(135 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on the hardware and software of a linear accelerator.
Yes
The device is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions, which are treatments aimed at healing or improving health, thus making it a therapeutic device.
No
The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions, indicating their use for treatment rather than diagnosis. While the device produces diagnostic kV X-rays, this is for treatment delivery and positioning, not for diagnosing conditions.
No
The device description explicitly states it is a "medical linear accelerator" consisting of both a radiation beam-producing component (hardware) and a control console using software. The performance studies also mention hardware verification and validation testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the TrueBeam and Edge Systems are for providing radiation therapy for treating lesions, tumors, and conditions. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a medical linear accelerator that produces radiation beams. This is consistent with a radiotherapy device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose or monitor a condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver radiation for treatment.
N/A
Intended Use / Indications for Use
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, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck turnors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung 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 carcinomaly tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as 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, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The TrueBeamTM Radiotherapy Delivery System is a medical linear accelerator. The system consists of two major components: 1) a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault in a healthcare facility and 2) a control console using the device software in an area located outside the treatment room.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiation
diagnostic kV X-ray
Anatomical Site
Anywhere in the body. Specifically mentioned: brain, spine, head, neck, oral cavity, hypopharynx, nasopharynx, sinonasal region, salivary gland, thyroid, thoracic region, lung, esophagus, breast, abdomen, pancreas, liver, colon, rectum, anus, prostate, bladder, testis, kidney, skin, bone.
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)
Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below. Bench testing results showed passing criteria were met, device conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
Software verification and validation bench testing were conducted. Results showed passing criteria were met and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
The biocompatibility evaluation for the patient-contact materials in this medical device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Electrical safety and electromagnetic compatibility (EMC) testing was conducted on this medical device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
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.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of four faces in profile, stacked on top of each other. The faces are stylized and appear to be connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K162472
Trade/Device Name: Truebeam STx. and Edge Radiotherapy Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 22, 2016 Received: December 27, 2016
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.
1
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
Robert Ochs. Ph.D. 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) K162472
Device Name
TrueBeam, TrueBeam STx and Edge Radiotherapy Delivery System
Indications for Use (Describe)
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, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck turnors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung 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 carcinomaly tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as 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, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Premarket Notification [510(k)] Summary TrueBeam Radiotherapy Treatment System
The following information follows the format of 21 CFR 807.92.
| I. Submitter's Name: | Varian Medical Systems, Inc.
3120 Hansen Way C-260
Palo Alto, CA 94304
Contact Name: Peter J. Coronado
Phone: 650.424.5731
Fax: 650.842.5040
Date: December 2016 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. Trade Name: | TrueBeamTM/TrueBeam STXTM/EdgeTM |
| Common Name: | Linear accelerator radiation therapy system |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050, Class II
Product Code: 90 IYE |
| III. Predicate Device: | TrueBeam Radiotherapy System and Accessories: K143224 |
| IV. Device Description: | The TrueBeamTM Radiotherapy Delivery System is a medical linear accelerator.
The system consists of two major components: 1) a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault in a healthcare facility and 2) a control console using the device software in an area located outside the treatment room. |
| V. Intended Use
Statement | The TrueBeam TM system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. |
| Indications for Use
Statement | The TrueBeam, TrueBeam STx 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) |
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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).
VI. Technological Characteristics:
Listed below is a comparison of significant changes to the predicate device.
| Feature | Cleared device | Device with change |
|---|---|---|
| Hyperarc Automated Dynamic Beam | No | Yes |
| Gated CBCT | No | Yes |
| Online 4D CBCT | No | Yes |
| Extended Length CBCT | No | Yes |
| iCBCT | No | Yes |
| 4D CBCT reconstruction new algorithm | No | Yes |
| Automatic Exposure Control | No | Yes |
| Auxiliary Device Interface v3.0 | No | Yes |
| Single Camera for Respiratory Gating | No | Yes |
VII. Summary of performance testing:
Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below. Bench testing results showed passing criteria were met, device conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
Software verification and validation bench testing were conducted. Results showed passing criteria were met and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
The biocompatibility evaluation for the patient-contact materials in this medical device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Electrical safety and electromagnetic compatibility (EMC) testing was conducted on this medical device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
Varian TrueBeam™, TrueBeam STx™ and Edge™ medical linear Standards accelerator models conform in whole or in part with the following FDA conformance:
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| AAMI/ANSI ES60601-1: 2005/
(R)2012 & A1:2012; C1:2009/
(R)2012 & A2:2010/ (R)2012
ANSI/AAMI/ISO 10993-1: 2009 | IEC 60601-1-2:2007
IEC 60601-1-3: 2013
IEC 60601-1-6: 2013
IEC 60601-2-1: 2014
IEC 60825: 2007 | IEC 61217: 2011
IEC 62274: 2005
IEC 62304: 2006 IEC
62366:2015 IEC
60976: 2007 |
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