(42 days)
Vitesse 2.0 is a software application used to facilitate intraoperative needle planning and anatomy contouring during the process of planning HDR brachytherapy procedures for patients with prostate cancer. Vitesse will export this data to be utilized for treatment planning.
Vitesse is a software application used to facilitate brachytherapy high dose rate treatment planning for patients with prostate cancer.
Vitesse 2.0 is a computer based software application which will allow for the facilitation of intraoperative needle planning and anatomy contouring during the process of planning High Dose Rate brachytherapy procedures. Vitesse provides image acquisition and needle planning functions. It does not provide any modeling of the HDR source nor dose it calculate radiation dose estimates. Vitesse only exports its images, contours and needle positions using the DICOM RT standard to the planning system where the source positions are modeled, and the dose is calculated, evaluated and the plan is finalized. Vitesse 2.0 does not provide a treatment plan, but instead exports a source location plan to treatment planning systems for completion.
This 510(k) summary for Varian Medical Systems, Inc. Vitesse 2.0 does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.
The document focuses on:
- Device Description and Intended Use: Explaining what the Vitesse 2.0 software does (facilitates intraoperative needle planning and anatomy contouring for HDR brachytherapy in prostate cancer) and what it does not do (no dose modeling or calculation, no final treatment plan).
- Technological Characteristics: Stating that the device is substantially equivalent to a predicate device (BrachyVision 6.0 K992762).
- Software Features: Listing the functionalities of the software (image acquisition, contouring, needle placement, visualization, database, etc.).
Information Not Found in the Provided Text:
Therefore, I cannot populate the table or provide answers for most of the requested points based solely on the provided text. The document doesn't include details about a specific study with quantitative performance metrics, acceptance criteria, sample sizes, expert involvement, or ground truth establishment.
Possible Reason:
For certain types of medical device submissions, particularly for software that is deemed "substantially equivalent" to an existing predicate and primarily performs planning and visualization functions without direct diagnostic or therapeutic output (i.e., it exports data to another system for dose calculation and treatment planning), the FDA may not require extensive performance studies with quantitative acceptance criteria, ground truth, or MRMC comparative effectiveness studies as would be expected for a diagnostic AI algorithm. The focus for such devices often lies on software verification and validation, ensuring it functions as intended and interfaces correctly, rather than clinical efficacy studies in the traditional sense.
Summary of available information:
| Requirement | Details from Vitesse 2.0 510(k) Summary |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Not provided. The document states the device is "substantially equivalent" to BrachyVision, implying it meets similar standards, but no explicit acceptance criteria or reported performance metrics (e.g., accuracy, precision) for Vitesse 2.0 itself are given. |
| 2. Sample Size (Test Set) & Data Provenance | Not provided. No details about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective nature) are included. |
| 3. Number & Qualifications of Experts for Ground Truth | Not provided. No information regarding experts used to establish ground truth is mentioned. This is consistent with the absence of a performance study focused on diagnostic accuracy or clinical outcomes. |
| 4. Adjudication Method | Not provided. As no ground truth establishment by experts is described, there is no mention of an adjudication method. |
| 5. Multi-Reader Multi-Case (MRMC) Study & Effect Size | Not provided. The document does not describe an MRMC study or any assessment of human reader improvement with or without AI assistance. This device is a planning tool, not a diagnostic AI intended to assist human readers in image interpretation. |
| 6. Standalone (Algorithm Only) Performance Study | Not provided. The document describes the software's features and its role in a workflow, but not a standalone performance study with specific metrics, as it is a tool for facilitating planning, not an independent decision-making algorithm. Its "performance" would likely be assessed through software validation rather than clinical studies. |
| 7. Type of Ground Truth Used | Not provided. There is no mention of ground truth established through expert consensus, pathology, or outcomes data. |
| 8. Sample Size for Training Set | Not provided. The document does not discuss a training set, as it describes a software application developed using traditional programming methods (Microsoft Visual C++) rather than a machine learning model that would typically require a training set. |
| 9. How Ground Truth for Training Set Was Established | Not provided. No training set or associated ground truth establishment is mentioned. |
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Varian Medical Systems, Inc. Vitesse 2.0
JUL 1 8 2005
510(k) Summary
as required by section 807.92(c)
| Date Prepared: | June 2, 2005 |
|---|---|
| Submitter: | Varian Medical Systems, Inc. |
| Address: | 3100 Hansen WayPalo Alto, CA 94304 |
| Phone: | (650) 424-5731 |
| Fax: | (650) 842-5040 |
| Contact: | Vy Tran |
| Trade Name: | Vitesse 2.0 |
| Common Name: | BrachyTherapy Planning System |
| Classification Name: | system, planning, radiation therapy treatment CFR 892.505 |
| Predicate Device: | Varian Medical Systems, Inc. - BrachyVision 6.0 K992762 |
Intended Use
Vitesse 2.0 is a software application used to facilitate intraoperative needle planning and anatomy contouring during the process of planning HDR brachytherapy procedures for patients with prostate cancer. Vitesse will export this data to be utilized for treatment planning.
Device Description
Vitesse 2.0 is a computer based software application which will allow for the facilitation of intraoperative needle planning and anatomy contouring during the process of planning High Dose Rate brachytherapy procedures. Vitesse provides image acquisition and needle planning functions. It does not provide any modeling of the HDR source nor dose it calculate radiation dose estimates. Vitesse only exports its images, contours and needle positions using the DICOM RT standard to the planning system where the source positions are modeled, and the dose is calculated, evaluated and the plan is finalized. Vitesse 2.0 does not provide a treatment plan, but instead exports a source location plan to treatment planning systems for completion.
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Varian Medical Systems, Inc. Vitesse 2.0
Hardware Platform and Operating System
The application runs on standard Intel PCs under Microsoft Window® 32-bit operating systems.
Peripherals and Accessories
The application interfaces with video sources and network sources.
Software Features
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- Image Acquisition/Import: The ability to acquire patient data from which a plan or evaluation is constructed
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- Structure Contouring: The ability to define patient structures within the image space.
- Needle Placement: The ability to plan needle placement and update 3. positions based on actual insertion positions.
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- Needle Identification: The ability to identify needle positions based upon post implant imagery.
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- 2D visualization: The ability to visualize the resulting needle placement and structures in 2D.
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- Database functions: The ability to manage the patient data in the application database including archiving, deleting and restoring data.
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- Licensing: The ability to license the system by application function and interface.
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- Interface: The ability to interface with other planning systems.
Application Development
The application was developed for 32-bit Microsoft Windows® operating system using Microsoft Visual C++.
Technological Characteristics
Vitesse 2.0 is substantially equivalent to the predicate device "BrachyVision". Refer to the "Substantial Equivalence Comparison Chart", Tab I.
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Image /page/2/Picture/10 description: The image is a black and white emblem. The emblem is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the emblem is a stylized image of what appears to be an eagle or other bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2005
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems 3100 Hansen Way PALO ALTO CA 94304-1038
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K051497 Trade/Device Name: Vitesse 2.0 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: MUJ Dated: June 2, 2005 Received: June 6, 2005
Dear Ms. Tran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your over ever 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 rear 20, 1710, 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 do not require approvate of 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your as were is creens of additional controls. Existing major regulations affecting your Apploral), It they of below 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 1 ocean bakers and rogination of limited to registration and listing (21 CFR Part 807); labeling All CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (2) 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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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oghi maniences of your device of your device to a legally premarked notheation: "The PDF missing for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire specific ac nevel the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entirely, formation on your responsibilities under the Act from the 807.77). Tou may ooually only constall and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if known): K051497
Device Name: Vitesse 2.0
Indications for use:
Vitesse is a software application used to facilitate brachytherapy high dose rate treatment planning for patients with prostate cancer.
Prescription Use 1 (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lymm
(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051497
§ 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.