(20 days)
Not Found
Not Found
No
The summary describes a computer-controlled system for radiation delivery, but does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical imaging or treatment planning. The "image-guided" aspect refers to standard image processing for targeting, not necessarily AI-driven analysis or decision-making.
Yes
The device is described as providing "treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy" for "lesions, tumors and conditions anywhere in the body when radiation treatment is indicated," indicating its use in treating medical conditions.
No
The CyberKnife System is described as a treatment planning and delivery system for radiation therapy, not a device used for diagnosis.
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 System is not an IVD (In Vitro Diagnostic).
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 lesions, tumors and conditions anywhere in the body when radiation treatment is indicated." This describes a therapeutic device that delivers radiation to treat conditions within the body.
- Device Description: The description details components like a "treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem" used to "accurately deliver radiation to the treatment target anywhere in the body." This further reinforces its role in delivering therapy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CyberKnife System does not perform any such analysis of bodily specimens.
Therefore, the CyberKnife System is 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
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 target locating subsystem to accurately deliver radiation to the treatment target anywhere in the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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 1 4 2005 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 1310 Chesapeake Terrace Sunnyvale, California 94089 Ph: (408) 716-4600 Fax: (408) 716-4601
Contact Person
Anne Schlagenhaft
Date Prepared
August 18, 2005
Device Name
Trade Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Classification Name: Medical charged-particle radiation therapy system
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 target locating subsystem to accurately deliver radiation to the treatment target anywhere in the body.
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 subject modifications is substantially equivalent to the predicate devices. The intended use, principles of operation, and technological characteristics are the same.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines representing wings or feathers.
Public Health Service
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Anne Schlagenhaft Sr. Regulatory Affairs Associate Accuray Incorporated 1310 Chesapeake Terrace SUNNVALE CA 94089
Re: K052325
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: MUJ
Dated: August 23, 2005 Received: August 25, 2005
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.
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 Scetion 5 IO(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence and thus premarket notification. The FDA Inding of Sabstantial equice 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), pleased If you desire specific advice for your device on our laboring regarities (
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "fulsomation on your responsibilities under the Act from the 807.97). You may obtain other general mionnal and Consumer Assistance at its toll-free number (800) DIVIsion of Cities of Cities of or at its Internet address 056-2011 07 (2019/04/2011/industry/support/index.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_ S2 S2 - 32 - 32 - 32 - 32 - 32 - 32 - 3
Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy
Indications For Use:
The CyberKnife System is indicated for treatment planning and image-guided The CyberKille System is murcated for treatherapy for lesions, tumors and stereofactic radiosurgery and procession readiation 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
ાર (Pcr 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Nancy C. Bragdon
(Division Sign-Off Division of Reproductive. and Radiological Devices 510(k) Number