IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for monitoring 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.

Device Description

IDENTIFY is a system for motion monitoring during radiotherapy treatment simulation and delivery. It incorporates patient safety, quality, and workflow efficiency. Its high precision SGRT cameras support proper patient positioning and enable to monitor the patient's respiratory motion and to detect intra-fraction patient position changes during the treatment.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria with reported performance metrics. The document is primarily a 510(k) summary for the IDENTIFY (4.0) device, outlining its intended use, description, and non-clinical testing for substantial equivalence to a predicate device.

Therefore, I cannot fulfill all parts of your request. I can, however, extract information about what non-clinical testing was conducted, which suggests certain underlying acceptance criteria related to safety, effectiveness, and performance against standards.

Here's what can be inferred and stated based on the provided text:

Acceptance Criteria and Study Information (Based on Inferred Information from Non-Clinical Testing Section):

The document does not present a table of explicit acceptance criteria with reported device performance in the format requested. Instead, it describes general compliance with standards and internal testing to ensure safety, effectiveness, and performance.

Inferred Acceptance Criteria from Non-Clinical Testing:

While not explicitly listed as a table of "acceptance criteria," the non-clinical testing section implies the device needed to meet the following:

Conformance to Applicable Requirements Specifications: The device must meet its defined functional and performance specifications.
Hazard Safeguards Functioning Properly: Safety mechanisms must work as intended.
Software Compliance: Adherence to FDA's "Content of Premarket Submissions for Device Software Functions" guidance, specifically for a "major" level of concern.
Electrical Safety: Compliance with IEC 60601-1 standards.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 standard.
Quality Management System: Adherence to ISO 13485.
Risk Management: Adherence to ISO 14971.
No Unresolved Anomalies: No Discrepancy Reports (DRs) with "Safety Intolerable" or "Customer Intolerable" priority remaining.
Performance at least as well as Predicate Device: The device performs comparably in terms of safety and effectiveness to the IDENTIFY (K230576).

Reported Device Performance:

The document states: "Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." And "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)."

Missing Information:

The document does not provide the following details that would be typically found in a clinical study report or a more detailed performance evaluation:

A specific table of quantitative acceptance criteria and corresponding numerical performance results.
Details on a specific "study" with a test set, sample sizes for test or training sets, data provenance, expert qualifications, or ground truth establishment methods for a clinical or performance evaluation.
Information on MRMC studies or a human-in-the-loop effect size.
Information on standalone algorithm performance.

Summary of Available Information from the Text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Inferred): Conformance to requirements, proper functioning of hazard safeguards, compliance with specific software guidances (FDA Software Functions guidance, "major" level of concern), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), Quality Management (ISO 13485), Risk Management (ISO 14971), and absence of critical unresolved anomalies (Safety Intolerable or Customer Intolerable DRs). Performance at least as well as the predicate device.
- Reported Device Performance: "Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." "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)."
Sample sizes used for the test set and the data provenance:
- Not provided. The document refers to "hardware and software verification and validation testing" but does not specify sample sizes for a test set of patient data or data provenance (e.g., country of origin, retrospective/prospective). This often implies bench testing and software verification without a dedicated clinical performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. This information would be relevant for a clinical performance study using expert labels, which isn't detailed here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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 provided. The document focuses on the device's own performance and substantial equivalence, not an MRMC study with human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Non-clinical Testing" section refers to "hardware and software verification and validation testing," implying performance of the device's functions, which would be "standalone" in nature. However, specific metrics or a dedicated "standalone study" in terms of clinical performance are not detailed. It's more about technical compliance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified as a formal ground truth for a clinical dataset. The "ground truth" for the non-clinical testing likely refers to engineering specifications, established safety standards, and validated software requirements.
The sample size for the training set:
- Not provided. Training set information is relevant for AI/ML devices, but IDENTIFY is described as a "system for motion monitoring," not explicitly an AI/ML diagnostic or predictive device in the traditional sense that would require a large training dataset with labeled ground truth of patient outcomes.
How the ground truth for the training set was established:
- Not applicable/Not provided. As above, a specific training set with associated ground truth is not detailed, as this appears to be a traditional medical device verification and validation rather than an AI/ML model for clinical decision support.

Summary

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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in bold blue letters, and 'ADMINISTRATION' in smaller blue letters below.

Varian Medical Systems, Inc. Lynn Allman Senior Director, Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304

February 7, 2025

Re: K242957

Trade/Device Name: Identify (4.0) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: January 7, 2025 Received: January 8, 2025

Dear Lynn Allman:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

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Sincerely, Digitally signed by Michael D. O'hara -S Date: 2025.02.07 16:52:37 -05'00' For Lora Weidner Assistant Director 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

Submission Number (if known)

K242957

Device Name

IDENTIFY (4.0)

Indications for Use (Describe)

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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Image /page/4/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. The logo is black and white.

PREMARKET NOTIFICATION

510(k) Summary

IDENTIFY

As required by 21 CFR 807.92

Submitter's Name:	Varian Medical Systems3100 Hansen WayPalo Alto CA94304
	Dr. Lynn Allman-Senior Director Regulatory AffairsPhone: (650)-424-5369E-mail: submissions.support@varian.comDate: 24 September 2024
Proprietary Name:	IDENTIFY
Classification Name:	accelerator, linear, medical21CFR892.5050, IYE, Class II
Common/Usual Name:	Patient identification & positioning/tracking system
Predicate Device:	IDENTIFY (K230576)
Device Description:	IDENTIFY is a system for motion monitoring during radiotherapytreatment simulation and delivery. It incorporates patient safety, quality,and workflow efficiency. Its high precision SGRT cameras supportproper patient positioning and enable to monitor the patient'srespiratory motion and to detect intra-fraction patient position changesduring the treatment.
Intended Use:	IDENTIFY is intended for patient motion monitoring, includingmonitoring of respiratory patterns. It can be used during radiotherapytreatment simulation and delivery and allows for data output toradiotherapy devices to synchronize image acquisition or treatmentdelivery with the acquired motion information.
Indications for Use:	IDENTIFY is indicated for adult patients undergoing radiotherapytreatment simulation and/or delivery. IDENTIFY is indicated forpositioning of patients, and for monitoring patient motion includingrespiratory patterns. It allows for data output to radiotherapy devices tosynchronize image acquisition or treatment delivery with the acquiredmotion information.
Significant differences:	TrueBeam Couch Control for couch position correctionOptional handheld free workflowSRS mode to switch from cm to mm display scalePlanning Tool accessibility on ARIA workstation

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Image /page/5/Picture/0 description: The image shows the Varian Medical Systems logo. 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 in black and white.

Non-clinical Testing

Hardware and software verification and validation testing was conducted according to the FDA Quality System Requlation (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, "Content of Premarket Submissions for Device Software Functions." 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. The documentation level required for IDENTIFY v4.0 is Enhanced, as a failure or flaw of the software function(s) could present a hazardous situation with probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use, as noted in the Level of Concern.

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:

ISO 14971:2019 ISO 15223-1:2021 ISO 20417:2021 IEC 60601-1:2005/AMD2:2020 IEC 60601-1-2:2014 +A1 2021 (4th Edition) IEC 60601-1-6:2010/AMD2:2020 IEC 62366-1:2015 +A1:2020 IEC 62304:2006+A1:2015 IEC 61217:2011 IEC 80001-1:2021 IEC 80001-2-2: 2012 IEC 81001-5-1:2021

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.

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.