(47 days)
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.
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, K100890.
The changes to the Varian High Energy Linear Accelerator provide support for treatments using the high intensity photon treatment mode, also known as FFF (Flattening Filter Free). Additionally, couch motion rules are modified to enable the use of patient support systems where the targeted anatomy and the treatment isocenter area below the surface of the couch top. Modifications that augment existing safety controls are also included.
All other features of the Varian High Energy Linear Accelerator models remain as cleared by K100890.
Here's a summary of the acceptance criteria and study information for the Varian High Energy Linear Accelerator, based on the provided 510(k) summary:
The 510(k) K112839 describes modifications to the Varian High Energy Linear Accelerator, primarily to support high-intensity photon treatment mode (FFF - Flattening Filter Free) and updated couch motion rules. The submission asserts substantial equivalence to its predicate device, K100890.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the functional and safety requirements, as well as compliance with applicable international standards. The performance is reported by demonstrating that the modified device functions equivalently or with improved safety features compared to the predicate device.
| Feature and/or Specification | Acceptance Criteria (Predicate Device K100890 Performance) | Reported Device Performance (Modified Device) |
|---|---|---|
| Release version of control software | C-Series 8.0 | C-Series 9.0 (Updated) |
| Gantry rotation collision protection (couch outside boundary) | Motion rules enforced when imaging arms are extended | Motion rules enforced whether imaging arms are extended or retracted (Improved) |
| Extended Travel Range Zone for Third-party Prone Breast Couch Insert | No (Support not present) | Yes (Support added) |
| Interlock preventing additional dose after beam hold | Hardware control | Hardware control plus additional secondary software check (Improved) |
| Software and hardware support for FFF / HIM (Flattening Filter Free/High Intensity Mode) | No (Support not present) | Yes (Support added) |
| Maximum rate at which dose delivery occurs for 10x photon energy | 600 MU per minute | 600 MU per minute (Unchanged) |
| Maximum rate at which dose delivery occurs for 10x FFF photon energy | None | 2400 MU per minute (New capability) |
| Maximum rate at which dose delivery occurs for 6x SRS photon energy | 1000 MU per minute | 1000 MU per minute (Unchanged) |
| Maximum rate at which dose delivery occurs for 6x FFF photon energy | None | 1400 MU per minute (New capability) |
| Maximum field size (3D Conformal Radiation Therapy) | 40cm x 40cm | 40cm x 40cm (Unchanged) |
| Maximum field size (IMRT) | 34cm x 40cm | 34cm x 40cm (Unchanged) |
| Maximum field size (SRS) | 15cm x 15cm | 15cm x 15cm (Unchanged) |
| Maximum allowable dose limit for fixed X treatment type (non-SRS and non-FFF) | 1999 MU | 1999 MU (Unchanged) |
| Maximum programmable dose | 9999 MU | 9999 MU (Unchanged) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is primarily bench testing for verification and validation of functional requirements, use cases, hazard mitigation, and compliance with international standards. Therefore, the concept of sample size and data provenance (country, retrospective/prospective) related to patient data is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission focuses on engineering and regulatory compliance testing of a medical device, not on diagnostic accuracy requiring expert interpretation of medical images or patient outcomes for a "ground truth" establishment.
4. Adjudication Method for the Test Set
Not applicable. As described above, the testing involved engineering verification and validation against pre-defined specifications and standards, not clinical adjudication of diagnostic or treatment outcomes by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for AI-powered diagnostic devices to assess the impact of AI assistance on human reader performance. The Varian High Energy Linear Accelerator is a treatment delivery device, and the changes described relate to its operational capabilities and safety features, not to diagnostic image interpretation or AI assistance for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. The device is a linear accelerator for radiation therapy, not a standalone AI algorithm. Its operation inherently involves human-in-the-loop (e.g., medical physicists, radiation oncologists, radiation therapists) for treatment planning and delivery. The "standalone" concept for an algorithm does not fit the nature of this device.
7. Type of Ground Truth Used
The "ground truth" for the performance testing effectively consisted of:
- Pre-defined specifications and functional requirements for the device.
- Hazard mitigation requirements based on risk analysis.
- Applicable international medical device standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-1).
The testing aimed to demonstrate that the device met these engineering and safety benchmarks, rather than clinical outcomes or pathological diagnoses.
8. Sample Size for the Training Set
Not applicable. The Varian High Energy Linear Accelerator is a hardware and software system for radiation therapy delivery. It does not utilize a "training set" in the machine learning sense for its operational functions as described in this submission. Its software development and configuration are based on established engineering principles and requirements, not statistical learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of machine learning for this device. The software and hardware capabilities are developed and validated against engineering specifications and regulatory standards.
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510(k) Summary
NOV 1 4 2011
The information below is provided for the Varian High Energy Linear Accelerator, following the format of 21 CFR 807.92.
| 1. | Submitter: | Varian Medical Systems3100 Hansen Way, M/S e110Palo Alto, CA 94304Contact Name: Vy TranPhone: 650/424.5731Fax: 650/842.5040E-mail: vy.tran@varian.com |
|---|---|---|
| ---- | ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 2. | Name of the Device:Trade / Proprietary Names: | Varian High Energy Linear AcceleratorNovalis Tx, Trilogy, Trilogy TxClinac iX, Clinac CxClinac 2100C, 2100 C/D, 2300 C/DClinac 21 EX, 23 EXClinac DHX, DMX |
|---|---|---|
| Common or Usual Names: | Novalis Tx, Trilogy, Trilogy TxClinac iX, Clinac CxClinac 2100C, 2100 C/D, 2300 C/DClinac 21 EX, 23 EXClinac DHX, DMX | |
| Classification Name: | Medical Charged Particle Radiation Therapy System21 CFR §892.5050Class II | |
| Product Code: | 90 IYE |
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- Predicate Device: Varian High Energy Linear Accelerator K100890
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- Description of the Device:
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, K100890.
The changes to the Varian High Energy Linear Accelerator provide support for treatments using the high intensity photon treatment mode, also known as FFF (Flattening Filter Free). Additionally, couch motion rules are modified to enable the use of patient support systems where the targeted anatomy and the treatment isocenter area below the surface of the couch top. Modifications that augment existing safety controls are also included.
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All other features of the Varian High Energy Linear Accelerator models remain as cleared by K100890.
-
- 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.
- Intended Use Statement
-
Indications for Use Statement 6.
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.
7. Substantial Equivalence
The modified device, the Varian High Energy Linear Accelerator, is substantially equivalent to the predicate device, the Varian High Energy Linear Accelerator (K100890).
The intended use and indications for use for the device are unchanged - see items 5 and 6 above.
The functionality of the Varian High Energy Linear Accelerator is equivalent to the functionality of the Varian predicate device in safety and effectiveness. Compared with the predicate device, the Varian High Energy Linear Accelerator (K100890), the basic operation is the same.
The comparison table below illustrates the substantial equivalence of the cleared device, Varian High Energy Linear Accelerator (K100890) and the modified device, Varian High Energy Linear Accelerator.
| Feature and/or Specification | Cleared Device (HighEnergy LinearAccelerator K100890) | Device with Change(High Energy LinearAccelerator) |
|---|---|---|
| Release version of control software | C-Series 8.0 | C-Series 9.0 |
| For gantry rotation from outside the treatmentroom, collision protection between the gantry& couch, when the couch is outside theboundary conditions set by the user | motion rules areenforced when theimaging arms areextended | motion rules are enforcedwhether the imaging armsare extended or retracted |
| Extended Travel Range Zone includes the 10cm additional height needed to support theThird-party Prone Breast Couch Insert | No | Yes |
| Interlock preventing additional dose frombeing delivered after beam hold has been set | Hardware control | Hardware control plusadditional secondarysoftware check |
| Software and hardware support for FFF / HIM(Flattening Filter Free/High Intensity Mode) | No | Yes |
| Maximum rate at which dose delivery occursfor 10x photon energy | 600 MU per minute | 600 MU per minute |
510(k) Summary - Varian High Energy Linear Accelerator
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| Feature and/or Specification | Cleared Device (High Energy Linear Accelerator K100890) | Device with Change (High Energy Linear Accelerator) |
|---|---|---|
| Maximum rate at which dose delivery occurs for 10x FFF photon energy | None | 2400 MU per minute |
| Maximum rate at which dose delivery occurs for 6x SRS photon energy | 1000 MU per minute | 1000 MU per minute |
| Maximum rate at which dose delivery occurs for 6x FFF photon energy | None | 1400 MU per minute |
| Maximum field size | 3D Conformal Radiation Therapy: 40cm x 40cm.IMRT: 34cm x 40cm.SRS: 15cm x 15cm | 3D Conformal Radiation Therapy: 40cm x 40cm.IMRT: 34cm x 40cm.SRS: 15cm x 15cm |
| Maximum allowable dose limit for fixed X treatment type (for non-SRS and non-FFF treatment types) | 1999 MU | 1999 MU |
| Maximum programmable dose | 9999 MU | 9999 MU |
8. Summary of Performance Testing
The design control procedures applied to the development of the Varian High Energy Linear Accelerator include requirements reviews, risk analysis, and verification and validation testing,
The verification and validation testing results from bench testing support the substantial equivalence of the modified device with its predicate, the unmodified device. Testing included testing against functional requirements, validation of use cases, hazard mitigation and control testing for compliance with applicable international medical device standards including the general safety standard IEC 60601-1, the electromagnetic compatibility standard IEC 60601-1-2, and the medical accelerator safety standard IEC 60601-2-1.
The objectives of the testing were to ensure that the pre-defined acceptance criteria and pass/fail criteria were met, including all specifications, functional requirements, use cases, hazard mitigations, and compliance with applicable international standards.
The conclusion from the results of the performance testing summarized above is that the defined criteria have been met, and that the specifications have been substantiated by the testing. The table in item 7 presents the key specifications relevant to the modifications for the Varian High Energy Linear Accelerator.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Vy Tran Vice President of Regulatory Affairs and Ouality Systems Varian Medical Systems 3100 Hansen Way, M/S E-110 PALO ALTO CA 94304-1129
NOV 1 4 2011
Re: K112839
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: September 26, 2011 Received: September 28, 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
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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 5.10(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 Pastel
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
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Indications for Use
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Device Name: Varian High Energy Linear Accelerator
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vitro Die
K112839
510K
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§ 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.