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.

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.

The Gating Reflector Block (Figure 01) has the following major components:

Body
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.

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.

AI/ML Overview

The provided text describes the regulatory filing for a medical device called the "Gating Reflector Block" (GRB). It is a passive hardware accessory used in radiotherapy to track patient motion, primarily respiratory patterns. The filing (K242874) seeks to register the GRB as an individual product, as it was previously cleared as an accessory to other Varian devices.

Based on the provided document, the device (Gating Reflector Block) is a passive hardware device and does not involve an AI algorithm, software, or human-in-the-loop performance studies as described in the prompt's requirements (e.g., MRMC studies, training/test sets, ground truth establishment for AI/software). Therefore, many of the requested details about acceptance criteria and studies (especially those related to AI/software performance) are not applicable to this specific device.

However, I can provide information based on the performance testing that was conducted for this hardware device, which focuses on safety and physical performance characteristics.

Here's a breakdown of the acceptance criteria and study information that is applicable:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/software device. Instead, the "acceptance criteria" for a passive hardware device like the GRB are met through demonstrated compliance with relevant standards and successful completion of specific non-clinical tests. The "performance" is reported as the successful demonstration of functionality and safety.

Acceptance Criteria Category	Reported Device Performance (Summary of Study Results)
Biocompatibility	Concluded to possess a low level of biological risk with an acceptable level of patient safety, conducted according to ISO 10993-1:2018 and FDA Guidance.
Cleaning, Disinfection, Sterilization, Reprocessing (Cleaning Validation)	Cleaning validation was conducted according to AAMI, ISO standards, and FDA guidelines, assessing the effectiveness of the provided cleaning procedure. The device is supplied nonsterile and is reusable/cleanable.
Product Verification and Validation Testing	Underwent formal design verification and validation testing, including usability testing, demonstrating that the device performs as intended.
Compliance with Quality System Regulations & Standards	Testing was performed according to FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard.
Physical Design & Functionality	Consistent physical design (light plastic block with 4 passive reflective markers), dimensions (88mm x 77mm x 53mm), material (ABS 737), and positioning method (on patient's upper abdomen/chest) with the predicate. Measures vertical, lateral, and longitudinal position.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of an AI/software test set. The testing performed was validation and verification of the physical device and its reprocessing instructions. These tests are typically conducted on a representative sample of devices, but a "test set" in the sense of a dataset for algorithm evaluation is not relevant here.
Data Provenance: Not applicable. This refers to physical device testing, not data collection for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth establishment by experts is relevant for AI/software diagnosis/prognosis, not for a passive hardware device like the GRB. The "ground truth" for this device's performance relates to its physical properties, functionality, and safety as determined through engineering and biological testing.

4. Adjudication method for the test set

Not applicable. Adjudication methods are used in studies involving human interpretation or AI output, not for the physical performance validation of a hardware device.

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

No. An MRMC study is relevant for AI-assisted diagnostic or clinical decision support software. The Gating Reflector Block is a passive hardware device for motion tracking, not an AI or software product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a passive hardware component. It does not contain an algorithm or software. Its performance is intrinsically linked to its use within a larger system (like the Respiratory Gating System Scanners) rather than as a standalone algorithmic product.

7. The type of ground truth used

The "ground truth" for this device's acceptance is based on:
- Engineering specifications and measurements: For dimensions, material properties, and marker effectiveness.
- Standardized test methods: For biocompatibility (e.g., ISO 10993 series) and cleaning validation (AAMI, ISO standards).
- Regulatory compliance: Adherence to FDA Quality System Regulation (21 CFR §820), ISO 13485, and ISO 14971.
- Demonstrated performance: The device "performs as intended" based on product verification and validation.

8. The sample size for the training set

Not applicable. This device is a passive hardware component, not an AI system that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this hardware device.

In Summary:

The K242874 filing for the Gating Reflector Block pertains to a physical medical device accessory. The "acceptance criteria" and "study" described in the document are focused on demonstrating the device's physical performance, safety, and compatibility with existing Varian systems through non-clinical testing and adherence to established regulatory and industry standards, rather than evaluating an AI algorithm's diagnostic or predictive capabilities. The device has been on the market for 13 years with approximately 27,000 units in the field, further supporting its established performance and safety.

Summary

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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). 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.

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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" (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 QS 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 Rule"). 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-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-regulatory

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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

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Indications for Use

510(k) Number (if known) K242874

Device Name Gating Reflector Block

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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K242874 Premarket Notification - 510(k) Summary

Gating Reflector Block

l. 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

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The key performance characteristics of the device are as follows:

1. Consists of 4 radix lenses and can be tracked by infrared cameras.
1. Precise locating features for position and orientation
1. Passive hardware device
1. Non-sterile device
1. Suitable for patient contact on intact skin
1. It is reusable and cleanable.

The Gating Reflector Block (Figure 01) has the following major components:

1. Body
1. 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.

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

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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

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Comparison of Technological Characteristics with the Predicate Device VII.

Table 1 Comparison of Subject Device to Predicate Device

Features and/orspecification	Predicate DeviceRespiratory Gating for Scanners 2.0K213927(Gating Reflector Block is listed as a requiredaccessory of RGSC v2.0)	Subject DeviceGating Reflector Block	Comparison
Device Name	Respiratory Gating for Scanners v2.0Gating Reflector BlockThe Gating Reflector block is a requiredaccessory of Respiratory Gating for Scannersv2.0 cleared under K213927	Gating Reflector Block	Changed.Gating Reflector Block was cleared as arequired accessory for Respiratory Gatingfor Scanners v2.0 in K213927 and will nowbe registered as an individual product.
Intended use	Respiratory Gating for Scanners (RGSC) isused to characterize the patient's respiratorypatterns, providing the necessary informationto diagnostic devices to acquire imagessynchronized with the breathing motion.RGSC can also be used to monitor the patientposition during the image acquisition.[The Gating Reflector Block is a requiredaccessory of RGSC cleared under K213927]RPM Gating Marker Block and GatingReflector Block are intended to be usedtogether with radiotherapy delivery systemsor respiratory gating and motionmanagement systems to track breathingpattern and / or other patient motions duringa treatment or image acquisition.	The Gating reflector block is intended tobe used together with radiotherapydelivery systems or respiratory gatingand motion management systems totrack breathing pattern and / or otherpatient motions during a treatment orimage acquisition.	Changed.Gating Reflector Block was cleared as arequired accessory for Respiratory Gatingfor Scanners v2.0 in K213927 and will nowbe registered as an individual product.A separate intended use statement is nowdefined 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 foruse	Respiratory Gating for Scanners (RGSC) isused to characterize the patient's respiratorypatterns, providing the necessary informationto diagnostic devices to acquire imagessynchronized with the breathing motion.RGSC can also be used to monitor the patientposition during the image acquisition.	The Gating Reflector Block is anaccessory medical device indicated foradult and pediatric patients undergoingradiotherapy treatment simulationand/or delivery. GRB is a reusabledevice indicated for monitoring patientmotion including respiratory patterns.	Changed.Gating Reflector Block was cleared as arequired accessory for Respiratory Gatingfor Scanners v2.0 in K213927.A separate indications for use statement isnow defined for the Gating Reflector Block.To allow for use with all compatibledelivery systems pediatric population hasbeen specified with the gating reflectorBlock. While the Respiratory Gating forScanners v2.0 does not include pediatricpopulation in its indications for use, it hasbeen adopted from its other parent deviceTrueBeam. The TrueBeam indications foruse is inclusive of pediatric population.
CompatibleDelivery Systems	Respiratory Gating Scanners (RGSC)[K213927]RPM Gating for Scanners 1.7MR1 [K102024]HET system [K213977]:● TrueBeam● TrueBeam STx● Vitalbeam● Edge	Respiratory Gating Scanners (RGSC)[K213927]RPM Gating for Scanners 1.7MR2[K102024]HET system [K213977]:● TrueBeam● TrueBeam STx● Vitalbeam● Edge	Substantially the same.
Design	Light plastic block with passive reflectivemarkers (4 dots)	Light plastic block with passive reflectivemarkers (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(ABS) 737	Acrylonitrile-Butadiene-StyreneCopolymer (ABS) 737	No change.
Features and/orspecification	Predicate DeviceRespiratory Gating for Scanners 2.0K213927(Gating Reflector Block is listed as a requiredaccessory of RGSC v2.0)	Subject DeviceGating Reflector Block	Comparison
Positioning	Positioned typically on the patient's upperabdomen or chest area within the videocamera's field of view during use.	Positioned typically on the patient's upperabdomen or chest area within the videocamera's field of view during use.	No change.
MeasuredParameters	Vertical, lateral, and longitudinal position ofthe gating reflector block.	Vertical, lateral, and longitudinalposition of the gating reflector block.	No change.
	Alignment markers are located on the sidesand top of the device to allow positioning andisocenter locations.	Alignment markers are located on thesides and top of the device to allowpositioning and isocenter locations.
Sterility	Provided nonsterile	Provided nonsterile	No change.
Packaging	Available in pack of 5	Available in pack of 5	No change.
Reprocessing,Sterility and Shelflife	Manual Cleaning	Manual Cleaning	No change in cleaning method.The Instructions for Use clarifies the GatingReflector Blocks cleaning process.
Patientcontactingcomponents	The cover and the body are made up of ABS737	The cover and the body are made up ofABS 737	No change.

510(k) Summary Traditional 510(k) Application Gating Reflector Block

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varian

A Siemens Healthineers Company

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varian

A Siemens Healthineers Company

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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.

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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.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.