(88 days)
Not Found
No
The description focuses on tracking respiratory patterns and synchronizing treatment based on this data, without mentioning AI/ML algorithms for analysis or prediction.
No
The device is described as an attachment to radiation therapy treatment systems, used to characterize respiratory motion and synchronize operations or monitor patient position during image acquisition and treatment. It does not treat a condition itself but rather aids in the precise delivery of therapeutic radiation.
No
Explanation: The device is described as an attachment to radiation therapy systems used for respiratory gating and patient position monitoring, not for diagnosing medical conditions. While it is used with "image acquisition devices used for diagnostics," the RPM itself does not perform the diagnostic imaging or interpretation. Its function is to characterize respiratory motion and synchronize other devices, not to diagnose.
No
The device description explicitly states it is an "attachment to radiation therapy treatment systems" and is used to "characterize the patient's respiratory motion information," implying the use of hardware components to acquire this data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The RPM Respiratory Gating System's intended use and description clearly state that it is used to track a subject's respiratory pattern and monitor patient position during image acquisition and radiation therapy. It interacts with the patient externally and does not analyze biological samples.
Therefore, the function and purpose of this device fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE, LHN
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.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of verification and validation testing demonstrate that the RPM Respiratory Gating System satisfies the intended use as described above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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OCT 1 5 2010 Premarket Notification [510(k)] Summary RPM Respiratory Gating System
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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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-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 |
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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
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):
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) | |
|---|---|
| (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K. | K102024 |
| Page 1 of 1 |