Identify

K210835 · Varian Medical Systems, Inc. · IYE · Apr 20, 2021 · Radiology

Device Facts

• Record ID: K210835
• Device Name: Identify
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Apr 20, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

IDENTIFY is intended for patient and accessory identification, positioning and tracking for imaging and radiation therapy treatments.

Device Story

System for patient setup, guidance, and monitoring during radiation therapy; utilizes cameras, RFID tags, optical markers, and palm scan unit to track patient/accessory position; includes PC workstations, interlock unit, and handheld controllers; operated by clinical staff in radiation oncology settings; provides real-time positioning data to ensure accurate treatment delivery; enhances patient safety through identification and tracking; supports workflow integration with Halcyon/Ethos systems.

Clinical Evidence

No clinical data. Bench testing only. Hardware and software verification and validation conducted per 21 CFR 820, ISO 13485, and ISO 14971. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2. Results demonstrate conformance to requirements and proper function of hazard safeguards.

Technological Characteristics

System includes cameras, RFID kit, interlock unit, calibration tools, palm scan unit, RFID tags, optical markers, PC workstations, and handheld controllers. Conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 62304 (software lifecycle), and ISO 14971 (risk management).

Indications for Use

Indicated for patient and accessory identification, positioning, and tracking for imaging and radiation therapy treatments.

Regulatory Classification

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.

Predicate Devices

• IDENTIFY (K192968)

Submission Summary (Full Text)

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April 20, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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 Systems<br>3100 Hansen Way, m/s E110<br>Palo Alto CA94304 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado-Director Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail]<br>Date: 16 April 2021 |
| Proprietary Name: | IDENTIFY |
| Product Code and Classification: | Medical Charged-Particle Radiation Therapy System<br>IYE 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 before<br>and during radiation treatment. The system consists of cameras, software,<br>PC workstations, RFID kit, Interlock unit, calibration tools, Palm scan unit,<br>RFID tags and optical markers, network components and cabling and<br>handheld controllers. |
| Intended Use | IDENTIFY is intended for patient and accessory identification, positioning<br>and tracking for imaging and radiation therapy treatments. |
| Indications for Use: | IDENTIFY is indicated for patient and accessory identification, positioning<br>and 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.