(120 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the hardware and integration of existing technology.
Yes
Justification: The device's intended use is to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body, which directly aligns with a therapeutic purpose.
No
Explanation: The device is described as a radiotherapy delivery system and medical linear accelerator, indicating its purpose is for treatment rather than diagnosis. While it uses "diagnostic kV X-ray," this is for guidance during therapy, not for diagnosing a condition itself.
No
The device description clearly states it is a "medical linear accelerator" and describes physical components like a "radiation beam-producing component" and a "control console area," indicating it is a hardware device.
Based on the provided information, the TrueBeam™ system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated." This describes a therapeutic treatment delivered directly to the patient's body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "medical linear accelerator" that produces radiation beams for treatment. This is consistent with a radiotherapy device, not an IVD device which would typically involve analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing diagnostic tests on samples, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The TrueBeam™ system's function is to deliver radiation therapy, which is a treatment modality.
N/A
Intended Use / Indications for Use
The TrueBeam ™ system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Product codes
90 IYE
Device Description
The TrueBeam™ Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device. The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
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
Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
Key Metrics
Not Found
Predicate Device(s)
Trilogy Mx Radiotherapy System and Accessories: K092871
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
K////106
Premarket Notification [510(k)] Summary TrueBeam Radiotherapy Treatment System
AUG 1 8 2011
The following information is provided following the format of 21 CFR 807.92.
| Submitter's Name: | Varian Medical Systems, Inc.
3100 Hansen Way E-110
Palo Alto, CA 94304 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Vy Tran
Phone: 650/424.5731
Fax: 650/842.5040
Date: June 2011 |
| Proprietary Name: | TrueBeam™ |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050, Class II
Product Code: 90 IYE |
| Common/Usual Name: | TrueBeam Radiotherapy Delivery System |
| Predicate Device: | Trilogy Mx Radiotherapy System and Accessories: K092871 |
| Device Description: | The TrueBeam™ Radiotherapy Delivery System is a medical linear accelerator
that integrates the previously cleared Trilogy Radiotherapy system and
associated accessories into a single device. |
| | The system consists of two major components, a photon, electron, and
diagnostic kV X-ray radiation beam-producing component that is installed in a
radiation-shielded vault and a control console area located outside the
treatment room. |
| Intended Use Statement | The TrueBeam ™ system is intended to provide stereotactic radiosurgery and
precision radiotherapy for lesions, tumors, and conditions anywhere in the
body where radiation treatment is indicated. |
| Indications for Use
Statement | The TrueBeam ™ system is intended to provide stereotactic radiosurgery and
precision radiotherapy for lesions, tumors, and conditions anywhere in the
body where radiation treatment is indicated. |
Technological Characteristics: Significant changes to the predicate device are listed below.
| Feature | Cleared device | Device with change |
|---|---|---|
| Energy used | 6-25MV | 4-25MV |
| LaserGuard II | . No | Yes |
| Proximity detection | Touchguards present on kV source, | |
| kV detector, positioning units | Addition of supplemental capacitive collision | |
| detection system (kV CCDS) on kV source |
Summary of performance testing:
Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with three lines extending from its wing.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Vy H. Tran Vice President, Corporate Regulatory Affairs Varian Medical Systems, Inc. Corporate Headquarters 3100 Hansen Way PALO ALTO CA 94304-1038.
AUG 1 8 2011
Rc: K111106
Trade/Device Name: TrueBeam Radiotherapy Treatment System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 7, 2011 Received: July 8, 2011
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 your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting of
2
medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary SPatel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
TrueBeam Radiotherapy Treatment System
Indications for Use
510(k) Number (if known): __ | | | | 06 ______________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
TrueBeam is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Patel
510K
Division of Rediological Devic Office of In Vitro Diagnostic Device Evaluation and Safety
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