(15 days)
Not Found
Not Found
No
The summary describes a robotic radiosurgery system with various tracking technologies, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets.
Yes
The device is described as a "Robotic Radiosurgery System" and is indicated for "stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions," which are therapeutic interventions.
No
Explanation: The device description states its purpose is for "treatment planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy," indicating it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it includes hardware components such as a linear accelerator, manipulator (robot), and a target locating subsystem, in addition to being computer-controlled.
Based on the provided information, the CyberKnife® Robotic Radiosurgery System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is 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." This describes a therapeutic intervention performed directly on the patient's body, not a test performed on samples taken from the body.
- Device Description: The description details a system for delivering radiation to a target within the body using a linear accelerator, robot, and tracking systems. This is consistent with a radiotherapy device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The CyberKnife system's function is to deliver treatment, not to perform diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The CyberKnife 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.
The CyberKnife® 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.
Product codes
TYE
Device Description
The CyberKnife 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 System 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
image-guided
image guided
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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.
0
510(k) SUMMARY
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) 789-4260
SEP 2 1 2007
Contact Person
Anne Schlagenhaft
Date Prepared
September 4, 2007
Device Name
Trade Name: CyberKnife® Robotic Radiosurgery System Classification Name: Medical charged particle radiotherapy device
Device Description
The CyberKnife 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 System 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 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 Robotic Radiosurgery System is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same or equivalent.
1
Image /page/1/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES". The symbol in the center consists of three curved lines that resemble a stylized representation of a person or a bird. The logo is black and white and appears to be a scan or photocopy.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 1 2007
Ms. Anne Schlagenhaft Sr. Regulatory Affairs Associate Accuray Corporation 1310 Chesapeake Terrace SUNNYVALE CA 94089
Re: K072504
Trade/Device Name: CyberKnife® Robotic Radiosurgery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: TYE Dated: September 4, 2007 Received: September 6, 2007
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 (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/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "PA" are in the center of the seal in a bold, blocky font. Below the letters, the word "Centennial" is written in a cursive font. There are four stars at the bottom of the seal.
classing and Premoting Publio Hoalth
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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" (21 CFR 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 vours.
Nancy Chogdon
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): K072504 Device Name: CyberKnife® Robotic Radiosurgery System Indications For Use:
The CyberKnife® 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.
X 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)
tony the thang
ion Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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