(66 days)
No reference devices were found to be explicitly identified in the text. The section for "Reference Device(s)" is marked as "Not Found."
No
The summary describes image processing for tracking a physical object (reflector block) and does not mention any AI or ML techniques being used for this processing or for characterizing respiratory patterns.
No
The device is described as an accessory to diagnostic devices (CT and PET CT Scanners) used to characterize respiratory patterns and synchronize image acquisition, not for treatment.
No
Explanation: The "Intended Use / Indications for Use" section states that RGSC provides "necessary information to diagnostic devices to acquire images synchronized with the breathing motion." It explicitly positions itself as providing information to diagnostic devices, rather than being a diagnostic device itself.
No
The device description explicitly lists multiple hardware components including a cabinet, infrared camera, reflector block, and visual coaching device, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "characterize the patient's respiratory patterns, providing the necessary information to diagnostic devices to acquire images synchronized with the breathing motion." It also monitors patient position. This is a physical measurement and synchronization function, not a diagnostic test performed on biological samples.
- Device Description: The device tracks the physical movement of a reflector block on the patient's body using infrared light. It processes this positional data to synchronize imaging. It does not analyze biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition.
- No mention of biological samples: The description explicitly states "No biologics or drugs are in this device". There is no indication that the device interacts with or analyzes any biological material from the patient.
- Accessory to imaging systems: It is described as an "accessory" to CT and PET CT Scanners, which are diagnostic imaging devices, but the RGSC itself is not performing the diagnostic imaging or analysis of the images for diagnostic purposes.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that definition.
N/A
Intended Use / Indications for Use
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.
Product codes
JAK
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 (
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
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.
1
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
2
Indications for Use
510(k) Number (if known) K151533
Device Name Respiratory Gating for Scanners
Indications for Use (Describe)
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.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Varian Medical Systems, Inc. Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038
Telephone: 1.650.493.4000 Toll Free: 800.544.4636
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 Systems
3100 Hansen Way, m/s E-110
Palo 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 |
4
IV. 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 (