(59 days)
No
The device is described as a passive hardware device with reflective markers. The processing of the reflected light is done by a camera and parent devices, not by the Gating Reflector Block itself, and there is no mention of AI or ML in the description of the device's function or components.
No.
The device is an accessory used for monitoring patient motion, specifically respiratory patterns, during radiotherapy treatment simulation and delivery. It does not provide any therapeutic effect itself but rather supports the treatment process by acting as a surrogate for tracking patient motion.
No.
The device is an accessory used for tracking patient motion, specifically respiratory patterns, during radiotherapy treatment simulation and delivery. It does not diagnose any medical condition but rather provides data for other systems to use in guiding treatment.
No
The device description explicitly states it is a "passive hardware device" with physical components (Body, Reflective Markers) and undergoes hardware-specific testing (Biocompatibility, Cleaning, Verification/Validation).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Gating Reflector Block is a passive hardware device that is placed on the patient's body (chest or abdomen) to track their respiratory motion using optical markers. It does not interact with or analyze any biological specimens.
- Intended Use: Its intended use is for monitoring patient motion during radiotherapy simulation and delivery, not for diagnosing or monitoring a disease through the analysis of biological samples.
The device is an accessory to other medical devices used in radiotherapy and motion management, but its function is purely mechanical/optical tracking of external movement, not in vitro analysis.
N/A
Intended Use / 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.
Product codes
JAK
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's upper abdomen or chest area
Indicated Patient Age Range
adult and pediatric 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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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
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) | |
|---|---|
| ☑ 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
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.
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The key performance characteristics of the device are as follows:
-
- Consists of 4 radix lenses and can be tracked by infrared cameras.
-
- Precise locating features for position and orientation
-
- Passive hardware device
-
- Non-sterile device
-
- Suitable for patient contact on intact skin
-
- It is reusable and cleanable.
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.
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.
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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
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.
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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
specification | Predicate Device
Respiratory Gating for Scanners 2.0
K213927
(Gating Reflector Block is listed as a required
accessory of RGSC v2.0) | Subject Device
Gating Reflector Block | Comparison |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Respiratory Gating for Scanners v2.0
Gating Reflector Block
The Gating Reflector block is a required
accessory of Respiratory Gating for Scanners
v2.0 cleared under K213927 | Gating Reflector Block | Changed.
Gating Reflector Block was cleared as a
required accessory for Respiratory Gating
for Scanners v2.0 in K213927 and will now
be registered as an individual product. |
| Intended use | Respiratory Gating for Scanners (RGSC) is
used to characterize the patient's respiratory
patterns, providing the necessary information
to diagnostic devices to acquire images
synchronized with the breathing motion.
RGSC can also be used to monitor the patient
position during the image acquisition.
[The Gating Reflector Block is a required
accessory of RGSC cleared under K213927]
RPM Gating Marker Block and Gating
Reflector Block are 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. | 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. | Changed.
Gating Reflector Block was cleared as a
required accessory for Respiratory Gating
for Scanners v2.0 in K213927 and will now
be registered as an individual product.
A separate intended use statement is now
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
use | Respiratory Gating for Scanners (RGSC) is
used to characterize the patient's respiratory
patterns, providing the necessary information
to diagnostic devices to acquire images
synchronized with the breathing motion.
RGSC can also be used to monitor the patient
position during the image acquisition. | 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. | Changed.
Gating Reflector Block was cleared as a
required accessory for Respiratory Gating
for Scanners v2.0 in K213927.
A separate indications for use statement is
now defined for the Gating Reflector Block.
To allow for use with all compatible
delivery systems pediatric population has
been specified with the gating reflector
Block. While the Respiratory Gating for
Scanners v2.0 does not include pediatric
population in its indications for use, it has
been adopted from its other parent device
TrueBeam. The TrueBeam indications for
use is inclusive of pediatric population. |
| Compatible
Delivery 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 reflective
markers (4 dots) | Light plastic block with passive reflective
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
(ABS) 737 | Acrylonitrile-Butadiene-Styrene
Copolymer (ABS) 737 | No change. |
| Features and/or
specification | Predicate Device
Respiratory Gating for Scanners 2.0
K213927
(Gating Reflector Block is listed as a required
accessory of RGSC v2.0) | Subject Device
Gating Reflector Block | Comparison |
| Positioning | Positioned typically on the patient's upper
abdomen or chest area within the video
camera's field of view during use. | Positioned typically on the patient's upper
abdomen or chest area within the video
camera's field of view during use. | No change. |
| Measured
Parameters | Vertical, lateral, and longitudinal position of
the gating reflector block. | Vertical, lateral, and longitudinal
position of the gating reflector block. | No change. |
| | Alignment markers are located on the sides
and top of the device to allow positioning and
isocenter locations. | Alignment markers are located on the
sides and top of the device to allow
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,
Sterility and Shelf
life | Manual Cleaning | Manual Cleaning | No change in cleaning method.
The Instructions for Use clarifies the Gating
Reflector Blocks cleaning process. |
| Patient
contacting
components | The cover and the body are made up of ABS
737 | The cover and the body are made up of
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
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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.