ONCENTRA-VISIR

K041719 · Nucletron Corp. · MUJ · Jul 22, 2004 · Radiology

Device Facts

• Record ID: K041719
• Device Name: ONCENTRA-VISIR
• Applicant: Nucletron Corp.
• Product Code: MUJ · Radiology
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Oncentra-VISIR is designed to be a tool for supporting the process of scheduling, preparing, setting up, delivering and recording radiation therapy.

Device Story

Oncentra-VISIR is a radiation therapy verification system used in clinical settings by radiation therapists/physicians. It retrieves patient data from dose planning systems and simulators, either automatically or via manual input. The system supports patient scheduling, presents setup data to operators and linear accelerators, and monitors treatment progress, including Monitor Unit values and in vivo dosimetry. Key features include Image Based Verification (IBV), which compares acquired treatment images against reference images (DRR or digital simulator) using automated edge detection to calculate couch shifts for patient repositioning. It supports Dynamic MLC IMRT, live MLC display, and port film scheduling. The system records all treatment data and maintains a detailed audit trail of edits. By automating verification and streamlining workflow, it assists in accurate radiation delivery and patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based verification system running on PC (Windows NT, 2000, or XP). Integrates with radiation therapy equipment (linacs) and dose planning systems. Features include automated edge detection for image comparison, MLC control interfaces, and audit logging. Connectivity via standard clinical interfaces for data retrieval and linac communication.

Indications for Use

Indicated for use as a tool to support the scheduling, preparation, setup, delivery, and recording of radiation therapy in patients undergoing such treatment.

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

• Helax-VISIR (K972617)

Submission Summary (Full Text)

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K041719

JUL 2 2 2004

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo. The logo contains a black circle with two white circles on opposite sides of the black circle.

#### 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: | 8671 Robert Fulton Drive<br>Columbia, MD 21046 |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick<br>Director Assurance & Regulatory Affairs |

#### Modified Device Name:

| Trade/Proprietary Name: | Oncentra-VISIR |
|-------------------------|----------------------------|
| Common/Usual Name: | VISIR |
| Classification Name: | Medical Linear Accelerator |
| Classification: | 21Cfr892.5050 Class II |
| Product Code | IYE |

## Legally Marketed Device(s)

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

| A-00-1-4-81-48-48<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Manufacturer | A BOOK OF CLE B<br>Uevice | CANILI<br>S |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-------------|
| ﮯ<br>A 137 | 11011<br>Carlos Stat<br>Free of each as and | · VO70G+ · |

## Description:

Oncentra-VISIR is a verification system designed to be a tool for supporting the process of preparing, setting up, delivering and recording radiation therapy. It will retrieve data from doseplan systems and simulators automatically or by manual input from the user. It will help administer patient sessions through the booking functionality. At each individual treatment Oncentra-VISIR will present setup data to the operator and also to the linac through a specific

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interface. Actual setup will be verified. During treatment Oncentra-VISIR can monitor the progress of both Monitor Unit values and optional in vivo dosimetry. All data relevant for the given treatment can be recorded.

The main areas of modification to the previously cleared device k972617 are:

- Image Based Verification (IBV) .
- This module allows the user to schedule image acquisitions on the treatment machine. Once the images are acquired thev are compared to a reference image such as a DRR or digital simulator image. Automated edge detection will mark both the reference and control image and perform a comparison. A resultant displacement is translated into the treatment couch shifts required to reposition the patient correctly for the desired beam placement within the patient.
- Improved user interface improved layout of data making it easier for the user to navigate . and display the data they require. Also improved workflow requiring less clicking and password entry than before.
- Optional double signature for treatment lets 2 therapists sign for treatment delivery .
- Dynamic MLC IMRT support .
- Live MLC display in treatment screens .
- More flexible port filming options such as film only and orthogonal film modes .
- Image acquisition (port film) scheduling .
- Detailed audit trail tracks all changes to patient data with time/date/signature stamps of anv . edit

The software runs on a PC on a Windows NT, 2000, or XP platform.

#### Intended use:

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

Oncentra-VISIR is designed to be a tool for supporting the process of scheduling, preparing, setting up, delivering and recording radiation therapy.

## Summary of technological considerations:

Oncentra-VISIR is substantially equivalent to the cleared predicate device, Helax-VISIR, 510(k)#: K972617.

e' Jan Willem Hazenoot

11/6/4
Date

Name. Jan-Millem Hazenoot Title: Business Segment Manager Nucletyon B.V. Veenendaal, The Netherlands

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 2004

Ms. Lisa Dimmick Director, Assurance & Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046

Re: K041719

Trade/Device Name: Oncentra-VISIR Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: June 23, 2004 Received: June 24, 2004

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 I ou may, attents 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.

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 promated 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 If you doch 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. Brigden

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

K041719

Device Name

Oncentra-VISIR

Indications for Usc

Oncentra-VISIR is designed to be a tool for supporting the process of Oncentra-VISIR is designed to be a toon for supporting the proposition therap

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NET AND THE CONSTITUTION VEEDED NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

sion Sign-Off)
an of Reproductive, Abdominal,
Radiological Devices K041719
(k) Number