(14 days)
No
The document does not mention AI, ML, or related terms like deep learning, neural networks, or algorithms that typically indicate AI/ML functionality. The description focuses on standard radiation treatment planning software modules.
No.
The device is described as radiation treatment planning software, which provides estimates of dose distributions. It does not directly administer treatment or perform a therapeutic function on a patient. It is a tool used by qualified medical personnel to plan treatments.
No
The device is a radiation treatment planning software that uses medical images to design treatment plans, not to diagnose medical conditions. Its purpose is to prepare for treatment, not to identify disease.
Yes
The device description explicitly states it is "radiation treatment planning software" and details various software modules and their functions. While it uses externally acquired medical images, the device itself is presented solely as software running on a standard computing platform (Windows XP). There is no mention of proprietary hardware components included with the device.
Based on the provided information, the Oncentra MasterPlan system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Oncentra MasterPlan's Function: The Oncentra MasterPlan system is a radiation treatment planning software. Its purpose is to analyze and plan radiation treatments based on externally acquired medical images. It does not involve the examination of specimens taken from the human body.
- Intended Use: The intended use clearly states it's for "analyzing and planning radiation treatments... for the purpose of treating patients with cancer." This is a treatment planning function, not an in vitro diagnostic function.
- Device Description: The description details software modules for image processing, beam modeling, dose calculation, optimization, and evaluation of treatment plans. These are all related to planning radiation therapy, not analyzing biological specimens.
Therefore, the Oncentra MasterPlan system falls under the category of medical software used for treatment planning, not as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Oncentra MasterPlan 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
The Oncentra MasterPlan 3.1 system is 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 affer review and approval by qualified medical personnel.
Oncentra MasterPlan 3.1uses externally acquired medical images and user input. The Oncentra MasterPlan 3.1software is based on a modular client/server design, with the treatment planning functions divided into "Activities".
Oncentra MasterPlan 3.1 contains the following Activities:
Anatomy Module: .
The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROIs) 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 Modelling (BM) module handles specification of the beam shapes and other manipulation of the treatment plan.
Connectivity Module: .
The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra Brachy system from external sources, and data output from the system to external 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 read-only 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 XP platform.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
externally acquired medical images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
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
Not Found
Key Metrics
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.
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K08/28
Dg. 1 of 3
Image /page/0/Picture/1 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a square containing a black circle with two white circles on either side. The black circle is positioned diagonally within the square, and the white circles are placed near the corners of the square.
NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 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 510(k) section
MAY 20 2008
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)
Submitter of 510(k):
| Company name: | Nucletron Corporation |
|---|---|
| Registration number: | 1121753 |
| Address: | 8671 Robert Fulton Drive |
| Columbia, MD 21046 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
| Director Assurance & Regulatory Affairs |
Modified Device Name:
| Trade/Proprietary Name: | Oncentra MasterPlan 3.1 |
|---|---|
| Common/Usual Name: | Radiation Therapy Planning System |
| Classification Name: | System,Planning,Radiation Therapy Treatment |
| Classification: | 21Cfr892.5050 Class II |
Legally Marketed Device(s)
Our modified device is based on the legally marketed device cited in the table below:
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NUClerron | August I
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1
K081281
pg. 2 of 3
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Description
The Oncentra MasterPlan 3.1 system is 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 affer review and approval by qualified medical personnel.
Oncentra MasterPlan 3.1uses externally acquired medical images and user input. The Oncentra MasterPlan 3.1software is based on a modular client/server design, with the treatment planning functions divided into "Activities".
Oncentra MasterPlan 3.1 contains the following Activities:
Anatomy Module: .
The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROIs) 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 Modelling (BM) module handles specification of the beam shapes and other manipulation of the treatment plan.
Connectivity Module: .
The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra Brachy system from external sources, and data output from the system to external 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 read-only 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.
2
K081281
pg. 3 of 3
The software runs on a Windows XP platform.
Intended use:
The Oncentra MasterPlan 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 affer review and approval by qualified medical personnel.
Summary of technological considerations:
Oncentra MasterPlan 3.1 is substantially equivalent to the cleared predicate devices:
| and and any and the same of the same of the same of the cases of | SCAN OR SEPORT TEST DESCRIPTION S BRESS STREET START AND STATES A
Comments of the control control of the commend of the more of the many of the many of the many of the may be any for the may be
and the same of the mail of the state of the state of the comments of the comments of | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Nucletron BV | . OTP 1 " | KO31349 |
| Nucletron B. | PI ATO PI ATO PI ATTACTO
. Rrachymerady
14.6 | K983343 |
Name: Paul van den Biggelaar
February 26 2008
Date
Name: Paul van den Biggelaar Title: Birector Oncentra Nucletron B.V. Veenendaal, The Netherlands
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of three overlapping lines, resembling an abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nucletron Corporation % Mr. Jay Yoriyuki Kogoma Senior Staff Engineer Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
MAY 20 2008
Re: K081281
Trade/Device Name: Oncentra MasterPlan 3.1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 5, 2008 Received: May 6, 2008
Dear Mr. Kogoma:
We have reviewed vour 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, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours.
Nancy Brogdon
Nancy C. Brogdon
Director, Division of Reproductive
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Oncentra MasterPlan 3.1
Indications for Use Statement
510(k) Number
Device Name
Oncentra MasterPlan 3.1
Indications for Use
The Oncentra MasterPlan 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 (Part 21 CFR 801 subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
NancyC Brogdon
(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number