SMART SEGMENTATION KNOWLEDGE BASED CONTOURING

K141248 · Varian Medical Systems, Inc. · MUJ · Sep 5, 2014 · Radiology

Device Facts

• Record ID: K141248
• Device Name: SMART SEGMENTATION KNOWLEDGE BASED CONTOURING
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Sep 5, 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

Software-only product for radiation therapy treatment planning; provides automated and manual segmentation of target volumes and organs at risk. Uses combined atlas and model-based approach; library of expert cases searchable by anatomy, staging, or free text. Expert cases registered to target image for structure propagation. New features include semi-automatic lung tumor segmentation and automated Calypso beacon detection. Includes structure dictionary with standardized labels for data mining and interoperability. Used by clinicians to improve inter/intra-user consistency in contouring. Output consists of delineated anatomical structures used to inform radiation therapy planning; benefits patient by supporting accurate, consistent treatment planning.

Clinical Evidence

Bench testing only. Verification and validation testing performed on production-equivalent device under clinically representative conditions to confirm performance and functionality of new and existing features met design input requirements.

Technological Characteristics

Software-only product. Employs atlas and model-based segmentation algorithms. Features include structure dictionary with standardized labels, expert case library, and automated detection tools for lung tumors and Calypso beacons. Supports interoperability via standardized structure codes.

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.

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

• Smart Segmentation Knowledge Based Contouring (K133227)

Submission Summary (Full Text)

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

September 5, 2014

Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94303

Re: K141248

Trade/Device Name: Smart Segmentation - Knowledge Based Contouring Regulation Number: 21CFR 892.5050 Regulation Name: Medical charged particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: July 22, 2014 Received: July 23, 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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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/Resourcesfor You/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/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara
for

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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## Page 3- Mr. Peter Coronado

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# Indications for Use

510(k) Number (if known): K141248

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

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

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K141248

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Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "I" that resembles a person with their arms raised. Below the word "VARIAN" are the words "medical systems" in a smaller, sans-serif font. The logo is black and white.

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

## May 7, 2014 Summary 510(k)

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:<br>Trade/Proprietary Names: | Smart Segmentation Knowledge Based Contouring<br>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 MUJ |

- 3. Predicate Devices: Smart Segmentation Knowledge Based Contouring K133227
- 4. Description of the Device:

The Smart Segmentation Knowledge Based Contouring was most recently cleared as the Varian Smart Segmentation Knowledge Based Contouring, K133227.

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 structures propagated. SmartSegmentation 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.

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- 5. Reason for Submission Changes in Device:
Changes in SS-KBC have prompted a new submission. Semi-automatic segmentation of lung tumors and sorting of expert cases based on similarity of image are changes new to Smart Segmentation Knowledge Based Contouring.

| New Features Table |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Segmentation Tools |
| New Lung tumor segmentation tool |
| Calypso beacon detection tool allows automated detection and Segmentation of implanted Calypso beacons. |
| Expert case Browser |
| Expert Case browser has been redesigned to allow retrieving Expert Cases based on similarity to clinical case. |
| It is easier to select a segmentation algorithm used to contour a structure. |
| Expert case library |
| New expert cases for Nasopharynx, Tonsil, Base of Tongue, Hypopharynx, Larynx. |
| Controlled Structure Terminology |
| SS-KBC contains a structure dictionary. The use of the structure dictionary allows identifying a structure by assigning a standardize label. The assigned label is uniquely matched to computer readable code, enabling effective data mining and exchange of knowledge models between systems using different naming schemes. |
| The structure creation in SS-KBC starts with a label search. The selected ID populates the structure ID, color and type. The structure ID can be edited and serves as custom structure name which will be displayed through the system (including the Expert Case Library). The default structure IDs can be changed in the RT Administration workspace. In order to ensure interoperability between systems which do not implement structure codes and labels, it is recommended to maintain the default IDs. |

- 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

SmartSegmentation Knowledge BasedContouring provides acombined atlas and model based approach for automated and manual segmentation of structures includingtarget volumes and organs at risk to support the radiation therapy treatment planning process.

- 8. Substantial Equivalence
Compared with the predicate devices, the Smart Segmentation Knowledge Based Contouring (K133227), the basic operation and technological characteristics are the same. Operational

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differences are described in the Instructions for Use for the SS-KBC 13.5. Also, the Intended Use and Indications for Use are unchanged.

The new features table lists the new features of Smart Segmentation Knowledge Based Contouring, as compared to the predicate device. The features of the predicate device are many while there are only a few added. Therefore Varian concludes the modified device, the Smart Segmentation Knowledge Based Contouring, is substantially equivalent to the predicate device, the Smart Segmentation Knowledge Based Contouring (K133227).

- 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.