(59 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features typically associated with AI/ML in medical devices like image analysis for diagnosis or treatment planning optimization using learning algorithms. The description focuses on the hardware and basic functionality of a linear accelerator.
Yes
The device is intended to provide radiation treatment for various medical conditions, indicating its use in therapy.
No
Explanation: The device is a radiotherapy delivery system, which means it is used for treatment rather than diagnosis. While it has a "diagnostic kV X-ray radiation beam-producing component," this is for imaging related to treatment delivery, not for diagnosing diseases.
No
The device description explicitly states it is a "medical linear accelerator" and describes hardware components like a "radiation beam-producing component" and a "control console area."
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 TrueBeam 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 delivery system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a "medical linear accelerator" that produces radiation beams for treatment. This aligns with a therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
Therefore, the TrueBeam Radiotherapy Delivery System is a therapeutic device, not an In Vitro Diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
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.
Not Found
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
DEC 20 2012
Premarket Notification [510(k)] Summary TrueBeam Radiotherapy Treatment System
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: October 2012 |
| 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: | TrueBeam Radiotherapy System and Accessories: K111106 |
| 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 | 4-25MV | 2.5, 4-25MV |
| 6 rotational Couch | No | Yes |
| 2D/3D Matching | No | Yes |
| 4D CBCT | No | Yes |
| Multi-scan CBCT Acquisition | No | Yes |
| Motion Management Interface (MMI) | No | Yes |
Summary of performance testing:
Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the 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 symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 20, 2012
Ms. Vy Tran Vice President, Regulatory Affairs and Quality Assurance Varian Medical Systems, Inc. 3100 Hansen Way, m/s C-255 PALO ALTO, CA 94304-1038
Re: K123291
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: October 19, 2012 Received: October 22, 2012
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 either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Ms. Vy Tran
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.
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 Diagnostics and Radiological Health 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,
Janine MAMorris -S
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
3
TrueBeam Radiotherapy Treatment System
Indications for Use
510(k) Number (if known): K 12 3291
TrueBeam Radiotherapy Treatment System 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)
AND/OR
Over-The-Counter Use (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)
(Division Sign Off)
Shipsion of Radiological H
` Office of In Vitro Diagnostics and Radiological Health
510(k) K123291
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