(147 days)
Not Found
Not Found
No
The description lists standard radiation therapy planning functions and algorithms (pencil beam) without mentioning any AI/ML techniques for tasks like contouring, auto-planning, or image analysis beyond basic processing and fusion.
No
The device is a treatment planning program used by medical professionals to plan radiation therapy, not to directly deliver or administer treatment.
No
This device is a radiation therapy external beam treatment planning program. Its purpose is to plan treatment, compute and display dose to the patient model, and calculate monitor units, not to diagnose a condition.
Yes
The device description outlines a software program ("RtDosePlan") that performs treatment planning functions based on input data (CT scans, other image sets). It does not mention or describe any accompanying hardware components that are part of the device itself. The functions listed are all software-based operations.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "radiation therapy external beam treatment planning program." Its purpose is to plan radiation treatment for patients based on imaging data (CT scans and other image sets). It does not involve the analysis of biological specimens.
- Intended Use: The intended use is for "planning the treatment with x-rays for patients undergoing radiation therapy." This is a treatment planning function, not a diagnostic function based on in vitro analysis.
The device is a software tool used in the clinical setting for treatment planning, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This product is to be used by radiation therapy oncologist, dosimetrist, and radiation therapy physicist, to plan the treatment with x-rays for patients undergoing radiation therapy for stationary and gantry arc beams. Support is included for field shaping with multi-leaf collimators and auxiliary blocking, and the use of wedges. Electron therapy and intensity modulated radiation therapy is not included in this product.
Product codes
90 MUJ
Device Description
RtDosePlan is a radiation therapy external beam treatment planning program that supports treatment planning for x-rays only. The following functions are included:
-
- Provide means to read in CT scans and form a patient model.
-
- Provide means to define a skin boundary.
- Provide means to convert CT numbers to physical density. 3.
-
- Provide means to define a plan that consists of one or more treatment beams.
-
- Provide means to define a treatment beam.
-
- Provide means to locate isocenter of the treatment beam within the patient model.
-
- Provide means to set the gantry, collimator, and couch angles, and to specify a gantry arc rotation.
-
- Provide means to specify a wedge.
-
- Provide means to shape a field with a multi-leaf collimator.
-
- Provide means to shape a field with auxiliary blocking (cerrobend).
-
- Provide means to fit a poly-energetic pencil beam algorithm for the purpose of computing the dose.
-
- Provide means to compute the dose to the patient model from the specified treatment beams.
-
- Provide means to display the dose on 2d planes in the patient model and 3d room views.
-
- Provide means to specify a dose prescription and calculate monitor units for each treatment beam.
-
- Provide means to outline regions of interest.
-
- Provide means to fuse other image sets and transfer outlines and points from the other image set.
-
- Provide means to compute and display dose volume histograms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
CT scans
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation therapy oncologist, dosimetrist, and radiation therapy 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)
Not Found
Reference Device(s)
Not Found
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.
0
KOa2961/
JAN 31 2003
RtDosePlan File: rtksum.doc
510(k) Summary
RtDosePlan is a radiation therapy external beam treatment planning program that supports treatment planning for x-rays only. The following functions are included:
-
- Provide means to read in CT scans and form a patient model.
-
- Provide means to define a skin boundary.
- Provide means to convert CT numbers to physical density. 3.
-
- Provide means to define a plan that consists of one or more treatment beams.
-
- Provide means to define a treatment beam.
-
- Provide means to locate isocenter of the treatment beam within the patient model.
-
- Provide means to set the gantry, collimator, and couch angles, and to specify a gantry arc rotation.
-
- Provide means to specify a wedge.
-
- Provide means to shape a field with a multi-leaf collimator.
-
- Provide means to shape a field with auxiliary blocking (cerrobend).
-
- Provide means to fit a poly-energetic pencil beam algorithm for the purpose of computing the dose.
-
- Provide means to compute the dose to the patient model from the specified treatment beams.
-
- Provide means to display the dose on 2d planes in the patient model and 3d room views.
-
- Provide means to specify a dose prescription and calculate monitor units for each treatment beam.
-
- Provide means to outline regions of interest.
-
- Provide means to fuse other image sets and transfer outlines and points from the other image set.
-
- Provide means to compute and display dose volume histograms.
Document Approved by: Wendel Dean Renner Windel D. Unandel W. Nennan Title: President
Wendel D. Neman
Date: Sept 4, 2007
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2003
Mr. Wendel Dean Renner President Math Resolutions, LLC 5975 Gales Lane COLUMBIA MD 21045
Re: K022961
Trade/Device Name: RtDosePlan Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: October 31, 2002 Received: November 4, 2002
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. Iisting 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 (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); 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.
2
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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
RtDosePlan File: rtinduse.doc
510(k) Number: K022961
\
Device Name: RtDosePlan
Indications for Use:
This product is to be used by radiation therapy oncologist, dosimetrist, and radiation therapy physicist, to plan the treatment with x-rays for patients undergoing radiation therapy for stationary and gantry arc beams. Support is included for field shaping with multi-leaf collimators and auxiliary blocking, and the use of wedges. Electron therapy and intensity modulated radiation therapy is not included in this product.
Document Approved by: Wendel Dean Renner Title: President
Wendel D. Renner
Date: Sept 4, 2002
NB / Prescription Device.
Nancy Breade
(Division Sign-Off)/
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022961