Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing, 3D reconstruction, and quantitative algorithms, but does not mention AI, ML, or related terms like deep learning or neural networks. There is also no information about training or test sets, which are typically associated with AI/ML development.

Therapeutic

No.
ILUMAVision is a software application for displaying and visualizing medical images and is not directly used for treating or diagnosing diseases.

Diagnostic

Yes
The device is described as a "preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments." This indicates its use in assessing and planning medical procedures, which falls under the definition of a diagnostic device. It also processes and visualizes medical images that are typically used for diagnosis.

SaMD (Software as a Medical Device)

Yes

The device is described solely as a software application that runs on standard PC hardware and processes medical images. There is no mention of any accompanying or integrated hardware component that is 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:

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.
ILUMAVision's Function: ILUMAVision is a software application that processes and visualizes medical images obtained from scanning devices (CT, MRI, PET, ultrasound). It works with images of the body, not with samples taken from the body.
Intended Use: The intended use describes the software's purpose as displaying, processing, and visualizing medical images for diagnosis, planning, and monitoring. This is distinct from performing tests on biological samples.

Therefore, ILUMAVision falls under the category of medical imaging software, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ILUMAVision is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.

It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.

Additionally, ILUMAVision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.

ILUMAVision is not intended for use with mammography.

Product codes

LLZ

Device Description

ILUMAVision is an image management software application used for the display and 3D visualization of medical image files obtained from scanning devices, such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) or three-dimensional (3D) ultrasound.

ILUMAVision uses image filtering, 3D reconstruction and quantitative algorithms to view, measure, and annotate images. ILUMA Vision can be used to make panoramic images and to monitor treatment progress, capture images, bookmark certain items in a treatment, generate and edit reports, and export datasets. The application can also query and import images directly from a Picture Archiving and Communication System (PACS) over a TCP/IP network.

It distributes DICOM 3.0 compliant images, using standard personal computer (PC) hardware. Images can also be saved in JPEG format.

The software is intended to run on a personal computer (PC).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, MRI, PET or 3D Ultrasound

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

radiologists, clinicians, referring physicians and other qualified individuals

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)

K081347

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

K094064

APR 3 0 2010

Premarket Notification (510(k)) Summary

1. Sponsor Information

3M IMTEC

2401 North Commerce

Ardmore, OK 73401

Ginger Cantor, RAC Contact Person: Regulatory Affairs Specialist Phone Number: (651) 733-1317 FAX Number: (651) 737-9665 e-mail: gcantor@mmm.com Date of Summary: December 29, 2009

2. Device Name and Classification:

Common or Usual Name:	Software application for medical purposes (diagnostic imaging)
Proprietary Name:	ILUMAVision, v. 2.2
Classification Name:	Picture Archiving and Communications System, Class II device, 21 CFR §892.2050
Performance Standards:	None

3. Predicate Device:

ILUMAVision, version 2.0 (K081347)

ILUMAVision 2.2 510(k) 29 Dec 2009

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4. Description of Device:

ILUMAVision is an image management software application used for the display and 3D visualization of medical image files obtained from scanning devices, such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) or three-dimensional (3D) ultrasound.

ILUMAVision uses image filtering, 3D reconstruction and quantitative algorithms to view, measure, and annotate images. ILUMA Vision can be used to make panoramic images and to monitor treatment progress, capture images, bookmark certain items in a treatment, generate and edit reports, and export datasets. The application can also query and import images directly from a Picture Archiving and Communication System (PACS) over a TCP/IP network.

It distributes DICOM 3.0 compliant images, using standard personal computer (PC) hardware. Images can also be saved in JPEG format.

The software is intended to run on a personal computer (PC).

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5. Intended Use/Indications for Use:

ILUMAVision is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.

It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.

Additionally, ILUMAVision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.

ILUMAVision is not intended for use with mammography.

Substantial Equivalent Determination 6.

Version 2.2 includes additional features of a temporal bone module, a virtual endoscope module and the functionality of exporting directly from the application

The additional software features have been suitably verified and validated; the table below identifies the equivalence between the modified ILUMAVision software (v. 2.2) and the cleared predicate ILUMA Vision software (v. 2.0).

While new features have been added, ILUMA Vision version 2.2 as modified in this pre-market notification submission has the same intended use, same intended users and indications for use as the predicate device ILUMA Vision version 2.0.

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| Feature | ILUMAVision
version 2.0
(Predicate- K081347) | ILUMAVision
version 2.2
(This submission) | Comment |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Indications for Use | A software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.

Intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.

Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.

ILUMA Vision is not intended for use with mammography. | A software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.

Intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.

Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.

ЗМ ІМТЕС

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Substantial Equivalence Summary Table
Feature	ILUMAVision
version 2.0
(Predicate- K081347))	ILUMAVision
version 2.2
(This submission)	Comment
Printing	Print to standard PC
connected printers	Print to standard PC
connected printers	No change from
original 510(k)
Import from PACS	Not in original 510k	New functionality	New feature
Export to PACS	Not in original 510k	New functionality	New feature
Volume Rendering	Radiographic Projection,
Surface rendering, Fly-
through	Radiographic Projection,
Surface rendering, Fly-
through	No change from
original 510(k)
Image Edit	Multi-tissue opacity
control, volume
sculpting, segmentation	Multi-tissue opacity
control, volume
sculpting, segmentation	No change from
original 510(k)
Region of Interest
(ROI)/Volume of Interest
(VOI)	2D region and 3D
volume of interest
selection tools	2D region and 3D
volume of interest
selection tools	No change from
original 510(k)
2D Measurements	2D measurement tools
including distance and
angle	2D measurement tools
including distance and
angle	No change from
original 510(k)
3D Measurements	3D measurement tools
including distance and
angle	3D measurement tools
including distance and
angle	No change from
original 510(k)
Implant Planning	Tools for pre-surgical
planning of dental
implant placement	Tools for pre-surgical
planning of dental
implant placement	No change from
original 510(k)
Stent Fabrication	Tools for pre-surgical
fabrication of stents to
aid dental implant
insertion	Not a current feature-
Note: Feature was never
incorporated into final
release of original cleared
ILUMA Vision, version
2.0	No change from
original 510(k)
Orthodontic Treatment
Planning	Tools for planning
orthodontic treatment	Tools for planning
orthodontic treatment	No change from
original 510k
Temporal Bone Module	This module is used to
isolate and examine the
temporal bone	New feature- not in
original 510(k)	New feature
Endoscope Module	This module allows the
user to perform a virtual
endoscopy	New feature - not in
original 510(k)	New feature

.

:

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three parallel lines instead of a single staff.

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

3M IMTEC % Ms. Ginger Cantor, RAC Regulatory Affairs Specialist 3M ESPE Dental Products 3M Center, Building 275-2W-08 ST. PAUL MN 55144

Re: K094064

APR 30 2010

Trade/Device Name: ILUMA Vision (Version 2.2) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 29, 2009 Received: December 31, 2009

Dear Ms. Cantor:

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.

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 comply with 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 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,

tmill

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K094064

Device Name: ILUMA Vision (Version 2.2)

Indications for Use:

ILUMAVision is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.

It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.

Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.

ILUMAVision is not intended for use with mammography.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Tobe B. Becker
(Division Sign-Off)

(Division Sign 7)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K094064

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