VariSeed 9.0

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 8. 2015 Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Regulatory Affairs 911 Hansen Wav PALO ALTO CA 94304 Re: K150636 Trade/Device Name: VariSeed 9.0 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK, MUJ Dated: March 9, 2015 Received: March 11, 2015 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education 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. Michal D'Hara for Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known): K150636 Device Name: VariSeed 9.0 Indications For Use: VariSeed is indicated for use as a treatment planning software application used by medical professionals to plan, guide, optimize and document low-dose-rate brachytherapy procedures and for use as a biopsy procedure tracking software application used by medical professionals to plan, guide, and document biopsy procedures based on template guided needle insertion. VariSeed may be used on any patient considered suitable for this type of treatment and is intended to be used outside of the sterile field in an operating room environment or in a normal office environment. ✔ 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 Center for Devices and Radiological Health (CDRH) Page 1 of _ {3}------------------------------------------------ # PREMARKET NOTIFICATION # 510(k) Summary # VariSeed 9.0 # As required by 21 CFR 807.92 | Submitter's Name: | Varian Medical Systems | |----------------------|----------------------------------------------------------------------| | | 3100 Hansen Way, m/s E110 | | | Palo Alto CA94304 | | | Contact Name: Peter J. Coronado-Director Regulatory Affairs | | | Phone: 650/424.6320 | | | Fax: 650/646.9200 | | | E-mail: submissions.support@varian.com | | | Date: 9th March 2015 | | Proprietary Name: | VariSeed 9.0 | | Classification Name: | system,planning,radiation therapy treatment | | | 21CFR892.5050, MUJ, Class II | | Common/Usual Name: | VariSeed, | | Predicate Devices: | VariSeed 7.1 (K030534) | | Device Description: | VariSeed 9.0 is a free-standing PC based treatment planning | | | software product designed for preoperative and intraoperative | | | planning of LDR implants, intraoperative tracking of the implant | | | procedure, and postoperative evaluation of completed implants. | | | VariSeed also provides tools for supporting intraoperative | | | template guided biopsy and using those results to guide future | | | treatment. | | Indications for Use: | VariSeed is indicated for use as a treatment planning software | | | application used by medical professionals to plan, guide, optimize | | | and document low-dose-rate brachytherapy procedures and for | | | use as a biopsy procedure tracking software application used by | | | medical professionals to plan, guide, and document biopsy | | | procedures based on template guided needle insertion. VariSeed | | | may be used on any patient considered suitable for this type of | | | treatment and is intended to be used outside of the sterile field in | | | an operating room environment or in a normal office | | | environment. | {4}------------------------------------------------ #### Changes in Technological Characteristics: The significant changes compared with the predicate are changes associated with and introducing (VariPath) which is designed to be used in the Operating Room as part of ultrasound guided structured biopsy procedures and with new features which make VariSeed usable as a general LDR treatment planning system. The complete list of changes and their related requirements can be found in the document Tracing Changed/New Features to System Requirements in Section 18 of this submission. #### Device Comparison Table | FEATURE AND/OR<br>SPECIFICATION OF<br>NEW/MODIFIED DEVICE | PREDICATE DEVICE | VariSeed 9.0 | |-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | VariSeed 7.1 - K030534 | | | Intended Use | VariSeed 7.1 is a software application used for<br>planning and evaluation of brachytherapy<br>procedures. | VariSeed is intended for use as a software<br>application used by medical professionals to plan,<br>guide, optimize, and document low dose rate<br>brachytherapy and procedures based on template<br>guided needle insertion | | Indications for Use | VariSeed 7.1 is a software application for planning<br>and evaluating brachytherapy procedures for the<br>treatment of prostate cancer that can be modeled<br>according to AAPM TG-43. It facilitates pre-<br>operative planning and post-operative evaluation as<br>well as intra-operative planning and evaluation. | VariSeed is indicated for use as a treatment planning<br>software application used by medical professionals<br>to plan, guide, optimize and document low-dose-rate<br>brachytherapy procedures and for use as a biopsy<br>procedure tracking software application used by<br>medical professionals to plan, guide, and document<br>biopsy procedures based on template guided needle<br>insertion. VariSeed may be used on any patient<br>considered suitable for this type of treatment and is<br>intended to be used outside of the sterile field in an<br>operating room environment or in a normal office<br>environment. | | Device Description | VariSeed 7.1 is a computer based software<br>application for planning and evaluating prostate<br>brachytherapy procedures. | VariSeed 9.0 is a free-standing PC based treatment<br>planning software product designed for preoperative<br>and intraoperative planning of LDR implants,<br>intraoperative tracking of the implant procedure,<br>and postoperative evaluation of completed implants.<br>VariSeed also provides tools for supporting<br>intraoperative template guided biopsy and using<br>those results to guide future treatment. | | Off-line planning with or<br>without ultrasound images | Yes | Yes | | Real-time planning using<br>images acquired from<br>ultrasound | Yes | Yes | | Nomogram planning | Yes | Yes | | Pre-operative planning<br>from live ultrasound | Yes | Yes | | Pre-operative planning<br>from digitizer | Yes | Yes | | Pre-operative planning<br>from imported images | Yes | Yes | | Post-operative evaluation<br>from imported images | Yes | Yes | | Post-operative evaluation<br>from digitizer | Yes | Yes | | Intra-operative plan and<br>evaluation from live<br>ultrasound | Yes | Yes | | Template Guided Biopsy | No | Yes | | AAPM TG-43 Support for<br>Anisotropy Constant | Yes | Yes | | AAPM TG-43 Support for<br>Anisotropy Factor | Yes | Yes | | AAPM TG-43 Support for<br>Anisotropy Function | Yes | Yes | | Real-time calculation of<br>isodoses and display over<br>patient anatomy as<br>isodose lines. | Yes | Yes | | Automatic source decay | Yes | Yes | | Conforms to AAPM TG-43<br>– Dosimetry of interstitial<br>brachytherapy sources | Yes | Yes | | Plan Approval | No | Yes | | Image import various file<br>formats | Yes | Yes | | Reformat volume of image<br>data to primary image<br>volume | No | Yes | | Import a DICOM RT<br>dataset including biopsy<br>data | No (images only) | Yes | | Support angle or curved<br>needles | No | Yes | | Initializing a plan based on<br>the contents of an existing<br>plan. | No | Yes | | Dose display on images as<br>color wash | No | Yes | | biopsy details reports | No | Yes | | biopsy tracking workspace | No | Yes | | biopsy visualization<br>workspace | No | Yes | | | | | | Export DICOM RT | Yes | Yes, including biopsy contents | | Sector analysis for<br>structures | No | Yes | | Independent of the<br>radiation delivery system | Yes | Yes | {5}------------------------------------------------ {6}------------------------------------------------ | Planning support for all<br>solid source delivery<br>systems –seed, and seed<br>train | Yes | Yes | |---------------------------------------------------------------------------------------|-----|-----| | User defined dose points | Yes | Yes | | Manual contouring | Yes | Yes | | Manual source localization | Yes | Yes | | Window level tools | Yes | Yes | | Multiple plan variations | Yes | Yes | | Included source<br>management utilities | Yes | Yes | | Included patient<br>management utilities | Yes | Yes | | Automated prostate<br>contouring. | Yes | Yes | | Contour editing | Yes | Yes | | Contour interpolation | Yes | Yes | | Contour margining | Yes | Yes | | Point and line landmarks. | Yes | Yes | | Source location export | Yes | Yes | | Volume editing | Yes | Yes | | Image, structure, and plan<br>data export to DICOM | Yes | Yes | | Dosimetric quality alerts | Yes | Yes | | Image set co-registration | Yes | Yes | ### Non-clinical Testing Verification and Validation were performed for all the new features and regression testing was performed against the existing features of VariSeed. System requirements created or affected by the changes can be traced to the test outcomes. Standards applied during testing were: - 1. IEC 62366(2007), Medical devices- Application of usability engineering to medical devices- - 2. IEC 62083(2009), Medical electrical equipment-Requirements for the safety of radiotherapy treatment planning systems - 3. IEC 63204(2009), Medical Device Software-Software lifecycle processes {7}------------------------------------------------ ### Conclusion of Non-Clinical testing The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable. Varian therefore considers VariSeed to be safe and to perform at least as well as the predicate device. ### Argument for Substantial Equivalence to the Predicate Device A subset of features of the current device is different to the predicate. Of these, the significant changes compared with the predicate are associated with extending the Indications for Use of VariSeed beyond the prostate to other treatment sites and introducing (VariPath) which is designed to be used in the Operating Room as part of ultrasound guided structured biopsy procedures. The use of the predicate and the new device, for both of the indications for use, involves the planning, guiding, and documenting the procedure. Referring to the 510(k) Decision-Making Flowchart in "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" Guidance Notes: - 1. The predicate (VariSeed 7.1) is a legally marketed device. (K030534) - 2. The device and its predicate have the same intended use. (Note: wording of Intended Use statement has been updated to include more detail on use). - 3. The device and its predicate have the same technological characteristics. Changes in VariSeed 9.0, compared to the predicate, can be traced to their related System Requirements using the document "Tracing Changed or New Features to System Requirements." The System Requirements can then be traced to the test procedures using the Requirements to Procedures Trace Matrix. The Test Reports show the test, the expected and observed results and whether the test is a pass or fail. For all testing, including testing of the changes, there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable. Varian considers the changes to be enhancements of the predicate. There are no changes in the principle of operation of the software. The Verification and Validation demonstrates that the device is as safe and effective as the predicate. Varian therefore believes that VariSeed 9.0 is substantially equivalent to the predicate.