(30 days)
The Trilogy ™ Delivery System and Trilogy Tx Delivery System are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated.
The Trilogy ™ Delivery System and Trilogy Tx Delivery System are indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The changes to the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System provide a modified software algorithm that implements gradual acceleration and deceleration of gantry rotation with direct drive.
All other features of the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System remain as cleared by K061140 and K033343, respectively.
This is a 510(k) summary for Modifications to the Trilogy™ Delivery System and Trilogy Tx Delivery System, which are medical charged-particle radiation therapy systems. The provided documents focus on regulatory clearance and do not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The submission states: "The changes to the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System provide a modified software algorithm that implements gradual acceleration and deceleration of gantry rotation with direct drive." It also explicitly mentions that "All other features of the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System remain as cleared by K061140 and K033343, respectively." This suggests that the modifications are software-related for gantry movement control, and the core functional performance criteria would likely have been established and tested during the original clearances (K061140 and K033343).
Therefore, based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided 510(k) summary. The summary is focused on demonstrating substantial equivalence to predicate devices for a software modification, not on detailed performance specifications or test results for new criteria.
- Sample size used for the test set and the data provenance: This information is not present in the provided 510(k) summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the provided 510(k) summary. Given the nature of the device (radiation therapy system) and the described change (software for gantry control), "ground truth" in the typical medical imaging/AI sense is not applicable here. Performance would be assessed through engineering tests, phantom studies, and potentially clinical validation.
- Adjudication method for the test set: Not applicable and not present in the provided 510(k) summary.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a radiation therapy delivery system, not an AI-assisted diagnostic or image analysis tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device's modification is a software algorithm for gantry control. Its performance would be evaluated within the context of the overall system, likely through engineering tests, and would be considered "standalone" in the sense that the algorithm itself controls the gantry movement. However, the exact performance metrics and testing details are not provided.
- The type of ground truth used: For a radiation therapy delivery system, ground truth would typically come from physical measurements (e.g., dosimetric measurements with phantoms, mechanical accuracy tests) against established engineering specifications. The exact type is not specified in this document.
- The sample size for the training set: Not applicable to the information provided. The "training set" concept is usually associated with machine learning or AI models developed from data, which isn't explicitly detailed as part of this software modification.
- How the ground truth for the training set was established: Not applicable, as no training set is described.
In summary, the provided 510(k) document is a regulatory submission for a software modification to an existing radiation delivery system. It attests to substantial equivalence based on the nature of the change and references prior clearances, rather than presenting detailed performance studies against specific acceptance criteria for the new software feature.
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510(k) Summary
The information below is provided for the Modifications to the Trilogy ™ Delivery System and Trilogy Tx Delivery System, following the format of 21 CFR 807.92.
FEB 9 2007
- Varian Medical Systems 1. Submitter: 3100 Hansen Way, M/S e110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: 650/424.5731 Fax: 650/842.5040 E-mail: vy.tran@varian.com
- Name of the Device: Trilogy TM Delivery System and Trilogy Tx Delivery System Trade / Proprietary Name: Trilogy TM Delivery System and Trilogy Tx Delivery System Common or Usual Name: Trilogy ™ Delivery System and Trilogy Tx Delivery System Classification Name: Medical Charged Particle Radiation Therapy System 21 CFR §892.5050 Class II Product Code: 90 ГУЕ
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- Description of the Device:
The changes to the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System provide a modified software algorithm that implements gradual acceleration and deceleration of gantry rotation with direct drive.
All other features of the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System remain as cleared by K061140 and K033343, respectively.
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- Intended Use Statement
The Trilogy ™ Delivery System and Trilogy Tx Delivery System are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated.
- Intended Use Statement
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- Indications for Use Statement
The Trilogy ™ Delivery System and Trilogy Tx Delivery System are indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Indications for Use Statement
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Substantial Equivalence 7.
The Modifications to the Trilogy ™ Delivery System and Trilogy Tx Delivery System submission illustrates substantial equivalence to the predicate devices.
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Image /page/1/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" and is arranged around the top and left side of the circle. The graphic in the center consists of three curved lines that appear to be stylized representations of human figures or abstract shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Vy Tran Corporate Director Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way, MS E-110 PALTO CA 94304-1038
9 2007
Re: K070094
Trade/Device Name: Trilogy™ Delivery System and Trilogy Tx Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: January 8, 2007 Received: January 10, 2007
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 Cosmelic 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Protecting and Promoting Public Health
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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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com
Indications for Use Statement
510(k) Number (if known):
Device Name:
Trilogy ™ Delivery System and Trilogy Tx Delivery System
Indications for Use: -
The Trilogy ™ Delivery System and Trilogy Tx Delivery System are indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR § 801.109)
Over-the-counter
Daniel Ch. Levinson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
§ 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.