(73 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific AI/ML-driven functionalities. The description focuses on the hardware components and basic imaging modality.
Yes.
The device delivers radiation treatment for lesions, tumors, and conditions, which is a therapeutic intervention.
No
Explanation: The device is a radiotherapy delivery system, not a diagnostic device. It uses diagnostic kV X-rays as an input imaging modality, but its purpose is treatment ("radiosurgery and precision radiotherapy"), not diagnosis.
No
The device description explicitly states it is a "medical linear accelerator" and consists of "two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component" and a "control console area," indicating it is a hardware-based system with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated." This describes a therapeutic device that delivers radiation to treat conditions within the body.
- Device Description: The description confirms it's a "medical linear accelerator" that produces radiation beams for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used to deliver treatment directly to the body.
N/A
Intended Use / Indications for Use
The Trilogy Mx™ system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Product codes
90 IYE
Device Description
The Trilogy Mx™ Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.
The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anywhere in the body
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K050442, K072916, K042720, K063270, K081036, K003636, K071992
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
092871
Premarket Notification [510(k)] Summary Trilogy Mx Radiotherapy Treatment System
NOV 30 2009
The following information is provided following the format of 21 CFR 807.92.
| Submitter's Name: | |
|---|---|
| ------------------- | -- |
Varian Medical Systems, Inc. 3100 Hansen Way e-110 Palo Alto, CA 94304
Contact Name: Vy Tran Phone: 650/424.5731 Fax: 650/842.5040 Date: 16th September 2009
21 CFR 892.5050, Class II Product Code: 90 IYE
Medical charged-particle radiation therapy system
Trilogy Mx Radiotherapy Delivery System
Trilogy Radiotherapy System and Accessories:
Trilogy Mx™
Proprietary Name:
Classification Name:
Common/Usual Name:
Predicate Devices:
Device Description:
The Trilogy Mx™ Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.
K072916, K042720, K063270, K081036, K003636, K071992,
The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
The Trilogy Mx™ system is intended to provide stereotactic radiosurgery
The Trilogy Mx™ system is intended to provide stereotactic radiosurgery
and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
and precision radiotherapy for lesions, tumors, and conditions anvwhere in the body where radiation treatment is indicated.
Statement of Intended Use
Statement of Indications for Use:
Technological Characteristics:
Refer to the Substantial Equivalence Comparison Chart
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three lines extending from the eagle's body. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NOV 3 0 2009
Ms. Vy Tran VP Corporate Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K092871
Trade/Device Name: Trilogy Mx™ Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system and the comments of the comments of the comments of Regulatory Class: II Product Code: IYE Dated: September 16, 2009 Received: September 18, 2009
Dear Ms. Tran:
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 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
2
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K092871 510(k) Number (if known): .
Device Name:_____Trilogy Mx
Indications For Use:
Trilogy Mx is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
logm 722
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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