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).

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.

AI/ML Overview

The provided text describes the VitalBeam Radiotherapy Delivery System, a medical linear accelerator system. It is a 510(k) premarket notification, indicating that the device aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device's safety and effectiveness to a predicate, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a diagnostic AI device.

Therefore, much of the requested information (acceptance criteria for performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance for AI, etc.) is not present in this document because it pertains to the performance evaluation of a diagnostic or algorithmic device, not a therapeutic hardware device like a linear accelerator.

The document mostly discusses the device's technical specifications, intended use, indications for use, and a comparison to a predicate device based on features and adherence to recognized standards.

Here's an attempt to answer the questions based on the provided text, highlighting what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) paired with reported performance results as would be typical for a diagnostic algorithm. Instead, the "acceptance criteria" for a radiotherapy delivery system in a 510(k) context largely revolve around demonstrating substantial equivalence to a predicate device and conformance to applicable safety and performance standards.

The document states:

Acceptance Criteria (Implicit): Conformance to applicable requirements specifications, assurance of hazard safeguards functioning properly, and compliance with recognized consensus standards (listed below). The ultimate "acceptance criterion" for 510(k) clearance is demonstrating that the device is as safe and effective as a legally marketed predicate.
Reported Device Performance: "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly."

Acceptance Criteria (Implicit from 510(k) context)	Reported Device Performance
Conformance to applicable requirements specifications	"conformance to applicable requirements specifications"
Hazard safeguards function properly	"assured hazard safeguards functioned properly"
As safe and effective as the predicate device (TrueBeam Radiotherapy System)	"is as safe, effective and perform as well as or better than the legally marketed device"
Conformance with FDA recognized consensus standards:	"conforms in whole or in part with the following FDA recognized consensus standards:" (followed by a list of IEC, AAMI/ANSI standards)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document describes a medical device (linear accelerator) for delivering radiation, not a diagnostic algorithm that would typically use test data sets of patient images or clinical records. The "testing" mentioned is likely engineering verification and validation testing of the hardware and software components, not clinical data analysis in the sense of AI performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and is not provided. The device described is a radiotherapy delivery system, not a diagnostic tool requiring expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and is not provided for the same reasons as above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and is not provided, as the VitalBeam Radiotherapy Delivery System is not a diagnostic AI device that would assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and is not provided. The VitalBeam is a hardware system for delivering radiation therapy, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable and is not provided. "Ground truth" in the context of diagnostic performance is not relevant for this type of device submission.

8. The sample size for the training set

This information is not applicable and is not provided. The device is a hardware system, not an AI model that would have a "training set."

9. How the ground truth for the training set was established

This information is not applicable and is not provided for the same reasons as above.

Summary

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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.

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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 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.

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-260Palo Alto, CA 94304Contact Name: Peter J. CoronadoPhone: 650.424.5731Fax: 650.842.9200Date: March 2015
II. Trade Name:	VitalBeam™
Common Name:	Linear accelerator radiation therapy system
Classification Name:	Medical charged-particle radiation therapy system21 CFR 892.5050, Class IIProduct Code: 90 IYE
III. Predicate Device:	TrueBeam Radiotherapy System and Accessories: K143224
IV. Device Description:	The VitalBeam™ Radiotherapy Delivery System is a medical linearaccelerator based on the previously cleared TrueBeam Radiotherapysystem and associated accessories.The system consists of two major components: a beam-producingcomponent that is installed in a radiation-shielded vault (hereafterreferred to as the treatment room) and a control console located outsidethe treatment room.
V. Intended UseStatement	The VitalBeam™ system is intended to provide stereotactic radiosurgeryand precision radiotherapy for lesions, tumors, and conditions anywhere inthe body where radiation treatment is indicated.
Indications for UseStatement	The VitalBeam System is intended to provide stereotactic radiosurgery andprecision radiotherapy for lesions, tumors, and conditions anywhere in thebody where radiation therapy is indicated for adults and pediatric patients.The VitalBeam System may be used in the delivery of radiation fortreatment that includes: brain and spine tumors (such as glioma,meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors,hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, andskull based tumors), head and neck tumors (such as unknown primary ofthe head and neck, oral cavity, hypopharynx, larynx, oropharynx,nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracictumors (such as lung cancer, esophageal cancer, thymic tumors, andmesothelioma), gynecologic tumors (such as ovarian, cervical,endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric,pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinarytumors (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.

Regulation Number and Section

§ 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.