(56 days)
Simulix Evolution is a radiation therapy simulation system is intended to prepare patients for radiation therapy. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment. The Ocentra Cone Beam CT option for the Simulis Evolution Radiotion Therapy Simulator is intended to assist the Radiation Oncologist in acquiring 3D "multi slice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning
Oncentra ConeBeam is an extension to the Nucletron Simulix Evolution system. The Simulix Evolution is a Radiation Therapy Simulation System which is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied. The Simulix Evolution is previously cleared under 510(k) #K033470. The Oncentra ConeBeam extension will give the Simulix Evolution system the capability to acquire Computer Tomography (CT) images. This is done by means of scanning the patient with a cone shaped X-ray beam. The cone shaped beam gives the possibility to acquire CT image information of a volume instead of CT image information of a single slice as with conventional fan beam CT. The images acquired with Oncentra ConeBeam will be used for the purpose of radiation therapy planning and to check the positioning of the patient.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for the Nucletron Simulix-Evolution with Oncentra™ ConeBeam, which describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not include details on acceptance criteria or performance studies.
Therefore, I cannot fulfill your request to provide the following information:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (algorithm only) study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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Image /page/0/Picture/1 description: The image shows the word "Nucletron" in bold, black font next to a square logo. The logo is a black square with a black circle inside, and two white circles on opposite sides of the black circle. The word "Nucletron" is in a simple, sans-serif font.
NUCLETRON B.V.
Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 Fax +31 318 550485
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Special 510(k) section
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)
K 052361
Submitter of 510(k):
Company name: Registration number: Address:
| Phone: |
|---|
| Fax: |
| Correspondent: |
Nucletron Corporation 1121753 8671 Robert Fulton Drive Columbia, MD 21046 410-312-4100 410-312-4197 Lisa Dimmick Director Assurance & Regulatory Affairs
Modified Device Name:
Trade/Proprietary Name: Common/Usual Name: Classification Name: Classification: Product Code
Simulix-Evolution with Oncentra™ ConeBeam Simulator System, Simulation, Radiation Therapy 21Cfr892.5840 Class II KPQ
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| Manufacturer | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Device | --------510(k) |
|---|---|---|
| Nucletron By์ เป็นที่ 2 ในปี 2008 - 1 ในปี 2008 - 1 เมื่อ 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | France of Children College of ChildrenSimulixEvolutionA Call Company | K033476 |
Description:
Oncentra ConeBeam is an extension to the Nucletron Simulix Evolution system. The Simulix Evolution is a Radiation Therapy Simulation System which is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the
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therapeutic irradiation field to be applied. The Simulix Evolution is previously cleared under 510(k) #K033470.
The Oncentra ConeBeam extension will give the Simulix Evolution system the capability to acquire Computer Tomography (CT) images. This is done by means of scanning the patient with a cone shaped X-ray beam. The cone shaped beam gives the possibility to acquire CT image information of a volume instead of CT image information of a single slice as with conventional fan beam CT.
The images acquired with Oncentra ConeBeam will be used for the purpose of radiation therapy planning and to check the positioning of the patient.
Intended use:
Simulix Evolution is a radiation therapy simulation system that is intended to prepare patients for radiation therapy. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using conventional radiographic and fluorographic system, patients are positioned. filmed and marked to prepare them for treatment.
The Ocentra Cone Beam CT option for the Simulix Evolution Radiotion Therapy Simulator is intended to assist the Radiation Oncologist in acquiring 3D "multi slice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning
Summary of technological considerations:
Simulix Evolution is substantially equivalent to the cleared predicate devices, Simulix Evolution, 510(k)#: K033470 and Simulix-MC CT Extension 510(k)# K932848.
Name: Frits van Krieken Title: Business Director Nucletron B.V. Veenendaal, The Netherlands
23-June 2005
Date
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is smaller than the central symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nucletron Corporation % Ms. Jan van Lochem Responsible Third Party Official KEMA Quality B.V. 4377 Country Line Road CHALFONT PA 18914
Re: K052361
OCT 2 4 2005
Trade/Device Name: Simulix Evolution with Oncentra™ Conebeam Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: KPQ Dated: October 12, 2005 Received: October 12, 2005
Dear Ms. Lochem:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 docs 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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Indications for Use Statement
| 510(k)Number | K052361 |
|---|---|
| Device Name | Simulix-Evolution with Oncentra™ ConeBeam |
| Indications forUse | Simulix Evolution is a radiation therapy simulation system is intended to preparepatients for radiation therapy.The Simulator emulates the geometrical positions of radiation therapy treatmentmachines. Using conventional radiographic and fluorographic system, patients arepositioned, filmed and marked to prepare them for treatment.The Ocentra Cone Beam CT option for the Simulis Evolution Radiotion TherapySimulator is intended to assist the Radiation Oncologist in acquiring 3D "multi slice"planning data in patient set-ups for the purpose of radiation therapy treatmentplanning and patient positioning |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
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()ver-The-Counter Use_________________________________________________________________________________________________________________________________________________________
Nancy C hisglom
Division Sign-O Division of Reproductive, Abdominal, A Dadininning Davis
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.