(45 days)
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.
The Varian RPM Respiratory Gating Device is an attachment to the Varian Clinac radiation therapy treatment systems, radiation therapy simulators, and image acquisition devices used for diagnostics and radiation therapy. The RPM system senses and records the respiratory motion and respiratory state of a patient using video tracking of an optical marker placed on the patient to a location indicated by the physician. Video camera is connected to a PC workstation is used for video tracking of markers.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for the RPM Respiratory Gating System.
It describes the device, its intended use, and states that it is substantially equivalent to a predicate device based on a comparison of technological characteristics. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes, data provenance, or ground truth establishment for any test sets.
- Details on expert involvement, adjudication methods, or MRMC studies.
- Results of a standalone algorithm performance study.
The document primarily focuses on establishing substantial equivalence to a predicate device, which is the basis for 510(k) clearance, rather than presenting detailed performance study results against specific acceptance criteria.
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K063270
VARIAN
medical systems
510(k) Summary
DEC 1 4 2006
The following information is provided following the format of 21 CFR §807.92 for the RPM Respiratory Gating System.
Varian Medical Systems 1. Submitter: 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 (650) 842-5040 Fax: Email: vy.tran@varian.com Date summary was prepared: October 25th, 2006
| 2. Name of the Device: | RPM Respiratory Gating System | |
|---|---|---|
| Trade/Proprietary Name: | RPM Respiratory Gating System | |
| Common or Usual Name: | Respiratory Gating System | |
| Classification Name: | Medical Charged-particle radiation therapy system | |
| 21 CFR §892.5050 | ||
| Class II | ||
| Product Code: IYE |
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- Predicate Device: RPM Respiratory Gating K983629
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Description of the Device: The Varian RPM Respiratory Gating Device is an attachment to the Varian Clinac radiation therapy treatment systems, radiation therapy simulators, and image acquisition devices used for diagnostics and radiation therapy. The RPM system senses and records the respiratory motion and respiratory state of a patient using video tracking of an optical marker placed on the patient to a location indicated by the physician. Video camera is connected to a PC workstation is used for video tracking of markers.
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Intended Use Statement: 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.
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Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. The comparison chart demonstrates that the device is substantially equivalent to its predicate device cited in the table. This chart is located in Tab 7 of the submission.
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Image /page/1/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is in a simple, sans-serif font and is easy to read.
DEC 1 4 2006
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K063270
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: October 26, 2006 Received: October 30, 2006
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, 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/9 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, blocky font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the circle.
Protecting and Promoting Public Health.
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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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K063270
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 be also used to monitor the patient position during the image acquisition, simulation and treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number __
§ 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.