(135 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms. The description focuses on camera-based motion monitoring and standard software verification/validation.
No.
This device is for monitoring and positioning patients during radiotherapy, not for providing therapy itself.
No
The device is indicated for positioning patients and monitoring patient motion during radiotherapy treatment, not for diagnosing medical conditions.
No
The device description explicitly states it is a "system for motion monitoring" and mentions "high precision SGRT cameras," indicating the presence of hardware components beyond just software. The performance studies also include hardware verification and validation testing, as well as electrical safety and EMC testing, further confirming it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "positioning of patients, and for monitoring patient motion including respiratory patterns" during radiotherapy. This is a direct interaction with the patient for treatment purposes, not for examining specimens in vitro (outside the body).
- Device Description: The description reinforces this by stating it's a "system for motion monitoring during radiotherapy treatment simulation and delivery." It focuses on patient positioning and motion detection.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on samples, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on the patient's physical position and motion during a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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)
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.
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/0 description: The image shows three blue circles in a row. The circles are all the same size and color. The circles are evenly spaced apart from each other. The background is white.
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 Systems
3100 Hansen Way
Palo Alto CA94304 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dr. Lynn Allman-Senior Director Regulatory Affairs
Phone: (650)-424-5369
E-mail: submissions.support@varian.com
Date: 24 September 2024 |
| Proprietary Name: | IDENTIFY |
| Classification Name: | accelerator, linear, medical
21CFR892.5050, 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 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. |
| 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. |
| Indications for Use: | 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. |
| 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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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.