(93 days)
No
The description focuses on hardware (Flat Panel detector) and standard image processing functionalities (acquisition, display, enhancement) without mentioning AI or ML algorithms.
No
The device is described as a "radiation therapy simulation system" intended to "prepare patients for radiation therapy" by emulating "geometrical positions of radiation therapy treatment machines" and helping position, film, and mark patients. It does not deliver therapy itself but rather aids in the planning and simulation process.
No
The device is described as a radiation therapy simulation system that emulates the geometrical positions of radiation therapy treatment machines to prepare patients for treatment, rather than diagnosing a condition.
No
The device description explicitly states that the Simulix Evolution option consists of a digital Flat Panel detector and a PC based simulator workstation. This includes hardware components (the Flat Panel detector) in addition to the software on the workstation.
Based on the provided information, the Simulix Evolution device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "preparing patients for radiation therapy" by emulating treatment machine geometry and using radiographic/fluorographic imaging for positioning and marking. This is a process performed on the patient, not on biological samples from the patient.
- Device Description: The description details a system for acquiring and processing radiographic and fluorographic images of the patient's body. It involves a flat panel detector and a workstation for image manipulation and database management. This is consistent with medical imaging equipment used for patient positioning and planning.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Simulix Evolution's function is entirely focused on the physical positioning and imaging of the patient for radiation therapy planning.
N/A
Intended Use / Indications for Use
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.
Product codes
KPQ
Device Description
Simulix Evolution is a Flat Panel detector option to the Nucletron Simulix HP simulator system. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using a conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment.
The Simulix Evolution option consists of a digital Flat Panel detector and a PC based simulator workstation.
The Flat Panel detector option replaces the current Image Intensifiers. The Flat Panel is a Amorphous silicon, digital detector, with a square image area of 41 by 41 cm.
The PC based simulator workstation is the current DTI workstation, but ported to a Windows platform. The PC based simulator workstation comes with functionality to support simulation procedures:
- . lmage acquisition
- Image display .
- Image enhancement and multiple views .
- Database and DICOM Import / Export functionality .
- Simulator controls
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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
Not Found
Key Metrics
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
FEB - 4 2004
Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold black font next to a logo. The logo is a black square with a black circle inside. Two white circles are on opposite sides of the black circle.
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)
Submitter of 510(k):
| Company name: | Nucletron Corporation |
|---|---|
| Registration number: | 1121753 |
| Address: | 8671 Robert Fulton Drive |
| Columbia, MD 21046 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
| Director Assurance & Regulatory Affairs |
Modified Device Name:
| Trade/Proprietary Name: | Simulix Evolution | |
|---|---|---|
| Common/Usual Name: | Simulator | |
| Classification Name: | System, Simulation, Radiation Therapy | |
| Classification: | 21Cfr892.5840 Class II | |
| Product Code: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 BV | Simulix HP | K946128 |
Description:
Simulix Evolution is a Flat Panel detector option to the Nucletron Simulix HP simulator system. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using a conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment.
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K033470
Page 2 of 2
KU33470
The Simulix Evolution option consists of a digital Flat Panel detector and a PC based simulator workstation.
The Flat Panel detector option replaces the current Image Intensifiers. The Flat Panel is a Amorphous silicon, digital detector, with a square image area of 41 by 41 cm.
The PC based simulator workstation is the current DTI workstation, but ported to a Windows platform. The PC based simulator workstation comes with functionality to support simulation procedures:
- . lmage acquisition
- Image display .
- Image enhancement and multiple views .
- Database and DICOM Import / Export functionality .
- Simulator controls �
The modifications to the previously cleared device K946128 are:
- . Flat Panel detector, which replaces the Image Intensifier
- Flat Panel workstation, which replaces the DTI workstation, previously cleared device . K954055
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:
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.
Summary of technoiogical considerations:
Simulix Evolution is substantially equivalent to the cleared predicate device, Simulix HP, 510(k)#: K946128.
12/9/13
Date
Name/ Jan-Willem Hazenoot Title: Business Segment Manager Nucletron B.V. Veenendaal, The Netherlands
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nucletron Corporation % Mr. J. A. van Vugt Responsible Third Party KEMA Quality B.V. P.O. Box 5185 6802 ED Arnhem, Arnhem THE NETHERLANDS
Re: K033470
Trade/Device Name: Simulix Evolution Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: 90 KPQ Dated: January 16, 2004 Received: January 20, 2004
Dear Mr. van Vugt:
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 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 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,
FEB - 4 2004
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Page 2
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 to regary 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, "Mitabranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtain. Ovider general 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/cdrb/dsmaldsmamon.html
Sincerely yours.
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
'1033470
Indications for Use Statement
510(k) Number K033470
Device Name
Simulix Evolution
Indications for Use
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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pct 21 CFR 801.109)
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Over-The-Counter Use_
Varry C. Brogdon
(Division Sign-Off) Division of Reproductive, Abo and Radiological Devices 510(k) Number