(28 days)
No
The description mentions "Automated edge detection" for image comparison, which is a traditional image processing technique and does not inherently indicate the use of AI or ML. There are no mentions of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML models.
No
The device is described as a "verification system" and a "tool for supporting the process of scheduling, preparing, setting up, delivering and recording radiation therapy," but it does not directly deliver therapy.
No
The device is described as a "verification system designed to be a tool for supporting the process of preparing, setting up, delivering and recording radiation therapy." It helps administer patient sessions, presents setup data, verifies actual setup, monitors treatment progress, and records relevant data. While it uses image comparison (Image Based Verification) to determine patient displacement and required couch shifts for correct beam placement, this function is for optimizing the delivery of therapy and ensuring correct setup, rather than diagnosing a disease or condition. Its purpose is to support the treatment workflow and verification, not to identify or characterize a medical condition.
Yes
The device is described as software running on a PC platform and its functions are entirely software-based, involving data retrieval, scheduling, verification, monitoring, and recording. While it interacts with hardware (linac, treatment machine), the device itself is the software system.
Based on the provided information, Oncentra-VISIR is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as supporting the process of scheduling, preparing, setting up, delivering, and recording radiation therapy. This is a clinical process directly related to patient treatment, not the examination of specimens from the human body.
- Device Description: The description focuses on managing patient data, scheduling, verifying setup, monitoring treatment progress (Monitor Units, in vivo dosimetry), and recording treatment data. While it uses image processing for verification, this is for positioning the patient for radiation therapy, not for diagnosing or monitoring a disease based on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, urine, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
In summary, Oncentra-VISIR is a system designed to manage and verify the delivery of radiation therapy, which is a treatment modality. It does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Oncentra-VISIR is designed to be a tool for supporting the process of scheduling, preparing, setting up, delivering and recording radiation therapy.
Product codes
IYE, 90 MUJ
Device Description
Oncentra-VISIR is a verification system designed to be a tool for supporting the process of preparing, setting up, delivering and recording radiation therapy. It will retrieve data from doseplan systems and simulators automatically or by manual input from the user. It will help administer patient sessions through the booking functionality. At each individual treatment Oncentra-VISIR will present setup data to the operator and also to the linac through a specific interface. Actual setup will be verified. During treatment Oncentra-VISIR can monitor the progress of both Monitor Unit values and optional in vivo dosimetry. All data relevant for the given treatment can be recorded.
The main areas of modification to the previously cleared device K972617 are:
- Image Based Verification (IBV). This module allows the user to schedule image acquisitions on the treatment machine. Once the images are acquired thev are compared to a reference image such as a DRR or digital simulator image. Automated edge detection will mark both the reference and control image and perform a comparison. A resultant displacement is translated into the treatment couch shifts required to reposition the patient correctly for the desired beam placement within the patient.
- Improved user interface improved layout of data making it easier for the user to navigate and display the data they require. Also improved workflow requiring less clicking and password entry than before.
- Optional double signature for treatment lets 2 therapists sign for treatment delivery.
- Dynamic MLC IMRT support.
- Live MLC display in treatment screens.
- More flexible port filming options such as film only and orthogonal film modes.
- Image acquisition (port film) scheduling.
- Detailed audit trail tracks all changes to patient data with time/date/signature stamps of anv edit.
The software runs on a PC on a Windows NT, 2000, or XP platform.
Mentions image processing
Image Based Verification (IBV). This module allows the user to schedule image acquisitions on the treatment machine. Once the images are acquired thev are compared to a reference image such as a DRR or digital simulator image. Automated edge detection will mark both the reference and control image and perform a comparison.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
Not Found.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
radiation therapy
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
JUL 2 2 2004
Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo. The logo contains a black circle with two white circles 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: | Oncentra-VISIR |
|---|---|
| Common/Usual Name: | VISIR |
| Classification Name: | Medical Linear Accelerator |
| Classification: | 21Cfr892.5050 Class II |
| Product Code | IYE |
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| A-00-1-4-81-48-48
Manufacturer | A BOOK OF CLE B
Uevice | CANILI
S |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-------------|
| ﮯ
A 137 | 11011
Carlos Stat
Free of each as and | · VO70G+ · |
Description:
Oncentra-VISIR is a verification system designed to be a tool for supporting the process of preparing, setting up, delivering and recording radiation therapy. It will retrieve data from doseplan systems and simulators automatically or by manual input from the user. It will help administer patient sessions through the booking functionality. At each individual treatment Oncentra-VISIR will present setup data to the operator and also to the linac through a specific
1
interface. Actual setup will be verified. During treatment Oncentra-VISIR can monitor the progress of both Monitor Unit values and optional in vivo dosimetry. All data relevant for the given treatment can be recorded.
The main areas of modification to the previously cleared device K972617 are:
- Image Based Verification (IBV) .
- This module allows the user to schedule image acquisitions on the treatment machine. Once the images are acquired thev are compared to a reference image such as a DRR or digital simulator image. Automated edge detection will mark both the reference and control image and perform a comparison. A resultant displacement is translated into the treatment couch shifts required to reposition the patient correctly for the desired beam placement within the patient.
- Improved user interface improved layout of data making it easier for the user to navigate . and display the data they require. Also improved workflow requiring less clicking and password entry than before.
- Optional double signature for treatment lets 2 therapists sign for treatment delivery .
- Dynamic MLC IMRT support .
- Live MLC display in treatment screens .
- More flexible port filming options such as film only and orthogonal film modes .
- Image acquisition (port film) scheduling .
- Detailed audit trail tracks all changes to patient data with time/date/signature stamps of anv . edit
The software runs on a PC on a Windows NT, 2000, or XP platform.
Intended use:
The modified device has the same intended use as the legally marketed predicate device cited:
Oncentra-VISIR is designed to be a tool for supporting the process of scheduling, preparing, setting up, delivering and recording radiation therapy.
Summary of technological considerations:
Oncentra-VISIR is substantially equivalent to the cleared predicate device, Helax-VISIR, 510(k)#: K972617.
e' Jan Willem Hazenoot
11/6/4
Date
Name. Jan-Millem Hazenoot Title: Business Segment Manager Nucletyon B.V. Veenendaal, The Netherlands
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 2004
Ms. Lisa Dimmick Director, Assurance & Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046
Re: K041719
Trade/Device Name: Oncentra-VISIR Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: June 23, 2004 Received: June 24, 2004
Dear Ms. Dimmick:
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 I ou may, attents 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.
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 promated 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 If you doch 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. Brigden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number
Device Name
Oncentra-VISIR
Indications for Usc
Oncentra-VISIR is designed to be a tool for supporting the process of Oncentra-VISIR is designed to be a toon for supporting the proposition therap
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NET AND THE CONSTITUTION VEEDED NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
sion Sign-Off)
an of Reproductive, Abdominal,
Radiological Devices K041719
(k) Number