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.

Device Description

Respiratory Gating for Scanners (RGSC) consists of the RGSC Cabinet (Containing Workstation Unit & Real-Time Unit). Infrared Camera, Reflector Block, and Visual Coaching Device. RGSC is used in the breathing-synchronized acquisition of images on CT and/or PET CT Scanners. RGSC is an accessory to these systems. RGSC is operated primarily by radiologist technicians and/or radiotherapists, in accordance with the prescription of radiologist or a radiation oncologist and under the general supervision of a chief technologists and/or medical physicists.

The infrared camera tracks the position and motion of the reflector block, which is placed on the patient's chest or abdomen during this process. This light, plastic block has four reflective markers which face the direction of the reflector block is in transitory contact with the patient's skin for a limited amount of time (< 24 hours). The Instructions for Use provides instruction on how to properly clean the block for re-use between patients. This component is not intended for sterilization.

Within the camera housing, an illuminator ring emits the infrared light which reflects off of the markers on the reflector block back to the camera. The camera is mounted either on the wall or ceiling along the central axis of the couch at a maximum distance of 4.0 meters from the block. The camera is directly connected to the RGSC Cabinet through the back panel. The housing also contains the class II laser used to calibrate the camera. This calibration is to be performed after installation and any time the camera's position has changed.

The RGSC Cabinet houses the Workstation Unit and Real-Time Unit. The Workstation contains the RGSC application which has functions for patient file creation and storage, calibration of the system, set up, recording, and review of a reference session. The Real-Time Unit contains software for the real-time image data processing, which is used in the dynamic tracking of the reflector block. The real-time unit controls the interface to the Wireless Access Point, Camera, and the 3d Party Diagnostic Imaging Scanner.

No biologics or drugs are in this device is not intended for single use. No parts of the system are provided sterile or are intended for sterilization.

The associated accessories include:

. Keyboard and Mount for RGSC Workstation
Monitor for RGSC Workstation ●
VCD Couch Mounting Arm .
VCD Battery Packs, Charging Station, and External DC Power Supply ●
. Wireless Access Point

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Respiratory Gating For Scanners" (RGSC) device by Varian Medical Systems. While it details various non-clinical tests conducted, it explicitly states that no clinical tests were included in this submission. Therefore, it is not possible to provide acceptance criteria and a study proving the device meets those criteria from the given text.

The information below is based only on the provided document and highlights why a comprehensive answer to your request cannot be fully constructed from it:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided text for device performance. The document focuses on regulatory compliance and substantial equivalence to a predicate device, rather than specific performance metrics and their acceptance thresholds.
Reported Device Performance: No clinical performance metrics (e.g., accuracy, sensitivity, specificity, or improvement in image quality due to gating) are reported based on a clinical study in this document. The document states "The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrate that Respiratory Gating for Scanners should perform as intended in the specified use conditions." This is a general statement about meeting design intent, not specific performance against clinical acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable, as no clinical test set was used for performance evaluation (stated "No clinical tests have been included in this submission").
Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable, as no clinical test set with ground truth established by experts was used.

4. Adjudication Method:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The document explicitly states "No clinical tests have been included in this submission."

6. Standalone Performance Study:

The document implies that standalone software verification and validation testing were conducted, but these were for functional correctness, not clinical performance. It does not describe a standalone clinical performance study of the algorithm without human-in-the-loop. The system is described as an accessory to diagnostic devices, indicating human operation.

7. Type of Ground Truth Used:

Not applicable, as no clinical test set requiring ground truth was used. The verification and validation activities mentioned are typically against engineering specifications or pre-defined software requirements, not clinical ground truth.

8. Sample Size for the Training Set:

Not applicable, as no clinical data-driven training of an AI/ML algorithm is described in this submission. The device description points to a system based on infrared tracking of a reflector block, not an AI model trained on a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary from the provided document:

The 510(k) submission for Varian Medical Systems' Respiratory Gating for Scanners (RGSC) did not include clinical tests to demonstrate its performance against specific clinical acceptance criteria. The approval was based on non-clinical data, including biocompatibility, electrical safety and EMC, software verification and validation, and mechanical testing. The argument for substantial equivalence relies on the device leveraging similar technological principles as its predicate (RPM Respiratory Gating System) for respiratory tracking and gating, with identified differences not extending or adding to the intended use or affecting safety and effectiveness. The document asserts that the non-clinical data supports the safety and intended performance of the device under specified use conditions.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 13, 2015

Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K151533

Trade/Device Name: Respiratory Gating For Scanners Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 5, 2015 Received: June 8, 2015

Dear Mr. Coronado:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151533

Device Name Respiratory Gating for Scanners

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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Varian Medical Systems, Inc. Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038

Telephone: 1.650.493.4000 Toll Free: 800.544.4636

www.varian.com

510k Summary

510k Submission for Respiratory Gating for Scanners

A partner for life

As required by 21 CFR 807.92; Reference: FDA's Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]"

SUBMITTER l.

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s E-110Palo Alto CA 94304-1038
Contact Name:	Peter J. Coronado
Position:	Director, Regulatory Affairs
Phone:	1.650.424.6230
Fax:	1.650.646.9200
Email:	submissions.support@varian.com
Date Prepared:	Friday, June 5, 2015

ll. DEVICE

Name of Device:	Respiratory Gating for Scanners
Common/Usual Name:	System, X-Ray, Tomography, Computed
Classification Name:	Computed Tomography X-ray System (21CFR892.1750)
Regulatory Class:	Class II
Product Code:	JAK

PREDICATE DEVICE lll.

Name of Predicate:	RPM Respiratory Gating System
510(k) Number:	K102024

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IV. DEVICE DESCRIPTION

No biologics or drugs are in this device is not intended for single use. No parts of the system are provided sterile or are intended for sterilization.

The associated accessories include:

. Keyboard and Mount for RGSC Workstation
Monitor for RGSC Workstation ●
VCD Couch Mounting Arm .
VCD Battery Packs, Charging Station, and External DC Power Supply ●
. Wireless Access Point

V. INDICATIONS FOR USE

Indications for Use Statement: 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.

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The Indications for Use statement for RGSC is not identical to the predicate device; however, the differences do not extend or add to the intended use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have within their intended use the same application in obtaining respiratory-synchronized images and monitoring patient position during image acquisition.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Respiratory tracking and gating is the technological principle for both the subject and predicate device. It is based on using an infrared camera to recognize and monitor the position of a plastic reflector block with reflective markers placed on the patient's chest or abdomen. The collected respiratory pattern can be gated to trigger image acquisition by a CT or PET CT scanner.

At a high level, the subject and predicate devices are based on the following same technological elements:

Reflector Block Plastic Block with Reflective Markers ●
. Infrared Tracking Camera - Used to Monitor the Movement and Location of the Reflector Block
. Placement of the Block on the Abdomen or Chest of the Patient to Measure Respiratory Motion
Support for Audio or Visual Coaching to guide patient in breathing patterns
. Support for Phase-Based or Amplitude-Based gating

The following technological differences exist between the subject and predicate devices:

Use of a wireless Visual Coaching Device (VCD) with couch mounting
Use of a camera with different resolution .
Use of a different Reflector Block design ●
Support for Database Mode (connection to ARIA DB) .
Support for Wide Screen Monitor Displays ●
Introduction of Baseline Drift Display and Correction ●
. Introduction of Additional Image and Data Export Functions
The predicate device is compatible for use with radiation therapy treatment devices whereas the subject device is not compatible for use with those types of devices
The predicate device is compatible for use with radiation therapy simulators whereas the subject device is not compatible for use with those types of devices

Further details about the differences between the predicate and subject device are included in the Substantial Equivalence Discussion of this submission.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Tests: Biocompatibility Testing:

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The biocompatibility evaluation for the Reflector Block component of RGSC was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA.

The Reflector Block component of RGSC is considered skin contacting for durations of less than 24 hours. The primary material of contact in this component. ABS 737, has no identified health or environmental effects, and no leachable material can be identified under the conditions specified for use of RGSC.

Electrical Safety and Electromagnetic Compatibility (EMC):

Electrical safety and EMC testing were conducted on RGSC, consisting of the electronic components: RGSC Cabinet (Workstation Unit and Real-Time Unit), VCD, Wireless Access Point, and Infrared Camera. The system complies with the FDA Recognized Standards AAMI ANSI ES 60601-1 for Basic Safety of Medical Electrical Equipment and IEC 60601-1-2 for EMC.

Software Verification and Validation Testing:

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "major" level of concern as the device is an accessory to a device with "major" level of concern. The appropriate level software documentation is provided with reference to the relevant guidance.

Mechanical Testing:

Testing of the VCD Couch Mounting ●
Testing of the Camera Wall/Ceiling Mounting ●
Simulated Use Testing ●

Animal Study:

No animal studies have been included in this submission.

Clinical Tests:

No clinical tests have been included in this submission.

VIII. CONCLUSIONS

The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrate that Respiratory Gating for Scanners should perform as intended in the specified use conditions. The data demonstrates that RGSC is as safe and effective as and performs as well as or better than the predicate device, RPM Respiratory Gating System (K102024) for the same use in respiratory-synchronized image acquisition and patient position monitoring during image acquisition.

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.