(275 days)
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No
The summary describes a software for dose planning and verification based on seed location and strength, without mentioning any AI/ML techniques for image analysis, planning optimization, or other functions.
No
TraPIS is a software for planning and verification of brachytherapy, it does not directly apply therapy to the patient. It's a tool used in the treatment planning process, not a therapeutic device itself.
No
Explanation: TraPIS is a software for planning and post-implant verification of brachytherapy, which is a treatment planning and verification tool, not a diagnostic device used to identify the presence or absence of a disease.
Yes
The device is explicitly described as "software (computer program)" and its function is solely related to planning and verification based on input data (ultrasound, CT, radiographs). There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, TraPIS is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. TraPIS is a software used for planning and verifying radiation therapy based on imaging data (ultrasound, CT, radiographs) and seed placement. It does not analyze biological samples.
- The intended use is for treatment planning and verification, not diagnosis or monitoring of a disease state through analysis of biological samples.
TraPIS falls under the category of medical device software, specifically for radiation therapy planning.
N/A
Intended Use / Indications for Use
TraPIS (Transperineal Prostate Implant Simulator) is a software (computer program) designed for planning and post-implant verification of brachytherapy for carcinoma of the prostate gland. The isotope library includes Palladium (103Pd), Iodine (125I) and Iridium (192Ir) seeds. TraPIS is intended for clinical as well as research and academic use.
In summary, the software is designed to provide a three-dimensional radiation dose distribution in the form of isolines (contours of equal dose) or point-dose-values for a specified seed pattern. An ultrasound-guided prostate boundary dictates the seed locations. A treatment plan consisting of seed strength and distribution can be developed such that the specified radiation dose distribution is achieved within the prostate boundary. Post-implant verification involves relocating the seeds to their actual locations revealed through CT scans and/or radiographs and recalculating the dose distribution.
Product codes
MUJ
Device Description
TraPIS (Transperineal Prostate Implant Simulator) is a software (computer program) designed for planning and post-implant verification of brachytherapy for carcinoma of the prostate gland. The isotope library includes Palladium (103Pd), Iodine (125I) and Iridium (192Ir) seeds. TraPIS is intended for clinical as well as research and academic use.
In summary, the software is designed to provide a three-dimensional radiation dose distribution in the form of isolines (contours of equal dose) or point-dose-values for a specified seed pattern. An ultrasound-guided prostate boundary dictates the seed locations. A treatment plan consisting of seed strength and distribution can be developed such that the specified radiation dose distribution is achieved within the prostate boundary. Post-implant verification involves relocating the seeds to their actual locations revealed through CT scans and/or radiographs and recalculating the dose distribution.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound-guided, CT scans and/or radiographs
Anatomical Site
prostate gland
Indicated Patient Age Range
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Intended User / Care Setting
clinical as well as research and academic use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Nov | 8 |999
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KPS & ASSOCIATES, Inc.
Computer Simulation Consultants (Medical Unit)
Section V - 510(k) Summary {21 CFR §807.87 (h)/807.92 (a)-(b)}
8807.92(a)(1) 1.
Submitter's Name: KPS & ASSOCIATES, Inc.
Address:
851 E. Northcrest Drive Salt Lake City, Utah 84103
Phone: Fax: E-mail:
(801) 359-4631 (801) 596-8048 kps@aros.net
Contact Person: Dr. Krishna P. Sinha
Date of Summary Preparation: February 12, 1999
| 2. | §807.92(a)(2) | Trade/Proprietary Name: | Tra PISO (Transperineal Prostate
Implant Simulator) |
|----|---------------|-------------------------|--------------------------------------------------------------------------------------------|
| | | Common/Usual Name: | Treatment Planning and
Verification Software for
Brachytherapy of Prostate
Cancer |
| | | Classification Name: | System, Planning, Radiation
Therapy Treatment |
| | | Device Class/Panel: | Class II/Radiology |
| | | Product Code: | MUJ |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its head and neck, and three curved lines representing its body. 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
NOV 1 8 1999
Krishna P. Sinha, Ph.D. President KPS & Associates, Inc. Computer Simulation Consultants (Medical Unit) 851 E. Northcrest Dr. Salt Lake City, Utah 84103
Re:
TRSPIS-Transperineal Prostate Implant Simulator Dated: August 19, 1999 Received: August 20, 1999 Regulatory class: II 21 CFR 892.5730/Procode: 90 MUJ
Dear Dr. Sinha:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K990475 SIO(K) NUMBER (IF KNOWN):
TraPIS DEVICE NAME :
INDICATIONS FOR USE:
TraPIS (Transperineal Prostate Implant Simulator) is a software (computer program) designed for planning and post-implant verification of brachytherapy for carcinoma of the prostate gland. The isotope library includes Palladium (103Pd), Iodine (125I) and Iridium TraPIS is intended for clinical as (192Ir) seeds. well as research and academic use.
In summary, the software is designed to provide a threedimensional radiation dose distribution in the form of isolines (contours of equal dose) or point-dose-values for a specified seed pattern. An ultrasound-guided -A treatprostate boundary dictates the seed locations. ment plan consisting of seed strength and distribution can be developed such that the specified radiation dose distribution is achieved within the prostate boundary. Post-implant verification involves relocating the seeds to their actual locations revealed through CT scans and/or radiographs and recalculating the dose distribution.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CORA, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Shmil h. Segm
(Division Sign-Off)
Division of Reproductive, Ab and Radiological I
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Over-The-Counter-Use (Optional Format: 1-2