SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING

K112778 · Varian Medical Systems · IYE · Dec 29, 2011 · Radiology

Device Facts

• Record ID: K112778
• Device Name: SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING
• Applicant: Varian Medical Systems
• Product Code: IYE · Radiology
• Decision Date: Dec 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Smart Segmentation - Knowledge Based Contouring provides a combined atlas and model based approach for automated and manual segmentation of structures including target volumes and organs at risk to support the radiation therapy treatment planning process.

Device Story

Smart Segmentation - Knowledge Based Contouring is a software-only product used in clinical radiation therapy planning. It utilizes a combined atlas and model-based approach to automate the segmentation of target volumes and organs at risk. The system includes a searchable library of expert-contoured cases, which can be filtered by anatomy, staging, or free text. Expert cases are registered to the target patient image, and structures are propagated to the new image. The device provides tools for manual contouring, editing, and deformation of structures. It supports inter- and intra-user consistency. The device does not perform dose calculations or treatment plan simulations; instead, it exports contouring information to external treatment planning software. It is intended for use by healthcare professionals involved in the radiation therapy planning process. By providing automated, consistent segmentation, the device aims to improve the efficiency and accuracy of the contouring process, ultimately supporting the delivery of radiation therapy.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technical performance comparisons, software verification, and validation of the segmentation algorithms against established clinical standards and predicate device functionality.

Technological Characteristics

Software-only product. Features include atlas and model-based segmentation, deformable registration, and an expert case database. Connectivity via DICOM standards. Operates as a module within a radiation therapy planning environment. No hardware components. Sterilization and material standards are not applicable.

Indications for Use

Indicated for automated and manual segmentation of anatomical structures, including target volumes and organs at risk, to support radiation therapy treatment planning for patients requiring such therapy.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• IKOEngelo™ Radiation Therapy Simulation System (K083591)
• Eclipse Treatment Planning System (K071873)

Submission Summary (Full Text)

{0}------------------------------------------------

K112778

# Premarket Notification [510(k)] Summary Smart Segmentation Knowledge Based Contouring

DEC 2 9 2011

The following information is provided following the format of 21 CFR 807.92.

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way E-110<br>Palo Alto, CA 94304<br>Contact Name: Vy Tran |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone]<br>Date: September 2011 |
| Proprietary Name: | Smart Segmentation - Knowledge Based Contouring |
| Classification Name: | Medical charged-particle radiation therapy system<br>21 CFR 892.5050, Class II<br>Product Code: 90 IYE |
| Common/Usual Name: | Smart Segmentation KBC |
| Predicate Device: | IKOEngelo™ Radiation Therapy Simulation System: (K083591)<br>Eclipse Treatment Planning System: (K071873) |
| Device Description: | Smart Segmentation - Knowledge Based Contouring is a software only<br>product that provides a combined atlas and model based approach to<br>automated segmentation of structures together with tools for manual<br>contouring or editing of structures. A library of already contoured expert<br>cases is provided which is searchable by anatomy, staging, or free text.<br>Users also have the ability to add or modify expert cases to suit their<br>clinical needs. Expert cases are registered to the target image and<br>selected structures propagated. Smart Segmentation Knowledge Based<br>Contouring supports inter and intra user consistency in contouring. This<br>product also provides an anatomy atlas which gives examples of<br>delineated organs for the whole upper body, as well as anatomy images<br>and functional description for selectable structures. It is not used to<br>simulate plans or calculate dose. The contouring information is<br>exported to the treatment planning software device. |
| Statement of Intended Use | Smart Segmentation - Knowledge Based Contouring provides a<br>combined atlas and model based approach for automated and manual<br>segmentation of structures including target volumes and organs at risk<br>to support the radiation therapy treatment planning process. |
| Statement of Indications for Use: | Smart Segmentation - Knowledge Based Contouring provides a<br>combined atlas and model based approach for automated and manual<br>segmentation of structures including target volumes and organs at risk<br>to support the radiation therapy treatment planning process. |
| Technological Characteristics: | Refer to the Substantial Equivalence Comparison Chart |

{1}------------------------------------------------

| | Predicate Device<br>IKOEngelo<br>K083591 | Predicate Device<br>Eclipse with Smart Segmentation<br>K071873 | New Device<br>Smart Segmentation -<br>Knowledge Based Contouring |
|----------------------------------------------------------------|------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------|
| General Usage | | | |
| Support for External beam PHOTON planning | yes | yes | yes |
| Support for External beam PHOTON inverse planning | yes | yes | yes |
| Support for External beam ELECTRON planning | yes | yes | yes |
| Support for External beam PROTON planning | yes | yes | yes |
| Automated Structure Deliniation | yes | yes | yes |
| Graphical User Interface | | | |
| Three View Layout | yes | yes | yes |
| Four View Layout (ortho & 3d) | no | yes | yes |
| 3d volume rendering | no | yes | yes |
| 3d volume MIP rendering | no | yes | yes |
| 3d volume MIP (rotating) rendering | no | yes | yes |
| 3d mesh rendering | no | yes | yes |
| 3d multiplane rendering single image | yes | yes | yes |
| 3d multiplane rendering blended image | no | yes | yes |
| 3d segments rendering | yes | yes | yes |
| Pixel Info Tool | yes | yes | yes |
| Distance Tool | yes | yes | yes |
| Pan Image | yes | yes | yes |
| Adjust window / level | yes | yes | yes |
| Angle Tool | yes | yes | yes |
| Area Profile Tool | no | yes | yes |
| Histogram Tool | yes | yes | yes |
| Select Structure Tool | yes | yes | yes |
| Planar Contour Drawing Tool | yes | yes | yes |
| Brush Tool | yes | yes | yes |
| Diffusion Brush Tool | no | yes | yes |
| Volumetric Contour Drawing Tool | no | yes | yes |
| Deform Structure Tool | no | no | yes |
| Image Threshold Tool | yes | yes | yes |
| PET Subvolume Threshold Tool | no | yes | yes |
| Boolean Structure Operations | yes | yes | yes |
| | | | |
| Auto Match 3d (rigid) | yes | yes | yes |
| Manual Match (rigid) | yes | yes | yes |
| Automatic Deformable Registration | yes | no | yes |
| Region og interest selection | yes | yes | yes |
| Structure Editing | | | |
| Clear Structure | yes | yes | yes |
| Delete Structure | yes | yes | yes |
| Delete Structure Set | yes | yes | yes |
| Copy Structure to registered image | yes | yes | yes |
| Duplicate structure | yes | yes | yes |
| Set Structure Status | no | yes | yes |
| Change Structure ID | yes | yes | yes |
| Change Structure color & Style | yes | yes | yes |
| Show PET Patient Data | no | yes | yes |
| Structure Segmentation and Expert Case Selection | | | |
| Default to algorithm based segmentation for certain structures | no | yes (algorithm based is only option) | yes |
| Expert Case browser | yes | no* | yes |
| Expert case search - filters | yes | no* | yes |
| Expert case search - free text search | no | no* | yes |
| Expert case search - add / remove bookmarks | yes | no* | yes |
| Expert opinion text display | yes | no* | yes |
| Add new customer case to database | no | no* | yes |
| Modify existing expert case on database | no | no* | yes |
| Generate thumbnail preview for expert case | yes | no* | yes |
| Anatomy text book display | yes | no* | yes |
| Connectivity | | | |
| DICOM compatibility | yes | yes | yes |

·

၊

:

{2}------------------------------------------------

Note: Eclipse with Smart Segmentation does not have an expert library for structure segmentation

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

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

DEC 2 9 2011

Ms. Vy Tran Vice President, Corporate Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way E-110 PALO ALTO CA 94304

Re: K112778

Trade/Device Name: Smart Segmentation-Knowledge Based Contouring Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 13, 2011 · Received: December 16, 2011

Dear Ms. Tran:

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 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 (reporting of

{4}------------------------------------------------

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### Smart Segmentation Knowledge Based Contouring

## Indications for Use

510(k) Number (if known): 上川2778/5001

Smart Segmentation - Knowledge Based Contouring Device Name:

Indications for Use:

Smart Segmentation - Knowledge Based Contouring provides a combined atlas and model based approach for automated and manual segmentation of structures including target volumes and organs at risk to support the radiation therapy treatment planning process.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

Mary Slastel

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

K112778/5001

ETPS_510(k) _Indications

કારમ

Date: June 30, 2010