(114 days)
Not Found
No
The summary describes a linear accelerator for radiotherapy with safety features related to motion control. There is no mention of AI or ML in the device description, intended use, or any other section. The changes described are related to establishing "motion zone rules" for safety, which appears to be a rule-based system, not AI/ML.
Yes
The device is intended to provide radiation treatment for lesions, tumors, and conditions, which is a therapeutic intervention.
No
Explanation: The device is described as a "radiotherapy treatment unit" intended to deliver radiation for treatment, not for diagnosis.
No
The device description clearly outlines hardware components such as a gantry, couch, stand, control console, electron gun, waveguide, and collimator, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states that the Varian High Energy Linear Accelerator is a "radiotherapy treatment unit" that generates a "radiotherapy treatment beam." This device is used to treat conditions within the body by delivering radiation.
- Intended Use: The intended use is to "provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated." This is a therapeutic use, not a diagnostic use involving in vitro testing.
The device's function is to deliver radiation for treatment, which is fundamentally different from the purpose of an IVD.
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 (comma separated list FDA assigned to the subject device)
90 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 the Varian High Energy Linear Accelerator, K112839.
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.
An extensive system of interlocks is designed to prevent or terminate beam-on unless essential treatment parameters are in place and system operating conditions relevant to safe operation are correct.
The changes to the Varian High Energy Linear Accelerator establish motion zone rules, which limit the motions of couch and gantry that can be initiated or directed from outside the treatment room. The purpose of the zone rules is to increase patient safety by reducing the possibility of collision between the gantry and the patient.
All other features and technological characteristics of the Varian High Energy Linear Accelerator models remain as cleared by K112839.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
K131807
Page 1 of 4
ww.varian.com
June 17, 2013
510(k) Summary
CT 11 2013
The information below is provided for the Varian High Energy Linear Accelerator. following the format of 21 CFR 807.92.
-
- 510(k) Owner: Varian Medical Systems 3100 Hansen Way, M/S C 260 Palo Alto, CA 94304 Contact Name: Peter J. Coronado - Director, Regulatory Affairs Phone: 650/424.6320 Fax: 650/842.5040 E-mail: submissions.support@varian.com
| 2. 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 Name: | Medical Linear Accelerator |
| Classification Name: | Medical Charged Particle Radiation Therapy System |
| 21 CFR §892.5050 | |
| Class II | |
| Product Code 90 IYE |
-
- Predicate Device: Varian High Energy Linear Accelerator K112839
-
- 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, K112839.
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.
1
An extensive system of interlocks is designed to prevent or terminate beam-on unless essential treatment parameters are in place and system operating conditions relevant to safe operation are correct.
The changes to the Varian High Energy Linear Accelerator establish motion zone rules, which limit the motions of couch and gantry that can be initiated or directed from outside the treatment room. The purpose of the zone rules is to increase patient safety by reducing the possibility of collision between the gantry and the patient.
All other features and technological characteristics of the Varian High Energy Linear Accelerator models remain as cleared by K112839.
-
- 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 modified device, the Varian High Energy Linear Accelerator. is substantially equivalent to the predicate device, the Varian High Energy Linear Accelerator (K112839).
- Substantial Equivalence
The functionality of the Varian High Energy Linear Accelerator is equivalent to the functionality of the Varian predicate device in safety and effectiveness. The design control procedures applied to the development of the Varian High Energy Linear Accelerator and its modifications include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met.
Compared with the predicate device, the Varian High Energy Linear Accelerator (K112839), the basic operation and technological characteristics are the same. Operational differences are described in the Instructions for Use for the Varian High Energy Linear Accelerator. The intended use for the device is unchanged.
A comparison table illustrating the substantial equivalence of the modified device to the predicate device appears below.
2
| FEATURE AND/OR
SPECIFICATION | CLEARED DEVICE
(HIGH ENERGY LINEAR
ACCELERATOR K112839) | DEVICE WITH CHANGE
(HIGH ENERGY LINEAR
ACCELERATOR) |
|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Intended 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. | Unchanged |
| 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. | Unchanged |
| Release version of control
software | C-Series 9.0 | C-Series 9.1 |
| Gantry and couch rotation
from outside the treatment
room are prevented or
limited within Exclusion
Zone areas defined by Zone
Rules. | No | Yes |
| Maximum rate at which dose
delivery occurs for 10x
photon energy | 600 MU per minute | 600 MU per minute |
| Maximum rate at which dose
delivery occurs for 10x FFF
photon energy | 2400 MU per minute | 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 | 1400 MU per minute | 1400 MU per minute |
| FEATURE AND/OR
SPECIFICATION | CLEARED DEVICE
(HIGH ENERGY LINEAR
ACCELERATOR K112839) | DEVICE WITH CHANGE
(HIGH ENERGY LINEAR
ACCELERATOR) |
| 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 |
3
K131807
Page 4 of 4
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Image /page/4/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with text around the perimeter and a stylized symbol in the center. The symbol appears to be an abstract representation of an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Cuntrol Center - WO66-G609 Silver Spring, MI) 20993-0002
October 11. 2013
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K131807
Trade/Device Name: Varian High Energy Linear Accelerator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle.radiation therapy system Regulatory Class: 11 Product Code: IYE Dated: October 2, 2013 Received: October 8, 2013
Dear Mr. 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 10 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. Iisting 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 cither 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practive requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
5
Page 2-Mr. Peter Coronado
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal/roblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K131807
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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K131807 510(k)
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