(56 days)
Not Found
Not Found
No
The description mentions "automated border detection" and "semi-automated overlay function," which are image processing techniques, but does not explicitly mention or imply the use of AI or ML.
No
The device is described as an "imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment," which indicates it is used for diagnostic or verification purposes, not for directly treating a disease or condition.
No
Explanation: The document describes a system for pre-treatment verification and real-time viewing of radiation therapy treatments, focusing on image verification and comparison. While it processes images and performs analysis, its primary function is to assure proper treatment delivery rather than to diagnose disease or conditions.
No
The description refers to a "Digital Portal imaging system," which strongly implies the inclusion of hardware components for image acquisition, even though the summary focuses on the software's processing and analysis capabilities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Digital Portal imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment." This involves imaging the patient's body in vivo (within the living organism) to guide and verify radiation therapy.
- Lack of Sample Analysis: There is no mention of analyzing biological samples or performing tests on substances taken from the body.
The device is a medical imaging system used for treatment guidance and verification, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Digital Portal imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment. Images maybe stored to hard disk for processing, analysis and hardcopy. This includes an automated border detection for field size and shape verification and a semi-automated overlay function of an anatomical template reference adding enhanced level of on-line assurance for image verification and comparison.
Product codes
IYE
Device Description
Digital Portal imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment. Images maybe stored to hard disk for processing, analysis and hardcopy. This includes an automated border detection for field size and shape verification and a semi-automated overlay function of an anatomical template reference adding enhanced level of on-line assurance for image verification and comparison.
Mentions image processing
Yes
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
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2017
Cablon Medical B.V. % Mr. Jurjen Weistra Business Unit Manager Theraview Klepelhoek 11 3833 GZ Leusden THE NETHERLANDS
Re: K170058
Trade/Device Name: TheraView TBI Imager Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: January 23, 2017 Received: February 3, 2017
Dear Mr. Weistra:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Attachment 4: Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K170058 Device Name
TheraView TBI Imager
Indications for Use (Describe)
Digital Portal imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment. Images maybe stored to hard disk for processing, analysis and hardcopy. This includes an automated border detection for field size and shape verification and a semi-automated overlay function of an anatomical template reference adding enhanced level of on-line assurance for image verification and comparison.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
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