(17 days)
No
The summary describes a modification to a radiotherapy delivery system involving support for third-party couch tops, focusing on mechanical and interface specifications. There is no mention of AI or ML.
Yes
The device is a component of a radiotherapy delivery system, which is a therapeutic treatment.
No.
The device is described as a delivery system for radiation treatment, not for diagnosing medical conditions.
No
The device description clearly details physical components (Trilogy Tx Delivery System, 3rd Party Couch Top Support, Exact couch, couch top) and their physical installation and positioning functions, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Trilogy Tx Delivery System and its associated couch components are used for radiotherapy, which is a treatment method that uses radiation to treat diseases like cancer. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated." This describes a treatment application, not a diagnostic test.
- Device Description: The description focuses on the physical components and their role in positioning and supporting patients during radiation treatment. There is no mention of analyzing biological specimens.
Therefore, the Trilogy Tx Delivery System with the 3rd Party Couch Top Support is a therapeutic device used for delivering radiation treatment, not an IVD.
N/A
Intended Use / Indications for Use
The Trilogy Tx 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 3rd Party Couch Top Support is designed to position and support patients for radiotherapy. The Varian Exact ® Couch is designed for use with non-Varian aftermarket table tops.
Product codes
90 IYE
Device Description
The Trilogy Tx Delivery System is being modified to include 3rd Party Couch Top Support.
The Exact couch patient positioning and support within the Trilogy Tx cleared device is partially accomplished by the motorized control of longitudinal, lateral, vertical and angular positions. The Exact couch top, also known as the couch stretcher top or the treatment table top is fastened to the Exact couch and is the primary portion of the couch for positioning and support. An Exact couch interface specification is available to non-Varian aftermarket couch top manufacturers for use in designing couch tops that are used on the Exact couch instead of the Varian Exact couch top.
3rd Party Couch Top Support (also known as Aftermarket "non-Varian" Couch Top Attachment) enables third party couch tops to be installed upon the Exact Couch base, replacing the original Varian Exact Couch Top. The replacement is implemented following a published Interface Specification. Physical installation is completed and qualified by Varian representatives at customer locations. following proprietary internal procedures to ensure safety and effectiveness equivalent to that of the original Exact Couch Top.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
062618
The information below is provided for the Trilogy Tx with 3th Party Couch Top, following the format of 21 CFR 807.92.
SEP 2 2 2006
-
- 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: vy.tran@yarian.com
| 2. Name of the Device: | Trilogy Tx with 3rd Party Couch Top Support | |
|---|---|---|
| Trade / Proprietary Name: | Trilogy Tx Delivery System | |
| Common or Usual Name: | Trilogy Tx | |
| 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 Medical Systems' Trilogy Tx Radiotherapy Delivery System - K061140
Description of the Device: 4.
The Trilogy Tx Delivery System is being modified to include 3rd Party Couch Top Support.
The Exact couch patient positioning and support within the Trilogy Tx cleared device is partially accomplished by the motorized control of longitudinal, lateral, vertical and angular positions. The Exact couch top, also known as the couch stretcher top or the treatment table top is fastened to the Exact couch and is the primary portion of the couch for positioning and support. An Exact couch interface specification is available to non-Varian aftermarket couch top manufacturers for use in designing couch tops that are used on the Exact couch instead of the Varian Exact couch top.
3rd Party Couch Top Support (also known as Aftermarket "non-Varian" Couch Top Attachment) enables third party couch tops to be installed upon the Exact Couch base, replacing the original Varian Exact Couch Top. The replacement is implemented following a published Interface Specification. Physical installation is completed and qualified by Varian representatives at customer locations. following proprietary internal procedures to ensure safety and effectiveness equivalent to that of the original Exact Couch Top.
-
- Intended Use Statement
The Trilogy Tx Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Intended Use Statement
1
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$$
-
- Indications for Use Statement
The Trilogy Tx 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 3rd Party Couch Top Support is designed to position and support patients for radiotherapy. The Varian Exact ® Couch is designed for use with non-Varian aftermarket table tops.
-
- Substantial Equivalence
The 3rd Party Couch Top submission illustrates substantial equivalence to the predicate device.
- Substantial Equivalence
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 2 2006
Mr. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems 3100 Hansen Way, M/S/ E-110 PALO ALTO CA 94304
Re: K062618
Trade/Device Name: Trilogy Tx with 3td Party Couch Top Support Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 31, 2006 Received: September 5, 2006
Dear Mr. 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.
1f your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center, with the word "Centennial" underneath. Three stars are arranged below the word "Centennial". The text "Protecting and Promoting Your Health" is written around the circle.
Promoting Public
3
Page 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 the win 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.xxx | (Gastroenterology/Renal/Urology. | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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/cdrl/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
4
Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a bold, sans-serif font, with a stylized "I" that has a dot above it. 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:
K062618
TRilogy Tx w 3rd Party Couch Top Support
The Trilogy Tx 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 3rd Party Couch Top Support is designed to position and support patients for radiotherapy. The Varian Exact ® Couch is designed for use with non-Varian aftermarket table tops.
(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
510(k) Number