SIMULIX EVOLUTION

K033470 · Nucletron Corporation · KPQ · Feb 4, 2004 · Radiology

Device Facts

• Record ID: K033470
• Device Name: SIMULIX EVOLUTION
• Applicant: Nucletron Corporation
• Product Code: KPQ · Radiology
• Decision Date: Feb 4, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5840
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Simulix Evolution is a radiation therapy simulation system is intended to prepare patients for radiation therapy. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment.

Device Story

Simulix Evolution is a radiation therapy simulation system used to prepare patients for treatment by emulating the geometry of radiation therapy machines. The device replaces traditional image intensifiers with an amorphous silicon digital flat panel detector (41x41 cm). It includes a PC-based workstation running on Windows XP that manages image acquisition, display, enhancement, and database functions. Clinicians use the system to position, film, and mark patients. The workstation supports DICOM import/export and provides simulator controls. By providing high-quality digital images and simulation tools, the device assists healthcare providers in accurately planning radiation therapy, potentially improving treatment precision and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiation therapy simulation system; amorphous silicon digital flat panel detector (41x41 cm); PC-based workstation; Windows XP platform; DICOM connectivity; replaces image intensifier technology.

Indications for Use

Indicated for patients requiring radiation therapy simulation to determine and mark geometrical positioning for treatment planning using radiographic and fluorographic imaging.

Regulatory Classification

Identification

A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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

• Simulix HP (K946128)

Reference Devices

• DTI workstation (K954055)

Submission Summary (Full Text)

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FEB - 4 2004

K033470

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold black font next to a logo. The logo is a black square with a black circle inside. Two white circles are 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 |
| | Columbia, MD 21046 |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
| | Director Assurance & Regulatory Affairs |

## Modified Device Name:

| Trade/Proprietary Name: | Simulix Evolution | |
|-------------------------|---------------------------------------|--|
| Common/Usual Name: | Simulator | |
| Classification Name: | System, Simulation, Radiation Therapy | |
| Classification: | 21Cfr892.5840 Class II | |
| Product Code:KPQ | | |

### Legally Marketed Device(s)

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

| Manufacturer | Device | 510(k) # |
|--------------|------------|----------|
| Nucletron BV | Simulix HP | K946128 |

## Description:

Simulix Evolution is a Flat Panel detector option to the Nucletron Simulix HP simulator system. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using a conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment.

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K033470
Page 2 of 2

KU33470

The Simulix Evolution option consists of a digital Flat Panel detector and a PC based simulator workstation.

The Flat Panel detector option replaces the current Image Intensifiers. The Flat Panel is a Amorphous silicon, digital detector, with a square image area of 41 by 41 cm.

The PC based simulator workstation is the current DTI workstation, but ported to a Windows platform. The PC based simulator workstation comes with functionality to support simulation procedures:

- . lmage acquisition
- Image display .
- Image enhancement and multiple views .
- Database and DICOM Import / Export functionality .
- Simulator controls �

The modifications to the previously cleared device k946128 are:

- . Flat Panel detector, which replaces the Image Intensifier
- Flat Panel workstation, which replaces the DTI workstation, previously cleared device . K954055

The software runs on a PC on a Windows XP platform.

## Intended use:

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

Simulix Evolution is a radiation therapy simulation system is intended to prepare patients for radiation therapy. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment.

### Summary of technoiogical considerations:

Simulix Evolution is substantially equivalent to the cleared predicate device, Simulix HP, 510(k)#: K946128.

12/9/13

Date

Name/ Jan-Willem Hazenoot Title: Business Segment Manager Nucletron B.V. Veenendaal, The Netherlands

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nucletron Corporation % Mr. J. A. van Vugt Responsible Third Party KEMA Quality B.V. P.O. Box 5185 6802 ED Arnhem, Arnhem THE NETHERLANDS

Re: K033470

Trade/Device Name: Simulix Evolution Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: 90 KPQ Dated: January 16, 2004 Received: January 20, 2004

Dear Mr. van Vugt:

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 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,

FEB - 4 2004

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Page 2

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 to regary 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, "Mitabranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtain. Ovider general Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/dsmaldsmamon.html

Sincerely yours.

Nancy C. Brygdon

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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'1033470

# Indications for Use Statement

510(k) Number K033470

Device Name

Simulix Evolution

Indications for Use

Simulix Evolution is a radiation therapy simulation system is intended to prepare patients for radiation therapy. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pct 21 CFR 801.109)

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Over-The-Counter Use_

Varry C. Brogdon

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