SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING

K133227 · Varian Medical Systems, Inc. · IYE · Mar 14, 2014 · Radiology

Device Facts

• Record ID: K133227
• Device Name: SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Mar 14, 2014
• 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 (SS-KBC) is a software-only product for radiation therapy treatment planning. It utilizes a combined atlas and model-based approach to automate the segmentation of anatomical structures, target volumes, and organs at risk. The system includes a searchable library of expert-contoured cases, which users can modify or supplement. Expert cases are registered to target images to propagate contours. The device supports 4D-CT data sets and includes a specific algorithm for mandible segmentation. Clinicians use the software to perform or edit segmentations, ensuring inter- and intra-user consistency. Output consists of delineated structures used in treatment planning. The device is intended for use by radiation oncology professionals to improve the efficiency and consistency of the contouring process, ultimately supporting precise radiation delivery.

Clinical Evidence

No clinical data. Verification and validation testing were performed on a production-equivalent device under clinically representative conditions to confirm that the software met design input requirements and user needs.

Technological Characteristics

Software-only product; atlas and model-based segmentation; supports 4D-CT data sets; DICOM compatible; includes tools for manual editing, deformable registration, and expert case library management.

Indications for Use

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

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

• Eclipse (K102011)
• Smart Segmentation Knowledge Based Contouring (K112778)

Submission Summary (Full Text)

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K133227
Page 1 of 5

Varian
3100
Palo Alto, CA
USA
*Tel* +1

Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto, CA 94304-1038
USA
*Tel* [phone]
www.varian.com

October 18, 2013

### 510(k) Summary

The information below is provided for the Smart Segmentation Knowledge Based Contouring, following the format of 21 CFR 807.92.

- 1. 510(k) Owner: Varian Medical Systems 3100 Hansen Way, M/S C 260 Palo Alto, CA 94304 Contact Name: Peter J. Coronado - Director, Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

| 2. Name of the Device: | Smart Segmentation Knowledge Based Contouring | |
|--------------------------|-------------------------------------------------|--|
| Trade/Proprietary Names: | Smart Segmentation - Knowledge Based Contouring | |

| Common Name: | Smart Segmentation Knowledge Based Contouring |
|-----------------------|----------------------------------------------------------------------------------------------------------|
| Classification Name: | Medical Charged Particle Radiation Therapy System<br>21 CFR §892.5050<br>Class II<br>Product Code 90 IYE |
| 3. Predicate Devices: | Eclipse K102011 |

- Smart Segmentation Knowledge Based Contouring K112778
- 4. Description of the Device:

The Smart Segmentation Knowledge Based Contouring was most recently cleared as the Varian Smart Segmentation Knowledge Based Contouring, K112778.

Smart Segmentation - Knowledge Based Contouring is a software only product that provides a combined atlas and model based approach to automated segmentation of structures together with tools for manual contouring or editing of structures. A library of already contoured expert cases is provided which is searchable by anatomy, staging, or free text. Users also have the ability to add or modify expert cases to suit their clinical needs. Expert cases are registered to the target image and selected

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structures propagated. Smart Segmentation Knowledge Based Contouring supports inter and intra user consistency in contouring. This product also provides an anatomy atlas which gives examples of delineated organs for the whole upper body, as well as anatomy images and functional description for selectable structures.

- 5. Reason for submission:
Changes in SS-KBC have prompted a new submission. Support of 4D-CT data sets and a new algorithm for segmentation of the mandible are changes new to Smart Segmentation Knowledge Based Contouring.

- 6. Intended Use Statement
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.

- 7. Indications for Use Statement
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.

## 8. Substantial Equivalence

The modified device, the Smart Segmentation Knowledge Based Contouring, is substantially equivalent to the predicate devices, the Smart Segmentation Knowledge Based Contouring (K112778) and Eclipse (K102011). The Intended Use and Indications for Use are unchanged.

Compared with the predicate devices, the Smart Segmentation Knowledge Based Contouring (K112778) and Eclipse with Smart Segmentation (K102011), the basic operation and technological characteristics are the same. Operational differences are described in the Instructions for Use for the SS-KBC 2.1. A comparison table illustrating the substantial equivalence of the modified device to the predicate devices appears below.

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| Changes in Technological characteristics: | | | |
|-------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------|------------------------------------|
| Feature List | Eclipse<br>(K102011) | Smart<br>Segmentation -<br>KBC 2.0<br>(K112778) | Smart<br>Segmentation -<br>KBC 2.1 |
| General Usage | | | |
| Support for External beam PHOTON<br>planning | yes | yes | yes |
| Support for External beam PHOTON<br>inverse planning | yes | yes | yes |
| Support for External beam ELECTRON<br>planning | yes | yes | yes |
| Support for External beam PROTON<br>planning | yes | yes | yes |
| Automated Structure Delineation | yes | yes | yes |
| Graphical User Interface | | | |
| Three View Layout | yes | yes | yes |
| Four View Layout (ortho & 3d) | yes | yes | yes |
| 3d volume rendering | yes | yes | yes |
| 3d volume MIP rendering | yes | yes | yes |
| 3d volume MIP (rotating) rendering | yes | yes | yes |
| 3d mesh rendering | yes | yes | yes |
| 3d multiplane rendering single image | yes | yes | yes |
| 3d multiplane rendering blended image | yes | 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 | yes | 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 | yes | yes | yes |
| Volumetric Contour Drawing Tool | yes | yes | yes |
| Deform Structure Tool | no | yes | yes |
| Image Threshold Tool | yes | yes | yes |
| PET Subvolume Threshold Tool | yes | yes | yes |
| Boolean Structure Operations | yes | yes | yes |
| Feature List | Eclipse<br>(K102011) | Smart<br>Segmentation -<br>KBC 2.0<br>(K112778) | Smart<br>Segmentation -<br>KBC 2.1 |
| Auto Match 3d (rigid) | yes | yes | yes |
| Manual Match (rigid) | yes | yes | yes |
| Automatic Deformable Registration | no | yes | yes |
| Region of interest selection | yes | yes | yes |
| Body Search Tool | yes | no | yes |
| Post-processing Tool (smoothing) | yes | no | yes |
| Add Margins Tool | yes | no | yes |
| High Density Tool | yes | no | yes |
| Flood Fill Tool | yes | no | yes |
| Extract Wall Tool | yes | no | yes |
| Structure templates | yes | no | yes |
| 4D-CT: player | yes | no | yes |
| 4D-CT: merge structures | yes | no | yes |
| 4D-CT: paste structures to all phases | yes | no | yes |
| 4D-CT: automatic segmentation | yes | no | yes |
| 4D-CT: RPM respiration trace viewer | no | no | 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 | yes | yes | yes |
| Change Structure ID | yes | yes | yes |
| Change Structure color & Style | yes | yes | yes |
| Show PET Patient Data | yes | yes | yes |
| Crop structure | yes | no | yes |
| Extend Segmentation | yes | no | yes |
| Interpolate Segmentation | yes | no | yes |
| Structure Segmentation and Expert Case Selection | | | |
| Default to algorithm based<br>segmentation for certain structures | yes (algorithm<br>based is only<br>option) | yes | yes |
| Expert Case browser | no | yes | yes |
| Expert case search - filters | no | yes | yes |
| Expert case search - free text search | no | yes | yes |

# Changes in Technological characteristics:

510(k) Summary – SS-KBC 2.1

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510(k) Summary – SS-KBC 2.1

·

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| ッフ<br>1<br>2 | r |
|--------------|-----|
| and | ﺴﺘﻤ |
| 0 | // |
| 1 | 20 |

| Feature List | Eclipse<br>(K102011) | Smart<br>Segmentation -<br>KBC 2.0<br>(K112778) | Smart<br>Segmentation -<br>KBC 2.1 |
|------------------------------------------------------|----------------------|-------------------------------------------------|------------------------------------|
| Expert case search - add / remove<br>bookmarks | no | yes | yes |
| Expert opinion text display | no | yes | yes |
| Add new customer case to database | no | yes | yes |
| Modify existing expert case on<br>database | no | yes | yes |
| Generate thumbnail preview for expert<br>case | no | yes | yes |
| Anatomy text book display | no | yes | yes |
| Expert Case Library content and supported structures | | | |
| Segmentation of mandible | no | no | yes |
| Connectivity | | | |
| DICOM compatibility | yes | yes | yes |

- 9. Summary of Non-Clinical Testing
Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.

Regression testing was performed to verify the integrity of any changes. Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel,

- 10. Conclusions from Non-Clinical testing
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian therefore considers Smart Segmentation Knowledge Based Contouring to be safe and effective and to perform at least as well as the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 14, 2014

Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K133227

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: January 31, 2014 Received: February 3, 2014

Dear Mr. Coronado:

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. Please note: CDRH does 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, 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 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.

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Page 2- Mr. Peter J. Coronado

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 [phone] or [phone] 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" (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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Andrew D. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K133227

Device Name: Smart Segmentation Knowledge Based Contouring

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 × (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 Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _______________________________________________________________________________________________________________________________________________________________________ K133227

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