(90 days)
No
The summary describes image handling software with standard image processing and database functionalities, with no mention of AI, ML, or related concepts.
No
The device is used to prepare patients for radiation therapy by simulating the geometrical positions of treatment machines and is an accessory to a radiation therapy simulation system. It does not directly treat or diagnose a disease.
No
The text indicates that the device is an accessory to a radiation therapy simulation system, intended to prepare patients for radiation therapy by emulating geometrical positions and assisting with patient positioning, filming, and marking. It processes images from an Image Intensifier for simulation procedures. This process is for treatment preparation and simulation, not for diagnosis of a disease or condition.
No
The device is described as image handling software that runs on a PC and is an accessory to a radiation therapy simulation system, which includes conventional radiographic and fluorographic systems (hardware). While the submission focuses on the software, the device's function is intrinsically tied to and dependent on the hardware components of the simulation system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to a radiation therapy simulation system and is used to prepare patients for radiation therapy by emulating the geometrical positions of treatment machines and using radiographic and fluorographic systems for positioning, filming, and marking. This is a process performed on the patient, not on a sample taken from the patient.
- Device Description: The description focuses on image handling software for acquiring and processing images from an Image Intensifier used in radiotherapy simulators. It describes functionalities related to image acquisition, display, enhancement, database management, and simulator controls. These are all related to the simulation process performed on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to aid in the physical positioning and preparation of the patient for radiation therapy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Oncentra Simulation is an accessory to a radiation therapy simulation system which 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.
Product codes
KPO
Device Description
Oncentra Simulation 2.3 is a revision of the image handling software of the Simulix Evolution. This software has been adapted such that images can be acquired and processed from an Image Intensifier such as used on the Nucletron Radiotherapy simulators Simulix MC, Simulix HP and Simulix HQ. This makes it a replacement for the predicate device DTI (K954055).
The PC based simulator workstation comes with functionality to support simulation procedures:
- Image acquisition
- Image display
- Image enhancement and multiple views
- Database and DICOM Import / Export functionality
- Simulator controls
The modification to the previously cleared device K033470 is:
- Added support for Image Intensifiers
The software runs on a PC on a Windows XP platform.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Conventional radiographic and fluorographic system
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Special 510(k) Oncentra Simulation
Page 36 March 2009
NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 +31 318 550485 Fax
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
JUN 1 5 2009
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by section 807.92(c)
Director Assurance & Regulatory Affairs
Submitter of 510(k):
Company name: Nucletron Corporation Registration number: 1121753 Address: 8671 Robert Fulton Drive Columbia, MD 21046 ﺔ 410-312-4100 Phone: Fax: 410-312-4197 Correspondent: Lisa Dimmick
New Device Name:
Trade/Proprietary Name: Oncentra Simulation 2.3 Common/Usual Name: Simulator Classification Name: System, Simulation, Radiation Therapy Classification: 21Cfr892.5840 Class II
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| . Manufacturer Sep 1 Device Device Device 510 510 | ||
|---|---|---|
| Nucletron BV | Simulix Evolution | K033470 |
Description:
Oncentra Simulation 2.3 is a revision of the image handling software of the Simulix Evolution. This software has been adapted such that images can be acquired and processed from an Image Intensifier such as used on the Nucletron Radiotherapy simulators Simulix MC, Simulix HP and Simulix HQ. This makes it a replacement for the predicate device DTI (K954055).
The PC based simulator workstation comes with functionality to support simulation procedures:
- . Image acquisition
March
1
Special 510(k) Oncentra Simulation
- . Image display
- Image enhancement and multiple views .
- . Database and DICOM Import / Export functionality
- Simulator controls .
The modification to the previously cleared device K033470 is:
- Added support for Image Intensifiers ◆
The software runs on a PC on a Windows XP platform.
Intended use:
The modified device has the same intended use as the legally marketed predicate device cited:
Oncentra Simulation is an accessory to a radiation therapy simulation system which 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.
Summary of technological considerations:
Oncentra Simulation is substantially equivalent to the cleared predicate device. Simulix Evolution, K033470.
Name: Joris Vogels Title: Business Manager Nucletron B.V. Veenendaal, The Netherlands
2-7 MARCH-2009
Date
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and tail feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2009
Ms. Elaina M. Colby RA/OA Manager Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046-2133
Re: K090706
Trade/Device Name: Oncentra Simulation Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: KPO Dated: May 8, 2009 Received: May 12, 2009
Dear Ms. Colby:
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.
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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrb/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2 ·
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Special 510(k) Oncentra Simulation
Page 38 March 2009
Indications for Use
K090706 510(k) Number (if known)
Device Name
Oncentra Simulation
Indications for Use
Oncentra Simulation is an accessory to a radiation therapy simulation system which 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 subpart D) AND/OR
Over-The-Counter Use (Part 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)
Arra M Whay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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