(236 days)
Not Found
No
The description mentions "digital image analysis and video tracking software" but does not use terms like AI, ML, deep learning, or neural networks, which are typically associated with AI/ML technologies in medical devices. The functionality described appears to be based on traditional image processing and tracking algorithms.
No.
The device's intended use is to synchronize the radiation beam with the patient's respiratory cycle, which is a control mechanism for radiation delivery, not a direct therapeutic action on the patient.
No.
The device characterizes respiratory patterns to trigger beam-hold and limit beam-on time during radiation therapy. While it monitors a physiological process, its primary function is to control a treatment system based on real-time data, not to diagnose a disease or condition. Its use is described as "to characterize (in simulation) the patient's respiratory patterns," which is for treatment planning and execution, not for diagnosis.
No
The device description explicitly mentions hardware components such as a video camera, PC workstation with digitization and display hardware, and a relay and I/O board, in addition to the software.
Based on the provided information, the Varian RPM Respiratory Gating device is not an IVD (In Vitro Diagnostic) device.
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. This testing is done outside of the body ("in vitro").
- Varian RPM Respiratory Gating Function: The Varian RPM Respiratory Gating device works by tracking the patient's external chest motion using a video camera. It uses this information to control the timing of radiation therapy delivery.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It directly interacts with the patient's external body and the radiation therapy equipment.
Therefore, the Varian RPM Respiratory Gating device falls under the category of a medical device used for treatment delivery and control, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
To obtain tracking of the subject respiratory pattern for radiation therapy treatment.
The Varian RPM Respiratory Gating device is an attachment to the radiation therapy simulator and Varian Clinac radiation therapy treatment system. It is to be used to characterize (in simulation) the patient's respiratory patterns and then, in treatment, 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.
Product codes
90IXO, 90LNH
Device Description
The video-based RPM Respiratory Gating System provides a respiration gating signal to a Clinac radiation therapy machine to "hold" the beam during planned intervals of the respiration cycle. The system derives beam-hold signals from the patient chest motion, which it tracks using a video camera connected to a PC workstation. The computer includes real-time and multi-channel video digitization and display hardware controlled by digital image analysis and video tracking software that runs as a Windows NT application. The PC also includes a relay and I/O board that under software control opens and closes the Clinac gating switch for beam-hold control.
The RPM Respiratory Gating System receives live video images from a monochrome CCD video camera equipped with an infrared ring illuminator. When used for planning, the RPM Respiratory Gating System receives images from both the camera and a simulator or fluoroscope. For treatment use, the RPM Respiratory Gating System receives images from the camera.
Before the operator can work with the system, the operator must create or select patient and session data records from a patient information database. The operator then records new data or displays recorded data for the current patient and session.
When the system is used for planning, the treatment is simulated. The operator sees live fluoroscopic images of the simulated treatment field, which are used to set the gating thresholds applied to the motion plots simultaneously generated by tracking the respiration motion. When used for treatment, the radiation beam is actively gated by the system, so that the beam is held (not irradiating) when the motion is outside the thresholds set in the planning session.
Mentions image processing
digital image analysis and video tracking software
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video Camera, Fluoroscope, Simulator
Anatomical Site
chest motion, upper abdomen 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
NIMS Respitrace System, K864886
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
JUN 8 1999
K98 3629
Date Summary was prepared;
October 13, 1998
Submitter's Name:
Varian Oncology Systems 3045 Hanover Street Palo Alto. CA 94304
Contact Person:
Linda S Nash Regulatory Compliance & Radiation Safety Manager Phone (650) 424-6990 (650) 424-4830 FAX E-Mail linda.nash@os.varian.com
Device Name:
RPM Respiratory Gating System
Classification Name:
Radiographic ECG/Respirator Synchronizer, 90IXO
Predicate Device:
NIMS Respitrace System, K864886
Product Description:
The video-based RPM Respiratory Gating System provides a respiration gating signal to a Clinac radiation therapy machine to "hold" the beam during planned intervals of the respiration cycle. The system derives beam-hold signals from the patient chest motion, which it tracks using a video camera connected to a PC workstation. The computer includes real-time and multi-channel video digitization and display hardware controlled by digital image analysis and video tracking software that runs as a Windows NT application. The PC also includes a relay and I/O board that under software control opens and closes the Clinac gating switch for beam-hold control.
The RPM Respiratory Gating System receives live video images from a monochrome CCD video camera equipped with an infrared ring illuminator. When used for planning, the RPM Respiratory Gating System receives images from both the camera and a simulator or fluoroscope. For treatment use, the RPM Respiratory Gating System receives images from the camera.
1
Before the operator can work with the system, the operator must create or select patient and session data records from a patient information database. The operator then records new data or displays recorded data for the current patient and session.
When the system is used for planning, the treatment is simulated. The operator sees live fluoroscopic images of the simulated treatment field, which are used to set the gating thresholds applied to the motion plots simultaneously generated by tracking the respiration motion. When used for treatment, the radiation beam is actively gated by the system, so that the beam is held (not irradiating) when the motion is outside the thresholds set in the planning session.
Intended Use:
To obtain tracking of the subject respiratory pattern for radiation therapy treatment.
Technological Characteristics:
See the attached "Comparison of Characteristics and Specifications Table".
2
Table 2 shows substantial functional equivalence of RPM Respiratory Gating System and Respitrace technologies as respiratory monitoring devices. Only the specifications that respirated woman of RPM Respiratory Gating System are compared in the table.
| Characteristic/Specification | RPM Respiratory
Gating System | Respitrace | Comments |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Objects physically
attached to patient | Light foam block
with retro-reflective
marker on it
attached to upper
abdomen area | Respiband inductive
coil ribbon wrapped
around the patient
stomach or rib cage | |
| Wire connections
made to patient | None | Wires connecting
Respiband to the
computer and
control box | |
| Measured parameter | Vertical position of
the marker attached
to abdomen in video
camera field of view | Respitrace output
voltage is a measure
of inductance of
Respiband coil
wrapped around the
abdomen or rib
cage. Inductance
varies with the
length of the coil,
which in turn varies,
with circumference
of the band wrapped
around the body. | RPM Respiratory
Gating System
responds to the
motion of the whole
body as well as
respiratory motion,
while Respitrace
responds to motion
only due to
abdomen or rib cage
size change. |
| Maximum signal
range | 0 to 479 (row
position in vertical
field of view of
video image) for
NTSC video
camera. | -5V to +5V | RPM Respiratory
Gating System
vertical camera field
of view varies as a
function of camera-
marker block
distance. For the
RPM Respiratory
Gating System
optics the vertical
FOV as a function
of distance is:
V-FOV = 0.12 *
Distance. |
| | | | For example at 250-
cm distance the V-
FOV is 30 cm. |
| Measurement
resolution | 0.1 pixels standard
deviation | 1 mV | The RPM
Respiratory Gating
System resolution is
equivalent to 1 /
4800 of V-FOV.
This translates to
$0.1 * 30 / 480 =$
0.00625 cm, or
0.0625 mm at 250
cm distance. |
| Measurement drift | None | 10 mV per second | |
| Sampling rate | 30 Hz | 200 samples/sec for
A/D converter. The
Respitrace output
signal bandwidth is
25 Hz. | |
| Distance to patient | 15 Ft Maximum
patient-camera
distance | 10 Ft Respitrace
cable length | |
Table 2 – Comparison of characteristics and specifications of RPM Respiratory Gating System and Respitrace
3
·
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1999 JUN
Linda Nash Regulatory Affairs & Quality Assurance Manager Varian Oncology Systems 3045 Hanover Street M/S H055 Palo Alto, California 94304-1129
Re:
K983629 RPM Respiratory Gating System Dated: March 8, 1999 Received: March 10, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 LNH Regulatory Class: I 21 CFR 892.1970/Procode: 90 IXO
Dear Ms. Nash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Varian Oncology System
Indications For Use
510(k) Number (if known):
Device Name: RPM Respiratory Gating
Indications for Use:
The Varian RPM Respiratory Gating device is an attachment to the radiation therapy simulator and Varian Clinac radiation therapy treatment system. It is to be used to characterize (in simulation) the patient's respiratory patterns and then, in treatment, 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (per 21 CFR 801.109) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K983629 |
|---|---|
| --------------- | --------- |