SIMUPLAN TREATMENT PLANNING SYSTEM

K093391 · Simuplan S.L. · MUJ · Dec 23, 2009 · Radiology

Device Facts

• Record ID: K093391
• Device Name: SIMUPLAN TREATMENT PLANNING SYSTEM
• Applicant: Simuplan S.L.
• Product Code: MUJ · Radiology
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Special
• 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

Computer-based software for radiation therapy planning; runs on Macintosh platform. Inputs: patient image sets (CT, MR, US, x-ray films) via DICOM, disk, or video. Workflow: clinician imports images; contours anatomical structures and tumor sites to generate 3D patient model or 2D reconstruction; defines treatment machine, implant applicators, or seed/template locations; selects radiation source (afterloading or seed). System calculates dose distribution based on target volume and prescription dose. Output: displayed dose distribution, printed treatment plan, and machine data for remote afterloading. Used in clinical settings by physicians/technicians. Physician reviews and confirms all outputs prior to treatment. Benefits: facilitates precise radiation dose planning for cancer therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based software; Macintosh platform; DICOM/HL7 interoperability; brachytherapy and external beam modules; dose calculation algorithms.

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)

Submission Summary (Full Text)

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K093391

## Special 510(k) SIMUPLAN Treatment Planning System October 28, 2009

DEC 2 3 2009

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Department of Health and Human Services Center of Device and Radiological Health Office of Device Evaluation Special 510(k) 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 number: | 3004147829 |
| Address: | Miguel Hernandez 25<br>La Eliana<br>46183 Valencia<br>Spain |
| Phone: | ([phone] |
| Fax: | ([phone] |
| Contact Person: | Conrado Pla Ph.D. |
| Modified Device Name: | |

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

#### Legally Marketed Device(s)

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

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

#### Description:

The SIMUPLAN Treatment Planning System is computer based software that runs on a Maclitosh platform. The planning system is comprised of 2 main components; external beam and bracilytheray.

#### Company Confidential

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### Special 510(k) SIMUPLAN Treatment Planning System October 28, 2009

The modified device, SIMUPLAN Treatment Planning System version 8.4 software included in this colors and module update only. The external beam software not included in this release.

With the brachytherapy module, the patients' image sets (i.e. CT, MR, US or x-ray films), are imported into the system by various methods: DICOM, disk, video, etc. From this data the patients' anatomical structures and tumor site is contoured in order to generate a 3D patient model, or x-ray films are used for 2D reconstruction of the implant area. Following the import of images, the next steps in the process will be to define the treatment machine, reconstruct implant applicators or define template and seed location. From this inframating the user will select the appropriate source (afterloading or seed) to be used for the planning session. Based on the target volume or reconstructed implant, treatment source and prescription dose the treatment plan will be calculated 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, machine data generated (for remote afterloading) and a hard copy of the isodose distribution is prepared for the patients' permanent record. The patient data is then saved unter 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 version 8.4 is substantially equivalent to the cleared predicate device, SIMUPLAN Treatment Planning System version 7.5, (#K030821).

Comado H

October 23, 2009

Name: Conrado Pla, Ph.D.

Title: President SIMUPLAN S.L.

Date

## Company Confidential

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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

# DEC 2-3 2009

Simuplan S.L. % Ms. Lu Anne Johnson President CAPAMED, Inc. 1917 29 % Ave RICE LAKE WI 54868

Re: K093391

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: December 2, 2009 Received: December 8, 2009

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 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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting 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): K093391

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 Device Evaluation (ODE)

Aorn M. Wh

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

510(k) Number_

Company Confidential

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