(67 days)
The Trilogy™ Radiotherapy Delivery System is a radiation therapy accelerator intended deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.
The modified 2300C/D, which will now be called the Trilogy™ Radiotherapy Delivery System, will include stereotactic functionality and remote couch motions as new features. The Trilogy™ Radiotherapy Delivery System is an image-guided, dual-energy, high-dose medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy and intensity modulated radiosurgery. The Trilogy™ system delivers megavoltage x-ray mountated fucilobargery. The treatment of cancer. The Treatment of cancer. The Trilogy™ system includes a dynamic multileaf collimator (Millennium™ MLC with Dynamic MLC software), electronic portal imaging device (AS1000™), asymmetric jaws, enhanced dynamic wedge, a stereotactic treatment delivery mode (6MV, 1000 MU/min, maximum field size of 15cm x 15cm) and remote couch motion. There will be a 0.75mm radius isocenter for all three rotational axes, which include the gantry, collimator and table axes. The Trilogy™ system will allow for stereotactic treatments that may be intracranial or extracranial and consist of single-session or fractionated delivery. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary turnors and metastases.
The provided text is a 510(k) Summary for the Varian Medical Systems Trilogy Radiotherapy Delivery System. This document focuses on demonstrating substantial equivalence to predicate devices and describes the device's features and intended use. It does not contain information about acceptance criteria or specific studies proving the device meets those criteria in the way a clinical performance study for a diagnostic AI device would.
The Trilogy Radiotherapy Delivery System is a medical linear accelerator for radiation therapy, not a diagnostic AI device that generates a "reported device performance" against "acceptance criteria" through a traditional clinical study with a test set, ground truth, and expert adjudication in the manner typically associated with AI/ML medical devices.
Therefore, I cannot populate the requested table and sections. The 510(k) pathway for this device, approved in 2003, predates the typical framework for evaluating AI/ML medical devices. The "study" referenced in K03343 refers to engineering and performance testing to ensure the device operates as intended and meets safety standards, not a clinical study to establish diagnostic performance.
Key reasons for not being able to fulfill the request as specified:
- Type of Device: The Trilogy system is a treatment delivery device (a linear accelerator), not a diagnostic AI device. Its regulatory submission focuses on engineering specifications, safety, and substantial equivalence to existing similar devices (predicates).
- Approval Year: The K03343 submission was approved in 2003, well before specific regulatory guidance and common practices for AI/ML device evaluation were established, especially regarding clinical performance metrics like sensitivity, specificity, or reader improvement.
- Lack of Performance Data: The provided 510(k) summary does not include data like sensitivity, specificity, AUC, or other performance metrics typically associated with AI/ML diagnostic tools. Instead, it describes technical features (e.g., isocenter radius, maximum field size, dose rates) and clinical applications (types of radiation therapy and lesions).
- No "Ground Truth" for Performance: For a treatment delivery device, "ground truth" isn't established in the same way as for a diagnostic device (e.g., pathology for a cancer detection AI). Validation focuses on accurate and precise delivery of radiation according to planned parameters.
- No "Test Set" of Patients/Images: The concept of a "test set" and "training set" with expert-adjudicated ground truth, as posed in the prompt, does not apply to this type of device according to the provided documentation.
In summary, the provided document describes a traditional medical device (radiation therapy accelerator) and its 510(k) clearance process, which does not involve the specific types of performance studies, acceptance criteria, or ground truth methodologies requested for an AI/ML device.
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K03343
DEC 2 3 2003
Image /page/0/Picture/12 description: The image shows the logo for Varian Medical Systems. The word "VARIAN" is written in all caps, with a stylized "I" that resembles a person. Below the word "VARIAN" is the phrase "medical systems" in a smaller font.
510(k) Summary
rian Medical Systems, Inc 100 flansen Way Palo Alto, CA 94304-1038 +1 650 493 4000
The following information is provided following the format of 21 CFR 807.92 for the Trilogy Radiotherapy Delivery System
- Varian Medical Systems 1. Submitter: 3100 Hansen Way M/S H055 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 (650) 842-5040 Fax: Email: vy.tran@varian.com Date summary was prepared: October 16, 2003
| 2. Name of the Device: | Trilogy Radiotherapy Delivery System |
|---|---|
| Trade/Proprietary Name: | Trilogy Radiotherapy Delivery System |
| Common or Usual Name: | Trilogy system |
| Classification Name: | Medical Charged Particle Radiation Therapy System21 CFR §892.5050Class IIProduct Code: 90 IYE |
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- Predicate Devices to claim substantial equivalence:
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- Description of the Device: The modified 2300C/D, which will now be called the Trilogy™ Radiotherapy Delivery System, will include stereotactic functionality and remote couch motions as new features. The Trilogy™ Radiotherapy Delivery System is an image-guided, dual-energy, high-dose medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The stereotactic applications include singlesession radiosurgery, fractionated stereotactic radiation therapy and intensity modulated radiosurgery. The Trilogy™ system delivers megavoltage x-ray mountated fucilobargery. The treatment of cancer. The Treatment of cancer. The Trilogy™ system includes a dynamic multileaf collimator (Millennium™ MLC with Dynamic MLC software), electronic portal imaging device (AS1000™), asymmetric jaws, enhanced dynamic wedge, a stereotactic treatment delivery mode (6MV, 1000 MU/min, maximum field size of 15cm x 15cm) and remote couch motion. There will be a 0.75mm radius isocenter for all three rotational axes, which include the gantry, collimator and table axes. The Trilogy™ system will allow for stereotactic treatments that may be intracranial or extracranial and
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consist of single-session or fractionated delivery. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary turnors and metastases.
- 5, Intended Use Statement: The Trilogy™ Radiotherapy Delivery System is a radiation therapy accelerator intended deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.
- Summary of the Technological Characteristics: The 2300 C/D, K913119 has 6. been modified to modifications made to include radiotherapy stereotactic functionality and remote couch motions as new features. These modifications are substantially equivalent to the features of the Brainlab Novalis Shaped Beam Surgery System, K002509. The addition of these new features also result in a name change from the Varian Clinac to the Varian Trilogy™ Radiotherapy Delivery System. The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 9 of the submission.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2003
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K033343 Trade/Device Name: Trilogy Radiotherapy Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: October 16, 2003 Received: October 17, 2003
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 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.
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.
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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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
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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510(k) Number (if known): Device Name: Trilogy Radiotherapy Delivery System
Indications For Use:
The Trilogy™ Radiotherapy Delivery System is a radiation therapy accelerator intended deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactive and are intended for therapy of lesions, e.g., arteriorenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
David Ch. Hageman.
(Division Sign-Off Division of Reproductive, a 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.