(30 days)
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.
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 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.
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.
This document is a 510(k) premarket notification for a Varian Medical Systems linear accelerator and multileaf collimator. It explicitly states that no animal studies or clinical tests were included in this pre-market submission.
Therefore, based on the provided text, there is no information available to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested by the prompt. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical tests, software verification and validation, and regression testing, rather than clinical performance data.
Specifically, the document states:
- "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."
As such, I cannot provide the requested information about:
- A table of acceptance criteria and reported device performance (in a clinical context).
- Sample size for test set and data provenance.
- Number of experts, qualifications, and ground truth establishment for a test set.
- Adjudication method.
- MRMC comparative effectiveness study parameters or effect size.
- Standalone algorithm performance.
- Type of ground truth used (clinical ground truth, specifically).
- Sample size for training set.
- How ground truth for the training set was established.
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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.
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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
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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 94304Contact Name: Peter J. CoronadoPhone: 650.424.6320Fax: 650.646.9200E-mail: submissions.support@varian.comDate 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, DMXUNIQUE• UNIQUE Power Edition• UNIQUE Performance EditionVarian 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 §892.5050Common/Usual Name:Medical Linear AcceleratorRegulatory Class:Class IIProduct 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 ofa gantry, couch, stand and control console. The device is permanently installed. Theradiotherapy treatment beam is generated by a linear accelerator assembly consisting of anelectron gun, waveguide and collimator. | |
| All other features and technological characteristics of the Varian High Energy LinearAccelerator models remain as cleared by K162476. | ||
| UNIQUE | ||
| The UNIQUE is a radiotherapy treatment unit. The equipment consists of a gantry, couch, standand control console. The device is permanently installed. The radiotherapy treatment beam isgenerated by a linear accelerator assembly consisting of an electron gun, waveguide andcollimator.All other features and technological characteristics of the UNIQUE models remain as cleared byK132705. | ||
| Varian Multileaf Collimator (MLC) | ||
| The Varian Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mountedon a Varian radiotherapy linear accelerator. The MLC head is mounted on a Varian LinearAccelerator, where it shapes the radiation beam before it is delivered to the patient. The MLChead is permanently bolted onto the casting that holds the X-Jaws and Y-Jaws of the VarianLinear Accelerator gantry. | ||
| All other features and technological characteristics of the Varian Multileaf Collimator (MLC)models remain as cleared by K133240. | ||
| Intended/IndicationsFor UseStatement: | 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 isintended to provide stereotactic radiosurgery andprecision radiotherapy for lesions, tumors andconditions anywhere in the body when radiationtreatment is indicated | The Varian High Energy Linear Accelerator isindicated for stereotactic radiosurgery andprecision radiotherapy for lesions, tumors andconditions anywhere in the body when radiationtreatment is indicated. | |
| UNIQUE | ||
| Intended Use | Indications for Use | |
| The UNIQUE is intended to provide stereotacticradiosurgery and precision radiotherapy forlesions, tumors and conditions anywhere in thebody when radiation treatment is indicated. | The UNIQUE is indicated for stereotacticradiosurgery and precision radiotherapy forlesions, tumors and conditions anywhere in thebody when radiation treatment is indicated. | |
| Varian Multileaf Collimator (MLC) | ||
| Intended Use | Indications for Use | |
| The Varian Multileaf Collimator is intended toassist the clinician in the delivery of externalbeam radiation to defined target volumes duringradiosurgery and radiotherapy while sparingsurrounding normal tissue and critical organsfrom excess radiation. | The Varian Multileaf Collimator is intended toassist the clinician in the delivery of externalbeam radiation to defined target volumes duringradiosurgery and radiotherapy while sparingsurrounding normal tissue and critical organsfrom excess radiation. |
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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 Proprietarynames | Predicate | This 510(k)Submission | |
|---|---|---|---|
| Varian HighEnergyLinearAccelerator | Novalis Tx, Trilogy, Trilogy Tx,Clinac iX, Clinac CXClinac 2100C, Clinac 2100 C/D,Clinac 2300 C/DClinac 21 EX, Clinac 23 EXClinac DHX, Clinac DMX | K162476(Clinac console softwarereferred to as C-Series v9.1) | Clinac Consolesoftware referredto asC-Series v9.5 |
| UNIQUE | UNIQUE Power EditionUNIQUE Performance Edition | K132705(Clinac console softwarereferred to as C-Series v9.1) | Clinac Consolesoftware referredto asC-Series v9.5 |
| VarianMultileafCollimator(MLC) | Millennium 52-leaf Multileaf CollimatorMillennium 80-leaf Multileaf CollimatorMillennium 120-leaf Multileaf CollimatorHigh-Definition 120 Multileaf Collimator(HD120 MLC) | K133240(MLC controller softwarereferred to as MLC v8.0) | MLC controllersoftware referredto 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.
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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.
§ 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.