(39 days)
No
The description focuses on manual selection and projection of markers, with no mention of automated learning or pattern recognition typical of AI/ML.
No
The device is a software system intended to assist in aiming a radiation beam for treatment, not to directly treat a patient or apply therapy.
No
The device's intended use is to assist in locating the position of a treatment beam's isocenter relative to the patient for radiation therapy, which is a treatment delivery function, not a diagnostic one. While it uses images (radiographs, CT scans), it processes them to align markers for therapy delivery, not to diagnose a disease or condition.
Yes
The device description explicitly states "VisiTrak is a radiation therapy localization software system" and lists only software functions. It also references other software systems as components. There is no mention of any hardware being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device, VisiTrak, is a software system used in radiation therapy to assist in aiming the radiation beam by localizing the treatment isocenter relative to the patient using imaging data (radiographs and CT scans) and internal markers.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is based on processing and aligning medical images.
Therefore, VisiTrak falls under the category of medical devices used in treatment planning and delivery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the device is by radiation oncologist and their therapy technicians and physicist to solve for the couch coordinates for each radiation therapy treatment of a radiation therapy patient to properly align the isocenter of the treatment machine with the isocenter location within the planning image set (typically CT) that was planned on a radiation therapy treatment planning system. Some internal marker must be visible on both radiographs of the patient taken at the time of treatment and the sectional images used for the treatment plan.
This product is to be used by radiation therapy oncologist or staff under their direction to locate the position relative to the patient of the isocenter of a treatment beam on a gantry mounted radiation therapy treatment machine. Some internal marker must be visible on both a radiograph of the patient taken at the time of treatment and the images used for the treatment plan in order to use this software to align the marker image on the radiograph with the plan to find the proper patient support system coordinates. Only a translation along the couch lateral, longitudinal, and height directions are considered and solved for. Possible rotations or repositioning of the patient are not considered.
Product codes
IYE
Device Description
VisiTrak is a radiation therapy localization software system that assist in aiming the radiation beam. This software uses functions from System 2100, a Radiological Image Display System, 510(k) K993530, and Dosimetry Check, a treatment plan delivery testing system, 510(k) K010225.
The following functions are included in VisiTrak:
- (1) Means to download a treatment plan from a treatment planning system, to include a stackable image set (such as the CT scans used to generate the plan), beam geometry, and optional regions of interest outlines. [This function from Dosimetry Checkl
- (2) Means to define and trace a marker that is visible in the stackable image set. [This function from System 2100]
- (3) Means to draw the markers on two dimensional plane images and three dimensional perspective room views.
- (4) Means to read in radiographic images made of the patient in the treatment position on the gantry mounted treatment machine.
- (5) Means to define the geometry for each radiographic image, i.e., in the treatment machine coordinates.
- (6) Means to project the defined markers onto the radiographic images.
- (7) Means to manually select couch coordinates to match up the images of the markers on the radiographs with the projected marker images.
- (8) Means to trace the images of the markers on the radiographs.
- (9) Means to solve for the best estimate of the couch coordinates that will align the projected and traced marker images.
- Means to display the couch coordinates for each treatment beam using the (10) couch position found in (7) or (9) above.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, radiographic images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation oncologist and their therapy technicians and physicist
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo and contact information for Math Resolutions, LLC. The logo includes the word "Math" above the word "Resolutions" with an integral symbol on the left. The contact information includes a website, address (5975 Gales Lane, Columbia, MD 21045), phone number (410-997-9578), and email address (WendelDRenner@comcast.net).
File: vtksum.doc
Contact Person: Wendel Dean Renner, President of Math Resolutions, LLC Date: March 17, 2005
510(k) Summary
VisiTrak is a radiation therapy localization software system that assist in aiming the radiation beam. This software uses functions from System 2100, a Radiological Image Display System, 510(k) K993530, and Dosimetry Check, a treatment plan delivery testing system, 510(k) K010225.
The trade name is VisiTrak. A common name is imaged guided radiation therapy. Regulatory Class is II.
A predicate device is Acculoc from Northwest Medical Physics Equipment, 21031 67th Ave. West, Lynnwood, WA 98036, 510(k) K970464. VisiTrak and Acculoc both mathematically solves for the x, y,z coordinates of the couch so that the projected image of a designated marker and the radiographic image of the same marker coincide on orthogonal views.
The following functions are included in VisiTrak:
- (1) Means to download a treatment plan from a treatment planning system, to include a stackable image set (such as the CT scans used to generate the plan), beam geometry, and optional regions of interest outlines. [This function from Dosimetry Checkl
- (2) Means to define and trace a marker that is visible in the stackable image set. [This function from System 2100]
- (3) Means to draw the markers on two dimensional plane images and three dimensional perspective room views.
- (4) Means to read in radiographic images made of the patient in the treatment position on the gantry mounted treatment machine.
- (5) Means to define the geometry for each radiographic image, i.e., in the treatment machine coordinates.
1
- (6) Means to project the defined markers onto the radiographic images.
- (7) Means to manually select couch coordinates to match up the images of the markers on the radiographs with the projected marker images.
- (8) Means to trace the images of the markers on the radiographs.
- (9) Means to solve for the best estimate of the couch coordinates that will align the projected and traced marker images.
- Means to display the couch coordinates for each treatment beam using the (10) couch position found in (7) or (9) above.
The intended use of the device is by radiation oncologist and their therapy technicians and physicist to solve for the couch coordinates for each radiation therapy treatment of a radiation therapy patient to properly align the isocenter of the treatment machine with the isocenter location within the planning image set (typically CT) that was planned on a radiation therapy treatment planning system. Some internal marker must be visible on both radiographs of the patient taken at the time of treatment and the sectional images used for the treatment plan.
Document Approved by: Wendel Dean Renner Title: President of Math Resolutions, LLC
Signature:
Date: March 17, 2005
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wendel Dean Renner President Math Resolutions, LLC 5975 Gales Lane COLUMBIA MD 21045
Re: K050372 Trade/Device Name: VisiTrak Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 11, 2005 Received: February 14, 2005
Dear Mr. Renner:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of 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 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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.
Sincercly 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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VisiTrak File: vtinduse.doc
510(k) Number: K050372
Device Name: VisiTrak
Indications for Use:
This product is to be used by radiation therapy oncologist or staff under their direction to locate the position relative to the patient of the isocenter of a treatment beam on a gantry mounted radiation therapy treatment machine. Some internal marker must be visible on both a radiograph of the patient taken at the time of treatment and the images used for the treatment plan in order to use this software to align the marker image on the radiograph with the plan to find the proper patient support system coordinates. Only a translation along the couch lateral, longitudinal, and height directions are considered and solved for. Possible rotations or repositioning of the patient are not considered.
Document Approved by: Wendel Dean Renner Title: President, Math Resolutions, LLC
Signature: U. Handel Dean Kinner
scription Use
Date:
Jauric bhagdon
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050312