MRI PATIENT POSITIONING DEVICES

K093738 · Medtec, Inc. · LNH · May 14, 2010 · Radiology

Device Facts

• Record ID: K093738
• Device Name: MRI PATIENT POSITIONING DEVICES
• Applicant: Medtec, Inc.
• Product Code: LNH · Radiology
• Decision Date: May 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.

Device Story

MRI Patient Positioning Devices consist of various immobilization and support systems, including hip/pelvic, breast/thorax, lower extremity, head/neck, and general support cushions. These devices are used in clinical MRI environments to stabilize patients, ensuring consistent positioning during imaging. They are operated by healthcare professionals (technicians, nurses, or physicians) to facilitate accurate diagnostic scans. By maintaining patient posture, the devices minimize motion artifacts, potentially improving image quality and diagnostic accuracy. The devices are passive mechanical supports; they do not process data or provide automated outputs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive mechanical positioning aids including baseplates, thermoplastics, cushions, and immobilization boards. Materials are non-magnetic to ensure compatibility with MRI environments. No energy source, software, or electronic components.

Indications for Use

Indicated for patients requiring support and positioning during MRI procedures.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Hip Fix, Hip and Pelvic Fixation (K950866)
• MRI Patient Positioning Devices (K080072)
• SINMED Positioning Devices (K060737)
• Carbon Fiber Conformal Couch Top (K973842)

Submission Summary (Full Text)

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K093738
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# 510(K) SUMMARY (as required by 807.92(c))

MAY 1 4 2010

## Submitter of 510(k):

MEDTEC, Inc. 1401 80 Street SE Orange City, IA 51041-0320 USA

Phone: [phone] Fax: [phone]

Contact Person:

Date of Summary:

Trade/Proprietary Name:

Classification Name:

Product Code:

Jenny Jones

January 15, 2010

MRI Patient Positioning Devices

MRI Patient Positioning Devices

LNH CFR 892.1000

#### Intended Use:

Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.

### Device Description:

The CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s. This 510(k) is to have these identical Class II products cleared for use in an MRI environment.

#### Predicate Devices:

Hip and Pelvic Immobilization System: Pelvic Thermoplastics, Pelvic Vac-Lok, Pelvic Board

- K950866 MEDTEC Inc, Hip Fix, Hip and Pelvic Fixation .
- K080072 CIVCO Medical Solutions, MRI Patient Positioning Devices .

Breast and Thorax Immobilization System: Belly Board, Arm Positioner

- K060737 SINMED Positioning Devices .
- K080072 CIVCO Medical Solutions, MRI Patient Positioning Devices .

# Lower Extremity Immobilization System: Knee Positioner, Foot Positioner

- K060737 SINMED Positioning Devices .
- K973842 MEDTEC Inc, Carbon Fiber Conformal Couch Top .
- K080072 CIVCO Medical Solutions, MRI Patient Positioning Devices ●

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K093738
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Head and Neck Immobilization System: Baseplates, Head Immobilization Thermoplastics, Headrests, Head Extension

- K060737 SINMED Positioning Devices .
- K080072 CIVCO Medical Solutions, MRI Patient Positioning Devices .

General Support System: General Support Cushions

- . K060737 - SINMED Positioning Devices
- K080072 CIVCO Medical Solutions, MRI Patient Positioning Devices .

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. 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 Room - WO66-G609 Silver Spring, MD 20993-0002

MedTec. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technologies Services LLC 1394 25th Street NW BUFFALO MN 55313

MAY 1 4 2010

Re: K093738

Trade/Device Name: MRI Patient Positioning Devices Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 28, 2010 Received: April 29, 2010

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. 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Enclosure

Sincerely yours.

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K093738

Device Name: MRI Patient Positioning Devices

Indications for Use:

Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.

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 Diagnostic Devices (OIVD)

signature

Page 1 of 1

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093783