(161 days)
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.
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.
This 510(k) pertains to MRI Patient Positioning Devices, which are Class II devices intended to support and position patients during an MRI. The submission is for identical products previously cleared under other 510(k)s, now seeking clearance for use in an MRI environment.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
Key Finding: The provided document does not contain information about specific acceptance criteria or a study that proves the device meets those criteria, particularly in the context of performance metrics or clinical outcomes. This submission is a 510(k) Premarket Notification for Substantial Equivalence, which primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical performance studies.
The document highlights the device's classification as Class II and its regulatory pathway via substantial equivalence to previously cleared predicate devices. The FDA's letter explicitly states: "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... to legally marketed predicate devices." This implies that the acceptance criteria are met by demonstrating equivalence to existing products, rather than through novel performance testing.
Therefore, many of the requested details about acceptance criteria and study particulars are not present in this type of submission.
Here's a breakdown based on the available information:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) is substantial equivalence to predicate devices in terms of intended use, design, materials, and safety for use in an MRI environment. The document implies that the device is identical to previously cleared devices but is now seeking specific clearance for MRI compatibility.
- Reported Device Performance: The document does not provide quantifiable performance metrics or a study demonstrating specific device performance against a set of numerical acceptance criteria. The "performance" is implicitly demonstrated through the device's classification as "identical Class II products cleared for use in an MRI environment" (implying safety and functionality within that environment, likely based on material compatibility and design).
Acceptance Criteria Reported Device Performance Substantial equivalence to predicate devices for intended use and safety in MRI environment. The device (MRI Patient Positioning Devices) is deemed substantially equivalent to the listed predicate devices (e.g., K950866 MEDTEC Inc, Hip Fix; K080072 CIVCO Medical Solutions, MRI Patient Positioning Devices; K060737 SINMED Positioning Devices; K973842 MEDTEC Inc, Carbon Fiber Conformal Couch Top). The FDA's letter explicitly states a finding of substantial equivalence based on the provided 510(k) premarket notification. The devices are described as "identical Class II products cleared for use in an MRI environment," suggesting that their design, materials, and functionality are consistent with existing, cleared MRI-compatible positioning devices, thereby meeting the safety and efficacy standards for their intended use in MRI. Compliance with general controls and relevant special controls (if any) for Class II devices. The FDA letter reminds the submitter of compliance with general controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration) and potential additional controls for Class II devices. The act of receiving the 510(k) clearance implies that the information submitted satisfies these regulatory requirements for market entry. -
Sample size used for the test set and the data provenance: Not applicable. This 510(k) submission does not describe a test set or data provenance for a clinical performance study. The substantial equivalence is based on comparing the new device's characteristics to cleared predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a test set requiring expert-established ground truth in this submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
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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 passive patient positioning device, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This submission does not involve ground truth determination for performance evaluation. The "ground truth" equivalent would be the established safety and efficacy profiles of the predicate devices.
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The sample size for the training set: Not applicable. This device is not an AI/machine learning product and does not involve a training set.
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How the ground truth for the training set was established: Not applicable. As above, no training set is involved.
In summary: This 510(k) submission is for a medical device that demonstrates substantial equivalence to existing products. The information provided does not detail clinical performance studies with specific acceptance criteria, test sets, or ground truth establishment typically associated with novel or high-risk devices or software. The "acceptance" is the FDA's determination of substantial equivalence, allowing the device to be marketed.
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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 ●
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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
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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 (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
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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
§ 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.