Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask

K182079 · Medtec Inc. Dba Civco Medical Solutions · IYE · Sep 7, 2018 · Radiology

Device Facts

• Record ID: K182079
• Device Name: Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
• Applicant: Medtec Inc. Dba Civco Medical Solutions
• Product Code: IYE · Radiology
• Decision Date: Sep 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Solstice™ SRS Head Immobilization System (when used with customizable cushion): The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning. Solstice™ Head Immobilization System (when used with headrest): The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning. Solstat Head Immobilization System and Open-Face Thermoplastic Mask: The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.

Device Story

System comprises baseplate, bowl, locking lever, and thermoplastic mask; used in healthcare facilities for patient immobilization during radiation therapy and imaging. Solstice model allows 10º tilting for corrective positioning; Solstat model is static. Thermoplastic mask, when heated, molds to patient anatomy; open-face design enables Surface Guided Radiation Therapy (SGRT) via external camera systems. Devices attach to treatment/simulation couch via pins. Clinicians use system to stabilize patient head/neck; immobilization accuracy is <1mm for Solstice and <3mm for Solstat. Benefits include precise, reproducible patient positioning, reduced intrafraction movement, and compatibility with SGRT and MR imaging.

Clinical Evidence

Bench testing only. Intrafraction movement for Solstice system measured <1.000mm (99.73% CI) over 5 minutes and <1mm (95.45% CI) over 30 minutes. SGRT compatibility validated using VisionRT AlignRT system. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10. MR safety/artifact testing conducted per ASTM F2119-07.

Technological Characteristics

Materials: Carbon fiber, black acetal, Kydex-T, nylon, polycarbonate, polycaprolactone. Non-magnetic construction for MR compatibility. Tilting mechanism (Solstice) allows -5° to +5° adjustment. Connectivity: None (mechanical). Sterilization: Non-sterile. Biocompatibility: ISO 10993-5/10 compliant.

Indications for Use

Indicated for adult and pediatric patients requiring positioning or immobilization for radiation therapy (SRS, SRT, SGRT, electron, photon, proton) or image acquisition (CT, MR) of the head, brain, and neck.

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

• CDR Systems Prone Head and Neck Immobilization System (K122888)

Submission Summary (Full Text)

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September 7, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and most prominent.

MEDTEC Inc. dba CIVCO MEDICAL SOLUTIONS % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313

Re: K182079

Trade/Device Name: Solstice™ SRS Immobilization System; Solstat™ Immobilization System; Solstice™ Thermoplastic Mask Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: July 31, 2018 Received: August 2, 2018

Dear Mr. Job:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jeff Ballew

for Robert A. 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) K182079

#### Device Name

(1 & 2) Solstice™ SRS Immobilization System (3) Solstat™ Immobilization System ; Solstice™ Thermoplastic Mask

#### Indications for Use (Describe)

1. Solstice™ SRS Immobilization System (when used with customizable cushion):

The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition. including Computed Tomography (CT), to support treatment planning.

2. Solstice™ SRS Immobilization System (when used with headrest):

The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.

3. Solstat™ Immobilization System & Solstice™ Thermoplastic Mask:

The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and consists of the word "CIVCO" in a sans-serif font, with a small blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.

# Section 5 - 510(k) Summary

### A. Submitter Information

| Submitter Name & Address: | MEDTEC, Inc.<br>d/b/a CIVCO Medical Solutions and CIVCO Radiotherapy<br>1401 8th St. SE<br>Orange City, IA 51041 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alena Newgren, Regulatory Specialist<br>Telephone: [phone], Fax: [phone]<br>[e-mail] |
| Date Summary Prepared: | May 21, 2018 |
| Trade Name: | Solstice™ SRS Immobilization System; Solstat™<br>Immobilization System; Solstice™ Thermoplastic Mask |
| Common Name: | Tilting Head Fixation System; Static Head Fixation System;<br>Open-Face Thermoplastic Mask |
| Classification Names & Numbers: | Medical charged-particle radiation therapy system (892.5050)<br>System, Nuclear Magnetic Resonance Imaging (892.1000) |
| Device Class: | Class II |
| Review Panels: | Radiology |
| Product Codes: | IYE, LNH |

### B. Predicate Devices

The proposed devices are substantially equivalent to the following predicate devices:

| Predicate Devices | Manufacturer |
|-----------------------------------------------------------------------------------------------------------------------------|-------------------|
| Systems Prone Head and Neck Immobilization System included in<br>CDR Systems Precision Patient Positioning System (K122888) | CDR Systems, Inc. |

The purpose of this 510(k) is to 1) release new SRS/SRT/SGRT compatible system, 2) and 2) identify intended use statements for the proposed devices. CIVCO Radiotherapy has not submitted any prior submissions for the proposed devices.

### C. Device Descriptions

The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level

## www.CivcoRT.com

Corporate Office | 2303 Jones Boulevard Suite B | Coralville, IA 52241 | USA | office +1 [phone] | [e-mail]

Global Sales Office | 1401 8th Street SE | Orange City, IA 51041 | USA | office +1 [phone] | fax [phone]

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Image /page/4/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a bold, sans-serif font. A small blue circle is placed above the "V" in CIVCO. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.

allows the bowl to be tilted up to 10º in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeters. The provider can correct the patient position for simulation and treatments by tilting the device.

The Static Head Fixation (Solstat) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and cannot be tilted. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can reproduce the patient position to under 3 millimeters within a treatment cycle.

The Open-Face Thermoplastic mask is comprised of a thermoplastic mask bonded with a frame. The frame has five swivel clamps that allow secure attachment onto either the Solstice or Solstat device. When heated, the thermoplastic mask can be formed around the patient anatomy and allows the Region of Interest (ROI) to be capture by camera systems, allowing Surface Guided Radiation Therapy to occur via camera systems. The same mask will be used throughout the course of the treatment. The Open-Face style mask is ideal for Surface Guided Radiation Therapy (SGRT) via camera systems.

The Solstice Immobilization device and Solstat Immobilization device are reusable devices that are provided non-sterile. Solstat and Solstice thermoplastic are single-patient reusable and is provided non-sterile and manufactured of non-magnetic materials. The devices are used in a healthcare facility/hospital. All devices are intended to be used on adult and pediatric patients. The following models are included in this submission:

| Device<br>Family | Part No. | Device Name |
|------------------------------------|-----------------------------------|------------------------------------------------------------|
| Tilting Head<br>Fixation<br>System | CHS03 | Solstice SRS Immobilization System<br>with Type-S Base |
| | CHS04 | Solstice SRS Immobilization System<br>with Posi Style Base |
| | Static Head<br>Fixation<br>System | CHS05 |
| CHS06 | | Solstat Immobilization System with Posi<br>Style Base |
| Open Face<br>Thermoplastic<br>Mask | | MTAPCIN1832SG |
| | MTAPCIN1832SG | Thermoplastic Mask, Narrow Frame, Open<br>Face |

### www.CivcoRT.com

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Image /page/5/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font. The "V" in CIVCO has a light blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.

#### D. Indications for Use/Intended Use Statements

#### Indications for Use:

Solstice™ SRS Head Immobilization System (when used with customizable cushion): The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.

#### Solstice™ Head Immobilization System (when used with headrest):

The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.

#### Solstat Head Immobilization System and Open-Face Thermoplastic Mask:

The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.

#### Device-Specific Intended Use:

#### Solstice SRS Head Immobilization:

The device is intended to immobilize the patient by encapsulating the head and provide corrective tilting of the head for treatment and simulation.

Solstat Head Immobilization System and Open-Face Thermoplastic Mask: The device is intended to immobilize the patient by encapsulating the head for treatment and simulation such as MRI.

### E. Comparison of Technological Characteristics

Technological characteristics that have changed between the proposed and predicate devices include changes in design and materials. The proposed Solstice Tilting Head Fixation System and predicate allow SRS/SRT and use headrests and thermoplastic masks, but the proposed Tilting device allows for infinitely adjustable angles from -5° to +5°, either used with customizable cushion (for SRS/SRT) or reusable headrest, and open-face mask to be used with camera systems and SGRT. Both the Solstat Static Head Fixation System and predicate system allow for patient immobilization, but the proposed device allows for use of customizable cushion and open-face mask to be used with camera

### www.CivcoRT.com

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Image /page/6/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a bold, sans-serif font. A small blue circle is placed above the "V" in "CIVCO". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.

systems and surface guided radiation therapy(SGRT). Different materials were used to manufacture the proposed devices and were selected with MR safety and effectiveness considerations.

| # | Feature | Predicate Device<br>(CDR Systems Prone<br>Head and Neck<br>Immobilization System) | CIVCO Device<br>(Solstice SRS<br>Immobilization System) | CIVCO Device (Solstat<br>Immobilization System<br>and Open-Face<br>Thermoplastic Mask) |
|---|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Indications for<br>Use | CDR Systems Precision<br>Patient Positioning System is<br>indicated to assist in the<br>proper positioning of patients<br>for radiation therapy and<br>radiosurgery simulation and<br>treatment including electron,<br>photon and proton<br>treatments. Place a clean<br>sheet over the device to<br>ensure a clean device from<br>patient to patient. | Tilting Head Immobilization<br>System (when used with<br>customizable cushion):<br>The device is indicated to<br>position and/or immobilize<br>adult and pediatric patients<br>undergoing radiation therapy<br>of the head, brain, and neck,<br>including Stereotactic<br>Radiosurgery (SRS),<br>Stereotactic Radiotherapy<br>(SRT), Surface Guided<br>Radiation Therapy (SGRT)<br>and electron, photon, and<br>proton treatments. The<br>device is also used during<br>image acquisition, including<br>Computed Tomography (CT),<br>to support treatment<br>planning.<br><br>Tilting Head Immobilization<br>System (when used with<br>headrest):<br>The device is indicated to<br>position and/or immobilize<br>adult and pediatric patients<br>undergoing radiation therapyof the head, brain, and neck,<br>including Surface Guided<br>Radiation Therapy (SGRT)<br>and electron, photon, and<br>proton treatments. The<br>device is also used during<br>image acquisition, including<br>Computed Tomography (CT),<br>to support treatment<br>planning. | The device is indicated to<br>position and/or immobilize<br>adult and pediatric patients<br>undergoing radiation therapy<br>of the head, brain, and neck,<br>including Surface Guided<br>Radiation Therapy (SGRT)<br>and electron, photon, and<br>proton treatments. The device<br>is also used during image<br>acquisition, including<br>Computed Tomography (CT)<br>Magnetic Resonance (MR)<br>Imaging, to support treatment<br>planning. |
| 2 | Classification | Class II (K122888) | Class II | Class II |
| 3 | Features | A headboard that attaches to<br>a baseplate that locates onto<br>a couch tabletop, onto a CDR | The Tilting Head Fixation<br>System can be attached to<br>the treatment or simulation | The Static Head Fixation<br>System can be attached to<br>the treatment or simulation |
| # | Feature | Predicate Device<br>(CDR Systems Prone<br>Head and Neck<br>Immobilization System) | CIVCO Device<br>(Solstice SRS<br>Immobilization System) | CIVCO Device (Solstat<br>Immobilization System<br>and Open-Face<br>Thermoplastic Mask) |
| | | Couch Overlay or Couch<br>Extension and provides<br>adjustable positive and<br>negative tilt for patient's<br>head. Can be used for<br>support of a patient's head in<br>supine or prone position. A<br>low temperature<br>thermoplastic mask can be<br>used for additional<br>immobilization. | couch, extension, or overlay<br>along with other optional<br>positioning and<br>immobilization devices and<br>accessories. The<br>thermoplastic mask is<br>attached onto the device and<br>is molded to the patient's<br>facial anatomy. The patient<br>lies directly on the treatment<br>surface in the supine<br>position. | couch, extension, or overlay<br>along with other optional<br>positioning and<br>immobilization devices and<br>accessories. The<br>thermoplastic mask is<br>attached onto the device and<br>is molded to the patient's<br>facial anatomy. The patient<br>lies directly on the treatment<br>surface in the supine position. |
| 4 | Materials | Carbon fiber/epoxy laminate<br>material with foam core.<br>MR Safe - Kevlar/epoxy<br>laminate material with foam<br>core. | Carbon Fiber, Black Acetal,<br>Kydex-T, Nylon,<br>Polycarbonate | Static Head Fixation(MR):<br>Kydex-T, Nylon,<br>Polycarbonate<br>Thermoplastic Mask(MR):<br>Polycaprolactone,<br>Polycarbonate |
| 5 | Device Body<br>Contact<br>Category | Limited contact duration (<24<br>hours) for surface devices<br>(skin). | Limited contact duration (<24<br>hours) for surface devices<br>(skin). | Limited contact duration (<24<br>hours) for surface devices<br>(skin). |
| 6 | Immobilization | SRS/SRT (marketing) | When used with<br>customizable cushion and<br>thermoplastic mask, the<br>system can immobilize the<br>patient to under 1<br>millimeter(SRS/SRT). | When used with customizable<br>cushion and thermoplastic<br>mask, the system can<br>reproduce the patient position<br>to under 3 millimeters within a<br>treatment cycle. |
| 7 | Performance | SRS/SRT, MR | SRS/SRT, SGRT, Adult &<br>Pediatrics | MRI, SGRT, Adult &<br>Pediatrics |

## www.CivcoRT.com

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Image /page/7/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and consists of the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller font. The logo is simple and modern, and the blue color gives it a professional and trustworthy look.

### F. Non-Clinical Testing

Non-clinical testing was completed to confirm that the proposed devices are as safe and effective as the predicate devices and to confirm that the changes in technological characteristics do not raise any new issues of safety or effectiveness.

For the Solstat Device, a scientific rationale was used to address RF heating, magnetically induced torque, and magnetically induced displacement force. The Solstat device was tested for image artifact using ASTM Standard F2119-07 as guidance and is considered MR Safe.

### www.CivcoRT.com

Corporate Office | 2303 Jones Boulevard Suite B | Coralville, IA 52241 | USA | office +1 [phone] | [e-mail]

Global Sales Office | 1401 8th Street SE | Orange City, IA 51041 | USA | office +1 [phone] | fax [phone]

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Image /page/8/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a sans-serif font. Above the "V" is a light blue circle. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.

For the Solstice Device, non-clinical testing using camera systems was done to substantiate the use for Stereotactic Radiosurgery (SRS) and Stereotactic Radiotherapv (SRT). Based on data obtained we can state that intrafraction movement during a 5-minute scanning window to the 99.73% Confidence Interval is less than 1.000mm. Additionally, based on the data obtained, we can state that intrafaction movement during a 30 minute scanning the 95.45% confidence intervals is less than 1mm.

Therefore, the Tilting Head Fixation System appropriately immobilizes a patient for SRS/SRT such that the intrafractional shifts are less than 1mm within a 5-mintute window with 99.73% confidence, and within a 30-minute window with 95.45% confidence.

Based on testing with VisionRT's AlignRT system, Solstat, and the Open-Face thermoplastic mask can be used for Surface Guided Radiation Therapy (SGRT) as the Region of Interest (ROI) is able to be seen by the camera system.

The devices are intended for limited contact duration (<24 hours) for surface devices (skin). Biocompatibility testing was completed for patient-contacting materials in accordance with ISO 10993-5 and ISO 10993-10.

#### G. Conclusion

This premarket submission for the Tilting Head Fixation System, Static Head Fixation System, and Open-Face Thermoplastic Mask has demonstrated substantial equivalence as defined and understood in the Federal Food, Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

### www.CivcoRT.com