(169 days)
THERAPLAN Plus Version 1.2 is intended to be used as a modelling system to assist health care professionals determine a course of Radiation Therapy to be delivered to a patient with cancer. It is designed to be used directly by a health care professional capable of assessing the suitability of the output for treatment planning purposes, or to have its output reviewed by someone with these qualifications prior to use.
THERAPLAN Plus Version 1.2 consists principally of application software running under a Windows operating system on a Pentium personal computer. Several THERAPLAN Plus Version 1.2 systems can be networked together for common access to pertinent data. The principal components of the THERAPLAN Plus Version 1.2 are listed below.
Hardware platform and Operating System: Pentium PC, Windows NT
Peripherals and accessories: Electromagnetic digitizer for manually entering patient anatomy, film scanner for entering anatomy from films, 9 track magnetic tape unit for entering CT and MR images of patient anatomy, laser text printer, 300 dpi, 4 pages per minute minimum, colour printer, 300 dpi.
Main software features:
Unit Modelling of electron and photon beams from accelerators or Cobalt therapy units. Includes entry of wedges, blocks, and multileaf collimators.
Source Modelling of point sources, line sources and wires. The operator selects parameters for the sources which are required for treatment planning, such as size, isotope, wall thickness, and half-life.
Patient Data Acquisition by means of CT or MR images, a film scanner, or manually entered contours. CT or MR data may be acquired directly for units which support the DICOM 3 image format and communication standard, or by means of a software interface supplied by Theratronics for other units.
Anatomy Modelling to prepare the patient data for treatment planning. The portions of the anatomy which are of interest are selected, and contouring is performed of the anatomy exterior, the treatment target volume, and interior organs as needed for treatment planning.
Brachytherapy Planning may be performed using sources established during Source Modelling. The location of multiple sources may be specified and sample dose calculations performed. The location of sources may be adjusted for optimization. Timedomain calculations may also be performed based on the pattern of sources and their halflives.
External Beam Planning may be performed using Unit Modelling data and Anatomy Modelling data. Electron and/or photon beams of different treatment units may be applied, and dose calculations performed. The location of the beams may then be adjusted for optimization. Arc therapy treatments can also be modeled.
The THERAPLAN Plus Version 1.2 also includes facilities for the operator to print the treatment plan information for review and to assist with the patient's treatment, and a compensator can be designed to help optimize the radiation pattern of an applied beam.
The provided text for the THERAPLAN Plus Version 1.2 510(k) submission describes the device, its features, and intended use, and concludes that its development and validation are in compliance with Theratronics product development procedures. These procedures reportedly ensure that system testing and validation demonstrate that the system meets its published specifications, performs as well as or better than predicate products, and is safe and effective for its intended use.
However, the provided document does not explicitly state specific acceptance criteria (metrics with numerical thresholds) or detail a standalone study that directly proves the device meets these criteria. The text primarily focuses on describing the device's functionality and its substantial equivalence to predicate devices. The "Conclusion" section makes a general statement about meeting specifications and performing comparably to predicate devices, but lacks the specific data requested regarding acceptance criteria and a dedicated study to prove it.
Therefore, the following information is not explicitly available in the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are listed, nor are numerical results presented against such criteria.
- Sample size used for the test set and the data provenance: No information about a specific test set, its size, or its origin (e.g., country, retrospective/prospective) is provided for a performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No details are given about how ground truth was established for any test data.
- Adjudication method for the test set: No adjudication method is mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: The document does not describe an MRMC study or any comparison of human readers with vs. without AI assistance. The device is a "Radiation Therapy Treatment Planning System" which assists healthcare professionals, but it's not an AI specifically designed to improve human reader performance in a diagnostic sense.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document does not describe a standalone performance study. The device is intended to be used by healthcare professionals.
- The type of ground truth used: No specific type of ground truth (e.g., pathology, outcomes data) is mentioned for any performance evaluation.
- The sample size for the training set: No information regarding a training set or its size is provided.
- How the ground truth for the training set was established: No information regarding ground truth establishment for a training set is provided.
Based on the provided text, the THERAPLAN Plus Version 1.2 is a "Radiation Therapy Treatment Planning System." Its validation focused on compliance with Theratronics product development procedures, aiming to ensure it meets published specifications and performs as well as or better than predicate products. However, the document does not furnish the specific details of a performance study demonstrating quantitative acceptance criteria.
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THERAPLAN Plus Version 1.2
510(k) Submission
..............................................................................................................................................................................
Summary of Safety and Effectiveness
| Prepared: | January 17, 1997 |
|---|---|
| JUL - 9 1997 | |
| Submitter: | Theratronics International Limited |
| Address: | 413 March RoadP. O. Box 13140Kanata Ontario CanadaK2K 2B7 |
| Phone: | (613) 591-2100 |
| Contact: | Mr. E. MartellVice President - Quality Assurance and Regulatory Affairs |
| Device: | Trade Name: THERAPLAN Plus Version 1.2Common Name: Radiation Therapy Treatment Planning SystemClassification Name: Treatment Planning Computer |
| PredicateDevices: | Theratronics "THERAPLAN PLUS Version 1.0", K954679Theratronics "THERAPLAN 500", K940237Nucletron "PLATO", K921991Radiation Oncology Computer Systems "TPS 1031", K862643Precision Therapy "Render-Plan", K894722ADAC "Pinnacle", K926008 |
Device Description:
THERAPLAN Plus Version 1.2 consists principally of application software running under a Windows operating system on a Pentium personal computer. Several THERAPLAN Plus Version 1.2 systems can be networked together for common access to pertinent data. The principal components of the THERAPLAN Plus Version 1.2 are listed below.
Hardware platform and Operating System: Pentium PC, Windows NT
Peripherals and accessories: Electromagnetic digitizer for manually entering patient anatomy, film scanner for entering anatomy from films, 9 track magnetic tape unit for
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entering CT and MR images of patient anatomy, laser text printer, 300 dpi, 4 pages per minute minimum, colour printer, 300 dpi.
Main software features:
Unit Modelling of electron and photon beams from accelerators or Cobalt therapy units. Includes entry of wedges, blocks, and multileaf collimators.
Source Modelling of point sources, line sources and wires. The operator selects parameters for the sources which are required for treatment planning, such as size, isotope, wall thickness, and half-life.
Patient Data Acquisition by means of CT or MR images, a film scanner, or manually entered contours. CT or MR data may be acquired directly for units which support the DICOM 3 image format and communication standard, or by means of a software interface supplied by Theratronics for other units.
Anatomy Modelling to prepare the patient data for treatment planning. The portions of the anatomy which are of interest are selected, and contouring is performed of the anatomy exterior, the treatment target volume, and interior organs as needed for treatment planning.
Brachytherapy Planning may be performed using sources established during Source Modelling. The location of multiple sources may be specified and sample dose calculations performed. The location of sources may be adjusted for optimization. Timedomain calculations may also be performed based on the pattern of sources and their halflives.
External Beam Planning may be performed using Unit Modelling data and Anatomy Modelling data. Electron and/or photon beams of different treatment units may be applied, and dose calculations performed. The location of the beams may then be adjusted for optimization. Arc therapy treatments can also be modeled.
The THERAPLAN Plus Version 1.2 also includes facilities for the operator to print the treatment plan information for review and to assist with the patient's treatment, and a compensator can be designed to help optimize the radiation pattern of an applied beam.
Intended Use:
THERAPLAN Plus Version 1.2 is intended to be used as a modelling system to assist health care professionals determine a course of Radiation Therapy to be delivered to a patient. The software is designed to run on a central host computer and support a number of peripherals and accessories. The system can be configured to enter scan data from
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various types of CT scanners and MR scanners or to manually enter patient contour outlines. THERAPLAN Plus Version 1.2 systems can be networked together for common access to pertinent data.
THERAPLAN Plus Version 1.2 is intended to be used directly by a health care professional capable of assessing the suitability of the output for treatment planning purposes, or to have its output reviewed by someone with these qualifications prior to use.
Conclusion:
The THERAPLAN Plus Version 1.2 development and validation is in compliance with Theratronics product development procedures. These procedures ensure that system testing and validation demonstrate that the system meets its published specifications, performs as well or better than the predicate products to which is substantially equivalent, and is safe and effective for its intended use.
END - -
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Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a symbol that resembles a stylized eagle or bird in flight, composed of three curved lines that suggest the wings and body of the bird. The overall design is simple and conveys a sense of professionalism and authority.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
E. S. Martell, Vice President Quality Assurance and Regulatory Affairs THERATRONICS International Limited P.O. Box 13140 Kanata, Ontario CANADA K2K 2B7
Re: K970236
THERAPLAN Plus Version 1.2 RTP System Dated: April 29, 1997 Received: April 30, 1997 Regulatory Class: H ... . . . . . . . . 21 CFR 892.5050/Procode: 90 IYE
JUL - 9 1997
Dear Mr. Martell:
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 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). You may, therefore, 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 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (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 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 deving 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 question 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/dsmamain.html".
Sincerely yours
W.J.Liau Yu
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Submission
Indications for Use
Page 1 of _1
| 510(k) Number (if known): | K970236 |
|---|---|
| --------------------------- | --------- |
Device Name: THERAPLAN Plus Version 1.2 Radiation Therapy Treatment Planning System
Indications For Use:
THERAPLAN Plus Version 1.2 is intended to be used as a modelling system to assist health care professionals determine a course of Radiation Therapy to be delivered to a patient with cancer. It is designed to be used directly by a health care professional capable of assessing the suitability of the output for treatment planning purposes, or to have its output reviewed by someone with these qualifications prior to use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| and the program and the program and the program and the may be | ||||
|---|---|---|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
| ( | ( |
Ra-Pach
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic
Radiological Devices
510(k) Number K970236
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use
(Optional Format 1-2-96)
l
§ 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.