(277 days)
Not Found
No
The summary describes standard radiation therapy planning software functionalities and dose calculation algorithms without mentioning AI or ML.
No.
The device is described as radiation therapy planning software, which assists in planning treatments but does not directly administer therapy itself.
No
The device is a radiation therapy planning software used to analyze and plan treatments, providing estimates of dose distributions. It is not used for diagnosing medical conditions.
Yes
The device description explicitly states "Oncentra Brachy 4.4 is a radiation therapy treatment planning software" and details various software modules. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Oncentra's Function: Oncentra is a software used for planning radiation therapy treatments. It analyzes medical images (DICOM data) and calculates dose distributions for the purpose of treating cancer within the patient's body. It does not analyze samples taken from the body.
The device's function is focused on treatment planning based on imaging data, not on analyzing biological specimens.
N/A
Intended Use / Indications for Use
Oncentra is radiation therapy 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 (comma separated list FDA assigned to the subject device)
MUJ
Device Description
Oncentra Brachy 4.4 is a radiation therapy 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.
Oncentra Brachy 4.4 is a brachytherapy treatment planning only version of the Oncentra treatment planning system (Oncentra 4.2- K121448) and does not include Oncentra external beam treatment planning capabilities. Oncentra Brachy 4.4 includes all Oncentra software that is required for brachytherapy treatment planning which includes
- 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.
- 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.
- Brachy Planning Module: The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations. The software allows reconstruction of the implant from external images, identification of the radioactive sources, optimization methods, displayed dose distributions and output of treatment times.
- 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 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.
- Collapsed Cone Algorithm (ACE): Is a model based dose calculation that has been implemented in accordance with the AAPM TG-186 recommendations for brachytherapy uniformity. This algorithm takes into account the effects of tissue heterogeneities (normal tissue, air and bone), shields and applicators within finite patient dimensions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-clinical testing
Oncentra Brachy 4.4 met Nucletron verification and validation requirements for medical device software. This included traceable test cases for each requirement, identified risk, clinical scenarios and usability issues. All test cases were well documented with the results demonstrating all acceptance criteria were met and the software is determined to be safe and effective for clinical use.
Summary of Clinical testing
Oncentra Brachy 4.4 includes AAPM TG 186 as an evaluation method, which was clinically tested to ensure the implementation met clinical requirements and user expectations. All sites were in agreement that Oncentra Brachy 4.4 (including AAPM TG 186) was safe, effective and met clinical requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K132816
Page 1 of 3
Traditional (510k) Oncentra Brachy 4.4
Image /page/0/Picture/2 description: The image shows the logo for Nucletron, an Elekta company. The logo consists of a stylized atom symbol on the left, with the word "Nucletron" in bold, sans-serif font to the right. Below "Nucletron" is the text "AN ELEKTA COMPANY" in a smaller font size.
JUN 1 3 2014
Page 1 May 2014
Nucletron B.V. Waargelder 1 3905 TH Veenendaal The Netherlands
Phone:(+31) 318-557-133 Fax: (+31) 629-031-313
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
| Submitter of 510(k): | |
|---|---|
| Company name: | Nucletron B.V. |
| Establishment Registration number: | 9611894 |
| Address: | Nucletron B.V. |
| Waargelder 1 | |
| 3905 TH Veenendaal | |
| The Netherlands | |
| Phone: | (+31) 318-557-133 |
| Fax: | (+31) 629-031-313 |
| Correspondent: | Leo Hovestadt |
| Quality Assurance and Regulatory Affairs | |
| leo.hovestadt@elekta.com | |
| Device Name: | |
| Trade/Proprietary Name: | Oncentra Brachy 4.4 |
| Common/Usual Name: | Radiation therapy planning system |
| Classification | Class II |
| Classification Name: | System, planning, radiation therapy treatment |
| 21 CFR 892.5050 | |
| Product Code: MUJ |
Legally Marketed Device(s)
Our device is a modification of the legally marketed device:
| Manufacturer | Device
ALLARIA ALEA A STATUS A STATUS STATE OF THE FE' TETHER | CANDI
JAVAI. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| and and and the more of the first for the comments of the comments of the comments of the comments of
Nucletron B.V
Comments of the comments of the commended the desires of the comments of the comments of the comments of | A Property LA A Pick of A continued Channel Clause Claud Charge Claudi Children A Ph
Jncentra 4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | K121448 |
1
Traditional (510k) Oncentra Brachy 4.4
Page 2 May 2014
Device description:
Oncentra Brachy 4.4 is a radiation therapy 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.
Oncentra Brachy 4.4 is a brachytherapy treatment planning only version of the Oncentra treatment planning system (Oncentra 4.2- K121448) and does not include Oncentra external beam treatment planning capabilities. Oncentra Brachy 4.4 includes all Oncentra software that is required for brachytherapy treatment planning which includes
- 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.
- 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.
- Brachy Planning Module: The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations. The software allows reconstruction of the implant from external images, identification of the radioactive sources, optimization methods, displayed dose distributions and output of treatment times.
- 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 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.
- Collapsed Cone Algorithm (ACE): Is a model based dose calculation that has been implemented in accordance with the AAPM TG-186 recommendations for brachytherapy uniformity. This algorithm takes into account the effects of tissue heterogeneities (normal tissue, air and bone), shields and applicators within finite patient dimensions.
Intended Use:
Oncentra is radiation therapy 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.
Summary of the Technical Characteristics
Oncentra Brachy 4.4 has the same technical characteristics as the legally marketed device (Oncentra 4.2) with the exclusion of external beam treatment planning software. There is no difference between the devices in the handling of images, planning brachytherapy treatments, analysis of the dose distribution or treatment plan output. A collapsed cone algorithm has been implemented to meet the AAPM TG 186 recommendations for brachytherapy uniformity; ACE (Advanced Dose calculation Engine) accounts for tissue heterogeneities, backscatter, attenuation, shielding and provides the user with a comparison of AAPM TG-43 and AAPM TG-186 based calculations.
2
KB2816
Page 3 of 3
Page 3 May 2014
Traditional (510k) Oncentra Brachy 4.4
Summary of Non-clinical testing
Oncentra Brachy 4.4 met Nucletron verification and validation requirements for medical device software. This included traceable test cases for each requirement, identified risk, clinical scenarios and usability issues. All test cases were well documented with the results demonstrating all acceptance criteria were met and the software is determined to be safe and effective for clinical use.
Summary of Clinical testing
Oncentra Brachy 4.4 includes AAPM TG 186 as an evaluation method, which was clinically tested to ensure the implementation met clinical requirements and user expectations. All sites were in agreement that Oncentra Brachy 4.4 (including AAPM TG 186) was safe, effective and met clinical requirements.
Conclusion
Based on the technical characteristics and comprehensive testing it is determined that Oncentra Brachy 4.4 is safe, effective and meets clinical, requirements.
| Labels | Values |
|---|---|
| Name | John Lapre |
| Title | President |
| Nucletron B.V. |
May 20, 2014
Date
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines that curve at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2014
Nucletron B. V. % Ms. Lu Anne Johnson President Capamed, Inc. 1917 29 % Avenue RICE LAKE WI 54868
Re: K132816
Trade/Device Name: Oncentra Brachy 4.4 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 20, 2014 Received: May 22, 2014
Dear Ms. Johnson:
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
4
Page 2-Ms. Lu Anne Johnson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
. *
Sincerely yours,
Robert A Ochs
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K132816 510(k) Number (if known):
Device Name: Oncentra Brachy 4.4
Indications for Use:
Oncentra is a radiation therapy 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 807 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Robert A Ochs
(Division Sign-Off) Division of Radiological Health Office of In Viro Diagnostics and Radiological Health 510(k)_K132816
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