Varian Head Frame

K142560 · Varian Medical Systems, Inc. · IYE · Dec 11, 2014 · Radiology

Device Facts

• Record ID: K142560
• Device Name: Varian Head Frame
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended 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.

Device Story

The Varian Head Frame is a rigid immobilization device for stereotactic radiosurgery and radiotherapy. It consists of a head ring and four invasive cranial pins (screws) that penetrate the skin to contact the skull bone, ensuring patient stability during CT imaging and treatment delivery on a charged particle accelerator. The frame is secured to the treatment couch via a mounting bracket. It is used in clinical settings by radiation oncology staff. By preventing patient movement, the device ensures precise targeting of cranial lesions, tumors, and other conditions requiring radiation, thereby improving treatment accuracy and patient safety.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed conformance to specifications and proper function of hazard safeguards. Biocompatibility testing (irritation, sensitization, acute systemic injection) and cleaning validation requirements were met.

Technological Characteristics

Materials: PEEK and aluminum cranial pins; nickel-plated anodized aluminum/delrin head ring posts. Fixation: Four-pin invasive skull contact. Sterilization: EtO for pins and posts; steam for head ring assembly. Connectivity: None (mechanical device). Standards: ANSI/AAMI/ISO 10993-1, -5, -10, -11; IEC 60601-1; IEC 60601-1-6; IEC 62366.

Indications for Use

Indicated for patients requiring stereotactic radiosurgery or radiotherapy for cranial lesions, tumors, and conditions where radiation treatment is indicated, necessitating rigid skull immobilization during imaging and treatment.

Regulatory Classification

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.

Predicate Devices

• Optical Guidance Platform (K071360)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

K142560

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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# 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: [phone] 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/<br>SPECIFICATION | OPTICAL GUIDANCE PLATFORM<br>510(k) ID #K071360 | HEAD FRAME V1.0 |
|--------------------------------|-------------------------------------------------|-----------------|
| Head ring patient<br>fixation: | Four pins | Four pins |

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# Premarket Notification [510(k)] Summary Varian Head Frame

| Materials: | Cranial pins: Delrin and aluminum<br>Head ring: nickel-plated anodized<br>aluminum/delrin posts | Cranial pins: PEEK and aluminum<br>Head ring: nickel-plated anodized<br>aluminum/delrin posts |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | Sterilization: | EtO for the cranial pins and head ring<br>posts;<br>Steam sterilization for the head ring<br>assembly only |
| Rigid fixation<br>mechanism: | | Head ring to a couch mount |
| Anatomy/head/neck<br>fixation (immobilization): | • Stereotactic head ring (FrameArray);<br>• commercially available head and<br>head & neck restraint systems, e.g.<br>based on the thermoplastic masks<br>attached to couch mount or floor<br>stand (FramelessArray) | Stereotactic head ring, head ring<br>posts and cranial screws/pins<br>only |
| Couch mount degrees of<br>freedom: | 3 DoF couch mount | 0 axes – requires TrueBeam 6<br>DoF couch |
| Positioning and<br>Localization features: | • Optical tracking of infrared markers.<br>• Ultrasound imaging.<br>• Active IR elements on SonArray array<br>and on FrameArray headring array;<br>• passive reflectors on FramelessArray<br>bite block and Body Array;<br>• optical tracking of infrared markers<br>connected to bite block and BodyLoc | Not Applicable - Immobilization<br>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.