SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5

K030821 · Simuplan S.L. · MUJ · Sep 17, 2003 · Radiology

Device Facts

• Record ID: K030821
• Device Name: SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
• Applicant: Simuplan S.L.
• Product Code: MUJ · Radiology
• Decision Date: Sep 17, 2003
• 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

Computer-based software for radiation therapy planning; runs on Macintosh platform. Inputs: patient transverse slices (CT, MR) or x-ray films via DICOM, disk, video, or scanner. Workflow: user contours anatomical structures and tumor sites to generate 3D patient model; defines treatment machine, applicators, templates, seed locations, or isocenters; selects source (brachytherapy) or beam data (linear accelerators). System calculates dose distribution based on target volume and prescription dose. Physician reviews, fine-tunes, and confirms output before treatment. Outputs: printed treatment plan, program card for remote afterloading, and hard copy of isodose distribution. Used in clinical settings by physicians to assist in radiation therapy planning; improves accuracy of dose delivery; does not directly treat patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based radiation therapy planning system; Macintosh platform; DICOM/disk/video/scanner connectivity; supports external beam and brachytherapy modalities; dose distribution calculation algorithms; physician-in-the-loop verification.

Indications for Use

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

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 Brachytherapy (K983343)
• PLATO SRS (K010784)

Submission Summary (Full Text)

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K030821

Premarket Notification SIMUPLAN Treatment Planning System Date : March 10, 2003

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SIMUPLAN S.L.

Miguel Hernandez 25 La Eliana 46183 Valencia Spain Phone: [phone] Fax: [phone]

Date: March 10, 2003

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

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

SEP 1 7 2003

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

### Device Name: b.

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

### Legally Marketed Predicate devices(s) C.

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

## as required by section 807.92(c)

### Submitter of 510(k) a.

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| Manufacturer | Device | 510(k) # |
|----------------|---------------------|----------|
| Nucletron B.V. | PLATO Brachytherapy | K983343 |
| Nucletron B.V. | PLATO SRS | K010784 |

### Description d.

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

The patients' transverse slices (i.e. CT, MR) or x-ray films are imported to the system from various methods: DICOM, disk, video, scanner. From this data the patient anatomical structures and tumor site is contoured in order to generate a 3D patient model, or x-ray films displaying the implant area are imported for standard brachytherapy treatment planning. The following step in the process will be to define the treatment machine, applicators, template, seed location, or isocenter. From this information the user will select the appropriate source (brachytherapy) or beam data (linear accelerators) to be used for the planning session. Based on the target volume or reconstructed implant, the treatment source (external beam or radioactive source) and prescription dose the treatment plan will be calculated and a dose distribution will be displayed. The physician is capable of fine tuning this treatment plan before final output. The approved treatment plan is then printed out, a program card written (remote afterloading) 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 data base. The program output does not directly treat the patient, all information must be confirmed by the physician prior to treatment.

### Intended use e.

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.

### f. Summary of technological considerations

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

Comrade Vlas

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

March 10, 2005

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2003

Conrado Pla, Ph.D. President SIMUPLAN S.L. Miguel Hernandez 25 La Eliana, 46183 Valencia SPAIN

Re: K030821

Trade/Device Name: SIMUPLAN Treatment Planning Systems Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: June 24, 2003 Received: June 30, 2003

Dear Dr. Pla:

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 adultcration.

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); 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 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 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. 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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SIMUPLAN Ko30821 Applicant: 510(k) Number (if known): _ SIMUPLAN Treatment Planning System Device Name:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109) (Optional Format 1-2-96)

David A. Flynn

*Prescription Use*