(28 days)
Not Found
No
The device description focuses solely on mechanical immobilization and does not mention any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is used for immobilization during imaging and radiation treatment, not for providing therapy itself.
No
The Varian Head Frame System is used for immobilization during imaging and treatment; it does not perform a diagnostic function itself.
No
The device description explicitly details physical hardware components (rigid halo, screws/pins, bracket) used for patient immobilization, which are not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Varian Head Frame System is a physical device used for immobilization of a patient's head during imaging and radiation treatment. It directly interacts with the patient's body (invasively) to hold them still.
- Intended Use: The intended use is for immobilization during imaging and treatment planning, and for immobilization during the treatment itself. It does not involve analyzing biological samples.
The description clearly indicates a device used on the patient for physical support and positioning, not for analyzing samples taken from the patient.
N/A
Intended Use / Indications for Use
The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The Head Frame provides rigid immobilization of a patient's skull by attaching a rigid halo (head frame) to the patient through four invasive contact points (called screws or pins) which penetrate the patient's skin and contact the bone of the skull. The head frame is secured to either the CT table or the treatment table via a bracket which is included in the system. This ensures the patient cannot easily move during imaging or treatment. This level of immobilization is generally used for stereotactic radiosurgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography scanner
Anatomical Site
cranial
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)
Results of verification and validation testing showed conformance to applicable requirements specifications and that the assured hazard safeguards functioned properly. Cleaning, sterilization and reprocessing testing validated the outlined procedures and demonstrated the Head Frame ring can be reprocessed up to 60 cycles and the posts can be reprocessed up to 286 cycles.
Clinical Tests No clinical tests have been included in this pre-market submission
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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April 2, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The text logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue.
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K180586
Trade/Device Name: Varian Head Frame Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 2, 2018 Received: March 5, 2018
Dear Mr. Coronado:
We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
1
(1-800-638-2041 or 301-796-7100).
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
Sincerely,
Michael D. O'Hara
For
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Varian Head Frame
Indications for Use (Describe)
The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com
Premarket Notification [510(k)] Summary
varian
Varian Head Frame
The following information is provided following the format of 21 CFR 807.92(c).
| Submitter's Name: | Varian Medical Systems, Inc.
3100 Hansen Way E-110
Palo Alto, CA 94304
Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200
Date: March 2, 2018 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of the Device:
Trade/ Proprietary
Names: | Varian Head Frame |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050, Class II
Product Code: IYE |
| Common/Usual
Name: | Head Frame |
| Predicate Device: | Varian Head Frame K142560 |
| Device Description: | The Head Frame provides rigid immobilization of a patient's skull by attaching a rigid halo
(head frame) to the patient through four invasive contact points (called screws or pins)
which penetrate the patient's skin and contact the bone of the skull. The head frame is
secured to either the CT table or the treatment table via a bracket which is included in
the system. This ensures the patient cannot easily move during imaging or treatment.
This level of immobilization is generally used for stereotactic radiosurgery. |
| Intended Use
Statement | The Varian Head Frame is for use with a charged particle accelerator to perform
immobilization of the treatment target for stereotactic radiosurgery or radiotherapy
treatments on cranial lesions, tumors and conditions where radiation treatment is
indicated. |
| Indications for Use
Statement | The Varian Head Frame System is for use with a computed tomography scanner to
perform imaging for treatment planning and a charged particle accelerator to perform
immobilization of the treatment target for stereotactic radiosurgery or radiotherapy
treatments on cranial lesions, tumors and conditions where radiation treatment is
indicated |
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Technological Characteristics:
| FEATURE AND/OR SPECIFICATION | VARIAN HEAD FRAME | VARIAN HEAD FRAME |
|---|---|---|
| OF NEW/MODIFIED DEVICE | ||
| (v1.0) K142560 | (v2.0) | |
| Indications for use | The Varian Head Frame System is for | The Varian Head Frame System is for |
| use with a computed tomography | use with a computed tomography | |
| scanner to perform imaging for | scanner to perform imaging for | |
| treatment planning and a charged | treatment planning and a charged | |
| particle accelerator to perform | particle accelerator to perform | |
| immobilization of the treatment | immobilization of the treatment | |
| target for stereotactic radiosurgery or | target for stereotactic radiosurgery or | |
| radiotherapy treatments on cranial | radiotherapy treatments on cranial | |
| lesions, tumors and conditions where | lesions, tumors and conditions where | |
| radiation treatment is indicated. | radiation treatment is indicated. | |
| Intended Use | The Varian Head Frame is for use with | The Varian Head Frame is for use with |
| a charged particle accelerator to | a charged particle accelerator to | |
| perform immobilization of the | perform immobilization of the | |
| treatment target for stereotactic | treatment target for stereotactic | |
| radiosurgery or radiotherapy | radiosurgery or radiotherapy | |
| treatments on cranial lesions, tumors | treatments on cranial lesions, tumors | |
| and conditions where radiation | and conditions where radiation | |
| treatment is indicated. | treatment is indicated. | |
| Head Frame Ring | Nickel-plated anodized aluminum | Nickel-plated anodized aluminum |
| Posts | Material: Delrin | Material: PEEK |
| CT | CT compatible | CT compatible |
| Sterilization: | Cleaning for the Head Frame and | Cleaning and Autoclave Sterilization |
| Posts | for the Cranial pins, Head Frame and | |
| Autoclave Sterilization for the Cranial | ||
| Pins only | Posts |
Summary of Performance Testing
Results of verification and validation testing showed conformance to applicable requirements specifications and that the assured hazard safeguards functioned properly. Cleaning, sterilization and reprocessing testing validated the outlined procedures and demonstrated the Head Frame ring can be reprocessed up to 60 cycles and the posts can be reprocessed up to 286 cycles.
Clinical Tests No clinical tests have been included in this pre-market submission
Standards conformance
The Varian Head Frame conforms with the following standards.
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IEC 62366:2007 ANSI/AAMI/ISO 10993-1:2009 ANSI/AAMI/ISO 10993-5:2009 AMSI/AAMI/ISO 10993-10:2010 AMSI/AAMI/ISO 10993-11:2010 AAMI TIR12 AAMI TIR30:2011
ANSI/AAMI ST81 ANSI/AAMI ST79 ANSI/AAMI ST35 AAMI TIR34 ASTM E2314-03 ISO 17664 ANSI/AAMI/ISO 17665-1
Conclusions
Based on the verification, validation and non-clinical cleaning and sterilization testing, the Varian Head Frame is as safe and effective and performs at least as well as the predicate device.