(242 days)
K 921991, K 951581, K 953391
Not Found
No
The description focuses on physical algorithms for dose calculation and user-defined parameters, with no mention of AI or ML.
No.
This device is a treatment planning system that helps prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. It is not directly involved in administering treatment to the patient.
No
The device is a treatment planning system for radiation therapy, used to calculate dose distributions based on imaging data, not to diagnose a patient's condition.
Yes
The device description explicitly states it is a "computer-based external beam and brachytherapy treatment planning system," which is a software system. While it utilizes patient anatomical information from hardware (radiographs, CT, MRI), the device itself is the software that processes this information and performs calculations. The description focuses on software modules and features.
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 taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The PLATO 3-D Treatment Planning System is used to plan radiation therapy for cancer patients. It takes imaging data (radiographs, CT, MRI) and helps determine the optimal radiation beam parameters and dose distribution for treatment.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is based on processing medical images and performing calculations related to radiation physics.
Therefore, the PLATO 3-D Treatment Planning System falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PLATO 3-D Treatment Planning System is used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop plans for external photon and electron therapy.
PLATO External Beam Planning RTS V2 and RTS 3D V2 has intended uses equivalent to its predecessor PLATO RTS V1. This device is used for external beam radiation therapy treatment planning for localization and treatment planning of malignant and benign lesions of patients.
Treatment of cancer may require use of external radiation beams from an external source. Teletherapy unit coordinates of beam placement including gantry angle, field size, and shape along with accurately calculated predicted dose computation, are necessary in present day planning for radiotherapy. The ability to calculate both coplanar and noncoplanar beams to a highly accurate level is desirable by the industry. PLATO RTS V 2 allows for accuracy and speed to clinically facilitate this need. The recent use of linear accelerator Multileaf Collimators for field shaping is desired and supported by RTS V2.
Product codes
90 IYE
Device Description
The PLATO 3-D Treatment Planning System described in this submission is a computer-based external beam and brachytherapy treatment planning system for clinical radiation therapy applications.
Based on an individual patient's anatomical information obtained from radiographs, CT or MRI scans, a treatment setup or source configuration, including insertion times for brachytherapy, is defined and the resultant dose distribution is calculations rely on physical algorithms describing the radiation transport process which finally leads to dose deposition inside a patient's anatomy.
Treatment set-up, or source parameters, are changed until the corresponding dose distribution are clinically acceptable. The operator performing the treatment planning forms part of the PLATO Radiation Treatment Planning System. The prescribed treatment is then administered to the patient, utilizing medical linear accelerators, cobalt units, afterloaders, or manual techniques.
The PLATO 3-D Treatment Planning System is modular in structure and consists of the following main features which are depicted in the attached system overview diagram.
RTS - A module for External Beam planning
EVAL 2.0 - An evaluation module for combination of external and brachytherapy planning using evaluation tools;
IPS-CT - Imports images from CT, MRI, radiographs and outlining features;
MLC - Multileaf Collimator
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT or MRI scans
Anatomical Site
Not Found
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)
K 921991, K 951581, K 953391
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
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS DATA PLATO 3D Radiation Therapy Planning System, External Beam Planning RTS V2 and RTS 3D V2
| October 17, 1996 | |
|---|---|
| Submitter/Contact: | Randolph Hemingway |
| Nucletron Corporation | |
| 7080 Columbia Gateway Drive | |
| Columbia, MD 21046-2133 | |
| Tel: (410) 312-4187 Fax: (410) 312-4199 | |
| PLATO External Beam Planning RTS V2 and RTS 3D V2 | |
| Trade/Proprietary Name: | RTS-2 3-D Radiation Treatment Planning System |
| Common Name: | 3-D Radiation Therapy Planning System |
| Classification Name: | Medical Charged Particle Radiation Therapy System |
| 21 CFR 892.5050 (Class II) | |
| Substantial Equivalence: | Nucletron PLATO Radiation Therapy Planning System |
| 510(k) K 921991 |
ADAC Pinnacle 3 APEX
510(k) K 951581
Siemens Treatment Management System (TMS)
510(k) K 953391 |
Device Description:
The PLATO 3-D Treatment Planning System described in this submission is a computer-based external beam and brachytherapy treatment planning system for clinical radiation therapy applications.
Based on an individual patient's anatomical information obtained from radiographs, CT or MRI scans, a treatment setup or source configuration, including insertion times for brachytherapy, is defined and the resultant dose distribution is calculations rely on physical algorithms describing the radiation transport process which finally leads to dose deposition inside a patient's anatomy.
Treatment set-up, or source parameters, are changed until the corresponding dose distribution are clinically acceptable. The operator performing the treatment planning forms part of the PLATO Radiation Treatment Planning System. The prescribed treatment is then administered to the patient, utilizing medical linear accelerators, cobalt units, afterloaders, or manual techniques.
The PLATO 3-D Treatment Planning System is modular in structure and consists of the following main features which are depicted in the attached system overview diagram.
1
RTS - A module for External Beam planning
EVAL 2.0 - An evaluation module for combination of external and brachytherapy planning using evaluation tools;
IPS-CT - Imports images from CT, MRI, radiographs and outlining features;
MLC - Multileaf Collimator
Device Intended Use:
As indicated above, the PLATO 3-D Treatment Planning System is used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system can be applied for external photon and electron therapy.
PLATO External Beam Planning RTS V2 and RTS 3D V2 has equivalent intended uses as its predecessor PLATO RTS V1. This device is used for external beam radiation therapy treatment planning for localization and treatment planning of malignant and benign lesions of patients.
Treatment of cancer may require use of external radiation beams from an external source, Teletherapy unit coordinates of beam placement including gantry angle, field size, and shape along with accurately calculated predicted dose computation, are necessary in present day planning for radiotherapy. The ability to calculate both coplanar and noncoplanar beams to a highly accurate level is desirable by the industry. PLATO RTS V 2 allows for the accuracy and speed to clinically facilitate this need. The recent use of linear accelerator Multileaf Collimators for field shaping is desired and supported by RTS V2.
Safety and Effectiveness
The PLATO Treatment Planning System is manufactured by Nucletron B.V. in The Netherlands that is officially registered as an ISO 9001 manufacturer. Accordingly, the system described herein will be manufactured in accordance with the ISO 9001 requirements, GMP regulations, and other applicable European standards.
The operator is provided with a comprehensive User's Manual, accompanied by an Instruction Manual, which provides the operator with a detailed tutorial. Nucletron employs a knowledgeable staff of clinical application specialists to complement the written documentation provided to the user. Such assistance is available during initial start-up and at other times when requested by the user. On-going training programs and seminars for users are conducted by Nucletron on a continual basis.
Nucletron's prior experience with treatment planning systems provides an extensive background in such devices and ensures that all systems are safe and effective as represented.
Software is designed in accordance with prescribed specifications, and detailed test plans ensure software integrity through definitive verification and validation procedures. A concept of "userfriendliness", safe, and effective operation is a top priority in all design and manufacturing efforts by Nucletron.
2
Conclusion:
: 3
The FDA 510K certification pre-market notification for the RTS 2 product contains adequate information and data to enable the determination of substantial equivalence with the documentation summarized in this submission.
- Nucletron's RTS 2 is subject to internal performance standards as defined by product design . specifications.
- . The RTS 2 external beam planning software will be developed and ongoing monitored to adhere to standards specified by Nucletron, Good Manufacturing Practices and ISO 9001 requirements.
- The information for users contains comprehensive instructions and documentation to ensure ● safe and effective use.
- Product Specifications and performance levels are substantially equivalent to other products . currently cleared by FDA for marketing in the U.S. Function and Dose calculation parameters have been tested and will be retested before actual product release.
- Close evaluation of other equivalent predicate devices demonstrates that RTS 2 is safe and ● effective for marketing.
3
Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a bird in flight or a human figure. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 1997
Randolph Hemingway Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046 --
Re: K964206
Plato RTS-2 3D Radiation Therapy Treatment Planning System Dated: March 30, 1-997………… Received: March 30, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Hemingway:
We have reviewed your Section 510(x) notification of intent to market the device referenced above and we have decemined 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 III (Premater 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. This response to your premarket notification 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(t) 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 yitte diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/cdrtv/dsmamain.html". پر پاک در
Sincerely yours,
William Fox
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
Enclosure
4
510(k) Number (if known): K964206
Device Name: PLATO External Beam Planning System RTS V2 & RTS 3D V2
Indications For Use;
PLATO 3-D Treatment Planning System is used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop plans for external photon and electron therapy.
PLATO External Beam Planning RTS V2 and RTS 3D V2 has intended uses equivalent to its predecessor PLATO RTS V1. This device is used for external beam radiation therapy treatment planning for localization and treatment planning of malignant and benign lesions of patients,
Treatment of cancer may require use of external radiation beams from an external source. Teletherapy unit coordinates of beam placement including gantry angle, field size, and shape along with accurately calculated predicted dose computation, are necessary in present day planning for radiotherapy. The ability to calculate both coplanar and noncoplanar beams to a highly accurate level is desirable by the industry. PLATO RTS V 2 allows for accuracy and speed to clinically facilitate this need. The recent use of linear accelerator Multileaf Collimators for field shaping is desired and supported by RTS V2.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vimill le. Seppem
Division of Reproductive, Abdominal, El and Radiological De 510(k) Number
Prescription Use V (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)