SIMUPLAN TREATMENT PLANNING SYSTEM

K120551 · Simuplan S.L. · MUJ · Jun 8, 2012 · Radiology

Device Facts

• Record ID: K120551
• Device Name: SIMUPLAN TREATMENT PLANNING SYSTEM
• Applicant: Simuplan S.L.
• Product Code: MUJ · Radiology
• Decision Date: Jun 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.

Device Story

SIMUPLAN Treatment Planning System is computer-based software for radiation therapy planning; runs on Macintosh platform. Inputs: patient image sets (CT, MR) via DICOM or disk. Process: localization of stereotactic frame; contouring of anatomical structures and tumor sites; calculation of treatment plan based on target volume, isocenter, machine parameters, and prescription dose. Output: displayed dose distribution; printed hard copy of isodose distribution for permanent record. Used in clinical settings by physicians/technicians. Physician reviews and modifies plan prior to final output; all information requires physician confirmation before patient treatment. Benefits: assists in precise radiation dose planning for external beam or brachytherapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based treatment planning system; Macintosh platform; DICOM compatibility; stereotactic radiosurgery module.

Indications for Use

Indicated for patients undergoing radiation therapy treatment with external beam or brachytherapy. No specific age or gender restrictions noted.

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

• SIMUPLAN Treatment Planning System, v 7.5 (K030821)
• SIMUPLAN Treatment Planning System, v 8.4 (K093391)

Submission Summary (Full Text)

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# 1120551

JUN - 8 2012

Image /page/0/Picture/2 description: The image shows a diagram of a semi-circle on top of a rectangle. The semi-circle is black and has a wavy line coming out of the top. There is an arrow pointing down from the semi-circle to the rectangle. The rectangle is white and has a semi-circle drawn inside of it.

Date: February 8, 2012

Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section

SIMUPLAN S.L. Miguel Hernandez 25 La Eliana 46183 Valencia Spain Phone: [phone] Fax: [phone]

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)

#### Submitter of 510(k)

| Company name: | SIMUPLAN S. L. |
|-----------------|-------------------------------------------------------------|
| Registration # | pending |
| Address: | Miguel Hernandez 25<br>La Eliana<br>46183 Valencia<br>Spain |
| Contact Person: | Conrado Pla Ph.D. |
| Phone: | ([phone] |
| Fax: | ([phone] |

#### Device Name

Trade/Proprietary Name: SIMUPLAN Treatment Planning System Common/Usual Name: Radiation Therapy Planning System Classification Name: Accelerator, Linear, Medical, Accessory 21 CFR 892.5050 Class II.

#### Legally Marketed Predicate devices(s)

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

| Manufacturer | Device | 510(k) # |
|--------------|-------------------------------------------|----------|
| SIMUPLAN | SIMUPLAN Treatment Planning System, v 7.5 | K030821 |
| SIMUPLAN | SIMUPLAN Treatment Planning System, v 8.4 | K093391 |

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# Description

The SIMUPLAN Treatment Planning System is computer based software that runs on a Macintosh platform. The modified device, SIMUPLAN Treatment Planning System version 8.5, is a stereotatic radiosurgery module update only.

The planning process begins with the selection of the treatment machine (linear accelerator) and the image set that will be used for treatment planning. The patients' image sets (i.e. CT, MR, etc.) are imported into the system by standard methods: DICOM, disk, etc. From this data the stereotatic frame is localized and the patients' anatomical structures and tumor site are contoured. The treatment plan will be calculated from the target volume, isocenter, treatment machine and prescription dose and a dose distribution will be displayed. This treatment plan can be modified by the physician prior to final output and patient treatment. The physician approved treatment plan is then printed out and a hard copy of the isodose distribution is prepared for the patients' permanent record. The patient data is then saved under a unique file name in the patient database. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.

#### Intended use

SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.

#### Summary of technological considerations

The SIMUPLAN Treatment Planning System software is substantially equivalent to the predicate devices.

Comedo He

Name: Conrado Pla Ph.D. Title: President SIMUPLAN S. L.

12, 2012

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Date

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# 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

SIMUPLAN S.L. % Ms. Lu Anne Johnson US Agent - SIMUPLAN S.L. Capamed Inc. 1917 29 % Avenue RICE LAKE WI 54868

JUN - 8 2012

Re: K120551

Trade/Device Name: SIMUPLAN Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system . Regulatory Class: II Product Code: MUJ Dated: April 9, 2012 Received: May 15, 2012

#### Dear Ms. Johnson:

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,

Janine M. Morris

Acting 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 Form

510(k) Number (if known): ____

Device Name: SIMUPLAN Treatment Planning System

Indications for Use:

SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.

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 In Vitro Diagnostic Devices (OIVD)

Michael D. Klein

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 20551

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