TheraView TBI

K170058 · Cablon Medical B.V. · IYE · Mar 3, 2017 · Radiology

Device Facts

• Record ID: K170058
• Device Name: TheraView TBI
• Applicant: Cablon Medical B.V.
• Product Code: IYE · Radiology
• Decision Date: Mar 3, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended 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.

Device Story

TheraView TBI Imager is a digital portal imaging system for radiation therapy; captures real-time treatment images; stores images to hard disk for analysis and hardcopy. System features automated border detection for field size/shape verification; semi-automated overlay function for anatomical template reference. Used in clinical radiation therapy settings by oncology staff; provides on-line assurance for image verification and comparison; assists clinicians in verifying treatment accuracy; enhances patient safety by ensuring radiation delivery matches planned treatment parameters.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Digital portal imaging system; utilizes radiation therapy imaging hardware; includes software for image processing, automated border detection, and anatomical template overlay. Connectivity includes hard disk storage for image analysis and hardcopy output. System is designed for integration into radiation therapy workflows.

Indications for Use

Indicated for patients undergoing radiation therapy requiring pre-treatment verification and real-time imaging of treatment fields. Used by clinicians for field size/shape verification and anatomical template comparison.

Regulatory Classification

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.

Predicate Devices

• TheraView (K062666)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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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