(21 days)
The Trilogy™ Radiotherapy Delivery System and Trilogy Tx Delivery System are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Trilogy™ Radiotherapy 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 Trilogy TM Radiotherapy Delivery System, K033343, is a dual-energy, high dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The Trilogy system allows for stereotactic treatments that may be intracranial or extracranial and consist of single-session or multisession ("fractionated") treatment delivery.
The provided text is a 510(k) Summary for the Varian Medical Systems' Trilogy Radiotherapy Delivery System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study description with acceptance criteria and performance metrics for the new device itself.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set details) are not explicitly available in this document.
However, I can extract information related to the acceptance criteria for specific technical specifications.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device demonstrates performance equivalent to its predicate device, the Varian Medical Systems' Trilogy Radiotherapy Delivery System (K033343), and the CyberKnife (K041315) for its intended use and indications. The acceptance criteria can be inferred from the specifications listed in the "Substantial Equivalence Comparison" table.
| Feature / Acceptance Criteria Category | Acceptance Criteria (from Predicate Device K033343 and K041315, and the new device) | Reported Device Performance (Trilogy Radiotherapy Delivery System & Trilogy Tx Delivery System) |
|---|---|---|
| Intended Use | To provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. (Matched from predicate CyberKnife K041315) | The Trilogy™ Radiotherapy Delivery System and the Trilogy Tx Delivery System are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. |
| Indications for Use | Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. (Matched from predicate CyberKnife K041315) | The Trilogy™ Radiotherapy Delivery System and the 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. |
| Isocenter | ≤1.5mm for all three rotational axes (from predicate K033343) | ≤1.5mm for all three rotational axes |
| Energy used | 4-25MV (from predicate K033343) | 4-25MV |
| Dose rate | 3DCRT and IMRT: Up to 600MU/min. SRS: Up to 1000MU/min (from predicate K033343) | 3DCRT and IMRT: Up to 600MU/min. SRS: Up to 1000MU/min |
| Maximum field size | 3DCRT: 40cm x 40cm. IMRT: 34cm x 40cm. SRS: 15cm x 15cm (from predicate K033343) | 3DCRT: 40cm x 40cm. IMRT: 34cm x 40cm. SRS: 15cm x 15cm |
| Remote touch motion | Small, corrective motions (≤ 2cm and 2°) and large, planned rotations. Secondary position readout indicators perform secondary verification. (from predicate K033343) | Small, corrective motions (≤ 2cm and 2°) and large, planned rotations. Secondary position readout indicators perform secondary verification. |
Study Description and Specifics (Based on Available Information):
The document does not detail a specific new study to demonstrate device performance in terms of clinical outcomes or complex image analysis. Instead, it relies on demonstrating substantial equivalence to previously cleared devices (predicates). This means the "study" is primarily a comparison of technical specifications and intended use against the predicates.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not explicitly stated. The document is a 510(k) summary focused on substantial equivalence by comparing technical specifications. It does not describe a clinical performance study with a "test set" in the context of image analysis or diagnostic accuracy. Data provenance would relate to the predicate devices' prior approvals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not explicitly stated. No expert panel or ground truth establishment is described for a clinical test set in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not explicitly stated. As there is no clinical test set described in the context of diagnostic or treatment efficacy, there is no adjudication method detailed.
5. 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:
- No. This document is for a radiotherapy delivery system, not an AI-assisted diagnostic or treatment planning software requiring MRMC studies for human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This document does not describe an AI algorithm or a standalone algorithmic performance study. It's for a medical linear accelerator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not explicitly stated. The "ground truth" in this context is the established safety and effectiveness of the predicate devices and their technical specifications, to which the new device is compared. For technical specifications like "Isocenter <=1.5mm", the ground truth would be precise physical measurements and engineering validation, not clinical expert consensus or pathology.
8. The sample size for the training set:
- Not applicable / Not explicitly stated. There is no "training set" described as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable / Not explicitly stated. As there is no training set, this information is not provided.
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MAY 15 2005
Kobe 1140
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VARIAN
medical systems
Varian Medical Systems, In 3100 Hansen Way Palo Alto, CA 94304-1038 el +1 650 493 4000 www.varian.com
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the Trilogy Radiotherapy Delivery System
- Submitter: Varian Medical Systems 3100 Hansen Way M/S H055 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 Fax: (650) 842-5040 Email: vy.tran@varian.com Date summary was prepared: April 21, 2006
-
- Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:
Trilogy Radiotherapy Delivery System and Trilogy Tx Trilogy Radiotherapy Delivery System Trilogy system Medical Charged Particle Radiation Therapy System 21 CFR §892.5050 Class II Product Code: 90 IYE
- Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:
-
Predicate Devices to claim substantial equivalence: 3.
-
Description of the Device: The Trilogy TM Radiotherapy Delivery System, K033343, ব . is a dual-energy, high dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The Trilogy system allows for stereotactic treatments that may be intracranial or extracranial and consist of single-session or multisession ("fractionated") treatment delivery.
-
Intended Use Statement: The Trilogy™ Radiotherapy Delivery and the Trilogy Tx is 5. intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
-
Substantial Equivalence The Trilogy Radiotherapy Delivery is substantially equivalent 6. to the predicate devices. The intended use, principles of operation, and technological characteristics are the same.
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stantial Equivalence Comparison
The Triley "" Radiotheray Delivery System and the Trilogy Tx Delivery System are Sybtent on the CyberKni
System, K041315 for Intended Use and Indications for Use and are subs
revised Intended Use and Indications for Use statements are equivalent to those used by CyberKni
| Intended Use | CyberKnife® System forStereotacticRadiosurgery/Radiotherapy,K041315 | Trilogy™ RadiotherapyDelivery System,K033343 | Trilogy™ Radiotherapy DeliverySystem | Trilogy Tx DeliverySystem |
|---|---|---|---|---|
| The CyberKnife System forStereotacticRadiosurgery/Radiotherapyis intended to providetreatment planning andimage-guided stereotacticradiosurgery and precisionradiotherapy for lesions,tumors, and conditionsanywhere in the body whenradiation treatment isindicated. | The Trilogy™Radiotherapy DeliverySystem is a radiationtherapy acceleratorintended to delivermegavoltage x-raytreatments forconventionalradiotherapy (threedimensional conformalradiotherapy andintensity modulatedradiotherapy) andstereotactic radiosurgeryand radiotherapy.Stereotactic treatmentsare intended for therapyof lesions, e.g.,arteriovenous | The Trilogy™Radiotherapy DeliverySystem is intended toprovide stereotacticradiosurgery andprecision radiotherapyfor lesions, tumors, andconditions anywhere inthe body whenradiation treatment isindicated. | The Trilogy TxDelivery System isintended to providestereotacticradiosurgery andprecision radiotherapyfor lesions, tumors, andconditions anywhere inthe body whenradiation treatment isindicated. |
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| Indicationsfor Use | The CyberKnife System forStereotacticRadiosurgery/Radiotherapyis indicated for treatmentplanning and image-guidedstereotactic radiosurgery andprecision radiotherapy forlesions, tumors, andconditions anywhere in thebody when radiationtreatment is indicated. | The TrilogyTMRadiotherapy DeliverySystem is a radiationtherapy acceleratorintended to delivermegavoltage x-raytreatments forconventionalradiotherapy (threedimensional conformalradiotherapy andintensity modulatedradiotherapy) andstereotactic radiosurgeryand radiotherapy.Stereotactic treatmentsare intended for therapyof lesions, e.g.,arteriovenousmalformations, primarytumors and metastases.Stereotactic treatmentsmay be intracranial orextracranial and consistof single-session orfractionated delivery. | The TrilogyTMRadiotherapy DeliverySystem is indicated forstereotacticradiosurgery andprecision radiotherapyfor lesions, tumors, andconditions anywhere inthe body whenradiation treatment isindicated. | The Trilogy TxDelivery System isindicated forstereotacticradiosurgery andprecision radiotherapyfor lesions, tumors, andconditions anywhere inthe body whenradiation treatment isindicated. |
|---|---|---|---|---|
| of single-session or fractionated delivery. | ||||
| Isocenter | Not Applicable | ≤1.5mm for all three rotational axes | ≤1.5mm for all three rotational axes | ≤1.5mm for all three rotational axes |
| Energy used | Not Applicable | 4-25MV | 4-25MV | 4-25MV |
| Dose rate | Not Applicable | 3DCRT and IMRT: Up to 600MU/min. SRS: Up to 1000MU/min | 3DCRT and IMRT: Up to 600MU/min. SRS: Up to 1000MU/min | 3DCRT and IMRT: Up to 600MU/min. SRS: Up to 1000MU/min |
| Maximumfield size | Not Applicable | 3DCRT: 40cm x 40cm.IMRT: 34cm x 40cm.SRS: 15cm x 15cm | 3DCRT: 40cm x 40cm.IMRT: 34cm x 40cm.SRS: 15cm x 15cm | 3DCRT: 40cm x 40cm.IMRT: 34cm x 40cm.SRS: 15cm x 15cm |
| Remotetouch motion | Not Applicable | Small, corrective motions ( $\leq$ 2cm and 2°) and large, planned rotations. Secondary position readout indicators perform secondary verification. | Small, corrective motions ( $\leq$ 2cm and 2°) and large, planned rotations. Secondary position readout indicators perform secondary verification. | Small, corrective motions ( $\leq$ 2cm and 2°) and large, planned rotations. Secondary position readout indicators perform secondary verification. |
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the state of the comments of the state of the states the states DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 15 2006
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K061140
Trade/Device Name: Trilogy Radiotherapy 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: April 20, 2006 Received: April 25, 2006
Dear Ms. Tran:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roteweary our becare ined 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 (Premarket it your a vice is che subject to such additional controls. Existing major regulations affecting your I tpp. o an 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.
Image /page/4/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The logo features the letters "FDA" in a bold, stylized font. There are three stars below the word Centennial. The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.
Preventing 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 (OS) 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.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 | |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology); | 240-276-0120 |
| Other | 240-276-0100 | |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Nancy C. Brogdon
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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PAGE 1 of 1
. Same in the
510(k) Number (if known): _ |<061140 Device Name: Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System
Indications For Use:
The Trilogy™ Radiotherapy 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)
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
Prescription Use Per 21 CFR 801.109)
§ 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.