(44 days)
The Synchrony Respiratory Tracking System provides an option to the CyberKnife Robotic Radiosurgery System and CyberKnife VSI Robotic Radiosurgery System that enables dynamic image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
Irradiation of lesions that move during breathing, such as those located in the lung or near the diaphragm, are typically performed during patient breath-holds. The Synchrony Tracking System option to the CyberKnife System is designed to treat lesions while they are moving during the respiratory cycle. This offers the ability to reduce normal tissue exposure by using smaller irradiation margins, shorten treatment times, increase accuracy and provide more comfort for the patient.
During respiratory tracking, a correspondence between surface (e.g., thorax/abdomen) movement and movement of the target lesion is developed prior to the start of treatment and is regularly updated during treatment each time the CyberKnife System acquires a new pair of x-ray images. This correspondence is then used to estimate lesion position in real time by monitoring surface movement during treatment.
The Synchrony Tracking System provides the CyberKnife System with the capability to monitor the patient's respiration and command the robot manipulator to compensate for the treatment target motion within the body, in real-time, while the radiation is being delivered.
The Synchrony Respiratory Tracking System includes a sensor assembly, tracking targets, electronics to translate signals, and a controller.
There is no information about acceptance criteria or a study that proves the device meets acceptance criteria in the provided text. The document is a 510(k) summary and an FDA clearance letter, which primarily discuss the device's description, intended use, and substantial equivalence to a predicate device, but do not detail performance studies or acceptance criteria.
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510(k) SUMMARY
MAR - 9 2012
1202333
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name, Address, Phone and Fax number of the Applicant
Accuray Incorporated 1310 Chesapeake Terrace Sunnyvale, California 94089 Ph: (408) 716-4600 Fax: (408) 716-4601
Contact Person
Anne Schlagenhaft
Date Prepared
December 6, 2011
Device Name
Trade Name: Synchrony Respiratory Tracking System, an option to the CyberKnife® Robotic Radiosurgery System and CyberKnife VSI" Robotic Radiosurgery System Classification Name: Medical charged particle radiotherapy device
Device Description
Irradiation of lesions that move during breathing, such as those located in the lung or near the diaphragm, are typically performed during patient breath-holds. The Synchrony Tracking System option to the CyberKnife System is designed to treat lesions while they are moving during the respiratory cycle. This offers the ability to reduce normal tissue exposure by using smaller irradiation margins, shorten treatment times, increase accuracy and provide more comfort for the patient.
During respiratory tracking, a correspondence between surface (e.g., thorax/abdomen) movement and movement of the target lesion is developed prior to the start of treatment and is regularly updated during treatment each time the CyberKnife System acquires a new pair of x-ray images. This correspondence is then used to estimate lesion position in real time by monitoring surface movement during treatment.
The Synchrony Tracking System provides the CyberKnife System with the capability to monitor the patient's respiration and command the robot manipulator to compensate for the treatment target motion within the body, in real-time, while the radiation is being delivered.
The Synchrony Respiratory Tracking System includes a sensor assembly, tracking targets, electronics to translate signals, and a controller.
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Intended Use
The Synchrony® Respiratory Tracking System is an option to the CyberKnife® Robotic Radiosurgery System and CyberKnife VSI™ Robotic Radiosurgery System and is intended to enable dynamic image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
Substantial Equivalence
The Synchrony® Respiratory Tracking System is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same or equivalent.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAR - 9 2012
Ms. Anne Schlagenhaft Senior Regulatory Affairs Specialist Accuray Incorporated 1310 Chesapeake Terrace SUNNYVALE CA 94089
Re: K120233
Trade/Device Name: Synchrony® Respiratory Tracking System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: January 20, 2012 Received: January 25, 2012
Dear Ms. Schlagenhaft:
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 for associated in the 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 I ou may, diereleve, mannet 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, additional 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 1 Tease be advisod and 1 1 1 1 mination that your device complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must or any I 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
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mequirements 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 predicated." The 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,
Janine M. Morris
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known):
Device Name: Synchrony® Respiratory Tracking System
Indications for Use:
The Synchrony Respiratory Tracking System provides an option to the CyberKnife Robotic Radiosurgery System and CyberKnife VSI Robotic Radiosurgery System that enables dynamic image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Pastel
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120233
Page 1 of
§ 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.