(77 days)
No
The summary focuses on exporting beam information and references previous clearances, with no mention of AI, ML, or related concepts.
Yes.
The device's intended use is to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions, which are therapeutic interventions.
No
The document describes a radiotherapy delivery system, which is a treatment device, not a diagnostic device Used for diagnosis purpose.
No
The device description explicitly refers to the "Trilogy ™ Radiotherapy Delivery System," which is a hardware system. The modification described is an "External System Gating Interface" which enables the export of beam information, implying interaction with hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Trilogy system is for "radiotherapy delivery" and "stereotactic radiosurgery and precision radiotherapy." This involves delivering radiation to treat conditions within the body.
- Device Description: The description focuses on the system's ability to export beam information for external gating devices, which is related to controlling the delivery of radiation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body. This device is used to treat conditions within the body using radiation.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
90 TYE, IYE
Device Description
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.
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.
K033343, K061140, K070094, 072916
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
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.
-
- 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
-
- 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.
-
- 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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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with a bird-like figure above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
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.
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/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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Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo features the word "VARIAN" in a bold, sans-serif font, with a stylized figure replacing the "I" in Varian. Below the word "VARIAN" are the words "medical systems" in a smaller, sans-serif font.
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