ONCENTRA BRACHY

K132816 · Nucletron B.V. · MUJ · Jun 13, 2014 · Radiology

Device Facts

• Record ID: K132816
• Device Name: ONCENTRA BRACHY
• Applicant: Nucletron B.V.
• Product Code: MUJ · Radiology
• Decision Date: Jun 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

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.

Device Story

Oncentra Brachy 4.4 is a software-only radiation therapy treatment planning system for brachytherapy. It ingests DICOM medical images to define patient anatomy and target volumes via an Anatomy Module. The Brachy Planning module reconstructs implants, identifies radioactive sources, and performs dose calculations. The system includes a Collapsed Cone Algorithm (ACE) that accounts for tissue heterogeneities, backscatter, attenuation, and shielding per AAPM TG-186. Users visualize plans in 3D via a Volume Rendering module and evaluate/compare plans using an Evaluator module. The software outputs treatment plans with estimated dose distributions for review and approval by qualified medical personnel. It is used in clinical settings to assist in planning cancer treatments, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

Bench testing included traceable test cases for all requirements, risks, and clinical scenarios. Clinical evaluation focused on the implementation of the AAPM TG-186 evaluation method; clinical sites confirmed the implementation met clinical requirements and user expectations for safety and effectiveness.

Technological Characteristics

Software-based radiation therapy planning system. Implements ACE (Advanced Dose calculation Engine) collapsed cone algorithm per AAPM TG-186. Supports DICOM connectivity. Functions as a standalone software application for brachytherapy planning.

Indications for Use

Indicated for cancer patients requiring 3D radiation therapy treatment planning. For use by qualified medical personnel only.

Regulatory Classification

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.

Predicate Devices

• Oncentra 4.2 (K121448)

Submission Summary (Full Text)

{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:[phone] Fax: [phone]

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.<br>Waargelder 1<br>3905 TH Veenendaal<br>The Netherlands |
| Phone: | ([phone] |
| Fax: | ([phone] |
| Correspondent: | Leo Hovestadt<br>Quality Assurance and Regulatory Affairs<br>[e-mail] |
| 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<br>ALLARIA ALEA A STATUS A STATUS STATE OF THE FE' TETHER | CANDI<br>JAVAI. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| and and and the more of the first for the comments of the comments of the comments of the comments of<br>Nucletron B.V<br>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<br>Jncentra 4<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 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.

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| 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 [phone] or [phone] 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 [phone] or [phone] 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

Page 1 of _1_