Vitesse is indicated for use as a treatment planning software application used by medical professionals to plan,guide,optimize and document high-dose-rate brachytherapy procedures

Device Description

The Varian VITESSE 5.0 is a stand-alone application which provides treatment planning features for high dose rate brachytherapy. Vitesse supports real-time ultrasound guided implant procedures as well as image import based workflows based on DICOM RT. Vitesse supports DICOM RT export of the plan to another external dose planning system (e.g., Brachy Vision) or directly to the brachytherapy afterloader treatment unit.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, unfortunately, much of the requested information (like specific performance metrics, sample sizes for test sets, expert details, or ground truth establishment) is not detailed in this 510(k) summary. This document primarily focuses on demonstrating substantial equivalence through software verification and validation, rather than a detailed performance study with quantifiable metrics against a ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Modification	Method of Evaluation	Acceptance Criteria (Explicitly Stated is Lacking)	Reported Device Performance (as stated)
Export plan to DICOM destination (e.g., Aria, Velocity) over network (DICOM C-STORE)	Software verification and validation covering the performance and use of this feature	Implied: Successful and accurate transfer of treatment plans via DICOM C-STORE.	Software verification and validation demonstrate the feature performs as intended.
Populate key elements of patient record from Aria via DICOM query (DICOM C-FIND)	Software verification and validation covering the performance and use of this feature	Implied: Successful and accurate retrieval and population of patient record elements via DICOM C-FIND.	Software verification and validation demonstrate the feature performs as intended.
Require user to enter valid Windows credentials and permissions prior to accessing Vitesse	Software verification and validation covering the performance and use of this feature	Implied: Successful enforcement of Windows security credentials and permissions.	Software verification and validation demonstrate the feature performs as intended.
Provide more direct visualization of region definitions on the main UI	Software verification and validation covering the performance and use of this feature	Implied: Region definitions are displayed clearly and accurately on the UI.	Software verification and validation demonstrate the feature performs as intended.
Provide support for PET images as secondary image volumes	Software verification and validation covering the performance and use of this feature	Implied: Successful import and display of PET DICOM images as secondary volumes without degradation.	Software verification and validation demonstrate the feature performs as intended.
Provides support for import of PET DICOM images as secondary image volumes	Software verification and validation covering the performance and use of this feature	Implied: Successful import and display of PET DICOM images as secondary volumes without degradation. (Redundant with previous entry)	Software verification and validation demonstrate the feature performs as intended.
Provides support of capturing color images (e.g., from color Doppler) and displaying them as color images	Software verification and validation covering the performance and use of this feature	Implied: Successful capture and accurate display of color images from various imaging modes.	Software verification and validation demonstrate the feature performs as intended.
Overall device requirements and risk control measures	Software verification and validation testing	Implied: Performance as intended at a level similar to the predicate device.	"Software verification and validation testing for Vitesse 5.0 demonstrates that the device requirements and risk control measures perform as intended at a level similar to the predicate."
Usability	Usability testing (according to IEC 62366)	Implied: Device performs well as intended for intended users, uses, and use environments.	"Usability testing was conducted according to the standard IEC 62366 to verify that the subject device performs well as intended for the intended users, uses, and use environments."
Cybersecurity	Assessment per FDA guidances ("Cybersecurity in Medical Devices" series)	Implied: Prevention of unauthorized access, modification, misuse, denial of use, or unauthorized use of information.	"Varian Medical Systems conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient."

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in terms of patient data or a dataset of medical images with ground truth for performance evaluation of specific features. The testing described is primarily software verification and validation testing and usability testing.

Software Verification and Validation: This typically involves testing against software requirements and design specifications, which may use simulated data or previously known cases, but specific sample sizes of patient data are not mentioned.
Usability Testing: The text states it was conducted, but provides no details on the number of participants or the nature of the test cases.
Data Provenance: Not applicable in the context of the described software verification and validation, as it doesn't involve clinical data from patients.

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 in the document. The study described is not a performance study against an established medical ground truth, but rather engineering verification and validation of software functionalities.

4. Adjudication method for the test set

This information is not provided as there is no described test set of medical cases requiring adjudication.

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, an MRMC comparative effectiveness study was not done. The device is a treatment planning software, not a diagnostic AI system for human readers. No AI assistance or human reader improvement effect size is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This document describes the validation of a standalone software application (Vitesse 5.0) which provides treatment planning features. Its performance is evaluated through software verification and validation testing and usability testing, as opposed to a clinical performance study measuring accuracy against pathology. The software itself is standalone, but it is a "treatment planning software application used by medical professionals," meaning it is intended for human-in-the-loop use. The "standalone" here refers to it being a distinct software product rather than an integrated component of a larger system, not a fully automated AI system without human involvement.

7. The type of ground truth used

The concept of "ground truth" as typically understood in performance studies (e.g., pathology, clinical outcomes) is not applicable here. The primary "truth" against which the software was tested was its software specifications and requirements. The testing ensures the software functions as designed and intended, meets usability criteria, and adheres to cybersecurity standards, rather than assessing its diagnostic or prognostic accuracy against a biological or clinical gold standard.

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is a treatment planning software, not a machine learning or AI model that requires a training set of data.

9. How the ground truth for the training set was established

This information is not applicable and therefore not provided as there is no training set mentioned or implied for this device.

Summary

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October 23, 2024

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Varian Medical Systems Lynn Allman Senior Director, Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304

Re: K241876

Trade/Device Name: Vitesse (5.0) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: September 23, 2024 Received: September 24, 2024

Dear Lynn Allman:

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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241876

Device Name

Vitesse (5.0)

Indications for Use (Describe)

Vitesse is indicated for use as a treatment planning software application used by medical professionals to plan,guide,optimize and document high-dose-rate brachytherapy procedures
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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038 Telephone: 1.650.493.4000 Toll Free: 800.544.4636

510(k) Summary

The following information is provided as required by 21 CFR 807.92

Submitter
Name and Address:	Varian Medical Systems, Inc.3100 Hansen Way, Palo Alto CA 94304
Contact Person:	Lynn Allman, Senior Director Regulatory Affairs
E-mail:	submissions.support@varian.com
Date Prepared:	27 June 2024
Device Information:
Proprietary Name:	Vitesse 5.0
Common/ Usual Name:	System, Image Processing, Radiological
Product Code and Classification:	Medical charged-particle radiation therapy systemMUJ 21 CFR 892.5050 Class II
Predicate Device:
Predicate Device Name:	VITESSE 3.0 (K123152)

Subject Device Description:

Intended Use/ Indications of Use Statement:

Vitesse is intended for use as a treatment planning software application used by medical professionals to plan, guide, optimize and document high-dose-rate brachytherapy procedures. Vitesse is indicated for use as a treatment planning software application used by medical professionals to plan, guide, optimize and document high-dose-rate brachytherapy procedures.

Comparison of Technological Characteristics with the predicate device

The modified device, referred to as the subject device throughout this summary, is Vitesse (Version 5.0) with additional software changes incorporated since the release of the predicate device, Vitesse 3.0

At a high level, both the predicate device and the subject devices are based on the same characteristics:

Both the subject device and the predicate device Both the devices are software only medical devices.

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Image /page/5/Picture/1 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is in black and white.

Both devices perform treatment planning, provide tools for qualified medical professionals to manage treatment sessions and adapt plans for patient to be treated with radiation therapy.
Both are compatible with radiation therapy devices. ●

The key changes exist between the subject and the predicate device.

. Vitesse will require the user to enter valid Windows credentials and permissions prior to accessing Vitesse.
. Provide more direct visualization of region definitions on the main UI. Currently, region definitions can only be visualized in a separate dialog.
. Provide the user with the ability to export a plan directly to a DICOM destination (e.g., Aria, Velocity) over the network (DICOM C-STORE).
. Provide the user with the ability to populate key elements of the patient record from the data in Aria via DICOM query (DICOM C-FIND).
. Provide support for import of common Enhanced MR DICOM images (i.e., standard images with orthogonal volumes).
. Provide support for import of PET DICOM images as secondary image volumes.
. Provides support for capturing color images. This allows images generated with color doppler and other color imaging modes to be captured in Vitesse and displayed as color images.

Other minor changes:

Version 5.0

DR Fixes and product improvements
Structure margins previewed on sagittal / coronal planes as well as transverse. ●
Autosave supported on all running instances of Vitesse, not just first. .
Autosave files not rejected by the user are sent to recycle bin and not deleted. ●
Batch margining of structures ●

Summary of Performance Testing (Non-Clinical Testing)

The following performance data was provided in support of the substantial equivalence determination.

. Software Verification and Validation Testing

The subject device is considered under the Enhanced documentation category. Software verification and validation testing for Vitesse 5.0 demonstrates that the device requirements and risk control measures perform as intended at a level similar to the predicate.

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Image /page/6/Picture/0 description: The image contains three blue circles in a row. The circles are evenly spaced and appear to be the same size. The background is white.

Image /page/6/Picture/1 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is black and white.

The subject device and the predicate device have the same intended use, and the significant differences do not result in a new intended use. Varian, therefore, believes that Vitesse 5.0 Treatment Planning is substantially equivalent to the predicate.

Software verification was conducted in accordance with IEC 62304 – "Medical device software -Software life cycle processes" and FDA guidance "Content of Premarket Submissions for Device Software Functions (June 2023)".

Cybersecurity and Interoperability requirements were assessed per FDA guidance's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Sept 2023)", "Postmarket Management of Cybersecurity in Medical Devices (Jan 2016)", "Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices (Jan 2016)".

Cybersecurity considerations related to the subject device are included within this submission. Varian Medical Systems conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.

Usability testing was conducted according to the standard IEC 62366 to verify that the subject device performs well as intended for the intended users, uses, and use environments.

New or Modified Feature	Method of Evaluation
Provide the user with the ability to export a plan directly to aDICOM destination (e.g., Aria, Velocity) over the network(DICOM C-STORE).	Software verification and validationcovering the performance and useof this feature
Provide the user with the ability to populate key elements ofthe patient record from the data in Aria via DICOM query(DICOM C-FIND)	Software verification and validationcovering the performance and useof this feature
Vitesse will require the user to enter valid Windowscredentials and permissions prior to accessing Vitesse	Software verification and validationcovering the performance and useof this feature
Provide more direct visualization of region definitions on themain Ul	Software verification and validationcovering the performance and useof this feature

Method of Evaluation

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Image /page/7/Picture/0 description: The image contains three blue circles in a row. The circles are evenly spaced and of the same size. The background is white.

Image /page/7/Picture/1 description: The image shows the Varian logo. The word "Varian" is in bold, black letters. Below the word "Varian" is the phrase "A Siemens Healthineers Company" in a smaller font.

Provide support for PET images as secondary image volumes	Software verification and validationcovering the performance and useof this feature
Provides support for import of PET DICOM images assecondary image volumes	Software verification and validationcovering the performance and useof this feature
Provides support of capturing color images. This allowsimages generated with color doppler and other color imagingmodes to be captures in Vitesse and displayed as color images	Software verification and validationcovering the performance and useof this feature

● Clinical Testing

No clinical studies were carried out for the subject device and therefore, no such clinical data is provided within this submission.

● Animal Testing

No animal testing was conducted for the subject device and therefore, no such data is provided within this submission

. Standards conformance

ISO 14971:2019 Medical devices - Application of risk management to medical devices
IEC 62083 Edition 2.0 2009-09 Requirements for the safety of radiotherapy treatment planning systems
IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
IEC 62366-1 Edition 1.0 2015-02 Application of usability engineering to medical devices
ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied.
ISO 20417:2021 Information supplied by the manufacturer of medical devices.
IEC 62304 Edition 1.1 2015-06 Medical device software Software life cycle processes ●
EN ISO 13485:2016 Medical devices Quality management systems Requirements for ● regulatory purposes

Conclusion

Overall, the subject device and the predicate device have the same intended use and indications for use. There is no change to the principle of operation of the differences between the subject and predicate do not result in a new intended use and do not raise new questions of safety and effectiveness. The non-clinical data, verification and validation demonstrate that the subject device is as safe and effective as the predicate device and perform as intended. therefore, Varian believes that the subject device Vitesse 5.0 is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.