(24 days)
Not Found
Not Found
No
The summary describes a robotic radiotherapy system with image-guided tracking, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
Yes
The device is intended to provide treatment planning and deliver radiation treatment for lesions, tumors, and conditions, which are therapeutic actions.
No.
The device is described as a treatment planning and delivery system for stereotactic radiosurgery and precision radiotherapy, indicating its use for therapeutic purposes rather than 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 In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the CyberKnife System is for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy. This involves delivering radiation to treat lesions, tumors, and conditions within the body.
- Device Description: The description details a system with a radiation generator, linear accelerator, robot, and target locating subsystem used to deliver radiation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The CyberKnife System does not perform this function. It is a therapeutic device that acts on the body.
Therefore, the CyberKnife System is a therapeutic medical device, not an IVD.
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 IYE
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. The CyberKnife System uses skull tracking, fiducial tracking and skeletal structure tracking for dynamic positioning and pointing of the linear accelerator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
JUN 1 0 2004 APPENDIX F. 510(k) SUMMA
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
April 15, 2004
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 target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking, fiducial tracking and skeletal structure tracking 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 Skeletal Structure Tracking algorithm is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2004
Ms. Anne Schlagenhaft Sr. Regulatory Affairs Associate Accuray, Inc. 1310 Chesapeake Terrace SUNNYVALE CA 94089
Re: K041315 Trade/Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: May 14, 2004 Received: May 17, 2004
Dear Ms. Schlagenhaft:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becaller of the device is substantially equivalent (for the indications Ferenced as re and no no sure) to legally marketed predicate devices marketed in interstate for use stared in the encreative) to togals. John Medical Device Amendments, or to econimores 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). and Cosmotion (110. (110.) that be nevice, subject to the general controls provisions of the Act. The I va may, therefere, marris of the Act include requirements for annual registration, listing of general controls provisions 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 such additional controls. Existing major regulations affecting your device can thay be subject to satin additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I DX has made a ceternmanulations administered by other Federal agencies. You must comply or any I cocar statures and reguirements, including, but not limited to: registration and listing (21 CFR Part with an the Ace I requirements and in good manufacturing practice requirements as set forth in the our); faboning (21 CFR Part 820); and if applicable, the electronic product quality Systems (QS) issues (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) I ins letter will anow you to oegh manceang your device of your device to a legally premarket notheation: "The PDF intrally stimally 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 If you desire specific arvice for your 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 Additionally, for questions on into property of the regulation entitled, "Misbranding Other of Comphanos at (201) example (21CFR Part 807.97) you may obtain. Other general by recrence to premation notified.com (er the Act may be obtained from the Division of Small mormation on your responser Assistance at its toll-free number (800) 638-2041 or Mandrarerors, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
3
510(k) Number (if known): K_0-413 12
Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy
Indications For Use:
The CyberKnife System is indicated for treatment planning and image guided The Cybertifies Bystein is marecision radiotherapy for lesions, tumors and stereofactic radiobargery and pody 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 Usc
OR (Per 21 CFR 801.109) Over-The-Counter Use_
(Optional Format 1-2-96)
David De Sygnm
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number .