(42 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on image acquisition, needle planning, and data export, which are standard functions for brachytherapy planning software.
No.
The device facilitates planning for a therapeutic procedure but does not directly deliver therapy or calculate treatment doses itself.
No
The device description clearly states it "does not provide any modeling of the HDR source nor dose it calculate radiation dose estimates." It facilitates planning but does not make a diagnosis or provide diagnostic information.
Yes
The device is explicitly described as a "software application" and its function is limited to facilitating planning and exporting data, not controlling hardware or delivering treatment. It relies on external systems for dose calculation and treatment planning.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Vitesse 2.0 Function: Vitesse 2.0 is a software application used for planning and facilitating a medical procedure (HDR brachytherapy for prostate cancer). It works with medical images and anatomical contours, not with biological specimens.
- No Specimen Analysis: The description clearly states that Vitesse 2.0 does not perform any analysis of biological samples. Its function is related to image acquisition, needle planning, and data export for treatment planning.
Therefore, Vitesse 2.0 falls under the category of medical devices used in the planning and execution of a treatment, not as an in vitro diagnostic tool.
N/A
Intended Use / Indications for 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.
Vitesse is a software application used to facilitate brachytherapy high dose rate treatment planning for patients with prostate cancer.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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 Way |
| Palo 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.
1
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
-
- Image Acquisition/Import: The ability to acquire patient data from which a plan or evaluation is constructed
-
- 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.
-
- Needle Identification: The ability to identify needle positions based upon post implant imagery.
-
- 2D visualization: The ability to visualize the resulting needle placement and structures in 2D.
-
- Database functions: The ability to manage the patient data in the application database including archiving, deleting and restoring data.
-
- Licensing: The ability to license the system by application function and interface.
-
- 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.
2
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.
3
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
4
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