(48 days)
Not Found
No
The document describes a radiation treatment planning software that uses externally acquired medical images and user input for dose calculations and treatment planning. There is no mention of AI, ML, or related concepts in the provided text. The performance studies focus on dosimetric validation against previous versions and established methods, not on the performance of AI/ML algorithms.
No
The device is radiation treatment planning software, which aids in planning therapy, but is not therapeutic itself.
No
Explanation: The device is described as radiation treatment planning software that analyzes and plans radiation treatments to estimate dose distributions. It is used to administer treatments after review and approval by medical personnel. Its primary function is planning and treatment administration, not diagnostic interpretation or diagnosis of diseases.
Yes
The device is described solely as "radiation treatment planning software" and its components are described as "modules" and a "client/server design." There is no mention of any accompanying hardware components that are part of the device itself. While it uses externally acquired medical images, these are inputs, not part of the device hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer." This is a treatment planning function, not a diagnostic function performed on in vitro samples.
- Device Description: The description reinforces the treatment planning nature of the software, focusing on dose distributions and use by qualified medical personnel for administering treatments.
- Lack of In Vitro Sample Analysis: There is no mention of analyzing biological samples (blood, tissue, etc.) outside of the body, which is a core characteristic of IVDs.
- Focus on Medical Images: The input is "externally acquired medical images," which are used for anatomical modeling and treatment planning, not for in vitro diagnostic testing.
The device is clearly a medical device used in the context of radiation therapy treatment planning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
Product codes
MUJ
Device Description
Oncentra 4.2 is an update of Oncentra MasterPlan 3.1- they are the same product with same technological characteristics. The technical described below is part of both Oncentra 4.2 and Oncentra MasterPlan 3.1.
The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
The Oncentra 4.2 software is based on a modular client/server design, with the treatment planning functions divided into "Activities".
Oncentra 4.2 contains the following Activities:
- Anatomy Module: The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROls) related to the patient anatomy and target volumes for treatment planning. The AM allows the user to create and edit image registration between image series so that image fusion tools can be utilized.
- Beam Module: The Beam Modeling (BM) module handles specification of the beam shapes and other manipulation of the treatment plan.
- Plan Manager: The Plan Manager activity allows the user to create a new, or modify an existing, external beam treatment plan for photon beams. The activity provides tools for manual, and, if applicable, automatic, manipulation of beam geometries and modifiers
- Connectivity Module: The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra MasterPian system from external sources, and data output from the system to extemal sources.
- Dose Module: The Dose Modelling (DM) module handles execution of External Beam dose calculations.
- Optimizer Module: The Oncentra Optimizer (OM) module handles execution of treatment plan optimization. This activity will result in an optimized treatment plan for which the final dose calculation must be performed by DM.
- Brachy Planning Module: The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations.
- Evaluation Module: The Evaluation Module (EM) handles the necessary tools for evaluating one treatment plan that has a calculated Dose result. EM supports the same tools as BM but in a readonly mode. Tools that are not read-only like new/delete beams, field shaping, edit MLC, apply/remove wedges, etc. are not supported in EM.
- Evaluator Module: The Oncentra Evaluator (EVAL) handles the necessary tools for evaluating and comparing multiple treatment plans and dose summation of two or more plans for a selected case. The user may also select a candidate plan and approve the plan for treatment. The EVAL is a read-only activity with the exception of the plan approval function.
- Volume Rendering: The Volume Rendering (VR) module handles visualization of plans and their corresponding dose in 3D. No plan related data is modified in this module.
In addition, various system utilities are available. The software runs on a Windows 7 and XP platform.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
externally acquired medical images (e.g. planning CT images)
Anatomical Site
Not Found
Indicated Patient Age Range
all ages
Intended User / Care Setting
Qualified medical personnel in radiotherapy clinics, suitably trained by Nucletron staff (or other competent people) in using the system. Users must also be trained in general Windows usage. Radiation physicists are responsible for local configuration and maintenance of the system.
POF and their associated actor:
- System Installation: Medical Engineers
- Manage Treatment Unit and Physics Data: Physicists
- Prescription: Physicians
- Define anatomy: Physicians, Radiation therapists, Physicists
- Approve structures: Physicians
- Create plan: Radiation therapists, Physicists
- Evaluate plan: Physicians
- Approve plan: Physicians
- Export plan: External beam: Physicians; Brachy: Radiation therapists, Physicists
- Validate plan: Physicists
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
Anatomy Modeling (AM) module: allows the user to create and edit image registration between image series so that image fusion tools can be utilized.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Dosimetric validation - Brachy: The dosimetric accuracy for brachy dose calculations has for earlier releases been evaluated by the physics team. Comparisons have been made between Oncentra Brachy releases and Plato version 14.3.5. phantom measurements, and data published in the TG-43 report [[1] AAPM TG-43 Rivard MJ, Coursey BM, DeWerd LA, Hanson WF, Huq MS, Ibbott GS, Mitch MG, Nath R and Williamson JF. (2004). Update of AAPM task group no. 43 report: a revised AAPM protocol for brachytherapy dose calculations. Med. Phys. 31, pp.633-674.]. The accuracy of applicator shielding calculations was validated by comparisons with the established Plato planning system. No changes have been made to the brachytherapy dose calculations, therefore only a comparison with the previous version has been performed to verify consistency. The results are well within expectable error margins and the dose calculations are deemed good for clinical use.
Dosimetric validation - External Beam: The base dose calculation algorithms of Oncentra have not been updated for this version. Comparison of results with those from earlier versions has been made to ensure that no unexpected changes have taken place. The results are well within expectable error margins and the dose calculations are deemed good for clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K121449
JUL 2 2012
Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square containing a black shape with two white circles. The black shape appears to be two overlapping circles with a portion cut out, creating a unique design within the square. The logo is simple and professional.
NUCLETRON B.V.
Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 +31 318 550485 Fax
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92
1. SUBSCRIBERS NAME & ADDRESS
| Company name: | Elekta Inc. D/B/A Nucletron Corporation |
|---|---|
| Registration number: | 1121753 |
| Address: | 7 St. Paul Street, Suite 1660 |
| Baltimore, Maryland 21202 | |
| Phone: | 770-670-2548 |
| Fax: | 770-729-1585 |
| Correspondent: | Thomas Valentine |
| VP QA/RA, Elekta Inc. D/B/A Nucletron Corporation | |
| Date: | May 1, 2012 |
2. MODIFIED DEVICE NAME- CLASSIFICATION:
Oncentra 4.2 Trade/Proprietary Name: Common/Usual Name: Radiation Therapy Planning System Classification Name: System,Planning,Radiation Therapy Treatment 21Cfr892.5050 Class II Classification:
3. PREDICATE DEVICE IDENTIFICAITON
Our modified device is based on the legally marketed device cited in the table below:
| . Sul a se affer si for a send and and and services and super and super | 12 - Device Device - Device - Torre - Torrest -
Manufacturer. Ing | 1510(k) # . |
|-------------------------------------------------------------------------|----------------------------------------------------------------------|--------------|
| Nucletron BV | Oncentra MasterPlan 3. | K081281 |
| Nucletron BV | ם
I ATO Brachvtherapy 14.0 | . K98334? |
1
4. OVERALL DESCRIPTION OF ONCENTRA 4.2
Oncentra 4.2 is an update of Oncentra MasterPlan 3.1- they are the same product with same technological characteristics. The technical described below is part of both Oncentra 4.2 and Oncentra MasterPlan 3.1.
1. Overview
The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
The system is intended for use by qualified medical personnel in radiotherapy clinics, suitably trained by Nucletron staff (or other competent people) in using the system. In addition to radiotherapy, the users must be trained in general Windows usage -- Nucletron does not provide specific training or documentation conceming standard Windows functionality.
The Oncentra system should be configured locally and maintained by radiation physicists. It is a requirement that the person responsible for the local configuration has been suitably trained in configuring and maintaining the system.
2. Primary Operating Functions
The following table shows the general Primary Operating Functions (POF) for the system, respectively workflow descriptions and which actor that is most probably to perform the workflow. The POF have been identified in the Action Error Analysis (AEA) for Oncentra. Changes to this table must be motivated by the changes or additions to the AEA.
| POF | Workflow Description | Actor |
|---|---|---|
| A. System Installation | The system (server/client) is installed or upgraded | |
| to a new version. | Medical Engineers | |
| B. Manage Treatment Unit | ||
| and Physics Data | The treatment unit parameters and data are | |
| installed, configured, updated and checked. | Physicists | |
| C. Prescription | Dose is prescribed; fractionation and treatment | |
| protocol are decided. | Physicians | |
| D. Define anatomy | Target and risk structures are defined on the | |
| planning CT images. Structures (ROI) are | ||
| contoured based on the information from the | ||
| physician. | Physicians | |
| Radiation therapists | ||
| Physicists | ||
| E. Approve structures | The defined structure set is approved. | Physicians |
| F. Create plan | The prescription is interpreted and a treatment plan | |
| developed. | Radiation therapists | |
| Physicists | ||
| G. Evaluate plan | The plan is evaluated according to the prescribed | |
| dose for the contoured structures. | Physicians | |
| H. Approve plan | The physicians approve a plan for treatment. | Physicians |
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| I. Export plan | The plan is exported to the treatment unit
verification system | External beam:
Physicians
Brachy:
Radiation therapists
Physicists |
|------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| J. Validate plan | The treatment plan is validated before treatment
delivery through independent calculations and
measurements. | Physicists |
3. Activities
Oncentra 4.2 uses externally acquired medical images and user input. The Oncentra 4.2 software is based on a modular client/server design, with the treatment planning functions divided into "Activities".
Oncentra 4.2 contains the following Activities:
· Anatomy Module:
- The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROls) related to the patient anatomy and target volumes for treatment planning. The AM allows the user to create and edit image registration between image series so that image fusion tools can be utilized.
·Beam Module
The Beam Modeling (BM) module handles specification of the beam shapes and other manipulation of the treatment plan.
·Plan Manager
The Plan Manager activity allows the user to create a new, or modify an existing, external beam treatment plan for photon beams. The activity provides tools for manual, and, if applicable, automatic, manipulation of beam geometries and modifiers
· Connectivity Module:
The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra MasterPian system from external sources, and data output from the system to extemal sources.
·Dose Module
The Dose Modelling (DM) module handles execution of External Beam dose calculations.
· Optimizer Module
The Oncentra Optimizer (OM) module handles execution of treatment plan optimization. This activity will result in an optimized treatment plan for which the final dose calculation must be performed by DM.
· Brachy Planning Module
The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations.
3
· Evaluation Module:
The Evaluation Module (EM) handles the necessary tools for evaluating one treatment plan that has a calculated Dose result. EM supports the same tools as BM but in a readonly mode. Tools that are not read-only like new/delete beams, field shaping, edit MLC, apply/remove wedges, etc. are not supported in EM.
· Evaluator Module
The Oncentra Evaluator (EVAL) handles the necessary tools for evaluating and comparing multiple treatment plans and dose summation of two or more plans for a selected case. The user may also select a candidate plan and approve the plan for treatment. The EVAL is a read-only activity with the exception of the plan approval function.
· Volume Rendering
The Volume Rendering (VR) module handles visualization of plans and their corresponding dose in 3D. No plan related data is modified in this module.
In addition, various system utilities are available. The software runs on a Windows 7 and XP platform.
5. SUBSTANTIAL EQUIVALENCE
The functionality for the Oncentra 4.2 is equivalent to its predicate device K081281 in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 (k) submission.
5.1 Dosimetric validation - Brachy
The dosimetric accuracy for brachy dose calculations has for earlier releases been evaluated by the physics team. Comparisons have been made between Oncentra Brachy releases and Plato version 14.3.5. phantom measurements, and data published in the TG-43 report [[1] AAPM TG-43 Rivard MJ, Coursey BM, DeWerd LA, Hanson WF, Huq MS, Ibbott GS, Mitch MG, Nath R and Williamson JF. (2004). Update of AAPM task group no. 43 report: a revised AAPM protocol for brachytherapy dose calculations. Med. Phys. 31, pp.633-674.]
The accuracy of applicator shielding calculations was validated by comparisons with the established Plato planning system
No changes have been made to the brachytherapy dose calculations, therefore only a comparison with the previous version has been performed to verify consistency.
The results are well within expectable error margins and the dose calculations are deemed good for clinical use.
4
5.2 Dosimetric validation - External Beam
The base dose calculation algorithms of Oncentra have not been updated for this version. Comparison of results with those from earlier versions has been made to ensure that no unexpected changes have taken place.
The results are well within expectable error margins and the dose calculations are deemed good for clinical use.
6. INTENDED USE:
The legally marked predicate device Oncentra MasterPlan 3.1 (K081281) has the same intended use as the modified device cited:
Oncentra 4.2
is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
7. CLINICAL USAGE OF ONCENTRA 4.2
Oncentra 4.2 is to be used in radiotherapy. Most patients are cancer patients who will receive radiotherapy treatment. There are also other conditions which can be-treated with radiotherapy such as AVM Arteriovenus Malformations, Keloids (scars), and after removal of osteophytes (bone spurs) among others. - Patient population > all ages and genders.
Name: John Lapre
Title: Vice President Research & Development
May 30, 2012
Date
Title: Vice President Research & Development Nucletron B.V. Veenendaal, The Netheflands
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
7 2012 JUL
Mr. Thomas Valentine Vice President, Quality and Regulatory Affairs Elekta Inc. D/B/A Nucletron Corporation 7 St. Paul Street, Suite 1660 BALTIMORE MD 21202
Re: K121448
Trade/Device Name: Oncentra 4.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 11, 2012 Received: May 15, 2012
Dear Mr. Valentine:
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 for use barba in the energeansy is toge 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 r ou may, alorested, mains of the Act include requirements for annual registration, listing of general on the profice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your dovice to to loving major regulations affecting your device can be found in Title 21, additional controls: Entraing may 10 895. 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 i teast of actised that I Dr a vise in that your device complies with other requirements of the Act that I Dri has made a actorized by other Federal agencies. You must or any 1 ouvral statuates and including, but not limited to: registration and listing (21 comply with and the rev 021 CFR Parts 801 and 809); medical device reporting (reporting of
6
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): 11121448
Device Name:
Oncentra 4.2
Indications for Use:
The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Page 1 of ______ | |
|---|---|
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K | K121448 |