(78 days)
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Not Found
No
The description focuses on robotic control, image guidance, and tracking technologies, without mentioning AI or ML.
Yes
The device is described as a "Robotic Radiosurgery System" that "provide[s] treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy" for "tumors, lesions and conditions" with a "treatment radiation generator." This demonstrates that the device directly applies a therapeutic intervention.
No
Explanation: The device is described as a "Robotic Radiosurgery System" intended for "treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy." Its function is to deliver radiation treatment, not to diagnose conditions.
No
The device description explicitly states it is a "computer controlled medical system" that includes hardware components such as a "treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem".
Based on the provided information, the CyberKnife VSI™ Robotic Radiosurgery System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body." This describes a therapeutic device that delivers radiation to treat conditions within the body.
- Device Description: The description details a system involving a linear accelerator, robot, and target locating subsystem to deliver radiation. This aligns with a radiotherapy device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, urine, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment decisions.
IVD devices are specifically designed to perform tests on samples taken from the human body. The CyberKnife VSI operates directly on the patient's body to deliver radiation therapy.
N/A
Intended Use / Indications for Use
The CyberKnife VSI Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.
Product codes
IYE
Device Description
The CyberKnife VSI Robotic Radiosurgery System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife VSI uses skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
anywhere in the body
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 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) 789-4264
Contact Person
Anne Schlagenhaft
Date Prepared June 30, 2009
Device Name
Trade Name: CyberKnife VSI™ Robotic Radiosurgery System Classification Name: Medical charged particle radiotherapy device
Device Description
The CyberKnife VSI Robotic Radiosurgery System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife VSI uses skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.
Intended Use
The CyberKnife VSI Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.
Substantial Equivalence
The CyberKnife VSI 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/1/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
SEP 1 8 2009
Ms. Anne Schlagenhaft Senior Regulatory Affairs Associate Accuray, Inc. 1310 Chesapeake Terrace SUNNYVALE CA 94089
Re: K091999
Trade/Device Name: CyberKnife VSI™ Robotic Radiosurgery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 21, 2009 Received: August 24, 2009
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 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 (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
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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,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance, Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris Acting 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): K091999
Device Name: CyberKnife VSI™ Robotic Radiosurgery System Indications For Use:
The CyberKnife VSI™ Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE),
Hoppe thitzhg
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 19/990 510(k) Number
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