(103 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML in medical devices.
Yes
The device is described as a "Treatment Planning and Delivery System" that provides "radiation treatment" for "lesions, tumors, and conditions anywhere in the body," indicating it is used to treat medical conditions.
No
The device is a treatment planning and delivery system used for radiation therapy, not for diagnosing conditions. While it assists in reviewing and tracking patient treatment, its primary function is therapeutic.
No
The device description explicitly states it is a "Treatment Planning and Delivery System" and is used on the "ViewRay radiation therapy system," which implies hardware components for delivering radiation. The software is part of a larger system that includes hardware.
Based on the provided information, the ViewRay™ Treatment Planning and Delivery System 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. They are used to provide information for diagnosis, monitoring, or screening.
- ViewRay System Function: The ViewRay system is described as a "Treatment Planning and Delivery System" for external radiation therapy. It uses MRI imaging and software tools to plan and deliver radiation treatment directly to lesions, tumors, and conditions within the body.
- Lack of Sample Analysis: The description does not mention any analysis of samples taken from the body. The system works with imaging data and directly interacts with the patient's body for treatment delivery.
Therefore, the ViewRay system falls under the category of a therapeutic device used for delivering radiation treatment, not an in vitro diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for Use
The ViewRay™ Treatment Planning and Delivery System is intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay™ System, an MRI image-guided radiation therapy system.
Use of the ViewRay™ Treatment Planning and Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Product codes
IWB, MUJ
Device Description
The ViewRay™ Treatment Planning and Delivery System (TPDS) provides tools for planning and delivery of external gamma beam stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. It is a computer-based device used by trained medical professionals. The Treatment Planning software is only designed to be used on the ViewRay radiation therapy system. The ViewRay TPDS is capable of assisting clinicians in reviewing, prescribing, tracking, and correcting the course of patient treatment using tools for contouring, visualization, data storage, anatomical target monitoring and reoptimization. The software described in this submission has been designed to conform with applicable ections of IEC 60601-1, IEC 60601-2-11, IEC 62083 and IEC 61217.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals
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
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.
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K102915
JAN 1 2 2011
510(k) Summary as required by section 807.92(c)
Submitter's name: ViewRay Incorporated 2 Thermo Fisher Way Oakwood, Ohio 44146 440-703-3210 Fax 440-703-3229
Contact person: Janice Brownlee
Date prepared: September 30, 2010
Trade Name of Device: ViewRay™ Treatment Planning and Delivery System
Common name: Radiation Therapy Treatment Planning and Delivery System
Classification name: Radionuclide Radiation System (21CFR 892.5750, Product Code IWB)
Predicate Device: Varian Medical Systems' Trilogy Mx™ System K092871 and Eclipse™ Treatment Planning System K091492
Description: The ViewRay™ Treatment Planning and Delivery System (TPDS) provides tools for planning and delivery of external gamma beam stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. It is a computer-based device used by trained medical professionals. The Treatment Planning software is only designed to be used on the ViewRay radiation therapy system. The ViewRay TPDS is capable of assisting clinicians in reviewing, prescribing, tracking, and correcting the course of patient treatment using tools for contouring, visualization, data storage, anatomical target monitoring and reoptimization.
The software described in this submission has been designed to conform with applicable ections of IEC 60601-1, IEC 60601-2-11, IEC 62083 and IEC 61217.
intended use: The ViewRay™ Treatment Planning and Delivery System is intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the System, an MRI image-guided radiation therapy system. /iewRay™
CONFIDENTIAL ViewRay Page 17 J
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Technological Characteristics compared to predicate device: The ViewRay™Treatment Planning and Delivery System shares many of the technological features and characteristics of the Varian Eclipse planning system, and the treatment delivery features of the Varian Trilogy System. The fundamental technical characteristics are the same as those of the predicate devices and minor differences are described in the comparison chart and discussion provided elsewhere in this 510(k) submission.
Conclusion: The ViewRay™ Treatment Planning and Delivery System has the same intended use, indications for use and user population as the Varian Eclipse™/Trilogy Mx™ System. The ViewRay™ Treatment Planning and Delivery System has most of the features and technological characteristics as the predicate devices, and the few distinguishing characteristics do not raise new types of safety or effectiveness issues.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Janice Brownlee VP, Regulatory Affairs and Quality Assurance ViewRay Incorporated 2 ThermoFisher Way OAKWOOD VILLAGE OH 44146
JAN 1 2 200
Re: K102915
Trade/Device Name: ViewRay™ Treatment Planning and Delivery System Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: MUJ Dated: September 20, 2010 Received: November 1, 2010
Dear Ms. Brownlee:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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1C. Regulatory Sections
Indications for Use
JAN 1 2 2011
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ViewRay™ Treatment Planning and Delivery System
Use of the ViewRay™ Treatment Planning and Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Division of Radiologi Office of In Vitro Diagnostic Device Evalu
510K K102915
CONFIDENTIAL ViewRay Page 16