(28 days)
No
The summary describes a radiotherapy system modification focused on varying radiation intensity and gantry speed, with no mention of AI or ML in the device description, intended use, or specific sections for AI/ML details.
Yes.
The device is intended to provide stereotactic radiosurgery and precision radiotherapy, which are forms of medical treatment using radiation for lesions, tumors, and other conditions. This directly impacts health and is a therapeutic intervention.
No
The device description indicates it is a radiotherapy system used for treatment, not diagnosis. It delivers radiation for lesions and tumors.
No
The device description explicitly refers to the "Trilogy System," which is a radiotherapy system (hardware). The modifications described are to enable a specific treatment delivery method (RapidArc) on this existing hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Trilogy System Function: The description clearly states the Trilogy System is used for "stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body." This involves delivering radiation to the body for treatment, not analyzing samples from the body.
The Trilogy System is a therapeutic device, specifically a radiotherapy system, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Trilogy ™ System with RapidArc is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Trilogy ™ System with RapidArc is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
The Trilogy System modifications enable the delivery a RapidArc treatment fields that simultaneously vary the intensity of radiation and gantry rotation speed.
All other features of the Trilogy System and remain as cleared by K061140, K033343, and K070094.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
The information below is provided for the Modifications to the Trilogy Radiotherapy Delivery System known as Trilogy System with RapidArc, following the format of 21 CFR 807.92.
- Submitter: Varian Medical Systems 1. 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
NOV
9 2007
| 2. Name of the Device: | Trilogy™ System with RapidArc |
|---|---|
| Trade / Proprietary Name: | Trilogy™ System with RapidArc |
| Common or Usual Name: | Trilogy™ System with RapidArc |
| Classification Name: | Medical Charged Particle Radiation Therapy System |
| 21 CFR §892.5050 | |
| Class II | |
| Product Code: | 90 IYE |
-
- Predicate Device to claim substantial equivalence: Varian Trilogy Tx Radiotherapy System -K070094
-
- Description of the Device:
The Trilogy System modifications enable the delivery a RapidArc treatment fields that simultaneously vary the intensity of radiation and gantry rotation speed.
All other features of the Trilogy System and remain as cleared by K061140, K033343, and K070094.
-
Intended Use Statement ર.
The Trilogy ™ System with RapidArc is 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 Statement 6.
The Trilogy™ System with RapidArc is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. -
- Substantial Equivalence
Trilogy ™ System with RapidArc submission illustrates substantial equivalence to the predicate device.
- Substantial Equivalence
1
Public Health Service
Image /page/1/Picture/2 description: The image is a black and white 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 caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems 3100 Hansen Way. M/S/E-110 PALO ALTO CA 94304
Re: K072916
Trade/Device Name: Trilogy System with RapidArc Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 11, 2007 Received: October 12, 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, 1796, 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.
2
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/cdrh/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
3
KC729/6
Image /page/3/Picture/1 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "i" that resembles a person. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font. The logo is simple and professional, conveying a sense of trust and reliability.
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):
KC729/6
Device Name:
Trilogy TM System with RapidArc
The Trilogy ™ System with RapidArc is 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)
Prescription Use ✗ OR Over-the-counter __
(Per 21 CFR § 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
Radiological Devices
510(k) Number K072914