(35 days)
Not Found
Not Found
No
The summary describes a computer-controlled system for radiation delivery with image guidance and tracking, but it does not mention AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
Yes.
The device is intended to provide treatment for lesions, tumors, and conditions, indicating a therapeutic purpose.
No
The provided text describes the CyberKnife System as being "intended to provide treatment planning and image guided stereotactic radiosurgery and precision radiotherapy." It clearly states its purpose is for "delivering radiation to the treatment target," which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the CyberKnife System includes hardware components such as a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem, in addition to computer control and software.
Based on the provided information, the CyberKnife System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- CyberKnife System Function: The CyberKnife System is described as a system for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy. It uses radiation to treat lesions, tumors, and conditions within the body.
- Lack of Sample Analysis: The description does not mention any analysis of samples taken from the body. The system works by delivering radiation directly to the target area within the patient.
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 System for Stereotactic Radiosurgery/Radiotherapy is intended to provide 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
90 MUJ
Device Description
The CyberKnife 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 sophisticated target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking and tracking of implanted fiducials for dynamic positioning and pointing of the linear accelerator.
Mentions image processing
Not Found
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
SEP - 3 2003
032345
APPENDIX F. 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 570 Del Rey Avenue Sunnyvale, California 94085 Ph: (408) 522-3740 Fax: (408) 522-3749
Contact Person
Anne Schlagenhaft
Date Prepared
July 29, 2003
Device Name
Trade Name:CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Classification Name: Medical linear accelerator
Device Description
The CyberKnife 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 sophisticated target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking and tracking of implanted fiducials for dynamic positioning and pointing of the linear accelerator.
Intended Use
The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Substantial Equivalence
The CyberKnife System with the FAST algorithm is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same.
1
Image /page/1/Picture/1 description: The image shows a logo with a stylized depiction of three birds in flight. The birds are represented by thick, curved lines, suggesting movement and freedom. To the left of the birds, there is a circular shape with text arranged around its perimeter, although the text is not clearly legible due to the image quality. The overall design is simple yet symbolic, likely representing a company or organization associated with nature, aviation, or a similar theme.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2003
Ms. Anne Schlagenhaft Senior Regulatory Affairs Associate Accuray Incorporated 570 Del Rey Avenue SUNNYVALE CA 94085
Re: K032345
Received: August 4, 2003
Trade/Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle Radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: July 29, 2003
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); 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,
2
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K_o32 345
CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Device Name:
Indications For Use:
The CyberKnife 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR (Per 21 CFR 801.109) Over-The-Counter Use
David G. Sumn
510(k) Num
(Optional Format 1-2-96)