(30 days)
Not Found
No
The summary describes a linear accelerator and multileaf collimator for radiation therapy, focusing on hardware and basic software control. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The Varian High Energy Linear Accelerator and UNIQUE are explicitly described as "radiotherapy treatment unit[s]" and are indicated for "radiation treatment for lesions, tumors and conditions anywhere in the body." The Varian Multileaf Collimator also assists in the delivery of this radiation treatment. These descriptions indicate a direct therapeutic function.
No
The device descriptions explicitly state that these are "radiotherapy treatment unit[s]" and an accessory for "delivery of external beam radiation," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly details physical hardware components such as a gantry, couch, stand, control console, electron gun, waveguide, and collimator, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these devices are for "stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated." This describes a therapeutic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device descriptions detail equipment used to generate and shape a radiation beam for treating patients. This aligns with therapeutic devices, not diagnostic ones.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing information for diagnosis based on in vitro testing.
IVDs are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. These devices are clearly designed for delivering radiation therapy directly to the patient's body.
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.
The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated.
The Varian Multileaf Collimator is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
Product codes
IYE
Device Description
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.
All other features and technological characteristics of the Varian High Energy Linear Accelerator models remain as cleared by K162476.
The UNIQUE 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.
All other features and technological characteristics of the UNIQUE models remain as cleared by K132705.
The Varian Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mounted on a Varian radiotherapy linear accelerator. The MLC head is mounted on a Varian Linear Accelerator, where it shapes the radiation beam before it is delivered to the patient. The MLC head is permanently bolted onto the casting that holds the X-Jaws and Y-Jaws of the Varian Linear Accelerator gantry.
All other features and technological characteristics of the Varian Multileaf Collimator (MLC) models remain as cleared by K133240.
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
clinician
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
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 all three devices was considered as a "major" level of concern.
No animal studies or clinical tests have been included in this pre-market submission.
Verification testing was performed to demonstrate that the performance and functionality of the new C-Series operating system and MLC controller existing features met the design input requirements for CCMC.
Regression testing was performed to verify the integrity of any changes. Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel.
Key Metrics
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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June 28, 2018
Varian Medical Systems, Inc. Peter J. Coronado Director, Regulatory Affairs 3100 Hansen Wav Palo Alto, California 94304
Re: K181404
Trade/Device Name: Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: May 25, 2018 Received: May 29, 2018
Dear Peter 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181404
Device Name Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (MLC)
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.
The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated.
The Varian Multileaf Collimator is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Varian Medical Systems
3100 Hansen Way Palo Alto, CA 94304
650.493.4000 800.544.4636
varian.com
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Premarket Notification 510(K) Summary
The following information is provided according to 21 CFR 807.92.
| Submitter: | Varian Medical Systems, Inc.
3100 Hansen Way Palo Alto, CA 94304
Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200
E-mail: submissions.support@varian.com
Date Prepared: May 25, 2018 | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
UNIQUE
• UNIQUE Power Edition
• UNIQUE Performance Edition
Varian Multileaf Collimator (MLC)
• Millennium 52-leaf Multileaf Collimator
• Millennium 80-leaf Multileaf Collimator
• Millennium 120-leaf Multileaf Collimator
• High-Definition 120 Multileaf Collimator (HD120 MLC) | |
| | Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (MLC) | |
| | Classification Name:
Medical Charged Particle Radiation Therapy System, 21 CFR §892.5050
Common/Usual Name:
Medical Linear Accelerator
Regulatory Class:
Class II
Product Code:
IYE | Predicate Devices:
Varian High Energy Linear Accelerator
(Version 9.1, K162476)
UNIQUE
(Version 9.1, K132705)
Varian Multileaf Collimator
(Version 8.0, K133240) |
| Device | Varian High Energy Linear Accelerator | |
| Description: | 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. | |
| | All other features and technological characteristics of the Varian High Energy Linear
Accelerator models remain as cleared by K162476. | |
| | UNIQUE | |
| | The UNIQUE 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.
All other features and technological characteristics of the UNIQUE models remain as cleared by
K132705. | |
| | Varian Multileaf Collimator (MLC) | |
| | The Varian Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mounted
on a Varian radiotherapy linear accelerator. The MLC head is mounted on a Varian Linear
Accelerator, where it shapes the radiation beam before it is delivered to the patient. The MLC
head is permanently bolted onto the casting that holds the X-Jaws and Y-Jaws of the Varian
Linear Accelerator gantry. | |
| | All other features and technological characteristics of the Varian Multileaf Collimator (MLC)
models remain as cleared by K133240. | |
| Intended/
Indications
For Use
Statement: | The indications for use and the intended use are identical in the subject devices as for the predicate. | |
| | Varian High Energy Linear Accelerator | |
| | Intended Use | Indications for Use |
| | 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 | 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. |
| | UNIQUE | |
| | Intended Use | Indications for Use |
| | The UNIQUE is intended to provide stereotactic
radiosurgery and precision radiotherapy for
lesions, tumors and conditions anywhere in the
body when radiation treatment is indicated. | The UNIQUE is indicated for stereotactic
radiosurgery and precision radiotherapy for
lesions, tumors and conditions anywhere in the
body when radiation treatment is indicated. |
| | Varian Multileaf Collimator (MLC) | |
| | Intended Use | Indications for Use |
| | The Varian Multileaf Collimator is intended to
assist the clinician in the delivery of external
beam radiation to defined target volumes during
radiosurgery and radiotherapy while sparing
surrounding normal tissue and critical organs
from excess radiation. | The Varian Multileaf Collimator is intended to
assist the clinician in the delivery of external
beam radiation to defined target volumes during
radiosurgery and radiotherapy while sparing
surrounding normal tissue and critical organs
from excess radiation. |
4
5
This bundled Special 510(k) submission provides detail on one significant change and its impact on three Varian devices so they could be addressed during one review: Varian High Energy Linear Accelerator. UNIQUE, and Multileaf Collimator (MLC). The indications for use and the intended use are identical in the subject devices as for the predicate.
Note: The Varian High Energy Linear Accelerator and UNIQUE devices are referred to as Clinac Console and Varian Multileaf Collimator (MLC) is referred to as MLC Controller.
Significant Difference
The significant difference compared to the predicate devices is:
- Architecture Change: The Clinac Console and MLC Controller has a new integrated hardware ● platform known as CCMC and the software is ported to support CCMC using VxWorks operating system
The High Energy Linear Accelerator and UNIQUE Clinac Console software, C-Series version 9.5, Multileaf Collimator (MLC) software, MLC version 8.5 is ported to support the new hardware platform CCMC.
The complete list of new risks and modified risks to High Energy Linear Accelerator, UNIQUE, and Varian Multileaf Collimator (MLC) are documented in "Summary of testing for Significant Change" in Section 18 of this submission.
| | Device Trade Names or Proprietary
names | Predicate | This 510(k)
Submission |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------|
| Varian High
Energy
Linear
Accelerator | Novalis Tx, Trilogy, Trilogy Tx,
Clinac iX, Clinac CX
Clinac 2100C, Clinac 2100 C/D,
Clinac 2300 C/D
Clinac 21 EX, Clinac 23 EX
Clinac DHX, Clinac DMX | K162476
(Clinac console software
referred to as C-Series v9.1) | Clinac Console
software referred
to as
C-Series v9.5 |
| UNIQUE | UNIQUE Power Edition
UNIQUE Performance Edition | K132705
(Clinac console software
referred to as C-Series v9.1) | Clinac Console
software referred
to as
C-Series v9.5 |
| Varian
Multileaf
Collimator
(MLC) | Millennium 52-leaf Multileaf Collimator
Millennium 80-leaf Multileaf Collimator
Millennium 120-leaf Multileaf Collimator
High-Definition 120 Multileaf Collimator
(HD120 MLC) | K133240
(MLC controller software
referred to as MLC v8.0) | MLC controller
software referred
to as MLC v8.5 |
Performance Data
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 all three devices was considered as a "major" level of concern.
The modified devices High Energy Linear Accelerator. UNIQUE, and Varian Multileaf Collimator (MLC) are substantially equivalent to the predicate devices K162476, K132705, and K133240 respectively. Compared with the predicate device, the basic operation and technological characteristics are the same.
6
Operational differences are described in the Instructions for Use and accompanying user documentation. The indications for use and the intended use for each device are identical.
The subject devices conform in whole or in part with standards provided in Section 09 of this submission. For those recognized standards in which there are clauses that are not applicable, Summary Reports with justifications have been included in the submission.
Summary of Non-Clinical Tests
No animal studies or clinical tests have been included in this pre-market submission.
Verification testing was performed to demonstrate that the performance and functionality of the new C-Series operating system and MLC controller existing features met the design input requirements for CCMC.
Regression testing was performed to verify the integrity of any changes. Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel.
Conclusion
The non-clinical data for CCMC supports the safety of the devices and the software verification and validation demonstrate that the subject devices should perform as intended in the specified use conditions. Varian therefore considers the High Energy Linear Accelerator, UNIQUE, and Varian Multileaf Collimator (MLC) to be safe and effective and to perform at least as well as the predicate devices.