The Medrad Flex Interface Device(FID) provides the interface, connection, and support functions to permit the use of Medrad Disposable Endorectal Prostate, Cervix, and Colon Coils, with the Siemens Medical Systems Vision 1.5 Tesla and Impact 1.0 Tesla MRI Scanner Systems.

The Medrad Flex Interface Device and the the Medrad Disposable Endorectal Prostate(BPX), Cervix(BCR), and Colon(PCC) Coils are intended for high resolution Magnetic Resonance Imaging of the human prostate, cervix, colon, and the surrounding pelvic anatomy.

Device Description

The Medrad Magnetic Resonance Endorectal Coil Imaging System consists of a disposable, receive only probe for MR Imaging of the associated anatomy. The Medrad Interface Device provides the interface, decoupling, and support functions required to successfully operate the probe with the Siemens Medical Systems Vision & Impact MRI Scanner Systems. The hardware is intended for repeated use with suitable Medrad disposable MRI probes. The Interface Device provides the tuning and impedance matching of the disposable probe to the Siemens Flex Coil Interface optionally used with the Siemens Vision & Impact MRI Systems.

AI/ML Overview

This document is a 510(k) summary for the Medrad Flex Interface Device, which is a connecting device for MRI systems. The provided text does not contain information about a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or image quality.

Instead, the documentation focuses on the device's description, intended use, and its substantial equivalence to a predicate device (Medrad Probe Interface Device - K926571) as required for regulatory approval. The "acceptance criteria" here are implicitly related to the device successfully providing the specified interface and connection functions, and regulatory compliance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the information that is available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit for this type of device)	Reported Device Performance (as per document)
Functional Interface: Device successfully connects the Medrad Disposable Endorectal Coils to Siemens MRI Systems.	The device "provides the interface, decoupling, and support functions required to successfully operate the probe with the Siemens Medical Systems Vision & Impact MRI Scanner Systems.""This connecting device enables the use of the Medrad Endorectal Coils."
Tuning and Impedance Matching: Device provides tuning and impedance matching.	"The Interface Device provides the tuning and impedance matching of the disposable probe to the Siemens Flex Coil Interface."
Repeated Use: Hardware suitable for repeated use.	"The hardware is intended for repeated use with suitable Medrad disposable MRI probes."
Compatibility: Compatible with specified Siemens MRI systems and Medrad coils.	"Permit the use of Medrad Disposable Endorectal Prostate, Cervix, and Colon Coils, with the Siemens Medical Systems Vision 1.5 Tesla and Impact 1.0 Tesla MRI Scanner Systems."
Substantial Equivalence: Deemed substantially equivalent to a predicate device for its intended use.	FDA found the device "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." (Predicate device: Medrad Probe Interface Device - K926571)

Regarding the Study:

The document does not describe a clinical performance study with specific metrics (like sensitivity, specificity, accuracy) that would typically be associated with AI or diagnostic imaging devices. Instead, the "study" demonstrating that the device meets criteria is the demonstration of substantial equivalence to a predicate device for its engineering and functional aspects. This typically involves engineering verification and validation, but not a large-scale clinical trial with performance metrics.

Therefore, the following information is NOT available in the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. 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: This is an interface device, not an AI or diagnostic tool that would involve human readers interpreting results. Therefore, an MRMC study is not relevant and not discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a device of this nature. The "ground truth" would be the successful physical and electrical connection and functionality.
8. The sample size for the training set: Not applicable, as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.

Summary

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510(k) SUMMARY MEDRAD FLEX INTERFACE DEVICE

K971380

OFFICIAL CONTACT:	Rodney J. RylandsMedrad, Inc.One Medrad DriveIndianola, PA 15051(412) 767-2400 Ext. 3778
CLASSIFICATION NAME:	Magnetic Resonance Diagnostic Accessory[21 CFR 892.1000}
COMMON/USUAL NAME:	Interface Device(Connector)
PROPRIETARY NAME:	Medrad Flex Interface Device
PREDICATE DEVICES:	Medrad Probe Interface Device - K926571

DEVICE DESCRIPTION:

INTENDED USE:

The Flex Interface Device is a connecting device between the Siemens MRI System/Siemens Flex Coil Interface and the Medrad Endorectal Imaging Coils. Therefore, this connecting device enables the use of the Medrad Endorectal Coils.

Anatomical Region:	Not Applicable
Nuclei Excited:	Not Applicable
Diagnostic Uses:	Not Applicable

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rodney J. Rylands Regulatory Affairs Coordinator Medrad, Inc. One Medrad Drive Indianola, PA 15051-0780

Re: K971380 Medrad Flex Interface Device Dated: April 10, 1997 Received: April 14, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH JUL - 3 1997

Dear Mr. Rylands:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W. Kiau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: MED RAD FLEX INTEAFACE DEVICE

Indications For Use:

MEDRAD FLEX INTERFACE DEVICE (FID 1.5T and FID 1.0T) FOR SIEMENS MRI SYSTEMS

INDICATIONS FOR USE

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eáml G. Gyom
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiologica! Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use

(Optional Format 1-2-96)

Medrad, Inc. One Medrad Drive Indianola, PA 15051-0780

767-2400

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.