(77 days)
The Trilogy ™ Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The External System Gating Interface is indicated for use in exporting beam information to external gating devices.
This 510(k) submission (K081188) for "Trilogy™ with External System Gating Interface" is for modifications to an existing radiotherapy delivery system. It primarily focuses on the ability to export beam information to external gating devices. As such, the concept of "acceptance criteria" and "device performance" in relation to clinical efficacy or diagnostic accuracy, as one might find for an AI-powered diagnostic device, is not directly applicable here.
This submission is about confirming that the modification (the external system gating interface) performs its intended function without compromising the safety and efficacy of the already cleared base device (Trilogy™ Radiotherapy Delivery System). The "study" here is more akin to verification and validation testing of the new interface rather than a full-scale clinical trial proving primary clinical effectiveness.
Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not provided in the document because they are not relevant to this type of device modification submission. Device modifications typically refer to verification and validation data to show that the modification performs as intended and does not negatively impact existing functionalities.
Let's break down what information is available and how it aligns with your questions, and where there are gaps due to the nature of the submission:
Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for this submission)
This submission is about a modification to an existing device (Trilogy Radiotherapy Delivery System) to enable the export of beam information to external gating devices. The "acceptance criteria" for such a modification would generally revolve around:
- Functionality: Does the interface correctly export the specified beam information?
- Accuracy: Is the exported information (e.g., beam status, timing) accurate and synchronized?
- Safety: Does the interface introduce any new hazards or compromise the safety of the overall system?
- Compatibility: Is the interface compatible with intended external gating devices (though specific devices are not named here)?
- Reliability: Does the interface consistently perform over time?
The provided document mentions the modification enables the export of beam information, but it does not detail the specific acceptance criteria or the test results (device performance data) used to demonstrate this. The FDA's substantial equivalence determination implies these tests were reviewed and deemed satisfactory, but the document itself is a summary, not the full submission.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred for this type of device modification) | Reported Device Performance (Not explicitly detailed in this summary document) |
|---|---|
| Functional Verification: Interface correctly exports beam information. | (Assumed to be met, but no data provided) |
| Accuracy of Exported Data: Beam status/timing data are accurate and synchronized. | (Assumed to be met, but no data provided) |
| Safety: No new hazards introduced; device remains safe. | (Assumed to be met, but no data provided) |
| Compatibility: Interface communicates with external gating devices as intended. | (Assumed to be met, but no data provided) |
| Reliability: Consistent performance of the interface. | (Assumed to be met, but no data provided) |
| Compliance: Adherence to relevant standards (e.g., electrical, EMC, software). | (Assumed to be met, but no data provided) |
| No Degradation of Existing Functionality: Base Trilogy system performance is maintained. | (Assumed to be met, but no data provided) |
1. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary. This type of submission would typically involve internal engineering verification and validation testing, not clinical data in the traditional sense for the modification itself.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts & Qualifications: Not applicable and not specified. For device modifications in radiotherapy, "ground truth" establishment usually refers to engineering specifications, performance against known good systems, or simulated scenarios, not clinical expert consensus on diagnostic images.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable and not specified. This is relevant for studies involving human interpretation or clinical outcomes, not for functional verification of a software/hardware interface.
4. 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
- MRMC Study: No, an MRMC study was not done. This device is not an AI-powered diagnostic tool, but a modification to a radiotherapy delivery system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an "algorithm." The device itself is a standalone radiotherapy delivery system. The modification is an interface that likely functions autonomously once configured, but this is not an "algorithm-only" performance evaluation as seen in AI submissions. The performance would be assessed through engineering tests.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated, but for this type of modification, the "ground truth" would be the engineering specifications for the beam information to be exported (e.g., "beam on/off status should be X," "timing signal should be Y"). Verification would confirm the interface accurately transmits data that matches these predefined specifications.
7. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device modification does not involve a "training set" in the machine learning sense.
8. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. This device modification does not involve a "training set" in the machine learning sense.
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Korssy
JUL 1 4 2008
510(k) Summary
The information below is provided for the Modifications to the Trilogy Radiotherapy Delivery System known as Trilogy with External System Gating Interface, following the format of 21 CFR 807.92.
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- Submitter: Varian Medical Systems 3100 Hansen Way, M/S e110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: 650/424.5731 Fax: 650/842.5040 E-mail: yy.tran@varian.com
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- Trilogy TM with External System Gating Interface Name of the Device: Trade / Proprietary Name: Trilogy ™ Radiotherapy Delivery System Common or Usual Name: Trilogy TM Radiotherapy Delivery System Classification Name: Medical Charged Particle Radiation Therapy System 21 CFR §892.5050 Class II Product Code: 90 TYE™
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- Predicate Device to claim substantial equivalence: Varian Trilogy Tx Radiotherapy System-K072916
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- Description of the Device:
The Trilogy System modifications enable the export of beam information to external gating devices.
All other features of the Trilogy System and remain as cleared by K033343, K061140, K070094 and 072916.
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- Intended Use Statement
The Trilogy ™ Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Intended Use Statement
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- Indications for Use Statement
The Trilogy ™ Radiotherapy Delivery System is 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
The External System Gating Interface is indicated for use in exporting beam information to external gating devices.
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- Substantial Equivalence
The submission for the Trilogy™ with External System Gating Interface illustrates substantial equivalence to the predicate device.
- Substantial Equivalence
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2008
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems 3100 Hansen Way, M/S/ E-110 PALO ALTO CA 94304
Re: K081188
Trade/Device Name: Trilogy™ with External System gating Interface Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 25, 2008 Received: April 28, 2008
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 vour 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.
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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely vours.
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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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 TM with External System Gating Interface
The Trilogy ™ Radiotherapy Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The External System Gating Interface is indicated for use in exporting beam information to external gating devices.
(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
Hogai M. Whang
(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.