Who is the manufacturer of TARGET3D FUSION?

Convergent Life Sciences, Inc. filed the 510(k) submission for TARGET3D FUSION (K140033).

What is the FDA product code for TARGET3D FUSION?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for TARGET3D FUSION?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TARGET3D FUSION?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TARGET3D FUSION

Q: What are the predicate devices for TARGET3D FUSION?

Multi-Modality Image Fusion (K120187); UROSTATION-3D Prostate Suite (K131448); Syntegra (K041182).

K140033 · Convergent Life Sciences, Inc. · LLZ · Feb 27, 2014 · Radiology

Device Facts

Record ID	K140033
Device Name	TARGET3D FUSION
Applicant	Convergent Life Sciences, Inc.
Product Code	LLZ · Radiology
Decision Date	Feb 27, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device, 3rd-Party Reviewed

Intended Use

target3D Fusion is a software application intended to be used by physicians in a clinic or hospital for visualization in 2D and 3D, registration, and fusion of Ultrasound (US), Magnetic Resonance (MR) and Computed Tomography (CT) images of the prostate. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ and regions of interest delineation, landmark selection, measurements, patient database management, and data reporting.

Device Story

target3D Fusion is a PC-based software application for prostate image guidance. It inputs pre-procedural DICOM images (MR/CT) and intra-procedural live ultrasound images. The software allows physicians to segment the prostate gland and identify regions of interest (ROIs) on pre-procedural images, storing them as surface meshes. It performs image registration using a combination of rigid, affine, and non-rigid (elastic) algorithms to map planning data onto live ultrasound frames. The output is a fused overlay displayed to the physician for real-time guidance during procedures. Used in clinics or hospitals by physicians, the device aids in anatomical delineation and target area identification, potentially improving procedural accuracy and clinical decision-making.

Clinical Evidence

Bench testing only. Segmentation accuracy: average absolute volume difference error of 2.8525%. Affine registration accuracy: errors measured as overlap between objects were under 0.0001 mm. Overall registration accuracy (manual, affine, and non-rigid): target registration error (TRE) measured using phantom beads was 1.7093 mm (SD 0.4008 mm).

Technological Characteristics

PC-based software running on Windows OS. Features include 2D/3D visualization, multi-modality DICOM image fusion, surface/volume rendering, multi-planar reformatting, and organ/ROI segmentation. Registration utilizes a combination of rigid, affine, and non-rigid (elastic) algorithms. Connectivity via standard DICOM data communication.

Indications for Use

Indicated for use by physicians in clinical or hospital settings for 2D/3D visualization, registration, and fusion of prostate US, MR, and CT images to assist in prostate procedures.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Multi-Modality Image Fusion (K120187)
UROSTATION-3D Prostate Suite (K131448)
Syntegra (K041182)

Related Devices

K170250 — SmartTarget · Smarttarget, Ltd. · Jun 7, 2017
K131448 — 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION · Koelis · Jul 26, 2013
K250664 — Navigo Workstation 2.3 (FPRMC00039) · UC-CARE , Ltd. · Aug 7, 2025
K173054 — Navigo Workstation Version 2.0 · UC-CARE , Ltd. · Jan 16, 2018
K100793 — UROSTATION 3D PROSTATE SUITE · Koelis · Sep 22, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ | Submitter's Name: | Convergent Life Sciences, Inc. | | | | | |----------------------------|------------------------------------------------------------------------------------------------|--|--|--|--| | Submitter's Address: | 2377 Gold Meadow Way, Suite 160, Gold River, CA 95670 | | | | | | Submitter's Telephone: | 916-526-2775 | | | | | | Contact Name: | Dinesh Kumar | | | | | | Date Summary was Prepared: | 11/18/2013 | | | | | | Trade or Proprietary Name: | target3D Fusion | | | | | | Common or Usual Name: | target3D Fusion | | | | | | Classification Name: | System, Image Processing, Radiological Picture Archiving and Communications, 21CFR 892.2050 | | | | | | Device Class: | II | | | | | | Product Code: | LLZ | | | | | | Predicate Devices: | Device Name 510(k) Number Multi-Modality Image Fusion K120187 | | | | | UROSTATION-3D Prostate Suite K131448 K041182 ## Intended Use target3D Fusion is a software application intended to be used by physicians in a clinic or hospital for visualization in 2D and 3D, registration, and fusion of Ultrasound (US), Magnetic Resonance (MR) and Computed Tomography (CT) images of the prostate. The software features also include multi-modality data communication, surface and volume . a rendering, segmentation, multi-planar reconstruction, organ and regions of interest delineation, landmark selection, measurements, patient database management, and data reporting. ## Description of the Device and Summary of the Technological Characteristics Syntegra target3D Fusion is a software application, which allows a physician to segment the prostate gland, and identify and label various structures including regions of interest (ROIs) on a pre-procedural DICOM image. The software further allows a physician to fuse the prepared pre-procedural DICOM image files with one or more intra-procedure live DICOM image files to guide the procedure. The software can delineate the gland boundary as well the boundaries of any other anatomical landmarks on a pre-procedure DICOM image. The structures including regions of interest are identified using visualization, and stored as standard surface format meshes. Each such structure is labeled uniquely. target3D Fusion provides a physician with image fusion such that the information from a pre-procedure or planning imaging modality such as MR or CT is mapped to the frame of {1}------------------------------------------------ reference of the intra-procedure or live imaging modality such as ultrasound for real-time guidance while taking advantage of diagnostic capabilities of the pre-procedural planning image. The mapped information contains at least one structural image, and the target area to be treated. The pre-procedure image is registered with the intra-procedure image using a combination of rigid, affine and non-rigid elastic registration provides a correspondence or a deformation map, which is used to map planning information from the frame of reference of the planning image to an intra-procedure image. # Substantial Equivalence target3D Fusion product's technological features are substantially equivalent to its predicate devices. Table 5.1 shows the comprehensive comparison of the features and technological characteristics of target3D Fusion with the predicates. The table shows that all of them: - are PC based software applications, ● - run on Windows operating system, . - . provide 2D and 3D medical image acquisition and visualization, - . fuse (co-register) pre-procedure medical images in DICOM formats with intra-procedure medical images, - . provide data communication between imaging modalities, - . provide surface and volume rendering, - . provide multi-planar reformatting, - . allow for organ and regions of interest delineation/segmentation, - . include image enhancements such as zoom controls, and - . incorporate patient database management. target3D Fusion differs in the following feature from its predicate devices. However, this does not cause any safety or effectiveness concerns: - . target3D Fusion uses a patented co-registration/fusion algorithm, which uses a combination of rigid, affine and non-rigid (elastic) registration. {2}------------------------------------------------ | Product | target3D Fusion | Multi-Modality Image Fusion | UROSTATION-3D Prostate Suite | Syntegra | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Convergent Life Sciences | Eigen | Koelis | ADAC Laboratories | | 510(k) Number | pending | K120187 | K131448 | K041182 | | Intended Use | target3D Fusion is a software application intended to be used by physicians in a clinic or hospital for visualization in 2D and 3D, registration, and fusion of Ultrasound (US), Magnetic Resonance (MR) and Computed Tomography (CT) images of the prostate. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi- planar reconstruction, organ and regions of interest delineation, landmark selection, measurements, patient database management, and data reporting. | Multi-Modality Image Fusion is a software application used by physicians in the clinic or hospital for 2-D and 3-D visualization, multi-modality image registration, and fusion of medical images. Additional software features include database management, communication, surface rendering, segmentation, ROI delineation, measurements, and reporting. | UROSTATION - 3D PROSTATE SUITE With MRI/3DTRUS fusion option and with Second Look 3D)TRUS fusion option is intended to be used by physicians in the clinic or hospital for 2D and 3D) visualization of the prostate gland and for the 3D) transrectal ultrasound based fusion of multiple imaging modalities (ultrasound, MRZI) in order to map such prostate gland. Additional software features include patient data management, multimodal data communication, multiplanar reconstruction, surface and volume rendering, organ delineation, region of interest delineation, 3D3 image registration and data reporting. | Syntegra is a software application for multi- modality image registration and diagnostic fusion. Images are registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined functional and anatomical data providing different angular perspectives for interpretation by trained professionals. | | Product Type | Software | Software | Software | Software | | Software Platform | PC running Windows OS | PC running Windows OS | PC running Windows OS | PC running Windows OS | | Product Usage | Clinic or hospital | Clinic or hospital | Clinic or hospital | Clinic or hospital | . {3}------------------------------------------------ | | setting | setting | setting | setting | |-----------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------| | Product | target3D Fusion | Multi-Modality Image Fusion | UROSTATION-3D Prostate Suite | Syntegra | | Manufacturer | Convergent Life Sciences | Eigen | Koelis | ADAC Laboratories | | 510(k) Number | pending | K120187 | K131448 | K041182 | | Visualization of Images | 2D and 3D | 2D and 3D | 2D and 3D | 2D and 3D | | Image Fusion/Registrat ion | Multiple modality image fusion | Multiple modality image fusion | Multiple modality image fusion | Multiple modality image fusion | | Display of Image Fusion | Fused overlay of images from different modalities | Fused overlay of images from different modalities | Fused overlay of images from different modalities | Fused overlay of images from different modalities | | Data Communication between Imaging Modalities | Yes | Yes | Yes | Yes | | Surface Rendering | Yes | Yes | Yes | Yes | | Volume Rendering | Yes | Yes | Yes | Yes | | Multi-planar reformatting | Yes | Yes | Yes | Yes | | Gland Segmentation | Yes | Yes | Yes | Yes | | Regions of Interest Segmentation (Delineation) | Yes | Yes | Yes | Yes | | Configurable Image Layouts | Yes | Yes | Yes | Yes | | Image Enhancements | Yes | Yes | Yes | Yes | ## Summary of Testing and Performance Data The software was tested against the engineering specifications and additional requirements arising from risk management activities. In addition, the software was rigorously tested and debugged as part of product development lifecycle. The following bench tests were conducted to meet the product requirements and customer expectations: - Segmentation Accuracy: Performance tests for segmentation compared segmentation algorithms in target3D Fusion with ground truth data. Average absolute volume difference errors were found to be 2.8525%. {4}------------------------------------------------ - · · Affine Registration Accuracy: Affine registration tests were performed to recover synthetic deformations between surfaces. The errors measured as the overlap between objects being registered were found to be under 0.0001 mm. - Overall Registration Accuracy: Registration errors for the entire system that included . manual, affine and non-rigid registration were measured by registering multimodality images of phantoms containing beads used as landmarks for computing target registration error. Target registration error measured as the average distance between beads across datasets was found to be 1.7093 mm with a standard deviation of 0.4008 mm. ## Conclusion Substantial equivalence comparison including intended use, function, specifications and technological characteristics of target3D Fusion with the predicate devices demonstrates that target3D Fusion is substantially equivalent to the listed predicates. {5}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heatth Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 27, 2014 Convergent Life Sciences, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1934 25th Street NW BUFFALO MN 55313 Re: K140033 Trade/Device Name: target3D Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: 11 Product Code: LLZ. Dated: February 11, 2014 Received: February 12, 2014 Dear Mr. Job: 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. Iisting of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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. FIDA 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. {6}------------------------------------------------ Page 2-Mr. Job If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.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 Small Manufacturers, International and Consumer Assistance 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, ![](https://i.imgur.com/999999999.png) for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. ### 510(k) Number (if known) K140033 Pending #### Device Name イ target3D Fusion #### Indications for Use (Describe) target >> Fusion is a software application intended to be used by physicians in a clinic or hospital for visualization in 2D and 3D, registration. and fusion of Ultrasound (US). Magnetic Resonance (MR) and Computed Tomography (CT) inages of the prossate. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ and regions of interest delinent selection, measurements, patient database management, and data reporting. Type of Use (Select one or both, as applicable) [8] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) FORM FDA 3881 (1/14)