(146 days)
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.
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.
This FDA 510(k) summary for Varian Medical Systems Inc.'s IDENTIFY device mentions non-clinical testing for hardware and software verification and validation, electrical safety, and electromagnetic compatibility. However, it does not include a study specifically demonstrating device performance against pre-defined acceptance criteria for its intended use (patient positioning and motion monitoring, including respiratory patterns).
The document focuses on conformance to regulatory standards and a conclusion that the product conformed to defined user needs and intended uses, and is considered safe and effective. It explicitly states: "The Verification and Validation demonstrates that the device is as safe and effective as the predicate." This implies that the validation activities were largely focused on ensuring the new device performs at least as well as its predicate and meets safety standards, rather than proving performance against specific quantitative metrics for its core functionality in a study format.
Therefore, many of the requested sections regarding a specific performance study (e.g., sample size, ground truth establishment, MRMC study, standalone performance) cannot be answered from the provided text.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for device performance (e.g., accuracy of positioning, respiratory motion tracking accuracy, beam-hold trigger accuracy) nor does it report specific quantitative performance metrics for these functions. It states that "Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly," but does not detail what these requirements or results were in measurable terms related to the device's clinical indications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document.
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)
Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.
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 provided in the document. The device is not described as an AI-assisted diagnostic tool that would typically involve human readers. Its primary function is motion monitoring and synchronization with treatment delivery.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study against specific clinical metrics for motion tracking or positioning accuracy is not described in the provided text. The non-clinical testing mentions "hardware and software verification and validation testing," which would imply testing the algorithm, but the specifics of such testing in terms of clinical performance metrics are absent.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided in the document.
8. The sample size for the training set
Not applicable, as this document does not describe a machine learning model's training phase for a diagnostic or predictive task. The device is for motion monitoring and synchronization, not typically modeled through a "training set" in the sense of supervised learning for image interpretation.
9. How the ground truth for the training set was established
Not applicable, as a training set for machine learning is not discussed.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| 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-Senior Director RegulatoryAffairsPhone: 650/424.6320Fax: 650/646.9200E-mail: submissions.support@varian.comDate: 24 February 2023 | |
| Proprietary Name: | IDENTIFY |
| Classification Name: | accelerator, linear, medical21CFR892.5050, IYE, Class II |
| Common/Usual Name:Predicate Device: | Patient identification & positioning/tracking systemIDENTIFY (K210835) |
| 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 camerassupport proper patient positioning and enable to monitor thepatient's respiratory motion and to detect intra-fraction patientposition changes during the treatment. |
| Intended Use | IDENTIFY is intended for patient motion monitoring, includingmonitoring of respiratory patterns. It can be used duringradiotherapy treatment simulation and delivery and allows for dataoutput to radiotherapy devices to synchronize image acquisition ortreatment delivery 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 radiotherapydevices to synchronize image acquisition or treatment deliverywith the acquired motion information. |
| Significant differences: | • Automated beam-hold when monitoring tolerances are exceeded(TrueBeam platform only) and the associated software and -hardware changes.• Interface changes (ADI / EXGI) related to the automated beam-hold functionality.• Removal of Patient ID (including welcome desk) and PatientSetup (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.
§ 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.