OTP 1.2

K031349 · Nucletron Corp. · MUJ · Aug 7, 2003 · Radiology

Device Facts

• Record ID: K031349
• Device Name: OTP 1.2
• Applicant: Nucletron Corp.
• Product Code: MUJ · Radiology
• Decision Date: Aug 7, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

Device Story

OTP 1.2 is a radiation treatment planning software system. It ingests externally acquired medical images and user inputs to facilitate 3D treatment planning. The system utilizes a modular client/server architecture organized into functional 'Activities,' including anatomy/target definition, image registration, beam modeling, dose calculation, and plan evaluation. It supports DICOM import/export and volume rendering. The software is operated by qualified medical personnel in a clinical setting to generate dose distribution estimates. These plans are reviewed and approved by clinicians to guide radiation therapy delivery, aiming to optimize treatment for cancer patients.

Clinical Evidence

No clinical data provided; device is software for radiation treatment planning.

Technological Characteristics

Modular client/server software architecture; runs on Windows XP platform. Features include anatomy/target definition, image registration, beam module, dose module, and volume rendering. Supports DICOM connectivity.

Indications for Use

Indicated for patients with cancer requiring 3D radiation treatment planning. Prescription use 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

• TheraPlan Plus (K970236)

Submission Summary (Full Text)

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K031349
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Image /page/0/Picture/2 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a square logo. Inside the square is a black circle with two white circles on opposite sides of it. The logo is simple and modern.

## NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone [phone] Fax [phone]

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Special 510(k) section

## 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: | 7080 Columbia Gateway Drive<br>Columbia, MD 21046-2133 |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick<br>Director Assurance & Regulatory Affairs |

## Modified Device Name:

| Trade/Proprietary Name: | OTP 1.2 |
|-------------------------|-----------------------------------|
| Common/Usual Name: | Radiation Therapy Planning System |
| Classification Name: | Accessory to Radiotherapy Device |
| Classification: | 21Cfr892.5050 Class II |

#### Legally Marketed Device(s)

Our device is substantially equivalent to the legally marketed predicate device cited in the table below:

| Manufacturer | of a was well of the first and the commend of the bell the may of the county of the count<br>Device | 510(k)<br>1 # |
|--------------|-----------------------------------------------------------------------------------------------------|---------------|
| Nucletron BV | TheraPlan Plus<br>A MARK STATUS CONTRACTORS CONTRACTOR | K970236 |

#### Description:

The Oncentra Treatment Planning (OTP 1.2) 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 after review and approval by qualified medical personnel.

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K031349
Payeref2

OTP 1.2 is uses externally acquired medical images and user input. The OTP software is based on a modular client/server design, with the treatment planning functions divided into "Activities".

OTP 1.2 contains the following Activities:

- Anatomy Module: .
- Structure Definition .
- Target Definition .
- Image Registration .
- Beam Module ●
- Connectivity Module: ●
- DICOM Import / Export .
- Dose Module .
- Evaluation Module: .
- Plan Evaluation .
- Volume Rendering ●

In addition, various system utilities are available.

The software runs on a Windows XP platform.

#### Intended use:

The modified device has the same intended use as the legally marketed predicate device cited:

OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

## Summary of technological considerations:

OTP is substantially equivalent to the cleared predicate device, TheraPlan Plus, 510(k)#: K970236.

T.J. Bt

April 15, 2003

Date

Name: Tim Bateman Title: Business Segment Manager Nucletron B.V. Veenendaal, The Netherlands

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radiation therapy system

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2003

Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046

Re: K031349 Trade/Device Name: OTP 1.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle

Regulatory Class: II Product Code: 90 MUJ Dated: July 14, 2003 Received: July 16, 2003

Dear Ms. Dimmick:

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 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); 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.

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number

K031349

Device Name

## OTP 1.2

Indications for Use

OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Daniel R. Seymore

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number