(29 days)
No reference devices were used in this submission
No
The description focuses on infrared tracking and image processing for motion detection and synchronization, without mentioning AI or ML algorithms.
No
The device is described as a "respiratory motion monitoring device" used to "characterize the patient's respiratory patterns" and "monitor the patient position during the image acquisition," providing information to "diagnostic devices to acquire images synchronized with the breathing motion." It does not directly treat or alleviate a medical condition.
No.
Explanation: The "Intended Use" section explicitly states that the device "provides the necessary information to diagnostic devices to acquire images synchronized with the breathing motion," indicating it is an accessory to, rather than a diagnostic device itself. Its purpose is to assist diagnostic devices, not to diagnose.
No
The device description explicitly lists hardware components such as a cabinet, reflector block, camera system, and visual coaching device. The performance studies also include hardware verification and validation testing.
Based on the provided information, the Respiratory Gating for Scanners (RGSC) device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- RGSC's Intended Use: The RGSC's 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.
- RGSC's Mechanism: The device works by tracking the physical motion of a reflector block placed on the patient's body using an infrared camera. It does not analyze any biological specimens from the patient.
- Integration with Diagnostic Devices: The RGSC provides information to diagnostic devices (CT and PET CT scanners) to improve image acquisition, but it is not performing the diagnostic test itself.
In summary, the RGSC is a device that assists in the process of acquiring diagnostic images by monitoring and synchronizing with the patient's breathing. It does not perform any analysis of biological samples, which is a key characteristic of an IVD.
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 (comma separated list FDA assigned to the subject device)
JAK
Device Description
Respiratory Gating for Scanners (RGSC) is a respiratory motion monitoring device used in the breathing-synchronized acquisition of images on CT and/or PET CT Scanners. It first received FDA clearance in 2015 (K151533). The device consists of the RGSC cabinet (containing workstation unit & real-time unit for user control and interaction), a gating reflector block placed on the patient, a camera system which is used to monitor the reflector block and report the patient's respiratory motion to the workstation, and a visual coaching device. RGSC is operated primarily by radiologist technicians and/or radiotherapists with current licensure and/or certification as required by regional authority, in accordance with the prescription of radiologist or a radiation oncologist and under the general supervision of chief technologists and/or medical physicists, as required by regional authority.
The concepts in the operation of the device include:
-
- Breathing-synchronized image acquisition
-
- Breathing motion tracking and recording
-
- Tracking, recording, and triggering with prospective and retrospective gating for diagnostic imaging
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 with four reflective markers which face the direction of the camera 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
January 14, 2022
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Varian Medical Systems, Inc. % Peter Coronado Senior Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K213927
Trade/Device Name: Respiratory Gating for Scanners v2.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: December 15, 2021 Received: December 16, 2021
Dear Mr. Peter 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213927
Device Name Respiratory Gating for Scanners v2.0
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) |
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Image /page/3/Picture/0 description: The image contains three blue circles in a horizontal row. The circles are evenly spaced and appear to be the same size. The background is white, which makes the blue circles stand out.
Image /page/3/Picture/1 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern.
Varian Medical Systems
3100 Hansen Way Palo Alto, CA 94304 650.493.4000 800.544.4636 varian.com
510(k) Summary (K213927)
The following information is provided as required by 21 CFR 807.92.
| SUBMITTER | |
|---|---|
| Name and Address: | Varian Medical Systems, Inc. |
| 3100 Hansen Way, m/s E110 | |
| Palo Alto, CA 94304 | |
| Contact Person: | Peter J. Coronado |
| Senior Director, Regulatory Affairs | |
| Phone: 650-424-6320 Fax: 650-646-9200 | |
| submissions.support@varian.com | |
| Date Prepared: | January 11, 2022 |
| SUBJECT DEVICE | |
| Subject Device Name: | Respiratory Gating for Scanners v2.0 |
| Common/Usual Name: | Respiratory Gating for Scanners |
| Regulation: | 21 CFR 892.1750 |
| Classification Name: | Computed Tomography X-Ray System |
| Regulatory Class: | Class II |
| Product Code: | JAK |
| PREDICATE DEVICE | |
| Predicate Device Name: | Respiratory Gating for Scanners (K151533) |
| Reference Device(s): | No reference devices were used in this submission |
DEVICE DESCRIPTION
Respiratory Gating for Scanners (RGSC) is a respiratory motion monitoring device used in the breathingsynchronized acquisition of images on CT and/or PET CT Scanners. It first received FDA clearance in 2015 (K151533). The device consists of the RGSC cabinet (containing workstation unit & real-time unit for user control and interaction), a gating reflector block placed on the patient, a camera system which is used to monitor the reflector block and report the patient's respiratory motion to the workstation, and a visual coaching device. RGSC is operated primarily by radiologist technicians and/or radiotherapists with current licensure and/or certification as required by regional authority, in accordance with the
4
Image /page/4/Picture/0 description: The image shows three blue circles in a row. The circles are all the same size and color. The circles are evenly spaced apart from each other. The background is white.
Image /page/4/Picture/1 description: The image shows the logo for Varian, a Siemens Healthineers company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is black and white.
arian Medical System 3100 Hansen War Palo Alto, CA 9430 800 544 4636 varian.com
prescription of radiologist or a radiation oncologist and under the general supervision of chief technologists and/or medical physicists, as required by regional authority.
The concepts in the operation of the device include:
-
- Breathing-synchronized image acquisition
-
- Breathing motion tracking and recording
-
- Tracking, recording, and triggering with prospective and retrospective gating for diagnostic imaging
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 with four reflective markers which face the direction of the camera is in transitory contact with the patient's skin for a limited amount of time (