The MR & Radiological Patient Positioning devices are used to aid in patient positioning and immobilization during radiotherapy procedures. The following models of the Patient Positioning Devices are included in this submission: . Bellyboard 126000 Bellyboard, which includes the following: 301101 Bellyboard Cushion o SBRT Accessories MTSBRT011 SBRT Patient Transfer System, which includes the following: MTSBRT012 Gurney Plate Assembly MTSBRT032 Transfer System Trans Slot MTSBRT033 Transfer System Longitudinal Slot MTSBRT014 Ski Assembly 20-CFHN-017 Type-S Strap Devices are sold non-sterile and may be reused for multiple patient or single patient use if set-up for a single patient. The proposed devices are non-implanted devices i that are large in size and manufactured of non-magnetic and plastic materials.

AI/ML Overview

The provided text describes the regulatory submission for CIVCO MR & Radiological Patient Positioning Devices and their testing for MR compatibility. It is a 510(k) summary, not a study report for a novel AI device with specific performance metrics like those typically found in clinical trials. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study details) is not applicable or cannot be extracted directly from this document.

However, I can extract the acceptance criteria and reported device performance related to MR compatibility, as well as general information about the testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (General Category)	Reported Device Performance/Outcome
RF heating	Devices passed acceptance criteria.
Magnetic induced torque	Devices passed acceptance criteria.
Magnetically induced displacement force	Devices passed acceptance criteria.
Image artifact (specifically for SBRT Patient Transfer System)	Image artifact was observed in a specific area. (Device labeled MR conditional to account for this.)
Biocompatibility	Completed for patient contacting materials (implied satisfactory, as overall conclusion is substantial equivalence and safety/effectiveness).
Safety & Effectiveness in MR environment	Demonstrated that changes in design and materials do not affect safety and effectiveness.

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

Sample Size for Test Set: Not explicitly stated as a number of patient cases or device units tested in a clinical performance manner. The testing was non-clinical and focused on the device itself for MR compatibility.
Data Provenance: The testing was non-clinical, involving direct device testing following ASTM standards. It is not patient or country-specific data but rather laboratory/device performance data. Therefore, it's neither retrospective nor prospective in the typical clinical study sense.

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

Not applicable. This was non-clinical engineering and materials testing for MR compatibility, not a study requiring expert clinical assessment for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was non-clinical engineering and materials testing, not a study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission concerns MR compatibility of patient positioning devices, not diagnostic or AI performance with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" here is objective physical measurements and observations against established engineering standards (ASTM F2182-9, F2119-07, F2052-06, F2213-06) for MR compatibility, along with biocompatibility testing results.

8. The Sample Size for the Training Set

Not applicable. This document does not describe an AI/machine learning study with training sets.

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

Not applicable. This document does not describe an AI/machine learning study.

Summary

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Image /page/0/Picture/0 description: The image shows the CIVCO Medical Solutions logo, which includes a stylized globe graphic and the company name in bold letters. To the right of the logo, there is a handwritten number "K121545" and the date "JUN - 8 2012" printed below it. The date indicates that the image or document is from June 8, 2012.

WWW.CIVCO.COM

Section 5.0 - 510(k) Summary

CIVCO MR & Radiological Patient Positioning Devices

A. General Information

Submitter's Name:	MEDTEC, Inc. d/b/a CIVCO Medical Solutions
Address:	1401 8th Street SE, Orange City, Iowa 51041
Telephone No.:	319-248-6628
Fax No.:	877-218-0324
Contact Person:	Amanda Stahle, Regulatory Affairs Specialist
Date Summary Prepared:	March 16, 2012
Trade Name:	Bellyboard, SBRT Accessories
Common Name:	MR & Radiological Patient Positioning Devices
Classification Names:	System, Nuclear Magnetic Resonance Imaging(21 CFR 892.1000, Product Code LNH)Accelerator, Linear, Medical(21 CFR 892.5050. Product Code IYE)

B. Predicate Devices

MEDTEC, Inc., doing business as CIVCO Medical Solutions, claims the proposed devices to be substantially equivalent to the following devices devices previously cleared by the FDA in the following 510(k)s:

Bellyboard
- O K060737 Sinmed Immobilization Systems (Head and Shoulder, Lung and Thorax, Pelvis and Lower Extremities, and Posicast) and Sinmed Repovac Cushions

SBRT Accessories ●

o K973842 MEDTEC, Inc. Carbon Fiber Conformal Couch Top
The predicate devices have been used for many years in radiological and other medical procedures. The purpose of this 510(k) is to have these products cleared for use in the MR environment.

The predicate devices have the same intended use with the exception of use in the MR environment. The design and materials have been changed where necessary to use these products in the MR environment. CIVCO has conducted testing to demonstrate that the changes in design and materials do not affect the safety and effectiveness of the device.

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	ⓞ 319.656.4447	ⓞ 319.656.4451
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 text "CIVCO" in bold, sans-serif font. Below "CIVCO" are the words "MEDICAL SOLUTIONS" in a smaller, sans-serif font. The overall design is clean and modern.

WWW.CIVCO.COM

C. Device Description

. Bellyboard
126000 Bellyboard, which includes the following: 301101 Bellyboard Cushion

o SBRT Accessories

MTSBRT011 SBRT Patient Transfer System, which includes the following: MTSBRT012 Gurney Plate Assembly

MTSBRT032 Transfer System Trans Slot MTSBRT033 Transfer System Longitudinal Slot MTSBRT014 Ski Assembly 20-CFHN-017 Type-S Strap

Devices are sold non-sterile and may be reused for multiple patient or single patient use if set-up for a single patient. The proposed devices are non-implanted devices i that are large in size and manufactured of non-magnetic and plastic materials.

D. Intended Use/Indications for Use

CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.

E. Technological Characteristics

Technological characteristics which have changed between the proposed and predicate devices include changes in the design and materials which were tested for use in a MR environment to ensure these differences do not affect the safety and effectiveness of the device. These changes include the use of fiberglass instead of carbon fiber, and the addition of a third hole to secure the device in the MR environment, preventing non-MR compatible devices from being used in the MR environment.

F. Non-Clinical Testing

MR compatibility test methodology generally followed ASTM Standards F2182-9, F2119-07, F2052-06 and F2213-06, but modifications were made to accommodate the large size of the proposed devices and to accommodate their external use (not implanted). The devices passed the acceptance criteria for RF heating, magnetic

Corporate Headquarters		102 First Street South		Kalona, IA 52247		USA		⓮ 319.656.4447		ⓕ 319.656.4451
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/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 bold, sans-serif font. The words "MEDICAL SOLUTIONS" are printed in a smaller font size below the company name.

WWW.CIVCO.COM

induced torque, and magnetically induced displacement force and demonstrate that the device is safe for use in the MR environment. Image artifact was observed in a specific area of the SBRT Patient Transfer System, but the device has been labeled MR conditional to account for this artifact. Biocompatibility testing was also completed for patient contacting materials.

G. Conclusion

ﺎ ﻓﻲ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

This premarket submission for the CIVCO MR & Radiological Patient Positioning Devices 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 current product offering and predicate devices, CIVCO MR & Radiological Patient Positioning Devices are safe and effective for their intended and indicated use.

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	319.656.4447	319.656.4451
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/3/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a blue seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features a stylized human figure with outstretched arms.

Public Health Service

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

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

JUL 9 2012

Re: K121545

Trade/Device Name: MR & Radiological Patient Positioning Devices Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and IYE Dated: May 24, 2012 Received: May 25, 2012

Dear Mr. Job:

This letter corrects our substantially equivalent letter of June 8, 2012.

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): _TBD

MR & Radiological Patient Positioning Devices Device Name:

Indications for Use:

CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.

Over-The-Counter Use Prescription Use_x Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Lalut D. Oth

ivision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121545.

Page 1 of

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.