(104 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 Trilogy Radiotherapy Delivery System (K081188, K072916).
The 8.0 release of the C-Series control software provides additional features, safety improvements, and usability improvements.
All other features of the Varian High Energy Linear Accelerator models remain as cleared by K081188, K072916.
This document is a 510(k) summary for the Varian High Energy Linear Accelerator. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device. This type of submission focuses on comparing the new device to an existing legally marketed device and typically doesn't involve clinical studies with acceptance criteria in the same way a novel device might.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain explicit acceptance criteria or reported device performance in the context of a clinical study. This document is a 510(k) summary, which aims to prove substantial equivalence to a predicate device (Varian Trilogy Radiotherapy System: K081188, K072916). Substantial equivalence is typically demonstrated through:
- Comparison of technological characteristics: Showing the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.
- Performance testing (bench, non-clinical): Demonstrating that engineering specifications and safety requirements are met. This is usually detailed in the full 510(k) submission, not typically summarized with explicit "acceptance criteria" tables in the public summary.
Therefore, since no clinical study results with acceptance criteria are presented in the provided text, this table cannot be populated as requested.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set for a clinical study is described. The 510(k) summary indicates that the Varian High Energy Linear Accelerator models provide various selections among features, specifications, and accessories that have been most recently cleared as the Trilogy Radiotherapy Delivery System. The 8.0 release of the C-Series control software provides additional features, safety improvements, and usability improvements. The assessment is likely based on engineering and software validation rather than a clinical efficacy study with a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical study with a test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set is described for a clinical study requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Varian High Energy Linear Accelerator is a medical device for radiation therapy delivery, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a linear accelerator, a hardware system for delivering radiation therapy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth collection for a clinical study is described. The "ground truth" for a device like this would likely pertain to its technical specifications, calibration accuracy, dose delivery precision, and safety mechanisms, which are verified through engineering tests and validation, not clinical ground truth in the diagnostic sense.
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning diagnostic or prognostic algorithm, there is no "training set" in the context of data used to train a model. Software development and hardware testing would involve various forms of internal testing and validation, but these are not referred to as "training sets."
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, there is no ground truth established for it in the context of this 510(k) summary.
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510(k) Summary
The information below is provided for the Varian High Energy Linear Accelerator, following the format of 21 CFR 807.92.
- Submitter: Varian Medical Systems 3100 Hansen Way, M/S e110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: 650/424.5731 Fax: 650/842.5040 E-mail: vy.tran@yarian.com
JUL 13 2010
| Name of the Device: | Varian High Energy Linear Accelerator |
|---|---|
| Trade / Proprietary Names: | 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 | |
| Common or Usual Names: | 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:
90 ГҮЕ
4. 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 Trilogy Radiotherapy Delivery System (K081188, K072916).
The 8.0 release of the C-Series control software provides additional features, safety improvements, and usability improvements.
All other features of the Varian High Energy Linear Accelerator models remain as cleared by K081188, K072916.
510(k) Summary - Varian High Energy Linear Accelerator
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-
- 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
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.
- Indications for Use Statement
-
- Substantial Equivalence
The Varian High Energy Linear Accelerator submission illustrates substantial equivalence to the predicate device.
- Substantial Equivalence
510(k) Summary - Varian High Energy Linear Accelerator
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
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 Corporate Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
/JUL 1 3 2010
Re: K100890
Trade/Device Name: Varian High Linear Accelerator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 28, 2010 Received: June 1, 2010
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 (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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(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 vours.
Amold H.B.
Donald J. St.Pierre Acting 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
510(k) Number (if known): K100890
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)
Muhel D'Shm
Office of In Vitro Diagnostic
510K KUNG 90
Page 1 of
§ 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.