Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image processing and registration techniques without mentioning AI/ML algorithms.

Therapeutic

No
This device is a software application for image visualization, registration, and fusion, used for mapping planning information. It does not directly provide therapy or therapeutic interventions.

Diagnostic

Yes
The device is described as "Multi-Modality Image Fusion is a software application to be used by physicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of MRI, CT and Ultrasound imaging modalities for mapping planning information across modalities." It aims to provide mapping planning information to physicians, which is a key function of diagnostic devices. Although the provided information does not explicitly state it as "diagnostic," the nature of processing and presenting medical images for physicians to use in mapping planning strongly implies a diagnostic purpose.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that the device is "software, which comprises of two software components". While performance studies mention "MMIF Hardware verification Test Procedure" and "complete system consisting of both the online and off line software installed on specified hardware", the core device being submitted for 510(k) is described as software. The hardware is likely the platform on which the software runs, not part of the regulated device itself.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for "2-D and 3-D visualization, image registration, and fusion of MRI, CT and Ultrasound imaging modalities for mapping planning information across modalities." This describes a tool for image processing and planning, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on software for image preparation, fusion, and visualization. It doesn't mention any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests. The focus is entirely on medical imaging data.

Therefore, this device falls under the category of medical imaging software, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Multi-Modality Image Fusion is a software application to be used by physicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of MRI, CT and Ultrasound imaging modalities for mapping planning information across modalities. Additional software features include database management, data communication, surface rendering, segmentation, regions of interest (ROI) delineation, volumetric measurements, and data reporting.

Product codes

LLZ

Device Description

Multi-Modality Image Fusion (MMIF) is software, which comprises of two software components, which is referred to as offline and online. The offline component perfains to the preparation of gland and suspected lesion boundaries on a DICOM image file days or hours prior to the biopsy procedure. The online component fuses the DICOM image files, which were, prepared on the offline component, with a snap shot incoming TRUS image. Each of the two software components can work together or independently.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MRI, CT, Ultrasound

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physicians in the 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

The conducted verification tests have confirmed static and dynamic performance of the complete system consisting of both the online and off line software installed on specified hardware. Furthermore these tests establish compliance to the specification under conditions simulation real environment of use.

Summary of Performance Studies

Bench performance tests, functionality tests, and system test were successfully completed.
Testing activities were conducted to establish the performance, safety, effectiveness, functionality usability, and reliability characteristics of the new device.
The purpose of the performance testing (bench testing) was to ensure the performance of the new MMIF software by verifying the accuracy of the specifications and simulating real customer data collected from the hospital setting.
Tests performed:

MMIF Hardware verification Test Procedure
MMIF Online Verification Test Procedure
MMIF Offline Software Application Verification Test Procedure
MMIF Risk Mitigation Verification Test Procedure
Registration Accuracy for Clinical Data (bench test)
Phantom Volume Measurements (bench test)
Phantom Registration Accuracy (bench test)

Key Metrics

Not Found

Predicate Device(s)

K041182, K081987, K093672, K053610

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

510(k) Summary

APR - 6 2012

510(k) Summary

Submitter's Name: Submitter's Address: Submitter's Telephone: Contact Name:

Date Summary was Prepared: Trade or Proprietary Name: Common or Usual Name: Classification Name:

Predicate Devices:

IGT, LLC dba Eigen 13366 Grass Valley Avenue, Grass Valley, CA 95945 530-274-1240 . William Mandel 21 Oct 2011

Multi-Modality Image Fusion Multi-Modality Image Fusion

System, Image Processing, Radiological, LLZ

Picture Archiving and Communications, 21CFR 892.2050

Device Name	510(k) Number
Syntegra	K041182
UniSyn	K081987
Aegis Navigation	K093672
Abaris	K053610

Intended Use

Multi-Modality Image Fusion is a software application to be used by physicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of MRI, CT and Ultrasound imaging modalities for mapping planning information across modalities. Additional software features include database management, data communication, surface rendering, segmentation, regions of interest (ROI) delineation, volumetric measurements, and data reporting.

Description of the Device and Summary of the Technological Characteristics:

Multi-Modality Image Fusion (MMIF) is software, which comprises of two software components, which is referred to as offline and online. The offline component perfains to the preparation of gland and suspected lesion boundaries on a DICOM image file days or hours prior to the biopsy procedure. The online component fuses the DICOM image files, which were, prepared on the offline component, with a snap shot incoming TRUS image. Each of the two software components can work together or independently.

Offline Software

The offline software can delineate suspected areas of interest using visualization and save this data in a standard format, e.g. as a surface mesh in VTK or STL format. Furthermore, the

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offline software can ontionally delineate the gland boundary from a DICOM image, or other volumes where the boundary can be easily observed. This addition data is also saved in a standard format. e.g. surface mesh in VTK or STL or as a binary volume. This software would be typically executed by Radiologists.

Online Software

The online unit software is designed to fuse two images by entering a fusion mode and load the DICOM image and the boundary data provided by the offline unit. The online unit performs rigid alignment, either selecting globally align that orients the two DICOM volumes based on the known relative orientation difference between the two or specify landmarks to register images rigidly. The online unit then elastically warps the image to register on the incoming image from the offline unit.

The registered image volume is displayed on the incoming offline image frame of reference. Also overlaid on the incoming offline and registered image volumes annotating the suspected lesion boundaries. The two volumes are displayed side-by-side in a locked view. Rotation, slicing, panning, or zooming one of the volumes has the same effect on the other enabling visualization of similar features in both volumes simultaneously.

Plan targets on the volumes by selecting suitable locations within the suspected areas of interest boundary. When sufficient targets have been added, exiting fusion mode imports all targets planned in the offline frame of reference back to the original reconstructed ultrasound volume. This is done based on the deformation field that was estimated from registration (rigid followed by elastic registration).

Substantial Equivalence:

| Manufactu
rer | Eigen | ADAC
Laboratories | Convergent
Imaging
Solutions | Sentinelle Medical
Inc. | Traxtal
Technologies lhc. |
|------------------|------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------|
| Product
Name | Multi-Modality
Image Fusion | Syntegra | UniSyn | Aegis Navigation | Abaris |
| 510(k)
number | pending | K041182 | K081987 | K093672 | K053610 |
| Intended
Use | Multi-Modality
Image Fusion is a
software
application used by | Syntegra is a
software
application for
multi-modality | UniSyn is a
software
application for
image | This device
provides two and
three-dimensional
image review. | ABARIS is a
stereotaxic
accessory for
Computed |

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physicians in the	image registration	registration and	manipulation, and	Tomography
clinic or hospital	and diagnostic	fusion display	analysis tools to	(CT), Magnetic
for 2-D and 3-D	fusion. Images are	of scanned	assist users in	Resonance, (MR),
visualization,	registered and	image data	screening,	Ultrasound (US),
multi-modality	displayed in a	from CT, PET,	diagnosis, planning	Positron Emission
image registration,	"fused" (overlaid	SPECT and	and performing	Tomography
and fusion of	in the same spatial	MR scanners.	image-guided	(PET), Single
medical images.	orientation)	UniSyn creates	interventional	Photon Emission

Additional	format to provide	multi-planar	procedures.	Computed
software features
include database	combined	reformat and	Supported imaging	Tomography
	functional and	maximum	modalities include	(SPECT),
management,	anatomical data	intensity	Magnetic	Fluoroscopy,
communication.	providing	projection	Resonance (MR),	Endoscopy and
surface rendering,	different angular	displays of the	Ultrasound (US),	other imaging
segmentation, ROI	perspectives for	data and	Single Photon	systems. it
delineation,	interpretation by	provides	Emission	displays the
measurements, and	trained	measurements	Computed	simulated image
reporting.	professionals	such as area,	Tomography	of a tracked
		volume and	(SPECT),	insertion tool
		Standard	Computed	such as a biopsy
		Uptake Values	Tomography (CT),	needle, guidewire
		for user defined	Positron	or probe on a
		regions on the	Emission	computer monitor
		image	Tomography	screen that shows
			(PET),	images of the
			Fluoroscopy and	target organs and
			Endoscopy. Images	the current and the
			and data are	projected future
			received from	path of the
			various imaging	interventional
			systems and other	instrument taking
			sources such as	into account
			calibrated spatial	movements of the
			positioning	patient. This is
			devices.	intended for
			This device	treatment
			provides the	planning and
			capability to	intra-operative
			overlay annotations	guidance for
			on 2D or 3D	surgical
			medical image	procedures.
			displays.	The device also
			These annotations	supports an
			may represent the	image-free mode
			position of	in which the
			instruments	proximity of the
			including but not	interventional
			limited to biopsy	device is
			needles, guidance	displayed relative
			wires, imaging	to another device.
			probes or other	The device is
			tracked devices.	intended to be
			This device is	used in clinical
			intended to assist	interventions and
			skilled medical	for anatomical
			professionals in	structures where
					skilled medical
professionals in
clinical screening
and	clinical screening	for anatomical
structures where
imaging is
currently used for	imaging is

.

510(k) Summary

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				510(k) Summary

				interventions, for
anatomical
structures where
imaging is
currently used for
visualizing such
structures,
including head and
neck, breast,
thoracic, and
abdominal
applications
(including	visualizing such
procedures. The
device is also
intended for use
in clinical
interventions to
determine the
proximity of
one device
relative to
another.
				pelvis).
Lossy compressed
mammographic
images and
digitized film
screen images must
not be
				reviewed for
primary image
interpretations.
Mammographic
images may only
be interpreted
using
				a FDA approved
monitor that offers
at least 5 MPixel
resolution and
meets other
technical
				specifications
reviewed and
accepted by the
FDA.
Where
Used	Office settings in
clinic or hospital	Office settings in
clinic or hospital	Office settings
in clinic or
hospital	Not specified	clinical
interventions
Software
Device	Yes	Yes	Yes	Yes	Yes
Image
Registratio
n	Multi-modality
image registration	Multi-modality
image registration	Multi-modality
image
registration	Multi-modality
image registration	Yes
Image
Fusion
/Overlay
Display	Fused overlay of
images from
multiple modalities	Fused overlay of
images from
multiple
modalities	Fusion overlay
of images from
multiple
modalities	overlay of images
from multiple
modalities	Yes
Opacity
Control	Yes	Yes	Yes	Not Specified	Not Specified
3-D
Rendering	Yes	Yes	Yes	Yes	Yes
Surface
Rendering	Yes	Yes	Yes	Yes	Yes
Regions of
interest	Yes	Yes	Yes	Yes	Yes
Configura	Yes	Yes	Yes	Yes	Yes

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510(k) Summary

ble image layouts
3D
Contouring	Yes	Not Specified	Yes	Yes	Yes
Export of
3D contours
for
planning	Yes	Not Specified	Yes	Not Specified	Yes
Image
Storage
and
Communication	DICOM, JPEG	DICOM (check)	DICOM	DICOM	DICOM
Modalities	CT, MRI,
Ultrasound	Positron Emission
Tomography
(PET) and
X-ray Computed
Tomography
(CT).	CT, PET,
SPECT and
MR scanners	MRI, US, SPECT,
CT, PET,
Fluoroscopy,
Endoscopy and
others	Computed
Tomography
(CT), Magnetic
Resonance, (MR),
Ultrasound (US),
Positron Emission
Tomography
(PET), Single
Photon Emission
Computed
Tomography
(SPECT),
Fluoroscopy,
Endoscopy and
other imaging

The product's technical features are substantially equivalent to Syntegra (K041182). UniSyn (K081987), Aegis Navigation (K093672) and Abaris (K053610). The Multi-Modality Image Fusion is a software product that runs on PC-based workstations. Image data is input to the devices and used to generate 3-D views and perform image processing. Like the four predicate devices, the software has image measurement, multi-planar reformatting, segmentation and image registration abilities, fusion of images from different modalities, image storage and retrieval, as well as patient information management functions.

The Syntegra and UniSyn are software products that accept multiple image data types including magnetic resonance, and computed tomography. Aegis Navigation and Abaris are systems that accept multiple modalities that include magnetic resonance, computed tomography and ultrasound. The Multi-Modality Image Fusion has been designed for processing medical images in standard DICOM format. The system is composed of two modules: an offline and an online module for image fusion for planning a procedure.

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Testing and Performance Data:

All product and engineering specifications were verified and validated. Test phantoms incorporating simulated prostates were developed and were used to verify system performance.

The device has been designed and manufactured to conform to the following standards:

ACRINEMA PS3.1-3.18 Digital Imaging and Communications in Medicine (DICOM)

ISO 14971 Application of Risk Management to Medical Devices

ISO 13485 Medical Devices - Quality Management Systems - Requirements For Regulatory purposes

The following tests were performed:

MMIF Hardware verification Test Procedure

MMIF Online Verification Test Procedure

MMIF Offline Software Application Verification Test Procedure .

MMIF Risk Mitigation Verification Test Procedure

Registration Accuracy for Clinical Data (bench test)

Phantom Volume Measurements (bench test)

Phantom Registration Accuracy (bench test)

All the above mentioned tests passed. Theses testing activities were conducted to establish the performance, safety, effectiveness, functionality usability, and reliability characteristics of the new device.

The purpose of the performance testing (bench testing) was to ensure the performance of the new MMIF software by verifying the accuracy of the specifications and simulating real customer data collected from the hospital setting.

The conducted verification tests have confirmed static and dynamic performance of the complete system consisting of both the online and off line software installed on specified hardware. Furthermore these tests establish compliance to the specification under conditions simulation real environment of use.

Conclusion:

The results of comparing the intended use, function, technological characteristics, mode of operation and specifications of the Multi-Modality Image Fusion with those of the two predicate devices demonstrate that the Multi-Modality Image Fusion is substantially

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equivalent to existing products on the market today.

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ﺎ ﺳﮯ ﺍ

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

·

The verification and validation testing included bench performance tests, functionality tests, and system test. All tests were successfully completed.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

APR - 6 2012

IGT LCC dba Eigen % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN. 55313

Re: K120187

Trade/Device Name: Multi-Modality Image Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications System Regulatory Class: II Product Code: LLZ Dated: March 1, 2012 Received: March 2 2012

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls: Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or uny 1 vict all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

9

Indications for Use Form

510(k) Number (if known):

Device Name: Multi-Mogality Image Fusion

Indications for Use: Multi-Modality Image Fusion is a software application to be used by physicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of MRI, CT and Ultrasound imaging modalities for mapping planning information across modalities. Additional software features include database management, data communication, surface rendering, segmentation, regions of interest (ROI) delineation, volumetric measurements, and data reporting.

Prescription Use (Part 21 CFR 801 Subpart D)	X
	AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE OF ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) K120187

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