ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING

K113102 · Nucletron · MUJ · Dec 12, 2011 · Radiology

Device Facts

• Record ID: K113102
• Device Name: ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
• Applicant: Nucletron
• Product Code: MUJ · Radiology
• Decision Date: Dec 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Brachytherapy planning with Oncentra manual Low Dose Rate Treatment Planning is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal including bronchial and surface applicator treatments, involving manually loaded radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to insertion. The software also provides the treatment time and dose distribution for the specific loading. From this information the patient can be treated with radioactive sources.

Device Story

Software package for manual low dose rate (LDR) brachytherapy treatment planning; runs on workstation. Inputs: radiographic images or manual coordinate specifications of radioactive sources (tubes, wires, seeds). Operation: reconstructs implant geometry; calculates dose distributions and treatment times; provides plan evaluation tools (dose volume histograms, dose verification, dose profiles). Output: hard copy reports of dose distribution and treatment parameters. Used by physicians in clinical settings to evaluate implants prior to manual source insertion. Benefits: assists in determining optimal source positioning/loading to improve treatment volume coverage; ensures accurate dosimetric planning before patient exposure.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing comparing output of subject device to predicate device.

Technological Characteristics

Software-based treatment planning system for LDR brachytherapy. Operates on Windows-based workstation. Provides dosimetric calculations for manually loaded radioactive sources (wires, tubes, seeds). Standalone software; no interface with external treatment machines or control units.

Indications for Use

Indicated for patients undergoing brachytherapy procedures, including intercavitary, interstitial, and intraluminal (bronchial) treatments, and surface applicator treatments requiring manually loaded radioactive sources.

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

• PLATO Brachytherapy (BPS14) (K983343)

Submission Summary (Full Text)

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DEC 1 2 2011

Page 27 September 2011

Image /page/0/Picture/3 description: The image shows the word "Nucletron" in bold black font next to a square logo. The logo is a black circle with two white circles on opposite sides of the black circle. The word "Nucletron" is in a sans-serif font and is slightly larger than the logo.

Nucletron Oncentra mLDR v1.0

Traditional 510(k)

Nucletron Corporation 7021 Columbia Gateway Drive Suite 200 Columbia, MD 21046-2133 U.S.A. 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 Corporation |
|-------------------------|-------------------------------------------------------|
| Registration number: | 3006624729 |
| Address: | 7021 Columbia Gateway Drive |
| | Columbia, MD 21046-2133 |
| Phone: | 443-545-2182 |
| Fax: | 443-769-1574 |
| Correspondent: | Michael Paul, |
| | Quality Assurance & Regulatory Affairs Manager |
| Date: | September 15, 2011 |
| New Device Name: | |
| Trade/Proprietary Name: | Oncentra manual Low Dose Rate Treatment Planning v1.0 |
| Common/Usual Name: | Treatment Planning System for Radiation Therapy |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification: | 21CFR 892.5050 Class II |

## Legally Marketed Device(s)

Our modified device is based on the legally marketed device cited in the table below:

Product Code MUJ

| Manufacturer | Device | 510(k)# |
|--------------|-----------------------------|---------|
| Nucletron BV | PLATO Brachytherapy (BPS14) | K983343 |

## Device description:

.

.

. .....

Oncentra manual Low Dose Rate Brachytherapy v1.0 is a software package designed for treatment planning of manually loaded low dose rate radioactive sources. This software runs on an Oncentra radiation therapy treatment planning system workstation.

Oncentra manual Low Dose Rate Brachytherapy v1.0 is capable of reconstructing the brachytherapy implant from radiographic images or the specification of coordinates, defining the location of the radioactive sources within the implant, and identifying a reference point, e.g.

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software program calculates the treatment data which includes dose distributions and treatment/implantation time.

The brachytherapy treatment planning session allows the physician to evaluate the implant prior to insertion of the low dose radioactive sources, e.g. tubes, wires, in order to determine the most optimal dose distribution within the treatment volume. Once the physician approves the treatment plan the implant is manually loaded with radioactive sources. The program provides a variety of plan evaluation tools to assist in the assessment of the implant quality, e.g. dose volume histogram, dose verification to defined points, dose profiles within the implant, etc.

This software program is for manually loaded low dose radioactive sources and does not interface with an external treatment machine, software programs or control units; it strictly provides hard copy output related to the dose distribution, total treatment time, and other treatment related information.

#### Intended use:

Brachytherapy planning with Oncentra manual Low Dose Rate Treatment Planning is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal including bronchial and surface applicator treatments, involving manually loaded radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to insertion. The software also provides the treatment time and dose distribution for the specific loading. From this information the patient can be treated with radioactive sources.

#### Summary of the Technical Characteristics

Oncentra manual Low Dose Rate Treatment Planning is the same device as the predicate device with a new user interface and Windows computer platform. The software provides treatment planning data for manually loaded low dose radioactive sources, e.g. wires, tubes and seeds.

#### Summary of Non- clinical testing

Comparison testing was performed between Oncentra manual Low Dose Rate Treatment Planning and the predicate device. The results demonstrated that the treatment planning output between the two products were within an acceptable range.

#### Summary of Clinical testing

Clinical testing was not required to demonstrate substantial equivalence.

#### Conclusion

The Oncentra manual Low Dose Rate Teatment Planning device is substantially equivalent to the cleared predicate device BATO Brachytherapy (#K983343).

Name: John Lapre

Sept. 27, 2011

---

Date

Name: John Lapre
Title: Vice President Research & Development
Nucletron B.V.
Veenendaal, The Netherlands

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

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

DEC 1 2 2011

Mr. Michael Paul QA/RA Manger Nucletron Corporation 7021 Columbia Gateway Drive, Suite 200 COLUMBIA MD 21046-2133

Re: K113102

Trade/Device Name: Oncentra Manual Low Dose Rate Treatment Planning v1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: October 15, 2011 Received: October 19, 2011

Dear Mr. Paul:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 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 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 Parts 801 and 809); medical device reporting (reporting of

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) KU3102 Number

Device Name Oncentra manual Low Dose Rate Treatment Planning v1.0

Indications for Usc

Brachytherapy planning with Oncentra manual Low Dose Rate Treatment Planning is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal including bronchial and surface applicator treatments, involving manually loaded radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to inserting. The software also provides the treatment time and dose distribution for the specific loading. Form this information the patient can be treated with radioactive sources.

Prescription Use X (Part 21 CFR 801 subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 subpart C)

(Division Sign-Off)

Division of Radiological Device Office of In Vitro Diagnostic Device Evaluation and Safety

510K K11362

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Concurrence of CDRH, Office of Device Evaluation (ODE)