(29 days)
IDENTIFY is indicated for patient and accessory identification, positioning and tracking for imaging and radiation therapy treatments.
Identify is used for patient-setup, guidance and to monitor a patient before and during radiation treatment. The system consists of cameras, software, PC workstations, RFID kit, Interlock unit, calibration tools, Palm scan unit, RFID tags and optical markers, network components and cabling and handheld controllers.
The provided text is a 510(k) summary for the Varian Medical Systems "Identify" device. It focuses on regulatory compliance, non-clinical testing, and an argument for substantial equivalence to a predicate device. Critically, it does not include details on acceptance criteria and a study proving the device meets those criteria, especially in the context of clinical performance or the improvement of human readers with AI assistance.
The "Identify" device, as described, is for patient and accessory identification, positioning, and tracking for imaging and radiation therapy. The description of its components (cameras, software, RFID, optical markers) suggests it's a patient localization and monitoring system, not primarily an AI-driven image analysis tool for diagnosis or decision support.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance: This document does not specify quantitative performance metrics or acceptance criteria for accuracy, precision, or other operational parameters of the "Identify" system. It mentions conformance to standards and "no DRs remaining which had a priority of Safety Intolerable or Customer Intolerable," which are general quality and safety statements, not specific performance criteria.
- Sample size and data provenance for a test set: No test set is described in terms of patient data or clinical cases. The testing seems to be focused on hardware/software verification and standard compliance.
- Number of experts and qualifications for ground truth establishment: Not applicable, as there's no mention of a human-read test set or ground truth established by experts.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No such study is mentioned. The device's function as described (patient tracking) does not lend itself to an MRMC study comparing human reader performance with and without AI assistance in the diagnostic sense.
- Standalone (algorithm only) performance: No such
performance metrics are provided for an AI algorithm. The device is a system. - Type of ground truth used: Not clearly defined in the context of clinical performance data.
- Sample size for the training set: Not applicable, as there's no mention of a machine learning model training set with clinical data.
- How the ground truth for the training set was established: Not applicable.
Summary of available information related to testing:
- Non-clinical Testing: Hardware and software verification and validation testing were conducted according to FDA Quality System Regulation (21 CFR §820), ISO 13485, ISO 14971, and other FDA-recognized consensus standards (IEC 62304, ISO 15223-1, IEC 60601-1, IEC 60601-1-2, IEC 61217, AAMI RT2, IEC 62366-1).
- Software Level of Concern: "Major," indicating that a failure could result in serious injury or death.
- Electrical Safety and EMC: Complies with IEC 60601-1 and IEC 60601-1-2.
- Conclusion: "The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable (applicable to the US)."
This document describes a device approval process based on substantial equivalence, primarily supported by adherence to recognized standards and internal V&V testing, rather than a clinical performance study with defined acceptance criteria and human-in-the-loop evaluations typically seen for AI-diagnostic devices.
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April 20, 2021
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Varian Medical Systems Inc. % Mr. Peter Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K210835
Trade/Device Name: Identify Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: March 12, 2021 Received: March 22, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210835
Device Name Identify
Indications for Use (Describe)
IDENTIFY is indicated for patient and accessory identification, positioning and tracking for imaging and radiation therapy treatments.
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
Identify
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems3100 Hansen Way, m/s E110Palo Alto CA94304 |
|---|---|
| Contact Name: Peter J. Coronado-Director Regulatory AffairsPhone: 650/424.6320Fax: 650/646.9200E-mail: submissions.support@varian.comDate: 16 April 2021 | |
| Proprietary Name: | IDENTIFY |
| Product Code and Classification: | Medical Charged-Particle Radiation Therapy SystemIYE 21 CFR 892.5050 Class II |
| Common/Usual Name: | Patient identification & positioning/tracking system |
| Predicate Device: | IDENTIFY (K192968) |
| Device Description: | Identify is used for patient-setup, guidance and to monitor a patient beforeand during radiation treatment. The system consists of cameras, software,PC workstations, RFID kit, Interlock unit, calibration tools, Palm scan unit,RFID tags and optical markers, network components and cabling andhandheld controllers. |
| Intended Use | IDENTIFY is intended for patient and accessory identification, positioningand tracking for imaging and radiation therapy treatments. |
| Indications for Use: | IDENTIFY is indicated for patient and accessory identification, positioningand tracking for imaging and radiation therapy treatments. |
| Significant differences: |
The significant differences compared to the predicate are:
Halcyon/Ethos compatibility Addition of further Risk Control Measures
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Non-clinical 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. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
Software verification and validation testing were conducted 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.
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.
Standards Conformance
Identify conforms to the following FDA recognised standards. IEC 62304:2006 ISO 15223-1:2016 IEC 60601-1:2005+A1:2012 IEC 60601-1-2:2014 IEC 61217:2011 AAMI RT2:2017 ISO 14971:2007 IEC 62366-1:2015
Identify also complies with the following non-FDA recognised standards.
ISO 13485:2016
Conclusion of Non-Clinical testing
The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable (applicable to the US). Varian therefore considers Identify to be safe and effective and to perform at least as well as the predicate device.
Argument for Substantial Equivalence to the Predicate Device
A subset of technological characteristics of the current device is different to the predicate. These differences are all considered by Varian to be enhancements of the predicate. There are no changes in the principle of operation of the device. The Verification and Validation demonstrates that the device is as safe and effective as the predicate. Varian therefore believes that Identify is substantially equivalent to the predicate.
§ 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.