(83 days)
No
The description focuses on digital image capture and processing, with no mention of AI, ML, or related concepts.
No
The device is described as an image workstation that processes X-ray images for planning and verification of radiation treatment, not directly delivering therapy.
Yes.
Explanation: The device is used to "verify a prescribed plan" in radiation treatment, which is a form of diagnostic assessment to ensure treatment accuracy. It processes X-ray images, a common modality for diagnostic purposes.
No
The device description explicitly states it is an "image workstation" that connects to a video signal and uses a "frame grabber" to convert images to digital. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Helax-IMCON is an image workstation that processes X-ray images from a radiotherapy simulator. It is used to verify or assist in planning radiation treatment.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is solely related to processing and displaying medical images.
Therefore, the Helax-IMCON falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Helax-IMCON is designed to be a tool for supporting the process of Radiotherapy treatment planning utilising simulator images. Helax - IMCON supports both the planning of a radiotherapy treatment and the verification of an established treatment plan. Helax-IMCON is used to define the field size and shape for the radiotherapy treatment of a patient, based on an image or series of merged images taken at the simulator. If the simulator has been equipped with the Helax-IMCON LCD panel these shapes can be projected onto the patient. Defined parameters can be exported to the clinics verification system or to the accelerator. Helax-IMCON is also used for verification of a treatment plan prepared with a treatment planning system as Helax-TMS. The treatment plan will be imported at the Helax-IMCON workstation. Helax-IMCON will then overlay the planned field size and shape on the image for verification purposes. Helax - IMCON is intended to be operated by radiographers ,physicists and physicians skilled in radiation therapy and trained in using the system.
Product codes
90LLZ, 90KPQ
Device Description
Helax-IMCON is an image workstation that replaces the fluoroscopic monitor at a radiotherapy simulator. It is connected to the video signal from the image intensifier of the simulator and the X-ray images are captured by a frame grabber and converted to digital images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiographers ,physicists and physicians skilled in 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)
Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Varis Images, Including Ximatron Digital Imaging (K952313)
Reference Device(s)
Not Found
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
1. Submitter's information
Helax AB PO Box 1704 S-751 47 Uppsala Sweden
Contact person Jan Törnqvist, Vice President Regulatory Affairs int 46 18 565017 Phone: Fax: int 46 18 565017 E-mail jan.tornqvist@helax.com
Submission dated: 1998-08-11
2. Device Name
Common or Usual name:
Helax-IMCON Simulator Workstation (IMCON)
Proprietary Name: Helax-IMCON
| • Standard Product Nomenclature: | System, Image Processing |
|---|---|
| • Regulation number: | 21 CFR § 892. |
| • Class: | II |
| • Product Code: | 90LLZ |
3. Predicate Device
Varis Images, Including Ximatron Digital Imaging (K952313).
Product is owned by Varian Associated Inc., 3045 Hanover Street, Palo Alto CA 94304-1129, USA.
4. Description of the Device
Helax-IMCON is an image workstation that replaces the fluoroscopic monitor at a radiotherapy simulator. It is connected to the video signal from the image intensifier of the simulator and the X-ray images are captured by a frame grabber and converted to digital images.
5. Statement of Intended Use
Helax-IMCON is designed to be a tool for supporting the process of Radiotherapy treatment planning utilising simulator images. Helax - IMCON supports both the
- 11 helax
1
planning of a radiotherapy treatment and the verification of an established treatment plan.
Helax- IMCON is used to define the field size and shape for the radiotherapy treatment of a patient, based on an image or series of merged images taken at the simulator. If the simulator has been equipped with the Helax-IMCON LCD panel these shapes can be projected onto the patient. Defined parameters can be exported to the clinics verification system or to the accelerator.
Helax-IMCON is also used for verification of a treatment plan prepared with a treatment planning system as Helax-TMS. The treatment plan will be imported at the Helax-IMCON workstation. Helax-IMCON will then overlay the planned field size and shape on the image for verification purposes.
Helax - IMCON is intended to be operated by radiographers ,physicists and physicians skilled in radiation therapy and trained in using the system.
The intended use is the same as the predicate devices.
Statement of Technological Characteristics 6.
The predicate device is presently in commercial distribution in the United States. The Helax-IMCON has the same technological characteristics and is similar in design, function, and application to the predicate device.
The Technological Characteristics are the same as the predicate device.
Differences 7.
There are no differences between the technology of the predicate device and the Helax-IMCON and only minor differences in configuration and specifications as noted in the predicate device comparison chart. These differences do not alter the intended use or affect the safety and effectiveness of the Helax-IMCON system when used as labelled.
Special controls 8.
Although there are no performance standard established by the FDA for these devices the Helax-IMCON is designed, and manufactured to meet, the following standards:
-
Electrical medical equipment General requirements for safety · IEC 601-1
-
Electrical medical equipment -Part 1 : General requirements for · IEC 601-1-4 safety
-
- Collateral Standard: Programmable clectrical medical systems.
-
· IEC 1217 Radiotherapy equipment - Coordinates, movements and scales
-
IEC 878 Graphical symbols for electrical equipment in medical practice
2
Image /page/2/Picture/0 description: The image shows a black square with a white check mark in the top left corner. Below the square, the word "helax" is written in white, sans-serif font. The check mark is partially cut off by the edge of the square.
Helax AB is certified according to European EG Medical Device Directive. Annex II Section 3.2 - Full Quality Assurance System, per 1997-01-08. The scope of the certification is: Design, development, production, installation and servicing of based systems in oncology in class IIb. Helax AB Quality System is also certified according to the requirements in ISO 9001 and EN 46001.
The Helax-IMCON product was developed by Helax AB. Part of the development work was done by Image Connectivity Sweden AB (ICS), under the control by Helax AB.
The Helax-IMCON product will be released, marketed, produced. serviced and maintained by Helax. A complete Device Master Record will be prepared, maintained and approved by Helax according to Helax procedures. The Helax-IMCON product will be a part of the Product Area VIS within Helax.
The device and its development process also comply with the FDA, CDRH, ODE, August 23, 1991. Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review
Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV
Vice President, Regulatory Affairs
Re:
K982857 Helax-IMCON Version 1.0 Dated: August 11, 1998 Received: August 13, 1998 Regulatory class: II 21 CFR 892.5840/Procode: 90 KPQ
Dear Ms. Tornqvist:
Jan Tornqvist
Klostergatan 12
Uppsala, Sweden
Helax AB
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitin diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, piense note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdri/dsmadsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) NUMBER (IF KNOWN): K982857
DEVICE NAME: Helax-IMCON version 1.0
INDICATIONS FOR USE:
Patients planned for radiation treatment, either to verify a prescribed plan, or to help at the planning at the simulator.
(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)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Daniel A. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Dey
510(k) Number K982857