(203 days)
No
The summary does not mention AI, DNN, or ML, and the description focuses on traditional image-guided radiotherapy components.
Yes
The device is described as a treatment delivery system that provides stereotactic radiosurgery and precision radiotherapy, which are therapeutic interventions.
No
The device is described as a treatment planning, imaging, and treatment delivery system for stereotactic radiosurgery and precision radiotherapy, not for diagnosing conditions. While it uses imaging, it is for guiding treatment.
No
The device description explicitly states it is a "treatment planning, imaging, and treatment delivery system" and details hardware components like a linear accelerator, a six-access manipulator, and a treatment couch. This indicates it is a complex hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for treatment planning and delivery of radiation therapy for specific anatomical sites and conditions. This involves using imaging to guide the physical delivery of treatment to the patient's body.
- Device Description: The device description details a system with components for imaging (x-ray), treatment planning (dose calculation), and treatment delivery (linear accelerator, robotic arm, couch). These are all characteristic of a therapeutic device, not a diagnostic device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's health status based on such analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to deliver treatment based on imaging and planning, not to perform in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The CyberKnife system is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS) and cervico-thoracic spine (CTS), head and neck.
Product codes
90-IWB, 90-MUJ
Device Description
The CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy is a treatment planning, imaging, and treatment delivery system for image-guided stereotactic radiosurgery and precision radiotherapy. The treatment planning system provides 3-dimensional viewing of the patient anatomy with appropriate dose calculation of the target volume and surrounding tissue structures. The imaging system provides real-time, orthogonal x-ray images of the patient in the treatment position to verify treatment position and accuracy and provides information suitable for dynamically positioning and pointing a linear accelerator. The treatment delivery system consists of a linear accelerator which provides 6 MV x-rays. A six-access manipulator provides automated positioning and pointing of the linear accelerator. The treatment couch provides positioning of the patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
brain, base of skull (BOS), cervico-thoracic spine (CTS), head and neck
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)
Varian Clinac™ 600SR, K913174
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.
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JUL 14 1999
Image /page/0/Picture/2 description: The image is a black and white graphic design. It features a black background with white abstract shapes. There is a white oval shape that is tilted and appears to be orbiting around a central point. Two white lines are shown at the top left of the image and converge towards the bottom right, intersecting with the oval shape.
A C C U R A Y
510(k) Summary of Safety and Effectiveness
| Establishment: | Accuray Incorporated
570 Del Rey Avenue
Sunnyvale, CA 94086
(408) 522-3740 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Luanne Termeer
Regulatory Affairs Manager |
| Summary Date: | 12/20/98 |
| Device Name: | The CyberKnife™ System for Stereotactic
Radiosurgery/Radiotherapy |
| Predicate Device: | Varian Clinac™ 600SR, K913174 |
| Device Description: | The CyberKnife® System for Stereotactic
Radiosurgery/Radiotherapy is a treatment planning, imaging, and
treatment delivery system for image-guided stereotactic
radiosurgery and precision radiotherapy. The treatment planning
system provides 3-dimensional viewing of the patient anatomy
with appropriate dose calculation of the target volume and
surrounding tissue structures. The imaging system provides real-
time, orthogonal x-ray images of the patient in the treatment
position to verify treatment position and accuracy and provides
information suitable for dynamically positioning and pointing a
linear accelerator. The treatment delivery system consists of a
linear accelerator which provides 6 MV x-rays. A six-access
manipulator provides automated positioning and pointing of the
linear accelerator. The treatment couch provides positioning of the
patient. |
1
Intended Use: The CyberKnife system is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS) and cervico-thoracic spine (CTS), head and neck.
Summary of Technological Characteristics:
See the Feature Comparison Chart on the following page.
2
FEATURE COMPARISON CHART
| Feature | Varian Clinac 600SR –
K913174 | Accuray CyberKnife®
System For Stereotactic
Radiosurgery/Radiotherapy |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Use | Provide x-radiation for use in stereotactic radiosurgery.
Treatment Planning with X-Knife, K923522 | Provide treatment planning and image guided stereotactic radiosurgery and precision radiotherapy |
| Single dose and fractionated
treatments | Yes | Yes |
| Microwave band | S | X |
| X-ray energy | 6MV (standing wave linac) | 6 MV (standing wave linac) |
| Dose rate | 800 cGy/min | 300 cGy/min |
| Microwave generator | High power magnetron | High power magnetron |
| Bending magnet | In-line | In-line |
| Isocenter floor height | 128 cm | 127 cm (nominal isocenter, system is not isocentric) |
| SAD | 100 cm | 80 cm |
| End of collimator to isocenter | 23 cm | 40 cm |
| Source/target positioning | Two-axis manipulator | Six-axis manipulator |
| Treatment table | Rotates patient about third axis | Stationary |
| Mechanical Isocenter Accuracy | $≥ 0.10$ cm radius circle | $≥ 0.05$ cm RMS for all treatment nodes |
| Dosimetry system reproducibility
with position | $± 2%$ or 1 MU whichever is
greater at any fixed gantry angle | $± 3%$ or 3 MU which ever is greater
at any fixed treatment node |
| Beam collimation | Heavy metal secondary
collimators allow selection of
narrow beams sizes 12.5 to 40
mm (12 steps) | Heavy metal secondary collimators
allow selection of narrow beams
sizes 5 to 60 mm (12 steps) |
| Head restraint | BRW or GTC head ring | Laitenen Stereoadapter headframe,
K881131
Uniframe head immobilization
system, K933227 |
| Target location reference | Metal localization rods connected
to headframe | Patient's skull |
| Treatment Planning System
(TPS) | Yes | Yes |
| TPS platform | HP715/75, 64MB/1GB | SGI 440, 128MB/2GB |
| Safety interlocks | Yes | Yes |
| Emergency stop | Yes | Yes |
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the caduceus. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 14 1999
Luanne Ng Requlatory Affairs Manager Accuray, Inc. 570 Del Rey Avenue Sunnyvale, CA 94086
Re: K984563
CyberKnife™ System for Trade Name: Steriotactic Radiosurgery/Radiotherapy Regulatory Class: II Product Code: 90-IWB and 90-MUJ Dated: April 15, 1999 Received: April 16, 1999
Dear Ms. Ng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(t) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a dassification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also. please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_K984563
Device Name The CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy
Indications For Use: To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS), cervico-thoracic spine (CTS), head and neck.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rat. G. Palla
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi
510(k) Number K984563
Prescription Use
Per 21 CFR 801.109
OR
Over-The Counter Use