(58 days)
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.
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.
The provided text is a 510(k) Premarket Notification for VariSeed 9.0, a treatment planning software. It describes the device, its intended use, and compares it to a predicate device (VariSeed 7.1). The document primarily focuses on establishing substantial equivalence to the predicate device and does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, expert qualifications, or ground truth details as requested.
The document indicates that "Verification and Validation were performed for all the new features and regression testing was performed against the existing features of VariSeed." It also states, "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." However, it does not provide the specific acceptance criteria, the reported device performance against those criteria, or the details of the studies conducted.
Therefore, many of the requested items cannot be extracted from the provided text.
Here's what can be gathered or inferred about the study and acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative or measurable format, nor does it provide reported device performance metrics against such criteria. Instead, it refers to a successful outcome of "conform[ing] to the defined user needs and intended uses" and the absence of high-priority discrepancy reports. The table below attempts to infer the nature of "acceptance criteria" from the document's content, primarily centered around functional correctness and safety.
| Acceptance Criterion (Inferred from Text) | Reported Device Performance (Inferred from Text) |
|---|---|
| Adherence to defined user needs and intended uses for new features | "The product conformed to the defined user needs and intended uses." |
| No "Safety Intolerable" Discrepancy Reports (DRs) | "No DRs remaining which had a priority of Safety Intolerable." |
| No "Customer Intolerable" Discrepancy Reports (DRs) | "No DRs remaining which had a priority of Customer Intolerable." |
| Functional correctness of all new features (e.g., Template Guided Biopsy) | "Verification and Validation were performed for all the new features... outcome was that the product conformed." |
| Functional correctness and non-degradation of existing features | "...regression testing was performed against the existing features of VariSeed... outcome was that the product conformed." |
| Compliance with applied standards (IEC 62366, 62083, 63204) | Implicitly met as part of successful verification and validation. |
| Device is as safe and effective as the predicate device | "The Verification and Validation demonstrates that the device is as safe and effective as the predicate." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "all the new features" and "existing features of VariSeed" were tested, but no number of test cases, patient data sets, or any other quantifiable sample size is provided.
- Data Provenance: Not specified. There is no mention of the origin (e.g., country) of any data used for testing, nor whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document describes "Verification and Validation" and mentions "System Requirements to Test Procedures Trace Matrix," implying internal testing by the manufacturer rather than a study involving external experts establishing ground truth in a clinical context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. The text implies internal testing and a process of addressing discrepancy reports until high-priority ones are resolved, but it doesn't describe an adjudication method for ground truth in a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study is mentioned. This device is a treatment planning software, not an AI-assisted diagnostic device, so this type of study would not typically be applicable in the sense of "human readers improving with AI."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The software is an "application used by medical professionals to plan, guide, optimize and document," implying human-in-the-loop operation. The "Verification and Validation" appears to cover the software's functionality, which could be considered standalone testing of the algorithm's output (e.g., calculations, image processing, biopsy tracking) in a simulated environment, but this isn't explicitly detailed as a distinct "standalone" study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used for testing. Given the nature of the device (treatment planning software), the "ground truth" for verification and validation would likely involve:
- Engineering specifications and requirements: Ensuring the software's calculations, image manipulations, and data handling functions operate according to predefined algorithms and specifications.
- Physics-based models: For dose calculations (e.g., AAPM TG-43 support), the ground truth would be the expected output based on established physics models.
- Simulated data or known phantom data: To verify accuracy of measurements, contours, and planning processes.
8. The sample size for the training set:
The document does not mention a "training set." This type of software, focusing on treatment planning and biopsy tracking based on established physics and medical principles, typically does not use machine learning in a way that requires a distinct "training set" in the context of pattern recognition or predictive modeling like a diagnostic AI. Its functions are largely deterministic and rule-based.
9. How the ground truth for the training set was established:
As no training set is mentioned, this information is not provided.
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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.
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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 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
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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)
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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. |
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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/ORSPECIFICATION OFNEW/MODIFIED DEVICE | PREDICATE DEVICE | VariSeed 9.0 |
|---|---|---|
| VariSeed 7.1 - K030534 | ||
| Intended Use | VariSeed 7.1 is a software application used forplanning and evaluation of brachytherapyprocedures. | VariSeed is intended for use as a softwareapplication used by medical professionals to plan,guide, optimize, and document low dose ratebrachytherapy and procedures based on templateguided needle insertion |
| Indications for Use | VariSeed 7.1 is a software application for planningand evaluating brachytherapy procedures for thetreatment of prostate cancer that can be modeledaccording to AAPM TG-43. It facilitates pre-operative planning and post-operative evaluation aswell as intra-operative planning and evaluation. | VariSeed is indicated for use as a treatment planningsoftware application used by medical professionalsto plan, guide, optimize and document low-dose-ratebrachytherapy procedures and for use as a biopsyprocedure tracking software application used bymedical professionals to plan, guide, and documentbiopsy procedures based on template guided needleinsertion. VariSeed may be used on any patientconsidered suitable for this type of treatment and isintended to be used outside of the sterile field in anoperating room environment or in a normal officeenvironment. |
| Device Description | VariSeed 7.1 is a computer based softwareapplication for planning and evaluating prostatebrachytherapy procedures. | VariSeed 9.0 is a free-standing PC based treatmentplanning software product designed for preoperativeand intraoperative planning of LDR implants,intraoperative tracking of the implant procedure,and postoperative evaluation of completed implants.VariSeed also provides tools for supportingintraoperative template guided biopsy and usingthose results to guide future treatment. |
| Off-line planning with orwithout ultrasound images | Yes | Yes |
| Real-time planning usingimages acquired fromultrasound | Yes | Yes |
| Nomogram planning | Yes | Yes |
| Pre-operative planningfrom live ultrasound | Yes | Yes |
| Pre-operative planningfrom digitizer | Yes | Yes |
| Pre-operative planningfrom imported images | Yes | Yes |
| Post-operative evaluationfrom imported images | Yes | Yes |
| Post-operative evaluationfrom digitizer | Yes | Yes |
| Intra-operative plan andevaluation from liveultrasound | Yes | Yes |
| Template Guided Biopsy | No | Yes |
| AAPM TG-43 Support forAnisotropy Constant | Yes | Yes |
| AAPM TG-43 Support forAnisotropy Factor | Yes | Yes |
| AAPM TG-43 Support forAnisotropy Function | Yes | Yes |
| Real-time calculation ofisodoses and display overpatient anatomy asisodose lines. | Yes | Yes |
| Automatic source decay | Yes | Yes |
| Conforms to AAPM TG-43– Dosimetry of interstitialbrachytherapy sources | Yes | Yes |
| Plan Approval | No | Yes |
| Image import various fileformats | Yes | Yes |
| Reformat volume of imagedata to primary imagevolume | No | Yes |
| Import a DICOM RTdataset including biopsydata | No (images only) | Yes |
| Support angle or curvedneedles | No | Yes |
| Initializing a plan based onthe contents of an existingplan. | No | Yes |
| Dose display on images ascolor wash | No | Yes |
| biopsy details reports | No | Yes |
| biopsy tracking workspace | No | Yes |
| biopsy visualizationworkspace | No | Yes |
| Export DICOM RT | Yes | Yes, including biopsy contents |
| Sector analysis forstructures | No | Yes |
| Independent of theradiation delivery system | Yes | Yes |
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| Planning support for allsolid source deliverysystems –seed, and seedtrain | 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 sourcemanagement utilities | Yes | Yes |
| Included patientmanagement utilities | Yes | Yes |
| Automated prostatecontouring. | 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 plandata 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:
-
- IEC 62366(2007), Medical devices- Application of usability engineering to medical devices-
-
- IEC 62083(2009), Medical electrical equipment-Requirements for the safety of radiotherapy treatment planning systems
-
- IEC 63204(2009), Medical Device Software-Software lifecycle processes
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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:
-
- The predicate (VariSeed 7.1) is a legally marketed device. (K030534)
-
- 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).
-
- 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.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.