(114 days)
Not Found
No
The description focuses on "atlas and model based approach" and "knowledge based contouring" using a library of expert cases, which are characteristic of traditional image processing and rule-based systems, not explicitly AI/ML. There is no mention of AI, ML, deep learning, or training/test sets for model development.
No.
The device is a software product designed to support the radiation therapy treatment planning process by automating and streamlining the segmentation of anatomical structures. It does not directly provide therapy or treatment to a patient.
No
Explanation: The device is used for automated and manual segmentation of structures for radiation therapy treatment planning. This is a planning and contouring tool, not a diagnostic device that identifies or characterizes a disease.
Yes
The device description explicitly states "Smart Segmentation - Knowledge Based Contouring is a software only product".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to support the radiation therapy treatment planning process." This is a clinical application related to treatment planning, not diagnostic testing performed on samples taken from the human body.
- Device Description: The description focuses on software for segmenting structures in medical images for radiation therapy planning. It does not mention analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is clearly described as a software product for medical image processing and contouring within the context of radiation therapy planning. This falls under the category of medical devices used for treatment planning and support, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
MUJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
whole upper body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, forming a trefoil shape. The profiles are rendered in a dark color, contrasting with the white background of the seal.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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)
(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)
(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 +1 650 493 4000 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.
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- 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: 650/424.6320 Fax: 650/646.9200 E-mail: submissions.support@varian.com
| 2. Name of the Device:
Trade/Proprietary Names: | Smart Segmentation Knowledge Based Contouring
Smart Segmentation – Knowledge Based Contouring |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Common Name: | Smart Segmentation Knowledge Based Contouring |
| Classification Name: | Medical Charged Particle Radiation Therapy System
21 CFR §892.5050
Class II
Product Code MUJ |
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- Predicate Devices: Smart Segmentation Knowledge Based Contouring K133227
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- 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.
5
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- 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.
- Reason for Submission Changes in Device:
| 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. |
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- 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.
- Intended Use Statement
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.
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- Substantial Equivalence
Compared with the predicate devices, the Smart Segmentation Knowledge Based Contouring (K133227), the basic operation and technological characteristics are the same. Operational
- Substantial Equivalence
6
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).
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- 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.
- Summary of Non-Clinical Testing
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.