(104 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on software updates and previously cleared features.
Yes
The device is described as providing "stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated," which directly refers to treating medical conditions.
No
The device is a linear accelerator intended for radiotherapy treatment, not for diagnosing conditions. Its purpose is to deliver radiation to treat lesions, tumors, and conditions, as stated in the "Intended Use / Indications for Use" section.
No
The device description explicitly states it is a "High Energy Linear Accelerator," which is a hardware device. While the submission mentions a software release (8.0 release of the C-Series control software), this software is a component of the hardware device, not a standalone software-only medical device.
Based on the provided information, the Varian High Energy Linear Accelerator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is 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 delivered directly to the patient's body using radiation.
- Device Description: The description details a "Linear Accelerator" which is a machine used to generate and deliver radiation beams for treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens.
Therefore, the Varian High Energy Linear Accelerator is a therapeutic device, not an in vitro diagnostic device.
N/A
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.
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 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.
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)
Not Found
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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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
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