The device is intended to be used for immobilization, positioning and re-positioning during Stereotactic Radiotherapy (SRT) and Stereotactic Radiosurgery (SRS) in all parts of the brain, head, and neck during external beam radiation therapy. The device is also used to immobilize and position the head during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems.

Device Description

The Head Immobilization System is intended for head and neck immobilization. The device is used as an aid in positioning and re-positioning of the patient during diagnostic and therapeutic treatments including radiation therapy. The fundamental component of the system is the trUpoint ARCH™ comprised of an arch, frame arm, bite assembly arm, and nasion assembly arm. A nasion cushion and bite cup also comprise the system. A storage plate is used to store the trUpoint ARCH™ and a Base Lock Replacement Kit is available to replace the base lock in the trUpoint ARCH™. Accessories to the proposed device that are manufactured by CIVCO Medical Solutions include the individual head support, thermoplastic mask, and baseplate. Accessories to the proposed device that not manufactured by CIVCO Medical Solutions include a bite tray, impression putty, and putty dispenser. The proposed devices are sold non-sterile. The nasion cushion and bite cup are single patient use devices whereas the trUpoint ARCH™ may be reused for multiple patients. The proposed devices are non-implanted devices that are large in size and manufactured of non-magnetic and plastic materials.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CIVCO Medical Solutions trUpoint ARCH™ Head Immobilization System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating the device's safety and compatibility in an MR environment and its efficacy in patient immobilization.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance and Remarks
MR Safety	RF Heating: Must pass relevant ASTM standards (F2182-11a, F2119-07, F2052-06e1, F2213-06).Magnetic Induced Torque: Must pass relevant ASTM standards.Magnetically Induced Displacement Force: Must pass relevant ASTM standards.	The devices passed the acceptance criteria for RF heating, magnetic induced torque, and magnetically induced displacement force, demonstrating safety for use in the MR environment. Modifications were made to accommodate the large size and external use of the devices.
Image Artifacts	Must be localized and documented, if present, with information on location and size included in Instructions for Use.	Image artifact was observed but was localized. Information regarding location and size has been included in the Instructions for Use.
Biocompatibility	Patient contacting materials must be biocompatible.	Biocompatibility testing was completed for patient contacting materials.
Intrafraction Immobilization	Patients must be immobilized within 1 mm during treatment.	Documented that the device immobilizes patients within 1 mm during treatment (intrafraction).
Interfraction Patient Shifts (Equivalence to competitor)	When comparing CT simulation images to daily image matching, the device should be equivalent to a competitor system regarding interfraction patient shifts.	Documented that the trUpoint ARCH™ device is equivalent to a competitor system with respect to interfraction patient shifts.

2. Sample Size Used for the Test Set and Data Provenance

MR Safety/Compatibility Testing: Not explicitly stated, but implies a sufficient number of devices were tested to meet ASTM standards.
Immobilization Efficacy Data (Zurich White Paper):
- Sample Size: Not explicitly stated in the provided text. It mentions data was "collected by the University Hospital Zurich" and analyzed in a "white paper."
- Data Provenance: Prospective (implied, as it was "collected by the University Hospital Zurich") from Switzerland. "Zurich's data" is referenced, indicating real-world patient data likely collected at an academic institution.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

MR Safety/Compatibility Testing: Not applicable. Ground truth for these tests is based on established engineering and materials science standards (ASTM).
Immobilization Efficacy Data: Not specified. The "ground truth" for intrafraction immobilization (within 1 mm) and interfraction shifts (equivalence to competitor) would likely be derived from high-resolution imaging modalities (e.g., CT, MR) and established clinical protocols for assessing patient movement during radiation therapy. The expertise would be in radiation oncology, medical physics, and imaging sciences, typically associated with a university hospital setting performing such studies.

4. Adjudication Method for the Test Set

MR Safety/Compatibility Testing: Not applicable. Automated measurements and compliance with engineering specifications are the primary evaluators.
Immobilization Efficacy Data: Not explicitly stated. For a study conducted at a university hospital, it would typically follow established clinical research protocols, potentially involving independent review of imaging data by medical physicists or radiation oncologists if subjective assessments were part of the data collection (though the metrics mentioned seem objective).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical head immobilization system, not an AI-powered diagnostic or treatment planning tool that would involve human readers interpreting images with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

MR Safety/Compatibility: Engineering specifications and established ASTM standards for material properties and interaction with MR fields.
Immobilization Efficacy (Zurich Data): Objective measurements from imaging data (e.g., CT, daily image matching) to quantify patient movement and shifts during diagnostic and therapeutic procedures. This would fall under outcomes data in the sense of measured performance related to the device's function.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is a physical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the company name in a simple, sans-serif font. The words "MEDICAL SOLUTIONS" are printed in a smaller font size below the company name.

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Section 5 - 510(k) Summary

A. Submitter Information

Submitter Name & Address:	MEDTEC, Inc. d/b/a CIVCO Medical Solutions1401 8th St. SEOrange City, IA 51041
Contact Person:	Amanda Stahle, Regulatory Affairs SpecialistTelephone: 319-248-6628, Fax: 877-218-0324amanda.stahle@civco.com
Date Summary Prepared:	January 20, 2014
Trade Name:	trUpoint ARCH™
Common Name:	Head Immobilization System
Classification Names:	System, Nuclear Magnetic Resonance ImagingAccelerator, Linear, Medical
Classification Numbers:	Class II under 21 CFR 892.1000 & 892.5050
Review Panels:	Radiology
Product Codes:	LNH & IYE

B. Predicate Device

The proposed Head Immobilization System is substantially equivalent to the following predicate devices:

Predicate Device	Manufacturer
K982019: Med-Tec Head Immobilization System	Med-Tec, Inc.
K112210: Fraxion™	Medical IntelligenceMedizintechnik GmbH

The purpose of this 510(k) is to expand the indications for use to include use in the MR environment. CIVCO has conducted MR safety and compatibility testing to confirm that the proposed device and accessories can be safely used in the MR environment.

C. Device Description

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	319.248.6757	319.248.6660
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	319.248.6757	319.248.6660
Europe Office	Pasteurstraat 6	2811 DX Reeuwijk	The Netherlands	+31(0) 182.394495	+31(0) 182.395014
Orange City Office	1401 8th Street SE	Orange City, IA 51041	USA	712.737.8688	712.737.8654

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Image /page/1/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the word "CIVCO" in bold, sans-serif font. Below the word "CIVCO" are the words "MEDICAL SOLUTIONS" in a smaller, sans-serif font. The overall design is clean and professional.

WWW.CIVCO.COM

available to replace the base lock in the trUpoint ARCH™. Accessories to the proposed device that are manufactured by CIVCO Medical Solutions include the individual head support, thermoplastic mask, and baseplate. Accessories to the proposed device that not manufactured by CIVCO Medical Solutions include a bite tray, impression putty, and putty dispenser.

The proposed devices are sold non-sterile. The nasion cushion and bite cup are single patient use devices whereas the trUpoint ARCH™ may be reused for multiple patients. The proposed devices are non-implanted devices that are large in size and manufactured of non-magnetic and plastic materials. The Head Immobilization System consists of the following models:

Part No.	Device Name
MTHF01	trUpoint ARCH™
MTHF016	Nasion Cushion
MTHF135	Bite Cup
MTHF300	trUpoint ARCH™ Storage Plate
MTHF01-LK	trUpoint ARCH™ Base Lock Replacement Kit

D. Indications for Use/Intended Use

E. Technological Characteristics and Indications for Use Comparison

Technological characteristics that have changed between the proposed device and Med-Tec Head Immobilization System (K982019) predicate device include changes in design and materials. The design changes include the addition of a frame arm that extends perpendicularly from the arch and holds the bite and nasion assemblies. The angles of the nasion and bite assemblies are now adjustable with indexing. The bite assembly is standard in the proposed device and provides further immobilization of the head in conjunction with bite tray and impression putty accessories. The head support and thermoplastic mask continue to serve as accessories to the system, and these accessories and the proposed device attach to a baseplate. Additional materials were used to manufacture the proposed device and were selected with MR safety considerations. The indications for use/intended use of the proposed device will include use in the MR environment and will specify use during Stereotactic Radiotherapy (SRT) and Stereotactic Radiosurgery (SRS).

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	319.248.6757	319.248.6660
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	319.248.6757	319.248.6660
Europe Office	Pasteurstraat 6	2811 DX Reeuwijk	The Netherlands	+31(0) 182.394495	+31(0) 182.395014
Orange City Office	1401 8th Street SE	Orange City, IA 51041	USA	712.737.8688	712.737.8654

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Image /page/2/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the company name in a sans-serif font. The words "MEDICAL SOLUTIONS" are printed in smaller letters below the company name. The logo is black and white.

www.civco.com

The technological differences between the proposed device and the Fraxion™ (K112210) predicate device include differences in design and materials. Both devices feature a frame as the fundamental component, but on the Fraxion ™ device a frontpiece completes the arch over the patient and this frontpiece directly receives the mouthpiece. On the proposed device, a frame arm extends perpendicularly from the arch from which a second arm extends and receives the bite cup and bite tray. In both devices a dental impression is created using putty, but on the Fraxion™ device this is secured to the mouthpiece using adhesive whereas on the proposed device the dental impression is formed directly to the bite tray. In the Fraxion™ device, the mouthpiece is fixed to the patient's maxilla using a vacuum. A patient control unit provides this vacuum and delivers an alert when the mouthpiece is loosened. The proposed device features a nasion cushion positioned snugly against the patient's nose. Both devices work with a cushion (head support) under the patient's head and a thermoplastic mask to provide immobilization over the head. A stereotactic frame with fiducials is utilized as part of the Fraxion™ system.

The Fraxion™ device is comprised of carbon fiber whereas the materials that comprise the proposed device were selected with MR safety considerations. The indications for use/intended use of the Fraxion™ predicate device does not specify use in the MR environment. Otherwise the indications for use of the Fraxion™ predicate are substantially similar to that of the proposed device including immobilization, positioning, and re-positioning of the head during SRT and SRS in a linear accelerator environment. Both devices are also used to immobilize and position the head during image acquisition to support treatment planning.

F. Non-Clinical Testing and White Paper on European Site Testing

CIVCO has conducted non-clinical testing to demonstrate that the design and materials do not affect the safety and effectiveness of the device in the MR environment. MR compatibility test methodology generally followed ASTM Standards F2182-11a. F2119-07, F2052-06e1 and F2213-06, but modifications were made to accommodate the large size of several of the proposed devices and to accommodate their external use (not implanted). The devices passed the acceptance criteria for RF heating, magnetic induced torque, and magnetically induced displacement force and demonstrate that the device is safe for use in the MR environment. Image artifact was observed, but these artifacts were localized. Information regarding location and size of the artifacts has been included in the Instructions for Use. Biocompatibility testing was also completed for patient contacting materials.

CIVCO also prepared a white paper on data collected by the University Hospital Zurich in Switzerland on the trUpoint ARCH™ device. This paper documented, based on Zurich's data, that the device immobilizes patients within 1 mm during treatment (intrafraction). This paper also documented, based on Zurich's data, that when comparing CT simulation images to daily image matching, the trUpoint ARCH device is equivalent to a competitor system with respect to interfraction patient shifts. This data is pending publication by the University Hospital Zurich.

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	P 319.248.6757	F 319.248.6660
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	P 319.248.6757	F 319.248.6660
Europe Office	Pasteurstraat 6	2811 DX Reeuwijk	The Netherlands	P +31(0) 182.394495	F +31(0) 182.395014
Orange City Office	1401 8th Street SE	Orange City, IA 51041	USA	P 712.737.8688	F 712.737.8654

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Image /page/3/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the word "CIVCO" in bold, sans-serif font. Below "CIVCO" are the words "MEDICAL SOLUTIONS" in a smaller, sans-serif font.

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G. Conclusion

This premarket submission for the Head Immobilization System 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. Based on comparison against the predicate devices and MR safety testing, the Head Immobilization System is safe and effective for its intended use.

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	⓮ 319.248.6757	ⓡ 319.248.6660
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	⓮ 319.248.6757	ⓡ 319.248.6660
Europe Office	Pasteurstraat 6	2811 DX Reeuwijk	The Netherlands	⓮ +31(0) 182.394495	ⓡ +31(0) 182.395014
Orange City Office	1401 8th Street SE	Orange City, IA 51041	USA	⓮ 712.737.8688	ⓡ 712.737.8654

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4. 2014

MEDTEC, Inc. d/b/a CIVCO Medical Solutions % Ms. Amanda Stahle 1401 8th Street S.E. ORANGE CITY IA 51041

Rc: K132908

Trade/Device Name: Trupoint Arch. Nasion Cushion, Bitc Cup. Trupoint Arch Storage Plate, Trupoint Arch Base Lock Replacement Kit Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Il Product Code: IYE Dated: January 21, 2014 Received: January 24, 2014

Dear Ms. Stahle:

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 10 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. Iisting 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/Medicall.cevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance 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.

Meshad D. 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

510(k) Number (if known): K132908

Device Name: Head Immobilization System

Indications for Use: The device is intended to be used for immobilization, positioning and re-positioning during Stereotactic Radiotherapy (SRT) and Stereotactic Radiosurgery (SRS) in all parts of the brain, head, and neck during external beam radiation therapy. The device is also used to immobilize and position the head during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _K132908

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Regulation Number and Section

§ 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.