FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM

K081112 · Isodose Control B.V. · MUJ · Jul 29, 2008 · Radiology

Device Facts

• Record ID: K081112
• Device Name: FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
• Applicant: Isodose Control B.V.
• Product Code: MUJ · Radiology
• Decision Date: Jul 29, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Flexiplan is a Brachytherapy Treatment Planning System used by medical professionals. Flexiplan is used for the creation of HDR or PDR treatment plans for remote afterloader based brachytherapy. It especially supports the Flexitron Remote Afterloader from Isodose Control. Flexiplan calculates a proposed treatment course based on imported clinical images and other user entered data. Flexiplan supports the evaluation of clinical images in calculating the local and global dose to organs at risk and target volume.

Device Story

Flexiplan is a software-based brachytherapy treatment planning system (TPS) running on a Windows PC. It ingests clinical images and user-entered data to assist medical professionals in planning radiation therapy. The system provides tools for image enhancement, contouring of target volumes (PTV), and organs at risk (OAR). It calculates optimal dwell times and dose distributions for HDR and PDR remote afterloaders, specifically the Flexitron. The software reconstructs applicators and evaluates proposed treatment plans. Output is transferred to the afterloader for patient treatment. Accessories include a film scanner for X-ray input, a printer for documentation, and a pen tablet or touch panel for precise contouring. The device is used in clinical settings to enable precise radiation delivery, sparing healthy tissue while treating tumors.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PC-based software running on Windows XP Professional/Vista. Includes monitor, keyboard, mouse, film scanner, printer, pen tablet, and touch panel. Connectivity via hospital network for image import. Software performs dose distribution calculations for HDR/PDR brachytherapy.

Indications for Use

Indicated for medical professionals creating HDR or PDR brachytherapy treatment plans for patients requiring remote afterloader-based radiation therapy.

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 BPS (K983343)
• BrachyVision (K992762)

Submission Summary (Full Text)

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KOSIII2

## 5. 510(k) Summary as required by 21 CFR 807.92

#### 5.1. Submitter of 510(k)

| 510(k) owner's name<br>address | Isodose Control BV<br>Maxwellstraat 16<br>6716 BX Ede<br>The Netherlands | JUL 29 2008 |
|--------------------------------|--------------------------------------------------------------------------|-------------|
| phone | [phone] | |
| fax | [phone] | |
| name of contactperson | Hub van de Bergh | |
| e-mail | [e-mail] | |
| date the summary was prepared | April 14, 2008 | |

#### 5.2. Device: Flexiplan

name of the device / trade or proprietary name: Flexiplan common or usual name: Brachytherapy Treatment Planning System classification name: Remote controlled radionuclide applicator system (per 21 CFR section 892.5700 Product code MUJ)

## 5.3. Legally Marketed Device(s)

The Flexitron device can be shown to be substantial equivalent to the legally marketed devices cited in the table below.

| Device | Manufacturer | 510(k) # |
|--------------|----------------------------|----------|
| PLATO BPS | Nucletron B.V. | K983343 |
| BrachyVision | Varian Medical Systems Inc | K992762 |

## 5.4. Description of the Device

#### 5.4.1. Flexiplan

Flexiplan is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on the input entered by the operator. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) and Pulsed Dose Rate (PDR) Remote Afterloaders. The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The main use of Flexiplan is to calculate the required dwell times at the pre - determined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR).

Flexiplan can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, Flexiplan will calculate the optimal dose distribution for the tumor volume. Evaluation tools are available to qualify of the proposed treatment. The therapy planning is then transferred from the Flexiplan to the Afterloader.

The Flexiplan software is intended to be used with the Flexitron Brachytherapy Remote Controlled Afterloading Device.

Company Confidential

Section 5: 510(k) Summary - page 1 of 2 060-5002-20080722c Flexiplan510(k)PMNsubmiss

Isodose Control B.V. Maxwellstraat 16, 6716 BX Ede The Netherlands 2 [phone] | 김 [phone] | @ [e-mail] | KvK: 30191600 www.isodosecontrol.com

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The Flexiplan System comprises subjoined listed subsystems:

- . Personal Computer It executes the Flexiplan software.
- . Monitor To visualise the treatment planning process.
- . Keyboard To enter treatment data.
- . Mouse To select objects on the screen

The PC is used to execute the Flexiplan software and runs under Windows XP Professional / Vista. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.

#### 5.4.2. Accessory: Film Scanner

The Film Scanner allows the user to scan in an X-Ray image to present it on the screen to visualise the implant.

#### 5.4.3. Accessory: Printer

The Printer allows for hard copy of the patients treatment plan and other stored data.

#### 5.4.4. Accessory: Pen Tablet

The Pen Tablet acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.

#### 5.4.5. Accessory: Touch Panel

The Touch Panel acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.

## 5.5. Intended use of the Device

The Flexiplan is used for the creation of treatment plans for High Dose Rate and Pulsed Dose Rate remote afterloader based brachytherapy. Flexiplan will calculate a proposed treatment course based on imported clinical images and other user entered data. Flexiplan also supports the evaluation of clinical images in calculating the local and global doses.

## 5.6. Technological characteristics of device compared to the predicate device

The Flexiblan Brachytherapy Treatment Planning System has similar technological characteristics compared to the legally marketed predicate devices listed above.

All these devices are based on a computer system, a monitor for data visualisation, keyboard and mouse for data entry.

## 5.7. Substantial Equivalence

From the discussion in previous paragraphs it can be concluded that the Flexiplan Brachytherapy Treatment Planning System has similar technological characteristics compared to the legally marketed predicate devices listed in paragraph 5.3.

The differences between Flexiblan and predicate devices do not concern the basic principle of operation nor does it adversely affects the safety or effectiveness of the device.

The intended use of Flexiplan and predicate devices are the same.

The conclusion is that Flexiplan is substantial equivalent to the legally marketed predicate devices.

Company Confidential

Section 5: 510(k) Summary - page 2 of 2 060-5002-20080722c Flexiplan510(k)PMNsubmission

Isodose Control B.V. Maxwellstraat 16, 6716 BX Ede The Netherlands ■ [phone] - 品 [phone] @ [e-mail] KvK: 30191600 www.isodosecontrol.com

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hub van de Bergh Quality Assurance & Regulatory Affairs Officer Isodose Control B.V. PO Box 615, 3900 AP Vcenendaal Landjuweel 11, 3905 PE THE NETHERLANDS

JUL 2 9 2008

Re: K081112

Trade/Device Name: Flexiplan Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: MUJ Dated: April 14, 2008

Received: April 30, 2008

#### Dear Mr. Hub van de Bergh:

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.

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Page 2

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892:xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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

510(k) Number (if known):

Device Name: ______________________________ Flexiplan

Indications for Use:

Flexiplan is a Brachytherapy Treatment Planning System used by medical professionals. Flexiplan is used for the creation of HDR or PDR treatment plans for remote afterloader based brachytherapy. It especially supports the Flexitron Remote Afterloader from Isodose Control. Flexiplan calculates a proposed treatment course based on imported clinical images and other user entered data. Flexiplan supports the evaluation of clinical images in calculating the local and global dose to organs at risk and target volume.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aont M Wham

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

Company Confidential

Section 4: Indications for Use Statement - page 2 of 2 060-5002-20080722c FiexIplan510/k)PMNsubmisslor

Isodose Control B.V. Maxwellstraat 16, 6716 BX Ede The Netherlands 2 [phone] [phone] @ [e-mail] KvK: 30191600 www.isodosecontrol.com