyze/measure images | Yes | Yes | Yes | Yes |
| Convert segmented regions to a
3D surface-rendered display | Yes | Yes | No | Yes |
| Manipulate display of 3D objects
(rotate, zoom, etc) | Yes | Yes | No | Yes |
| Color-coded thickness display of
anatomy | Yes | No | No | Yes |
| Design | | | | |
| Supported on standard, off-the-
shelf Windows platform | Yes | Yes | Yes | No |
| Conforms to DICOM standard for
data exchange | Yes | No | Yes | No |
| Conforms to JPEG standard for
lossless compress of digital
medical images | Yes | No | Yes | No |
| System comprised of client and
server software components | Yes | No | Yes | No |
The following table illustrates the comparison of specific features and functionality of Kuvia3D to the predicate devices, demonstrating substantial equivalence.
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Image /page/6/Picture/0 description: The image shows the logo for Qmetrics Technologies. The logo features a red graphic on the left that resembles a rising sun or a series of lines radiating outward. To the right of the graphic is the word "Qmetrics" in black, with the "Q" in red. Below "Qmetrics" is the word "TECHNOLOGIES" in a smaller, gray font.
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Image /page/7/Picture/0 description: The image shows the logo for Qmetrics. The logo consists of a red graphic on the left, resembling a sunrise or a series of radiating lines. To the right of the graphic is the word "Qmetrics" in bold, with the "Q" in red and the rest of the word in black. Below "Qmetrics" is the word "TECHNOLOGIES" in smaller, gray letters.
Color Coding of anatomical thickness measurements:
The color coding of cartilage thickness is equivalent to the color coding and thickness map display of corneal and ganglion cell complex structures provided by the reference device RTVue XR (K120238).
Color coding the thickness of anatomical features has also been demonstrated for more than a decade with results published in the open literature (e.g. for measuring bladder wall thickness and corneal thickness). Color coding merely provides a simplified means of rapidly assessing differences in thickness (as opposed to moving a cursor over parts of interest and reading thickness data displayed on a screen). The basic information on which the coding is based does not change. Digital data displayed and thicknesses rendered via color coding do not raise new questions of safety and effectiveness since the underlying algorithms and libraries used to generate the segmentations are the same for each.
Testing:
Kuvia3D complies with the voluntary DICOM and JPEG standards for device performance and is designed and manufactured according to engineering quality processes and standards as detailed in the 510(k) submission. Verification activities were conducted on system, unit and software component levels to validate that Kuvia3D conforms to defined product and user requirements and intended uses. Nonclinical software testing was conducted under simulated use conditions. Predefined acceptance criteria were met and demonstrate that the device is as safe and effective as the predicate devices.
Substantial Equivalence Conclusion:
Kuvia3D is substantially equivalent to the predicate device as listed in terms of intended use, specific features/functionality, and design. Color-coded display of anatomical feature size is also a feature found in reference device RTVue XR (K120238). The thickness values are presented to the user as a color-coded display, a feature similar to the predicate. This and any other difference between Kuvia3D and the predicate device do not raise any new questions of safety or effectiveness.
Conclusion:
The 510(k) Pre-Market Notification for Kuvia3D contains adequate information and data to determine that Kuvia3D is as safe and effective as the legally marketed predicate device.