RPM RESPIRATORY GATING SYSTEM by VARIAN MEDICAL SYSTEMS

The RPM Respiratory Gating System is used to obtain tracking of the subject respiratory pattern for respiratory synchronized image acquisition and radiation therapy treatment. It can also be used to monitor the patient position during image acquisition, simulation and treatment.

Device Description

The Varian RPM Respiratory Gating is an attachment to radiation therapy treatment systems such as conventional linear accelerators, proton therapy systems, radiation therapy simulators and image acquisition devices used for diagnostics and radiation therapy. The RPM device is to be used to characterize the patient's respiratory motion information to synchronize their operation with the respiratory motion. The imaging devices either trigger the image acquisition based on the signal received from RPM, or they use respiratory motion signal to trigger beam-hold and limit the beam-on time to those points in the respiratory cycle where the target volume is within acceptable motion limits. The RPM device can also be used to monitor the patient's position during the image acquisition and treatment therapy process.

AI/ML Overview

The RPM Respiratory Gating System is an attachment to radiation treatment systems used to characterize a patient's respiratory motion for synchronized image acquisition and radiation therapy treatment, and to monitor patient position during these processes.

1. Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary for a substantial equivalence claim, not a detailed study report with specific acceptance criteria and performance data. The table below summarizes the features and specifications of the device, comparing the previously cleared predicate device with the current device. The implication is that the performance of these features meets acceptable standards for the intended use, as no changes were made to these core functional specifications.

Feature and/or Specification of New/Modified Device	Cleared Device Feature/Specification	Device With Change
Intended Use	Tracking respiratory pattern for synchronized image acquisition and radiation therapy treatment; monitoring patient position during image acquisition, simulation, and treatment.	No change
Indications for Use	Tracking respiratory pattern for synchronized image acquisition and radiation therapy treatment; monitoring patient position during image acquisition, simulation, and treatment.	No change
Objects physically attached to patient	Light plastic block with retro-reflective markers (2 or 6 dots), typically on upper abdomen or chest.	No change
Wire connections made to patient	None	No change
Measured parameters	Vertical, lateral, and longitudinal position of the marker block.	No change
Maximum signal range	32 cm vertical by 41 cm lateral at 380 cm working distance (50 mm lens); 29 cm vertical by 38 cm lateral at 180 cm working distance (25 mm lens).	No change
Measurement resolution (at 380 cm, 50 mm lens)	Vertical: 0.013 cm; Lateral: 0.023 cm; Longitudinal: 0.055 cm.	No change
Measurement resolution (at 180 cm, 25 mm lens)	Vertical: 0.004 cm; Lateral: 0.002 cm; Longitudinal: 0.018 cm.	No change
Measurement drift	None	No change
Distance to patient	15 ft maximum patient-camera distance.	No change
Compatible with radiation therapy treatment devices	Yes (Varian accelerators)	Varian Linear Accelerators, Proton therapy Systems that are capable of being gated.
Compatible with radiation therapy simulators	Yes	No change
Compatible with Image acquisition systems	Yes (General interface); support for triggered/gated and 4D image acquisition.	No change
Supported patient coaching methods	Audio and/or visual	No change
Supported breathing methods	Free-breathing, voluntary breath-hold	No change
Patient position monitoring	Yes	No change
Recognition and management of periodicity changes	Yes	No change
Support for phase-based and amplitude-based gating	Both phase and amplitude based gating	No change

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

The document states, "Results of verification and validation testing demonstrate that the RPM Respiratory Gating System satisfies the intended use as described above." However, this 510(k) summary does not provide specific details on:

The sample size used for the test set.
The country of origin of the data.
Whether the data was retrospective or prospective.

Given that this is a 510(k) for a device with "No change" to most of its core features and specifications compared to a predicate device, it's highly probable that the "verification and validation testing" referred to was an internal engineering and performance evaluation, rather than a clinical study with human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the 510(k) summary. Given the absence of specific clinical study details, it's unlikely that "experts" were formally used to establish ground truth in the context of clinical accuracy for this type of device in this submission. The "ground truth" would more likely refer to established engineering benchmarks and measurements of physical parameters.

4. Adjudication Method for the Test Set:

This information is not provided in the 510(k) summary.

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:

This type of study is not applicable to the RPM Respiratory Gating System as described. This device is an attachment to radiation therapy systems for tracking respiratory patterns and monitoring patient position. It is not an AI-assisted diagnostic or interpretive tool that would involve human readers or affect their diagnostic performance.

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

The device itself is a standalone system in the sense that it performs its function of tracking respiratory patterns and providing gating signals without direct human interpretation of the tracking data in real-time. The "verification and validation testing" mentioned would assess the standalone performance of its measurement accuracy, resolution, drift, and compatibility. However, the details of such standalone testing are not explicitly described in terms of methodology or specific results.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The type of "ground truth" for this device would relate to the physical accuracy of its measurements (e.g., how accurately it measures the position of the marker block, its resolution, and drift). This would be established through engineering standards and calibrated measurement tools, not typically through expert consensus, pathology, or outcomes data, which are more relevant for diagnostic or prognostic devices.

8. The Sample Size for the Training Set:

This information is not provided and is likely not relevant for this device. The RPM Respiratory Gating System, as described, is a sensing and tracking system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on established optical tracking principles.

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

This information is not provided and is likely not relevant for this device, as it does not appear to use a training set in the machine learning context.

Summary

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OCT 1 5 2010 Premarket Notification [510(k)] Summary RPM Respiratory Gating System

K102024

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The following information is provided following the format of 21 CFR 807.92.

Submitter's Name:	Varian Medical Systems, Inc.3100 Hansen Way e-110Palo Alto, CA 94304
Contact Name: Vy TranPhone: 650/424.5731Fax: 650/842.5040Date: 14 July 2010
Proprietary Name:	RPM Respiratory Gating System
Classification Name:	Medical charged-particle radiation therapy system21 CFR 892.5050, Class IIProduct Code: IYE, LHN
Common/Usual Name:	RPM Respiratory Gating System
Predicate Devices:	RPM Respiratory Gating System (K063270)
Device Description:	The Varian RPM Respiratory Gating is an attachment to radiationtherapy treatment systems such as conventional linearaccelerators, proton therapy systems, radiation therapy simulatorsand image acquisition devices used for diagnostics and radiationtherapy. The RPM device is to be used to characterize the patient'srespiratory motion information to synchronize their operation withthe respiratory motion. The imaging devices either trigger theimage acquisition based on the signal received from RPM, or theyuse respiratory motion signal to trigger beam-hold and limit thebeam-on time to those points in the respiratory cycle where thetarget volume is within acceptable motion limits. The RPM devicecan also be used to monitor the patient's position during the imageacquisition and treatment therapy process.
Statement of Intended Use	The RPM Respiratory Gating System is used to obtain tracking of thesubject respiratory pattern for respiratory synchronized imageacquisition and radiation therapy treatment. It can also be used tomonitor the patient position during image acquisition, simulation andtreatment.
Statement of Indications for Use:	The RPM Respiratory Gating System is used to obtain tracking of thesubject respiratory pattern for respiratory synchronized imageacquisition and radiation therapy treatment. It can also be used to

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monitor the patient position during image acquisition, simulation and treatment.

FEATURE AND/OR SPECIFICATION OFNEW/MODIFIED DEVICE	CLEARED DEVICE FEATURE/SPECIFICATION	DEVICE WITH CHANGE
Intended Use	The RPM Respiratory Gating System isused to obtain tracking of the subjectrespiratory pattern for respiratorysynchronized image acquisition, andradiation therapy treatment. It can be alsoused to monitor the patient position duringthe image acquisition, simulation andtreatment.	No change
Indications for Use	The RPM Respiratory Gating System isused to obtain tracking of the subjectrespiratory pattern for respiratorysynchronized image acquisition, andradiation therapy treatment. It can be alsoused to monitor the patient position duringthe image acquisition, simulation andtreatment.	No change
Objects physically attached to patient	Light plastic block with retro-reflectivemarkers (2 or 6 dots), positioned typicallyon patient's upper abdomen or chest area.	No change
Wire connections made to patient	None	No change
Measured parameters	Vertical, lateral and longitudinal position ofthe marker block, which is typicallypositioned on patient's abdomen or chest invideo camera field of view.	No change
Maximum signal range	32 cm vertical by 41 cm lateral at 380 cmworking distance from video camera with 50mm lens;29 cm vertical by 38 cm lateral at 180 cmworking distance from the camera with 25mm lens.	No change
Measurement resolution	At 380 cm distance from the camera using50 mm lens (cm):Vertical: 0.013Lateral: 0.023Longitudinal: 0.055At 180 cm distance from the camera using25 mm lens (cm):Vertical: 0.004Lateral: 0.002Longitudinal: 0.018	No change
Measurement drift	None	No change
Distance to patient	15 ft maximum patient-camera distance	No change
Compatible with radiation therapytreatment devices	Yes (Varian accelerators)	Varian Linear Accelerators, Proton therapySystems that are capable of being gated.
Compatible with radiation therapysimulators	Yes	No change
FEATURE AND/OR SPECIFICATION OFNEW/MODIFIED DEVICE	CLEARED DEVICE FEATURE/SPECIFICATION	DEVICE WITH CHANGE
Compatible with Image acquisitionsystems used in radiation oncology anddiagnostics.	Yes (General interface)Support for both triggered/gated and 4Dimage acquisition.	No change
Supported patient coaching methods	Audio and/or visual	No change
Supported breathing methods	Free-breathing, voluntary breath-hold	No change
Patient position monitoring	Yes	No change
Recognition and management ofperiodicity changes in respiratorypattern	Yes	No change
Support for phase based and amplitudebased gating	Both phase and amplitude based gating	No change

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Summary of Performance Testing

(

Results of verification and validation testing demonstrate that the RPM Respiratory Gating System satisfies the intended use as described above.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.

Public Health Service

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

Ms. Vy Tran Vice President Varian Medical Systems 3100 Hansen Way PALO ALTO CA 94304

0CT 1 5 2010

Re: K102024

Trade/Device Name: RPM Respiratory Gating System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 14, 2010 Received: July 19, 2010

Dear Ms. Tran:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Dan

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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OCT .1 5 2010

Indications for Use

510(k) Number (if known):

K102024

Device Name:

: …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

RPM Respiratory Gating System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K.	K102024
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Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.