(51 days)
Not Found
No
The summary describes a linear accelerator system for radiotherapy and does not mention any AI or ML components.
Yes
The device is intended to provide stereotactic radiotherapy for treating various lesions, tumors, and conditions, which directly relates to the treatment of diseases and conditions.
No
The device is described as a "Radiotherapy Delivery System" and its "Intended Use / Indications for Use" clearly state it is "intended to provide stereotactic radiotherapy for lesions, tumors, and conditions," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a "medical linear accelerator" and consists of "two major components: a beam-producing component... and a control console". This indicates a significant hardware component, not a software-only device.
Based on the provided information, the VitalBeam System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the VitalBeam System is for providing stereotactic radiotherapy for treating lesions, tumors, and conditions. This is a therapeutic treatment delivered directly to the patient's body using radiation.
- Device Description: The device is described as a medical linear accelerator, which is a machine used to generate and deliver radiation for cancer treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The VitalBeam System does not perform this function. It delivers treatment to the body.
Therefore, the VitalBeam System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The VitalBeam System is intended to provide stereotactic radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
The VitalBeam System 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 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), gastrontestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid turnors (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 (comma separated list FDA assigned to the subject device)
IYE
Device Description
The VitalBeam™ Radiotherapy Delivery System is a medical linear accelerator based on the previously cleared TrueBeam Radiotherapy system and associated accessories.
The system consists of two major components: a beam-producing component that is installed in a radiation-shielded vault (hereafter referred to as the treatment room) and a control console located outside the treatment room.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anywhere in the body, brain and spine, head and neck, thoracic, gynecologic, gastrointestinal, genitourinary, breast, skin
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)
Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2015
Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Varian Oncology Systems Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K150706
Trade/Device Name: VitalBeam Radiotherapy Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 7, 2015 Received: April 9, 2015
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 O'Hara
for
Robert Ochs, Ph.D. Acting 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) K150706
Device Name
VitalBeam Radiotherapy Delivery System
Indications for Use (Describe)
The VitalBeam System is intended to provide stereotactic radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
The VitalBeam System 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 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), gastrontestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid turnors (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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Premarket Notification [510(k)] Summary VitalBeam Radiotherapy Treatment System
The following information is provided following the format of 21 CFR 807.92.
| I. Submitter's Name: | Varian Medical Systems, Inc.
3100 Hansen Way C-260
Palo Alto, CA 94304
Contact Name: Peter J. Coronado
Phone: 650.424.5731
Fax: 650.842.9200
Date: March 2015 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. Trade Name: | VitalBeam™ |
| 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 VitalBeam™ Radiotherapy Delivery System is a medical linear
accelerator based on the previously cleared TrueBeam Radiotherapy
system and associated accessories.
The system consists of two major components: a beam-producing
component that is installed in a radiation-shielded vault (hereafter
referred to as the treatment room) and a control console located outside
the treatment room. |
| V. Intended Use
Statement | The VitalBeam™ 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 VitalBeam System is 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 VitalBeam System 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 |
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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 Comparisons to the predicate device are listed below: Characteristics:
| Feature | Cleared device | Device with change |
|---|---|---|
| Bar-code Conical Collimator Verification (BCCV) | Yes | No |
| Patient, Accessory Verification System (PAVS) | Yes | No |
| High Definition 120-leaf collimator | Yes | No |
VII. Summary of performance testing:
Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
The Varian VitalBeam™ medical linear accelerator conforms in whole Standards conformance: or in part with the following FDA recognized consensus standards:
| AAMI/ANSI/IEC 60601-1:2005 | IEC 60601-2-1: 2009 |
|---|---|
| IEC 60601-1-2:2007 | IEC 60601-2-29: 2008 |
| IEC 60601-1-3: 2008 | IEC 60601-2-44: 2009 |
| IEC 60601-1-6:2010 | IEC 60976: 2007 |
| IEC 60825: 2007 | IEC 62274: 2005 |
| IEC 61217: 2011 | IEC 62366:2007 |
| IEC 62304: 2006 |
Conclusion: Based on the verification and validation non-clinical testing, the Varian VitalBeam™ medical linear accelerator is as safe, effective and perform as well as or better than the legally marketed device identified in section III above.