(90 days)
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.
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.
This 510(k) submission for Oncentra Simulation 2.3 is a special 510(k) for a software revision and focuses on demonstrating substantial equivalence to a predicate device (Simulix Evolution, K033470). It does not contain the detailed study information typically found in an original 510(k) or PMA submission regarding acceptance criteria, performance studies, or ground truth establishment.
Here's an analysis based on the provided text, highlighting what is not available in this document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating that the revised software, Oncentra Simulation 2.3, performs its intended functions (image acquisition, display, enhancement, database functionality, simulator controls, and support for Image Intensifiers) adequately and is substantially equivalent to the predicate device.
The "performance" described is functional equivalence, not diagnostic accuracy. The key performance aspect mentioned is "Added support for Image Intensifiers." This is a functional addition, and its 'performance' is implicitly met if the system successfully interfaces with and processes images from Image Intensifiers as intended.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Functional Equivalence to Predicate Device (Simulix Evolution, K033470) | Oncentra Simulation 2.3 is stated to be "substantially equivalent to the cleared predicate device." |
| Support for Image Intensifiers | "Added support for Image Intensifiers" is the primary modification. |
| Image Acquisition | Functionality is included. |
| Image Display | Functionality is included. |
| Image Enhancement and Multiple Views | Functionality is included. |
| Database and DICOM Import/Export Functionality | Functionality is included. |
| Simulator Controls | Functionality is included. |
2. Sample Size Used for the Test Set and Data Provenance:
Not specified. This document describes a software revision and its functional equivalence to a predicate device. It does not detail a study involving a test set of patient data with specific sample sizes. The evaluation would have been more about verifying the software's functionality and compatibility rather than analyzing a clinical dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable/Not specified. Since there's no mention of a clinical test set requiring ground truth for diagnostic accuracy, there's no information on experts or their qualifications.
4. Adjudication Method for the Test Set:
Not applicable/Not specified. As there is no clinical test set described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is not mentioned or implied by the document. The submission focuses on substantial equivalence based on technological considerations and functional performance, not a comparative effectiveness study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable/Not specified. The device is a simulation system, an accessory to radiation therapy. It's an imaging and planning tool used by humans, not an AI algorithm making independent diagnostic decisions. The "algorithm" in this context refers to the software's functional logic, not a standalone diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not specified. As no clinical performance study involving diagnostic accuracy is described, no ground truth types are mentioned. The ground truth for a software revision like this would likely be engineering specifications and functional testing results.
8. The sample size for the training set:
Not applicable/Not specified. This is a software revision, not a machine learning model that requires a training set in the conventional sense. The "training" for the software would involve development, testing against specifications, and verification/validation activities.
9. How the ground truth for the training set was established:
Not applicable/Not specified. Again, this is not a machine learning context. The "ground truth" for software development typically refers to design specifications, requirements, and expected functional behavior, which are verified through various software testing methodologies.
In summary:
This 510(k) submission pertains to a software revision for a radiation therapy simulation system. It demonstrates substantial equivalence primarily by showing that the updated software (Oncentra Simulation 2.3) has the same intended use and similar technological characteristics to a legally marketed predicate device, with the key modification being "Added support for Image Intensifiers." The document does not contain information about clinical performance studies, diagnostic accuracy metrics, test/training sets, or expert evaluations in the context of ground truth establishment. Such detailed clinical performance data is typically found in submissions for novel devices or devices with significant changes affecting clinical outcomes, not usually for a functional software update like this one.
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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
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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
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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.
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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
Page 1 of 1
§ 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.