(187 days)
Not Found
No
The description details standard treatment planning software functionalities like importing images, contouring structures, defining treatment parameters, calculating dose distributions, and physician review. There is no mention of AI/ML techniques for tasks like automated contouring, treatment plan optimization using learning algorithms, or predictive modeling. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
Explanation: The device is a treatment planning system used to create individual treatment plans for radiation therapy. It does not directly treat the patient; instead, it generates information that must be confirmed by a physician before treatment. Therefore, it is not a therapeutic device itself, but rather a tool used in the planning phase of therapy.
No
Explanation: The device is a treatment planning system used to prepare individual treatment plans for radiation therapy. It does not provide a diagnosis of a disease or condition. The output from the device, which includes dose distribution, is used for treatment, not diagnosis. Additionally, the description explicitly states the program output does not directly treat the patient and all information must be confirmed by the physician prior to treatment, meaning it is a tool for treatment planning rather than diagnosis.
Yes
The device is described as "a computer based software that runs on a MacIntosh platform" and its function is treatment planning based on imported imaging data. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- SIMUPLAN's Function: SIMUPLAN is a treatment planning system for radiation therapy. It uses medical images (CT, MR, x-ray) to create a plan for delivering radiation to a patient. It does not analyze biological samples from the patient's body.
- Intended Use: The intended use clearly states it's for "preparing individual treatment plans for patients undergoing radiation therapy treatment." This is a planning tool, not a diagnostic test performed on a sample.
Therefore, SIMUPLAN falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 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)
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.
0
Premarket Notification SIMUPLAN Treatment Planning System Date : March 10, 2003
Image /page/0/Picture/2 description: The image shows a black semi-circle on top of a rectangle. There is a line coming from the top of the semi-circle with an arrow pointing down. There are also two dashed semi-circles inside the rectangle.
SIMUPLAN S.L.
Miguel Hernandez 25 La Eliana 46183 Valencia Spain Phone: (+34) 96-274-3827 Fax: (+34) 96-272-5132
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. (+34) 96-274-3827 Phone: Fax: (+34) 96-272-5132
Device Name: b.
| 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) 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.
1
| 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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Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains an image of a bird in flight. The bird is stylized with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUM." is arranged around the top half of the circle.
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.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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