(91 days)
Not Found
No
The device description focuses on mechanical immobilization and does not mention any software or algorithms that would utilize AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is used for immobilization during treatment planning and radiation therapy, not for delivering therapeutic treatment itself.
No
The device is described as an immobilization system for treatment planning and delivery, not for diagnosing conditions. It facilitates imaging for treatment planning by holding the patient still but does not itself perform diagnostic functions like analyzing images or identifying diseases.
No
The device description explicitly details a physical head frame, screws/pins, and a bracket, indicating it is a hardware device for patient immobilization.
Based on the provided information, 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.
- 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 does not perform any tests on biological samples.
- Intended Use: The intended use is for immobilization during imaging and treatment, not for diagnostic testing of samples.
- Device Description: The description focuses on the physical components and how they are used to secure the patient's head.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on sample analysis.
Therefore, the Varian Head Frame System falls under the category of a medical device used for patient positioning and immobilization, not an In Vitro Diagnostic.
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
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
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
Results of verification and validation testing showed conformance to applicable performance requirements specifications and assured hazard safeguards functioned properly. Biocompatibilty testing requirements for irritation, sensitization, and acute systemic injection have been met. Cleaning validation test requirements have been met.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that appears to be three faces in profile, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Varian Medical Systems, Inc. % Peter J. Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K142560 Trade/Device Name: Varian Head Frame Regulation Number: 21 CFR 892.5050 Regulation Name: Regulatory Class: Class II Product Code: IYE Dated: September 9, 2014 Received: September 11, 2014
Dear Peter Coronado,
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
December 11, 2014
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
For
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Device Name
Head Frame System
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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Premarket Notification [510(k)] Summary Varian Head Frame
The following information is provided following the format of 21 CFR 807.92.
I. Submitter's Name: Varian Medical Systems, Inc. 3120 Hansen Way C-260 Palo Alto, CA 94304 Contact Name: Peter J. Coronado Phone: 650.424.5731 Fax: 650,842,5040 Date: September 2014 II. Trade Name: Varian Head Frame Common Name: Head Frame Classification Name: Medical charged-particle radiation therapy system 21 CFR 892.5050, Class II Product Code: IYE III. Predicate Device: Optical Guidance Platform: K071360 IV. 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. V. Intended Use The Varian Head Frame is for use with a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery Statement: or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated. 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 Statement 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.
VI. Technological Characteristics:
| FEATURE/
SPECIFICATION | OPTICAL GUIDANCE PLATFORM
510(k) ID #K071360 | HEAD FRAME V1.0 |
|--------------------------------|-------------------------------------------------|-----------------|
| Head ring patient
fixation: | Four pins | Four pins |
4
Premarket Notification [510(k)] Summary Varian Head Frame
| Materials: | Cranial pins: Delrin and aluminum
Head ring: nickel-plated anodized
aluminum/delrin posts | Cranial pins: PEEK and aluminum
Head ring: nickel-plated anodized
aluminum/delrin posts |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | Sterilization: | EtO for the cranial pins and head ring
posts;
Steam sterilization for the head ring
assembly only |
| Rigid fixation
mechanism: | | Head ring to a couch mount |
| Anatomy/head/neck
fixation (immobilization): | • Stereotactic head ring (FrameArray);
• commercially available head and
head & neck restraint systems, e.g.
based on the thermoplastic masks
attached to couch mount or floor
stand (FramelessArray) | Stereotactic head ring, head ring
posts and cranial screws/pins
only |
| Couch mount degrees of
freedom: | 3 DoF couch mount | 0 axes – requires TrueBeam 6
DoF couch |
| Positioning and
Localization features: | • Optical tracking of infrared markers.
• Ultrasound imaging.
• Active IR elements on SonArray array
and on FrameArray headring array;
• passive reflectors on FramelessArray
bite block and Body Array;
• optical tracking of infrared markers
connected to bite block and BodyLoc | Not Applicable - Immobilization
device only |
Results of verification and validation testing showed conformance to applicable VII. Summary of performance requirements specifications and assured hazard safeguards functioned properly. testing: Biocompatibilty testing requirements for irritation, sensitization, and acute systemic injection have been met. Cleaning validation test requirements have been met.
The Varian Head Frame System conforms in whole or in part with the following Standards conformance: standards:
| ANSI/AAMI/ISO 10993-1:2009 | ANSI/AAMI/ISO 10993-5:2009 |
|---|---|
| ANSI/AAMI/ISO 10993-10:2010 | ANSI/AAMI/ISO 10993-11:2010 |
| ANSI/AAMI/ISO 60601-1:2005 | IEC 60601-1-6:2005 |
| IEC 62366:2007 |
Conclusion: Based on the verification, validation and non-clinical 10993 standard testing, the Varian Head Frame is as safe, effective and performs as well as or better than the legally marketed device identified in section III above.