(14 days)
Not Found
No
The device description and performance studies focus on physical properties and compatibility with imaging modalities, with no mention of AI or ML.
No.
The device's stated intended use is to aid in the support and positioning of patients during imaging and radiotherapy procedures, not to treat a disease or condition.
No
The device is described as a patient positioning and immobilization aid during medical procedures, not for identifying pathologies or conditions. Its purpose is mechanical support and positioning, not diagnostic assessment.
No
The device description clearly outlines physical components made of non-magnetic and plastic materials, such as bellyboards, cushions, and transfer systems, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the support and positioning of patients during MR, radiological, and other procedures." This describes a physical support and positioning device used during medical imaging or treatment procedures.
- Device Description: The description details physical components like bellyboards, cushions, and transfer systems made of non-magnetic and plastic materials. These are external devices used for patient positioning and immobilization.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
- Performance Studies: The performance studies focus on MR compatibility (RF heating, torque, displacement force, artifact) and biocompatibility of patient-contacting materials. These are relevant for a physical medical device used in imaging environments, not for an IVD.
In summary, the device's function, description, and testing all point to it being a physical patient positioning and support device, not an in vitro diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
LNH, IYE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, radiological
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
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
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.
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
4
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
5
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.
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