(106 days)
Not Found
No
The document describes a standard radiation therapy treatment planning system that performs calculations based on physician input and image data. There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections. The focus is on traditional treatment planning workflows and calculations.
No.
The device is a treatment planning system that helps prepare individual treatment plans and does not directly treat the patient.
No
Explanation: The device is a treatment planning system used to prepare individual treatment plans for radiation therapy. It does not diagnose diseases or conditions; instead, it uses existing diagnostic images (CT, MR) to plan therapy.
Yes
The device is explicitly described as "computer based software" and the submission is for a "software update only." It processes medical images and outputs treatment plans, which are typical functions of software-only medical devices in this domain.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic or monitoring purposes.
- SIMUPLAN's Function: SIMUPLAN is a treatment planning system. Its purpose is to process medical images and other patient data to create a plan for radiation therapy. It does not analyze biological specimens from the patient's body.
- Input Data: The input data for SIMUPLAN is primarily medical imaging (CT, MR, etc.) and patient-specific information, not biological samples.
- Output: The output is a treatment plan and dose distribution, which is used to guide external beam or brachytherapy, not to diagnose a condition based on laboratory analysis.
Therefore, SIMUPLAN falls under the category of medical devices used for treatment planning, not 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, etc.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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.
0
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: (+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 # | pending |
| Address: | Miguel Hernandez 25 |
| La Eliana | |
| 46183 Valencia | |
| Spain | |
| Contact Person: | Conrado Pla Ph.D. |
| Phone: | (+34) 96-274-3827 |
| Fax: | (+34) 96-272-5132 |
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 |
Page 1 of 3
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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
Page 2 of 3
Date
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is black and white and appears to be a seal or emblem.
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
3
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
4
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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