(64 days)
CyberKnife System
Not Found
No
The description focuses on image-guided tracking and robotic control, without mentioning AI or ML algorithms for image analysis, treatment planning, or tracking. The performance studies also focus on verifying tracking software performance against existing systems, not on validating AI/ML model performance.
Yes
The device is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions, and conditions anywhere in the body, which directly constitutes a therapeutic purpose.
No
Explanation: The device is described as a system for "treatment planning and image-quided stereotactic radiosurgery and precision radiotherapy" and "accurately deliver radiation to the treatment target." While it uses diagnostic X-ray system to locate the target, its primary function is therapeutic (delivering radiation) rather than diagnosing diseases or conditions.
No
The device description explicitly mentions hardware components such as a linear accelerator, manipulator (robot), and a diagnostic X-ray system, indicating it is a hardware-based medical device with integrated software.
Based on the provided information, the CyberKnife and CyberKnife VSI Systems are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The CyberKnife system is a therapeutic device that delivers radiation directly to a patient's body. It uses imaging (X-rays) to guide the treatment, but it does not analyze biological samples like blood, urine, or tissue.
- The intended use is for treatment planning and delivery of radiation. The description clearly states the system is for "treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body." This is a therapeutic purpose, not a diagnostic one based on in vitro analysis.
Therefore, the CyberKnife system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CyberKnife and CyberKnife VSI Systems are intended to provide treatment planning and image-quided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.
The CyberKnife® Robotic Radiosurgery System and CyberKnife VSI™ Robotic Radiosurgery System are 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.
Product codes
IYE
Device Description
The CyberKnife Robotic Radiosurgery System and CyberKnife VSI Robotic Radiosurgery System are computer controlled medical systems 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 target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife and CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
anywhere in the body, brain, bony, skull base, nasopharyngeal, neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder.
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
Archived images from CyberKnife patient lung treatments were used to test tracking performance which proved to be equivalent to the predicate CyberKnife tracking systems.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was done to verify that the new tracking software, performs as designed, as well as regression testing to verify integrity of existing features. Archived images from CyberKnife patient lung treatments were used to test tracking performance which proved to be equivalent to the predicate CyberKnife tracking systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CyberKnife System
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.
0
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) 789-4260
Contact Person
Anne Schlagenhaft
Date Prepared September 30, 2010
Device Name
Trade Names: CyberKnife VSI™ Robotic Radiosurgery System CyberKnife® Robotic Radiosurgery System Common Name: Radiosurgery/radiotherapy treatment planning and delivery system Classification Name: Medical charged particle radiotherapy device
Device Description
The CyberKnife Robotic Radiosurgery System and CyberKnife VSI Robotic Radiosurgery System are computer controlled medical systems 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 target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife and CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute.
Intended Use
The CyberKnife and CyberKnife VSI Systems are intended to provide treatment planning and image-quided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.
NOV 1 7 2010
1
The CyberKnife Systems may be used to treat astrocytoma, glioma, skull base tumors, metastases (brain and bony), nasopharyngeal carcinoma, meningioma, acoustic neuroma, schwannoma, pituitary adenoma, hemangioblastoma, craniopharngioma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, and tumors of the neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder. Patients should be examined by a team of physicians to determine if they are candidates for CyberKnife treatment.
Substantial Equivalence
The CyberKnife and CyberKnife VSI Systems are substantially equivalent to the predicate CyberKnife System. The source energy, beam properties, design, materials and other physical properties are the same or equivalent to the predicate CyberKnife Testing included in the premarket notification demonstrated that the System. performance characteristics of the device are equivalent to the predicate CyberKnife System.
Testing was done to verify that the new tracking software, performs as designed, as well as regression testing to verify integrity of existing features. Archived images from CyberKnife patient lung treatments were used to test tracking performance which proved to be equivalent to the predicate CyberKnife tracking systems.
The intended use, principles of operation, technological characteristics and labeling are the same or equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the eagle. The text is arranged in a circular fashion around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
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
Ms. Anne Schlagenhaft Senior Regulatory Affairs Associate Accuray Incorporated 1301 Chesapeake Terrace SUNNYVALE CA 94089
NOV 1 7 2010
Re: K102650
Trade/Device Name: CyberKnife® Robotic Radiosurgery System and 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: September 13, 2010 Received: September 23, 2010
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code 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 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements 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 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 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,
Signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K102650 Device Name: CyberKnife® Robotic Radiosurgery System and CyberKnife VSI™ Robotic Radiosurgery System Indications For Use:
The CyberKnife® Robotic Radiosurgery System and CyberKnife VSI™ Robotic Radiosurgery System are 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) AND/OR
Over-The-Counter Use (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) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
Division of Radiological Devices
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K 5102650
Page 1 of