(25 days)
VitalBeam 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.
VitalBeam 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, 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, 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, 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).
VitalBeam is a medical linear accelerator.
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.
The VitalBeam device is a medical linear accelerator for radiation therapy. The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results for acceptance criteria in the way a clinical trial for a new drug or diagnostic might.
Based on the provided information, the acceptance criteria and performance are related to engineering and safety standards, as well as verification and validation (V&V) testing. There is no information about clinical performance or studies involving human readers, training sets, or ground truth established by experts in the context of AI or diagnostic performance metrics like sensitivity/specificity.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) and corresponding device performance values. Instead, it focuses on adherence to engineering and safety standards.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Quality Management System | FDA Quality System Regulation (21 CFR §820) | Hardware and software verification and validation bench testing conducted according to this regulation. |
| ISO 13485 QMS standard | Testing conducted according to this standard. | |
| ISO 14971 Risk Management Standard | Testing conducted according to this standard. | |
| Electrical Safety & EMC | IEC 60601-1 (safety) | The system complies with this standard. |
| IEC 60601-1-2 (EMC) | The system complies with this standard. | |
| AAMI/ANSI ES60601-1: 2005/(R)2012 & A1:2012; C1:2009/(R)2012 & A2:2010/ (R)2012 | Conforms in whole or in part. | |
| Software V&V | FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (for "major" level of concern) | Software V&V conducted and recorded as recommended. Test results showed passing criteria was met for conformance to applicable requirements specifications and assured hazard safeguards functioned properly. |
| Biocompatibility | ANSI/AAMI/ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1" | No change to patient-contact materials, therefore no change in conformance. |
| Other Conformances | IEC 60601-1-3: 2013 | Conforms in whole or in part. |
| IEC 60601-1-6: 2013 | Conforms in whole or in part. | |
| IEC 60601-2-1: 2014 | Conforms in whole or in part. | |
| IEC 60825: 2007 | Conforms in whole or in part. | |
| IEC 61217: 2011 | Conforms in whole or in part. | |
| IEC 62274: 2005 | Conforms in whole or in part. | |
| IEC 62304: 2006 | Conforms in whole or in part. | |
| IEC 62366:2015 | Conforms in whole or in part. | |
| IEC 60976: 2007 | Conforms in whole or in part. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "Hardware and software verification and validation bench testing." This implies internal engineering tests, rather than a clinical study with patients or patient data. Specific sample sizes for these bench tests are not provided, nor is information about the provenance of any "data" in the context of clinical images or patient data (as this is an equipment submission, not an AI diagnostic algorithm).
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 to the type of safety and engineering testing described in the 510(k) summary for a linear accelerator. The "ground truth" here refers to whether the device meets its engineering specifications, not a medical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study assessing diagnostic performance requiring adjudication of labels.
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
Not applicable. The VitalBeam is a radiation therapy delivery system, not an AI diagnostic or assistive tool for human readers. The document highlights new features like 'Hyperarc™ new automated treatment type' and 'CBCT changes' which involve advanced imaging and treatment delivery techniques. While these are technological advancements, their evaluation in this 510(k) does not involve MRMC studies in the typical sense of AI diagnostics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "Software verification and validation testing" for a "major" level of concern software. This testing demonstrates the software's ability to function correctly according to its specifications. While this is testing the "algorithm only" in a sense, it's about the performance of the machine control software, not a diagnostic algorithm where "standalone" performance typically refers to metrics like AUC, sensitivity, or specificity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the verification and validation (V&V) testing involved adherence to engineering specifications and safety standards. For example, ensuring that radiation doses are delivered accurately, safety interlocks function as designed, and imaging systems perform within established parameters. This is verified against engineering and physics principles, not medical diagnostic ground truths like pathology.
8. The sample size for the training set
Not applicable. This is a V&V summary for a medical device (linear accelerator), not an AI algorithm development where a specific training set size would be relevant.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI algorithm.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2017
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K172013
Trade/Device Name: VitalBeam Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 30, 2017 Received: July 3, 2017
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
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ResourcesforYou/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,
Michael D. O'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) K172013
Device Name VitalBeam
Indications for Use (Describe)
VitalBeam is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, turnors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
VitalBeam 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, 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, 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, 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
The following information follows the format of 21 CFR 807.92.
| I. Submitter's Name: | Varian Medical Systems, Inc.3120 Hansen Way C-260Palo Alto, CA 94304Contact Name: Peter J. CoronadoPhone: 650.424.5731Fax: 650.842.5040Date: July 2017 |
|---|---|
| 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: K162472 |
| IV. Device Description: | VitalBeam is a medical linear accelerator.The system consists of two major components, a photon, electron, anddiagnostic kV X-ray radiation beam-producing component that isinstalled in a radiation-shielded vault and a control console arealocated outside the treatment room. |
| V. Intended UseStatement | VitalBeam is intended to provide stereotactic radiosurgery and precisionradiotherapy for lesions, tumors, and conditions anywhere in the bodywhere radiation treatment is indicated. |
| Indications for UseStatement | VitalBeam 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, oculartumors, 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, andmesothelioma), 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 asprostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoidtumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such assquamous cell, basal cell, and melanoma), benign diseases (such asschwannoma, arteriovenous malformation, cavernous malformation, trigeminalneuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (includingall parts of the body such as brain, bone, liver, lung, kidney, and skin) andpediatric tumors (such as glioma, ependymoma, pituitary tumors,hemangioblastoma, craniopharyngioma, meningioma, metastasis,medulloblastoma, nasopharyngeal tumors, arteriovenous malformation,cavernous malformation and skull base tumors) |
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Significant changes to the predicate device are listed below.
VI. Technological Characteristics:
| Feature | Cleared device | Device with change |
|---|---|---|
| Enlarged Bounding Box | No | Yes |
| Delta Couch shift | No | Yes |
| Single Isocenter Multiplan | No | Yes |
Features cleared in TrueBeam™-TrueBeam STx™-Edge™ v2.7 (K162472) and included in VitalBeam v2.7:
- Hyperarc™ new automated treatment type ●
- Cone Beam Computed Tomography (CBCT) changes:
- Gated CBCT New CBCT acquisition technique O
- Online 4D & Extended Length CBCT New advanced reconstructor -O imaging application integration
- iCBCT New CBCT images reconstruction algorithms o
- 4D CBCT Reconstruction New algorithms for binning CBCT projections o into different phases within existing 4D CBCT feature.
- Automatic Exposure Control (AEC) - New kV imaging system capability to control the kV exposure automatically
- Auxiliary Device Interface (ADI) 3.0 - New 3rd party device interface version
- Single Camera for Respiratory Gating with new algorithms ●
VII. Summary of performance testing:
Hardware and software verification and validation bench testing was conducted according to the FDA Quality System Regulation (21 CFR §820). ISO 13485 QMS standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below including electrical safety and EMC. Test results showed passing criteria was met for conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
Software verification and validation testing were conducted and recorded as recommended by FDA's "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. A failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
There was no change to the patient-contact materials biocompatibility in this medical device. Therefore, no change occurred in conformance to ANSI/AAMI/ ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1"
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.
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Varian VitalBeam™ medical linear accelerator model conforms in whole Standards or in part with the following FDA recognized consensus standards: conformance:
| AAMI/ANSI ES60601-1: 2005/(R)2012 & A1:2012; C1:2009/(R)2012 & A2:2010/ (R)2012ANSI/AAMI/ISO 10993-1: 2009 | IEC 60601-1-2:2007IEC 60601-1-3: 2013IEC 60601-1-6: 2013IEC 60601-2-1: 2014IEC 60825: 2007 | IEC 61217: 2011IEC 62274: 2005IEC 62304: 2006IEC 62366:2015IEC 60976: 2007 |
|---|---|---|
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Conclusion: The results of verification, validation and safety standards testing demonstrate that the VitalBeam medical linear accelerator is substantially equivalent to the predicate device.
§ 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.