(97 days)
No
The description focuses on hardware modifications and firmware checks for safety interlocks and position readouts, with no mention of AI or ML algorithms for treatment planning, image analysis, or other functions.
Yes
The device is indicated for "stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated," which are therapeutic applications.
No
The provided text describes a radiotherapy treatment unit, which is a therapeutic device used to treat lesions, tumors, and conditions. It is not used for diagnosis.
No
The device description explicitly details hardware components such as a gantry, couch, stand, control console, linear accelerator assembly (electron gun, waveguide, collimator), and mentions modifications to target hardware. While software/firmware is mentioned for monitoring and checks, the core device is a physical linear accelerator.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "radiotherapy treatment unit" that generates a "radiotherapy treatment beam." It is used to treat lesions, tumors, and conditions in the body using radiation.
- Intended Use: The intended use is for "stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body." This is a therapeutic use, not a diagnostic test performed on samples outside the body.
The device is a therapeutic medical device used for radiation treatment, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Product codes
IYE
Device Description
The Varian High Energy Linear Accelerator models provide various selections among the features, specifications, and accessories that have been most recently cleared as the Varian High Energy Linear Accelerator, K131807.
The High Energy Linear Accelerator is a radiotherapy treatment unit. The equipment consists of a gantry, couch, stand and control console. The device is permanently installed. The radiotherapy treatment beam is generated by a linear accelerator assembly consisting of an electron gun, waveguide and collimator.
The High Energy (HE) Linear Accelerator device is modified to provide a yield monitoring capability, which triggers an interlock in response to detected beam deviations when specific target hardware anomalies are present. The yield monitoring capability provides an additional check for unexpected changes in radiation beam output, beyond the existing beam checks and dosimetry interlocks provided by the dual ion chamber design. The purpose of the yield monitoring capability is to prevent an undetected decrease in dose output, which can occur in the case of failures within the target hardware. If such hardware failures are present, the yield monitoring capability triggers an interlock and treatment is prevented if 6X, 6FFF, or 6SRS beams do not meet specified output limits. For additional detail please see the Description of Modifications included in the submission.
The Primary Position Readout (PRO) and Secondary Position Readout (SPRO) are enhanced by the addition of a firmware check for polarity mismatch. The function of the PRO and SPRO remains unchanged. The enhancement provides a secondary check of the positions reported by the PRO and SPRO for all motion axes: jaws, gantry, couch and collimator. The firmware enhancement is an improvement that verifies the polarity of both the PRO and SPRO components, and notifies the user in the case of a polarity mismatch. Notifications continue until the polarity has been corrected.
All other features and technological characteristics of the Varian High Energy Linear Accelerator models remain as cleared by K131807.
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)
Software Verification and Validation Testing:
Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
Clinical Tests: No clinical tests have been included in this pre-market submission
Conclusions: The non-clinical data support the safety of the device and the software verification and validation demonstrate that the High Energy Linear Accelerator device with the new yield interlock functionality and firmware check for polarity mismatch performs as intended. Varian therefore considers the High Energy Linear Accelerator to be safe and effective and to perform at least as well as the predicate devices.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three wave-like lines below them. The profiles and waves are black, and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2016
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K162476
Trade/Device Name: Varian High Energy Linear Accelerator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 10, 2016 Received: November 14, 2016
Dear Mr. Coronado:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162476
Device Name
Varian High Energy Linear Accelerator
Indications for Use (Describe)
The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com
Premarket Notification [510(k)] Summary
Varian High Energy Linear Accelerator
The following information is provided following the format of 21 CFR 807.92(c).
| Submitter's Name: | Varian Medical Systems, Inc.
3100 Hansen Way E-110
Palo Alto, CA 94304
Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date: September 2, 2016 |
| Name of the Device:
Trade/ Proprietary
Names: | Varian High Energy Linear Accelerator
Novalis Tx, Trilogy, Trilogy Tx
Clinac iX, Clinac Cx
Clinac 2100C, 2100 C/D, 2300 C/D
Clinac 21 EX, 23 EX
Clinac DHX, DMX |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050, Class II
Product Code: IYE |
| Common/Usual
Name: | Medical Linear Accelerator |
| Predicate Device: | Varian High Energy Linear Accelerator K131807 |
| Device Description: | The Varian High Energy Linear Accelerator models provide various selections among the
features, specifications, and accessories that have been most recently cleared as the
Varian High Energy Linear Accelerator, K131807.
The High Energy Linear Accelerator is a radiotherapy treatment unit. The equipment
consists of a gantry, couch, stand and control console. The device is permanently
installed. The radiotherapy treatment beam is generated by a linear accelerator assembly
consisting of an electron gun, waveguide and collimator.
The High Energy (HE) Linear Accelerator device is modified to provide a yield monitoring
capability, which triggers an interlock in response to detected beam deviations when
specific target hardware anomalies are present. The yield monitoring capability provides
an additional check for unexpected changes in radiation beam output, beyond the
existing beam checks and dosimetry interlocks provided by the dual ion chamber design.
The purpose of the yield monitoring capability is to prevent an undetected decrease in
dose output, which can occur in the case of failures within the target hardware. If such
hardware failures are present, the yield monitoring capability triggers an interlock and
treatment is prevented if 6X, 6FFF, or 6SRS beams do not meet specified output limits.
For additional detail please see the Description of Modifications included in the |
| | submission. |
| | The Primary Position Readout (PRO) and Secondary Position Readout (SPRO) are
enhanced by the addition of a firmware check for polarity mismatch. The function of the
PRO and SPRO remains unchanged. The enhancement provides a secondary check of the
positions reported by the PRO and SPRO for all motion axes: jaws, gantry, couch and
collimator. The firmware enhancement is an improvement that verifies the polarity of
both the PRO and SPRO components, and notifies the user in the case of a polarity
mismatch. Notifications continue until the polarity has been corrected. |
| | All other features and technological characteristics of the Varian High Energy Linear
Accelerator models remain as cleared by K131807. |
| Intended Use
Statement | The Varian High Energy Linear Accelerator 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 | The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and
precision radiotherapy for lesions, tumors and conditions anywhere in the body when
radiation treatment is indicated. |
4
Technological Characteristics:
Performance Data:
Software Verification and Validation Testing
Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
Clinical Tests No clinical tests have been included in this pre-market submission
Conclusions
The non-clinical data support the safety of the device and the software verification and validation demonstrate that the High Energy Linear Accelerator device with the new yield interlock functionality and firmware check for polarity mismatch performs as intended. Varian therefore considers the High Energy Linear Accelerator to be safe and effective and to perform at least as well as the predicate devices.