Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image processing techniques like segmentation, registration, and fusion, but does not mention AI or ML. The performance studies focus on accuracy metrics typical of these traditional methods.

Therapeutic

No
The device is a software application for visualization, registration, and fusion of medical images to guide procedures, but it does not directly treat or diagnose a disease.

Diagnostic

No

The device is described as a software application for visualization, registration, and fusion of medical images to guide procedures. While it utilizes the "diagnostic capabilities of the pre-procedural planning image," its primary function is not to provide a diagnosis itself, but rather to aid in procedural guidance by mapping information from diagnostic images. Its features focus on image manipulation (segmentation, rendering, reconstruction, delineation) and fusion for practical use during a procedure, not for generating a new diagnostic interpretation.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "target3D Fusion is a software application" and the entire summary focuses on software functionalities like image processing, registration, fusion, and data management, without mentioning any accompanying hardware components that are part of the medical device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens from the human body. The intended use and device description clearly state that target3D Fusion is used for visualizing, registering, and fusing medical images (Ultrasound, MR, CT) of the prostate within the patient's body. It does not analyze samples like blood, urine, or tissue outside the body.
The purpose is image processing and guidance for procedures. The software's functions revolve around manipulating and combining medical images to assist physicians in planning and guiding procedures, not to diagnose a condition by analyzing biological samples.

Therefore, target3D Fusion falls under the category of medical imaging software or image processing software, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

LLZ

Device Description

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 ofreference 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound (US), Magnetic Resonance (MR), Computed Tomography (CT)

Anatomical Site

prostate

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physicians in a clinic or hospital

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 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%.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Average absolute volume difference errors for segmentation: 2.8525%.
Overlap between objects for affine registration: under 0.0001 mm.
Target registration error: 1.7093 mm with a standard deviation of 0.4008 mm.

Predicate Device(s)

K120187, K131448, K041182

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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,

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)