(185 days)
No
The provided text does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
Explanation: The device is described as providing "stereotactic radiotherapy for lesions, and conditions anywhere in the body where radiation therapy is indicated" and for "delivery of radiation for treatment that includes" various tumors and benign diseases, which are all therapeutic applications.
No
The device is described as a medical linear accelerator for radiotherapy, which is a treatment modality, not a diagnostic one, despite its ability to produce diagnostic kV X-rays for imaging.
No
The device description explicitly states it is a medical linear accelerator with hardware components (radiation beam-producing component and control console).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The TrueBeam and Edge Systems are described as "medical linear accelerators" that produce radiation beams for treatment. They are installed in a radiation-shielded vault and used to deliver radiation directly to the patient's body.
- Intended Use: The intended use is to "provide stereotactic radiotherapy for lesions, and conditions anywhere in the body where radiation therapy is indicated." This involves treating the patient directly with radiation, not analyzing samples taken from the patient.
The device's function is to deliver therapeutic radiation, which is a form of treatment, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The TrueBeam and Edge Systems are intended to provide stereotactic radiotherapy for lesions, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: bram and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as ung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carvinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavemous malformation, trigeninal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, pitutary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).
Product codes
IYE
Device Description
The TrueBeam™ and Edge™ Radiotherapy Delivery Systems are medical linear accelerators that integrate the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.
The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain and spine, head and neck, oral cavity, hypopharynx, larynx, oropharynx, nasopharynx, sinonasal, salivary gland, thyroid, thoracic, lung, esophageal, thymic, gynecologic, ovarian, cervical, endometrial, vulvar, vaginal, gastrointestinal, gastric, pancreatic, hepatobiliary, colon, rectal, anal, genitourinary, prostate, bladder, testicular, kidney, breast, skin, bone, liver
Indicated Patient Age Range
adults and pediatric patients
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)
No changes have been made to the device and no new testing has been performed.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2014
Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 84304
Re: K140528
Trade/Device Name: TrueBeam, TrueBeam STx, Edge Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 31, 2014 Received: August 4, 2014
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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'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
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Indications for Use
510(k) Number (if known) K140528
Device Name
TrueBeam and Edge Radiotherapy Delivery System
Indications for Use (Describe)
The TrueBeam and Edge Systems are intended to provide stereotactic radiotherapy for lesions, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: bram and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as ung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carvinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavemous malformation, trigeninal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, pitutary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com
Premarket Notification [510(k)] Summary
TrueBeam/Edge Radiotherapy Delivery Systems
The following information is provided following the format of 21 CFR 807.92(c).
| Submitter's Name: | Varian Medical Systems, Inc.
3100 Hansen Way E-110
Palo Alto, CA 94304
Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200
Date: 31 July 2014 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | TrueBeam™/ TrueBeam STx™ Radiotherapy Delivery System
Edge™ Radiotherapy Delivery System |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050, Class II
Product Code: IYE |
| Common/Usual Name: | Medical linear accelerator |
| Predicate Devices: | TrueBeam Radiotherapy System and Accessories: K123291
CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems:
K102650
Agility™ K123808 |
| Device Description: | The TrueBeam™ and Edge™ Radiotherapy Delivery Systems are medical linear
accelerators that integrate the previously cleared Trilogy Radiotherapy system
and associated accessories into a single device.
The system consists of two major components, a photon, electron, and
diagnostic kV X-ray radiation beam-producing component that is installed in a
radiation-shielded vault and a control console area located outside the
treatment room. |
| Intended Use
Statement | The TrueBeam and Edge Systems are intended to provide stereotactic
radiosurgery and precision radiotherapy for lesions, tumors, and conditions
anywhere in the body where radiation therapy is indicated for adults and
pediatric patients. |
| Indications for Use
Statement | The TrueBeam and Edge Systems are intended to provide stereotactic
radiosurgery and precision radiotherapy for lesions, tumors, and conditions
anywhere in the body where radiation therapy is indicated for adults and
pediatric patients.
The TrueBeam and Edge Systems may be used in the delivery of radiation for
treatment that includes: brain and spine tumors (such as glioma, meningioma,
craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma,
orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors),
head and neck tumors (such as unknown primary of the head and neck, oral
cavity, hypopharynx, larynx, oropharynx, nasopharynx, sinonasal, salivary
gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal
cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as
ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors
(such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma),
genitourinary tumors (such as prostate, bladder, testicular, and kidney),
breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-
Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and
melanoma), benign diseases (such as schwannoma, arteriovenous
malformation, cavernous malformation, trigeminal neuralgia, chordoma,
glomus tumors, and hemangiomas), metastasis (including all parts of the body
such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as
glioma, ependymoma, pituitary tumors, hemangioblastoma,
craniopharyngioma, meningioma, metastasis, medulloblastoma,
nasopharyngeal tumors, arteriovenous malformation, cavernous
malformation and skull base tumors). |
| Technological
Characteristics | This device has the same technological characteristics as the previously
cleared TrueBeam device K123291. This submission does not introduce any
device modifications. |
| Substantial
Equivalence | The indication for use statement for the TrueBeam and Edge radiotherapy
delivery systems is similar but not identical to its primary predicate device
K123291. The changes made with this submission include specific indications
for some typical lesions, tumors and conditions that may be treated with
radiation. The addition of this text to the indication statement does not
change the therapeutic effect of the device. These treatment sites fall within
the previously cleared general indication “to provide stereotactic radiosurgery
and precision radiotherapy for lesions, tumors, and conditions anywhere in
the body where radiation therapy is indicated”. The device itself is unchanged
from the previous submission K123291. The principles of operation,
technological characteristics and labeling are substantially equivalent.
The functionality and intended use of the TrueBeam and Edge systems is
substantially equivalent to that of its predicate devices, CyberKnife and
CyberKnife VSI Systems (K102650) and Agility™ K123808, in safety and
effectiveness. |
| Summary of
performance testing | No changes have been made to the device and no new testing has been
performed. |
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