Who is the manufacturer of RPM RESPIRATORY GATING SYSTEM?

Varian Medical Systems filed the 510(k) submission for RPM RESPIRATORY GATING SYSTEM (K102024).

What is the FDA product code for RPM RESPIRATORY GATING SYSTEM?

IYE. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for RPM RESPIRATORY GATING SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RPM RESPIRATORY GATING SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RPM RESPIRATORY GATING SYSTEM

Q: What are the predicate devices for RPM RESPIRATORY GATING SYSTEM?

RPM Respiratory Gating System (K063270).

K102024 · Varian Medical Systems · IYE · Oct 15, 2010 · Radiology

Device Facts

Record ID	K102024
Device Name	RPM RESPIRATORY GATING SYSTEM
Applicant	Varian Medical Systems
Product Code	IYE · Radiology
Decision Date	Oct 15, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2

Intended Use

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 Story

RPM Respiratory Gating System is an external attachment for radiation therapy and imaging systems (linear accelerators, proton therapy, simulators). It tracks patient respiratory motion to synchronize imaging or beam delivery; limits radiation beam-on time to specific respiratory cycle phases where target volume is within motion limits. Input: video camera captures position of a light plastic block with retro-reflective markers placed on patient's chest or abdomen. System processes marker position (vertical, lateral, longitudinal) to generate respiratory signal. Used in clinical settings by radiation oncology staff. Output: respiratory signal used by external devices for gating/triggering or patient position monitoring. Benefits: enables motion-managed radiation therapy, reducing dose to healthy tissue by ensuring beam delivery only when target is in position.

Clinical Evidence

No clinical data. Performance established via bench testing and verification/validation of system functionality, including signal tracking accuracy, measurement resolution, and compatibility with radiation therapy and imaging systems.

Technological Characteristics

System consists of a video camera and a plastic block with retro-reflective markers. Measures vertical, lateral, and longitudinal position of markers. Supports phase-based and amplitude-based gating. Compatible with Varian linear accelerators and proton therapy systems. Connectivity via general interface for triggered/gated image acquisition. Operates at distances up to 15 ft. No wire connections to patient.

Indications for Use

Indicated for patients undergoing radiation therapy or diagnostic imaging requiring respiratory synchronization or position monitoring. Used for tracking respiratory patterns and monitoring patient position during simulation, image acquisition, and treatment.

Regulatory Classification

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.

Predicate Devices

RPM Respiratory Gating System (K063270)

Related Devices

K063270 — RPM RESPIRATORY GATING SYSTEM · Varian Medical Systems, Inc. · Dec 14, 2006
K121845 — SDX SYSTEM · Dyn'R Sas · Oct 19, 2012
K243900 — eMotus Respiratory Motion Management System · Empnia, Inc. · Jun 27, 2025
K983629 — RPM RESPIRATORY GATING SYSTEM · Varian Medical Systems, Inc. · Jun 8, 1999
K223159 — Radixact Treatment Delivery System · Accuray Incorporated · Jun 23, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ ## OCT 1 5 2010 Premarket Notification [510(k)] Summary RPM Respiratory Gating System K102024 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i ... The following information is provided following the format of 21 CFR 807.92. | Submitter's Name: | Varian Medical Systems, Inc. 3100 Hansen Way e-110 Palo Alto, CA 94304 | |-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name: Vy Tran Phone: 650/424.5731 Fax: 650/842.5040 Date: 14 July 2010 | | | Proprietary Name: | RPM Respiratory Gating System | | Classification Name: | Medical charged-particle radiation therapy system 21 CFR 892.5050, Class II Product 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 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. | | Statement of Intended Use | 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. | | Statement of Indications for Use: | 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 | {1}------------------------------------------------ monitor the patient position during image acquisition, simulation and treatment. | FEATURE AND/OR SPECIFICATION OF NEW/MODIFIED DEVICE | CLEARED DEVICE FEATURE/SPECIFICATION | DEVICE WITH CHANGE | |---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Intended Use | 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 be also used to monitor the patient position during the image acquisition, simulation and treatment. | No change | | Indications for Use | 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 be also used to monitor the patient position during the image acquisition, simulation and treatment. | No change | | Objects physically attached to patient | Light plastic block with retro-reflective markers (2 or 6 dots), positioned typically on patient's upper abdomen or chest area. | No change | | Wire connections made to patient | None | No change | | Measured parameters | Vertical, lateral and longitudinal position of the marker block, which is typically positioned on patient's abdomen or chest in video camera field of view. | No change | | Maximum signal range | 32 cm vertical by 41 cm lateral at 380 cm working distance from video camera with 50 mm lens; 29 cm vertical by 38 cm lateral at 180 cm working distance from the camera with 25 mm lens. | No change | | Measurement resolution | At 380 cm distance from the camera using 50 mm lens (cm): Vertical: 0.013 Lateral: 0.023 Longitudinal: 0.055 At 180 cm distance from the camera using 25 mm lens (cm): Vertical: 0.004 Lateral: 0.002 Longitudinal: 0.018 | 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 | | FEATURE AND/OR SPECIFICATION OF NEW/MODIFIED DEVICE | CLEARED DEVICE FEATURE/SPECIFICATION | DEVICE WITH CHANGE | | Compatible with Image acquisition systems used in radiation oncology and diagnostics. | Yes (General interface) Support for both 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 in respiratory pattern | Yes | No change | | Support for phase based and amplitude based gating | Both phase and amplitude based gating | No change | {2}------------------------------------------------ Summary of Performance Testing ( Results of verification and validation testing demonstrate that the RPM Respiratory Gating System satisfies the intended use as described above. . {3}------------------------------------------------ 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 {4}------------------------------------------------ ## Page 2 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 {5}------------------------------------------------ OCT .1 5 2010 ## Indications for Use 510(k) Number (if known): K102024 Device Name: : ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… RPM Respiratory Gating System Indications for Use: 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. 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) | | |--------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | <div>(Division Sign-Off)</div> <div>Division of Radiological Devices</div> <div>Office of In Vitro Diagnostic Device Evaluation and Safety</div> | | | 510K. | K102024 | | | Page 1 of 1 |