Gating Reflector Block

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November 21, 2024 Varian Medical Systems, Inc. % Lynn Allman Sr. Director, Regulatory Affairs 3100 Hansen Way PALO ALTO, CA 94304 Re: K242874 Trade/Device Name: Gating Reflector Block Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 20, 2024 Received: September 23, 2024 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). 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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-regulatory {2}------------------------------------------------ assistance/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, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K242874 Device Name Gating Reflector Block Indications for Use (Describe) The Gating Reflector Block is an accessory medical device indicated for adult and pediatric patients undergoing radiotherapy treatment simulation and/or delivery. GRB is a reusable device indicated for monitoring patient motion including respiratory patterns. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Submitter's Name - Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304 Contact Name: Lynn Allman, PhD., Senior Director Regulatory Affairs Phone : (650) 424-5369 E-mail : submissions.support@varian.com Date Prepared: 20 September, 2024 ### II. Device Information Proprietary Name: Gating Reflector Block Regulation Number: §892.1750 Classification Name: Computed tomography x-ray system Product Code: JAK Common name: System, X-ray, Tomography, Computed ### III. Predicate Device Proprietary Name: Respiratory Gating for Scanners v2.0 (K213927) (Gating Reflector Block is listed as a required accessory of RGSC v2.0) Regulation Number: §892.1750 Classification Name: Computed tomography x-ray system Product Code: JAK Common name: System, X-ray, Tomography, Computed ### IV. Device Description The Gating Reflector Block is a passive hardware device used for tracking the respiratory motion of the patient. It is intended to be used as an accessory to with Respiratory Gating System Scanners (K213927); TrueBeam STx™, Edge™, VitalBeam (K213977); and RPM Respiratory Gating System 1.7MR2 (K102024) to support motion management during imaging acquisition or radiation therapy treatment. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Varian logo. The logo consists of the word "varian" 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. The key performance characteristics of the device are as follows: - 1. Consists of 4 radix lenses and can be tracked by infrared cameras. - 2. Precise locating features for position and orientation - 3. Passive hardware device - 4. Non-sterile device - 5. Suitable for patient contact on intact skin - 6. It is reusable and cleanable. The Gating Reflector Block (Figure 01) has the following major components: - 1. Body - 2. Reflective Markers The device has 4 mounted optical markers such that the reflected light can be processed by a camera to quantify the displacement of the markers, thus obtaining the patient's breathing curve. The device consists of a plastic block and back plate and the optical markers. The optical lenses reflect the IR light wavelengths used by parent devices. Their arrangement ensures that the spatial displacement and the rotation of the block is detectable by optical monitoring systems. The alignment to the treatment room lasers is ensured by the printed alignment marks on the top and the sides of the block. Image /page/5/Picture/13 description: The image shows three different views of a black marker block. The marker block has four radix markers, alignment markers, and a cover. The text on the marker block includes "Rx only", "Gating Reflector Block", and a barcode. Figure 01: Gating Reflector Block The major function of the device is to act as a surrogate device for tracking patient motion. Current parent devices track respiratory motion after placing the gating block on the chest of the patient. The IR reflectors are used by the parent devices to calculate the position and rotation of the block. {6}------------------------------------------------ Image /page/6/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, sans-serif font. The logo is black and white. Note: With the parent devices, the subject device has been called by these names in addition to Gatinq Reflector Block: HET Marker Block, Reflector block, Truebeam reflector block. This 510k aims to unify this into one name 'Gating Reflector Block'. #### V. Intended Use The Gating reflector block is intended to be used together with radiotherapy delivery systems or respiratory gating and motion management systems to track breathing pattern and / or other patient motions during a treatment or image acquisition. ### VI. Indications for Use The Gating Reflector Block is an accessory medical device indicated for adult and pediatric patients undergoing radiotherapy treatment simulation and/or delivery. GRB is a reusable device indicated for monitoring patient motion including respiratory patterns. {7}------------------------------------------------ Image /page/7/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 logo is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern, and the text is clear and easy to read. ### Comparison of Technological Characteristics with the Predicate Device VII. ## Table 1 Comparison of Subject Device to Predicate Device | Features and/or<br>specification | Predicate Device<br>Respiratory Gating for Scanners 2.0<br>K213927<br>(Gating Reflector Block is listed as a required<br>accessory of RGSC v2.0) | Subject Device<br>Gating Reflector Block | Comparison | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Respiratory Gating for Scanners v2.0<br><br>Gating Reflector Block<br>The Gating Reflector block is a required<br>accessory of Respiratory Gating for Scanners<br>v2.0 cleared under K213927 | Gating Reflector Block | Changed.<br>Gating Reflector Block was cleared as a<br>required accessory for Respiratory Gating<br>for Scanners v2.0 in K213927 and will now<br>be registered as an individual product. | | Intended use | Respiratory Gating for Scanners (RGSC) is<br>used to characterize the patient's respiratory<br>patterns, providing the necessary information<br>to diagnostic devices to acquire images<br>synchronized with the breathing motion.<br>RGSC can also be used to monitor the patient<br>position during the image acquisition.<br><br>[The Gating Reflector Block is a required<br>accessory of RGSC cleared under K213927]<br><br>RPM Gating Marker Block and Gating<br>Reflector Block are intended to be used<br>together with radiotherapy delivery systems<br>or respiratory gating and motion<br>management systems to track breathing<br>pattern and / or other patient motions during<br>a treatment or image acquisition. | The Gating reflector block is intended to<br>be used together with radiotherapy<br>delivery systems or respiratory gating<br>and motion management systems to<br>track breathing pattern and / or other<br>patient motions during a treatment or<br>image acquisition. | Changed.<br>Gating Reflector Block was cleared as a<br>required accessory for Respiratory Gating<br>for Scanners v2.0 in K213927 and will now<br>be registered as an individual product.<br>A separate intended use statement is now<br>defined for Gating Reflector Block | | Features and/or | Predicate Device | Subject Device | Comparison | | specification | Respiratory Gating for Scanners 2.0 | Gating Reflector Block | | | | K213927 | | | | | (Gating Reflector Block is listed as a required | | | | | accessory of RGSC v2.0) | | | | Indications for<br>use | Respiratory Gating for Scanners (RGSC) is<br>used to characterize the patient's respiratory<br>patterns, providing the necessary information<br>to diagnostic devices to acquire images<br>synchronized with the breathing motion.<br>RGSC can also be used to monitor the patient<br>position during the image acquisition. | The Gating Reflector Block is an<br>accessory medical device indicated for<br>adult and pediatric patients undergoing<br>radiotherapy treatment simulation<br>and/or delivery. GRB is a reusable<br>device indicated for monitoring patient<br>motion including respiratory patterns. | Changed.<br>Gating Reflector Block was cleared as a<br>required accessory for Respiratory Gating<br>for Scanners v2.0 in K213927.<br>A separate indications for use statement is<br>now defined for the Gating Reflector Block.<br>To allow for use with all compatible<br>delivery systems pediatric population has<br>been specified with the gating reflector<br>Block. While the Respiratory Gating for<br>Scanners v2.0 does not include pediatric<br>population in its indications for use, it has<br>been adopted from its other parent device<br>TrueBeam. The TrueBeam indications for<br>use is inclusive of pediatric population. | | Compatible<br>Delivery Systems | Respiratory Gating Scanners (RGSC)<br>[K213927]<br>RPM Gating for Scanners 1.7MR1 [K102024]<br>HET system [K213977]:<br>● TrueBeam<br>● TrueBeam STx<br>● Vitalbeam<br>● Edge | Respiratory Gating Scanners (RGSC)<br>[K213927]<br>RPM Gating for Scanners 1.7MR2<br>[K102024]<br>HET system [K213977]:<br>● TrueBeam<br>● TrueBeam STx<br>● Vitalbeam<br>● Edge | Substantially the same. | | Design | Light plastic block with passive reflective<br>markers (4 dots) | Light plastic block with passive reflective<br>markers (4 dots) | No change. | | Dimensions | 87.7mm x 77.5 mm x 53.4 mm | 88mm x 77mm x 53 mm | Substantially the same. | | Material | Acrylonitrile-Butadiene-Styrene Copolymer<br>(ABS) 737 | Acrylonitrile-Butadiene-Styrene<br>Copolymer (ABS) 737 | No change. | | Features and/or<br>specification | Predicate Device<br>Respiratory Gating for Scanners 2.0<br>K213927<br>(Gating Reflector Block is listed as a required<br>accessory of RGSC v2.0) | Subject Device<br>Gating Reflector Block | Comparison | | Positioning | Positioned typically on the patient's upper<br>abdomen or chest area within the video<br>camera's field of view during use. | Positioned typically on the patient's upper<br>abdomen or chest area within the video<br>camera's field of view during use. | No change. | | Measured<br>Parameters | Vertical, lateral, and longitudinal position of<br>the gating reflector block. | Vertical, lateral, and longitudinal<br>position of the gating reflector block. | No change. | | | Alignment markers are located on the sides<br>and top of the device to allow positioning and<br>isocenter locations. | Alignment markers are located on the<br>sides and top of the device to allow<br>positioning and isocenter locations. | | | Sterility | Provided nonsterile | Provided nonsterile | No change. | | Packaging | Available in pack of 5 | Available in pack of 5 | No change. | | Reprocessing,<br>Sterility and Shelf<br>life | Manual Cleaning | Manual Cleaning | No change in cleaning method.<br>The Instructions for Use clarifies the Gating<br>Reflector Blocks cleaning process. | | Patient<br>contacting<br>components | The cover and the body are made up of ABS<br>737 | The cover and the body are made up of<br>ABS 737 | No change. | 510(k) Summary Traditional 510(k) Application Gating Reflector Block {8}------------------------------------------------ # varian A Siemens Healthineers Company {9}------------------------------------------------ # varian A Siemens Healthineers Company {10}------------------------------------------------ Image /page/10/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, sans-serif font. ### VIII. Summary of Performance Testing (Non-Clinical Testing) The following performance data was provided in support of the substantial equivalence determination. ## Biocompatibility Testing The biocompatibility evaluation for the subject device was conducted according to ISO 10993-1:2018: 'Biological Evaluation of a Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process" and the FDA Guidance: "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process". The evaluation concluded that the Gating Reflector Block possess a low level of biological risk with an acceptable level of patient safety. ## Cleaning, Disinfection, Sterilization, Reprocessing Gating Reflector Block is supplied nonsterile. Cleaning validation for the subject device was conducted according to AAMI, ISO standards and FDA guidelines to assess the effectiveness of the provided cleaning procedure for the device. ## Product verification and Validation testing Gating Reflector Block has undergone formal design verification and validation testing including usability testing; and it demonstrates the device performs as intended. Testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard. ## Use of Consensus Standards: The following list of FDA-recognized, voluntary consensus standards were utilized in the design and evaluation of the subject device's safety and efficacy. ### Table 2 List of Consensus Standards | Standard | | | | |-------------------|-------------|-------------|--------------| | AAMI ANSI 62366-1 | AAMI TIR12 | ISO 10993-1 | ISO 10993-10 | | ANSI AAMI ST98 | ISO 11737-1 | ISO 10993-5 | ISO 10993-18 | | ISO 10993-23 | ISO 17664-2 | | | ### IX. Summary of non-applicable Testing ### Clinical Testing No animal or clinical studies were conducted. {11}------------------------------------------------ Image /page/11/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, sans-serif font. The logo is black and white. ## Magnetic Resonance Testing (MR) No MR claims are being made; thus, the MR Safety status of the Gating Reflector Block has not been evaluated. ## Electrical Safety and Electromagnetic Compatibility (EMC) Gating Reflector Block is a passive hardware device which does not contain any electrical or mechanical components. Therefore, no EMC testing is required. No electrical safety and electromagnetic compatibility tests have been included in this submission in support of the substantial equivalence discussion. ## Software Verification and Validation Testing Gating Reflector Block is a passive hardware device which does not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination. #### X. Determination of Substantial Equivalence to the Predicate Device Gating Reflector Block has been on the market for 13 years with approximately 27,000 devices in the field and is currently cleared as an accessory with Respiratory Gating System Scanners (K213927); TrueBeam™, TrueBeam STx™, Edge™, VitalBeam (K213977); and RPM Respiratory Gating System 1.7MR2 (K102024). These devices are manufactured by Varian Medical Systems and Varian has decided to separately clear the Gating Reflector Block as a Class II accessory to medical devices. Gating Reflector retains its compatibility with all three parent devices. There is no change to the principle operation of the device. A separate indications for use and intended use statements are now defined for the Gating Reflector Block. Varian believes these changes remain substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness. No technological changes are introduced because of the separate indications for use and intended use. The results of verification and validation as well as conformance to relevant safety standards demonstrate that the device meets the safety and performance criteria. Varian considers Gating Reflector Block to be as safe and effective as the predicate and to perform at least as well as the predicate Gating Reflector Block which was prior included as an accessory to Respiratory Gating for Scanners v2.0 within K213927.