K Number
K093391
Device Name
SIMUPLAN TREATMENT PLANNING SYSTEM
Manufacturer
Date Cleared
2009-12-23

(54 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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. 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.
More Information

Not Found

No
The description focuses on standard treatment planning functionalities like image import, contouring, 3D modeling, dose calculation, and plan modification, without mentioning any AI/ML-specific features or algorithms.

No
The device is a treatment planning system for radiation therapy, providing information that must be confirmed by a physician before direct patient treatment. It does not directly treat the patient.

No

This device is a treatment planning system used to prepare individual treatment plans for radiation therapy, not to diagnose a condition. It processes existing image sets to generate a 3D patient model and calculate dose distributions for treatment; it does not identify or characterize diseases.

Yes

The device is described as "computer based software that runs on a Maclitosh platform" and the submission is for a "software included in this colors and module update only." It processes image data and outputs treatment plans, but does not include any hardware components.

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze samples taken from the human body (like blood, urine, tissue). The SIMUPLAN Treatment Planning System uses medical images (CT, MR, US, x-ray films) of the patient's anatomy and tumor site. It does not analyze biological samples.
  • The intended use is for treatment planning, not diagnosis based on biological samples. The system helps physicians plan radiation therapy based on imaging data, not to diagnose a condition by analyzing a sample.

The device is clearly described as a software system that processes medical images to create a treatment plan for radiation therapy. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.

N/A

Intended Use / 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.

Product codes

MUJ

Device 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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, MR, US or x-ray films

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K030821

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

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K093391

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

DEC 2 3 2009

Image /page/0/Picture/3 description: The image shows a semi-circular object on top of a rectangular object. The semi-circular object is dark and has a wavy line coming out of the top. There is an arrow pointing down from the semi-circular object to the rectangular object. The rectangular object has dotted lines emanating from the center.

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: (+34) 96-274-3827 Fax: (+34) 96-272-5132

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
La Eliana
46183 Valencia
Spain
Phone:(+34) 96-274-3827
Fax:(+34) 96-272-5132
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:

ManufacturerDevice510(k) #
SIMUPLANSIMUPLAN Treatment Planning System, v 7.5K030821

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

Page 17 of 20

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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

2

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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 (800) 638-2041 or (301) 796-7100 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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