(161 days)
Not Found
No
The summary explicitly states the device is identical to previously cleared devices and is being cleared for use in an MRI environment. There is no mention of AI or ML in the description, intended use, or performance studies.
No
The device is described as a patient positioning device used for support during MRI, rather than for treatment or therapy. It acts as an aid for imaging, not a therapeutic intervention.
No.
The device's Intended Use is for patient support and positioning during MRI, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Patient Support Device" and "identical Class II products," which are physical devices used for positioning patients. There is no mention of software as the primary or sole component.
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 an MRI." This describes a physical support device used during a medical imaging procedure.
- Device Description: The description reinforces that these are "Patient Support Devices" used in an "MRI environment."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, calibrators, controls, and analytical procedures performed on biological samples.
Therefore, this device falls under the category of a medical device used for patient support during imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.
Product codes (comma separated list FDA assigned to the subject device)
LNH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Not Found
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.
K950866, K080072, K060737, K973842
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.
0
K093738
page 1/2
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: 712-737-8688 Fax: 712-737-8654
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 ●
Page 6 of 41
1
K093738
page 2/2
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 .
Page 7 of 41
2
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
3
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.
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
4
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