IDENTIFY

K230576 · Varian Medical Systems, Inc. · IYE · Jul 25, 2023 · Radiology

Device Facts

• Record ID: K230576
• Device Name: IDENTIFY
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jul 25, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

IDENTIFY is intended for patient motion monitoring, including monitoring of respiratory patterns. It can be used during radiotherapy treatment simulation and delivery and allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.

Device Story

IDENTIFY is a Surface Guided Radiation Therapy (SGRT) system used in radiotherapy clinics. It utilizes high-precision cameras to capture patient surface data, enabling real-time monitoring of patient positioning and respiratory motion during treatment simulation and delivery. The system detects intra-fraction patient motion and provides automated beam-hold functionality (on TrueBeam platforms) when motion exceeds defined tolerances. Data is output to radiotherapy devices to synchronize treatment delivery or image acquisition with the patient's motion state. Operated by clinical staff, the system enhances workflow efficiency and patient safety by ensuring treatment is delivered only when the patient is correctly positioned and within motion thresholds. It benefits patients by reducing the risk of geographic miss during radiation delivery.

Clinical Evidence

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

Technological Characteristics

SGRT system using high-precision cameras for motion monitoring. Conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 62304 (software), IEC 62366-1 (usability), and ISO 14971 (risk management). Features automated beam-hold interface (ADI/EXGI) for TrueBeam integration. Software classified as major level of concern.

Indications for Use

Indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. Used for patient positioning and monitoring of patient motion, including respiratory patterns. Allows data output to radiotherapy devices to synchronize image acquisition or treatment delivery with motion information.

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 (K210835)

Submission Summary (Full Text)

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July 25, 2023

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Varian Medical Systems Inc. % Mr. Peter Coronado Senior Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304

Re: K230576

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: June 23, 2023 Received: June 23, 2023

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/cfpmn/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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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,

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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) K230576

Device Name IDENTIFY

Indications for Use (Describe)

IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for montoring patient motion including respiratory patterns. It allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/1 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font.

# PREMARKET NOTIFICATION

K230576

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-Senior Director Regulatory<br>Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail]<br>Date: 24 February 2023 |
| Proprietary Name: | IDENTIFY |
| Classification Name: | accelerator, linear, medical<br>21CFR892.5050, IYE, Class II |
| Common/Usual Name:<br>Predicate Device: | Patient identification & positioning/tracking system<br>IDENTIFY (K210835) |
| Device Description: | IDENTIFY is a system for motion monitoring during radiotherapy<br>treatment simulation and delivery. It incorporates patient safety,<br>quality, and workflow efficiency. Its high precision SGRT cameras<br>support proper patient positioning and enable to monitor the<br>patient's respiratory motion and to detect intra-fraction patient<br>position changes during the treatment. |
| Intended Use | IDENTIFY is intended for patient motion monitoring, including<br>monitoring of respiratory patterns. It can be used during<br>radiotherapy treatment simulation and delivery and allows for data<br>output to radiotherapy devices to synchronize image acquisition or<br>treatment delivery with the acquired motion information. |
| Indications for Use: | IDENTIFY is indicated for adult patients undergoing radiotherapy<br>treatment simulation and/or delivery. IDENTIFY is indicated for<br>positioning of patients, and for monitoring patient motion including<br>respiratory patterns. It allows for data output to radiotherapy<br>devices to synchronize image acquisition or treatment delivery<br>with the acquired motion information. |
| Significant differences: | • Automated beam-hold when monitoring tolerances are exceeded<br>(TrueBeam platform only) and the associated software and -<br>hardware changes.<br>• Interface changes (ADI / EXGI) related to the automated beam-<br>hold functionality.<br>• Removal of Patient ID (including welcome desk) and Patient<br>Setup (including accessory verification). |

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Image /page/4/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is black and white.

### 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 safequards 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+A1:2015 ISO 15223-1:2021 IEC 60601-1:2005+A1:2012 IEC 60601-1-2:2014 (4th Edition) IEC 61217:2011 ISO 14971:2019 IEC 62366-1:2015 +A1:2020 BS EN ISO 20417:2021 IEC EN 60601-1-6: 2010 +A1:2013

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.

### Arqument 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.