K Number

Device Name

MEDRAD ATD-T INTERFACE DEVICE

Manufacturer

MEDRAD, INC.

Date Cleared

1998-04-30

(157 days)

Product Code

MOS

Regulation Number

892.1000

Intended Use

The purpose of the ATD-T is to provide interface and support functions to allow the use of Medrad disposable endorectal coils with the GEMS Signa 1.5 Tesla MRI Scanner System and Torso Array Coil. The use of the ATD-T is a requirement whenever MR imaging is to be performed using the GEMS Signa 1.5 Tesla MRI System with the Torso Array Coil and any of the Medrad family of disposable endorectal coils. Use of the ATD-T is indicated with all 1.5 Tesla Endorectal Coils.

Device Description

The Medrad Magnetic Resonance Endorectal Imaging System consists of a disposable, receive only endorectal coil for MR imaging of the male prostate gland and associated anatomy, or other target region of interest, including the cervix and colon. The Medrad ATD-T provides the interface, decoupling, and support functions required to successfully operate the endorectal coils with the GEMS Signa MRI Scanner System with Phased Array capability, and the GEMS Torso Array Coil operating at 1.5 Tesla. The ATD-T consists of two electronic devices, a printed circuit board installed in an Input Port housing attached to the Torso Array Coil posterior cable, and an external unit placed between the Torso Array Coil output cable and the system Phased Array Coil Port. This hardware is intended for repeated use with suitable Medrad disposable MRI Endorectal Coils. The ATD-T sets the tuning and impedance matching of a nominal endorectal coil to the nominal system Larmour frequency, 63.87 MHz for the GEMS Signa 1.5 Tesla MRI System. The electronic components required to provide effective decoupling disposable endorectal coils resonant response from the MRI RF excitation field during the transmit portion of the MR imaging pulse sequence are included in the ATD-T Input Port Unit. The ATD-T External Unit combines the signal from the two posterior coil elements of the Torso Array coil to drive a single Phased Array Coil Port, making one Port available for the output of the endorectal coil. It includes internally selectable circuitry to enable it to be used with either the current version of the GEMS/Gore Torso Array Coil [using PA Ports 3, 4, 5, and 6], or the future version designed to meet IEC-601 First Fault detection conditions [using PA Ports 2, 4, 5, and 7]. The ATD-T is designed as a durable item with an expected life of at least three thousand procedures, equivalent to at least five years of service. The specific application of this version of the ATD-T involves MR imaging at 1.5 Tesla, using a Medrad disposable endorectal coil, and a GEMS Signa 1.5 Tesla MRI System including the GEMS Phased Array feature and the Torso Array Coil.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

GE 1.5T ATD-III

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a hardware interface device for MRI coils and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No
The device is described as providing "interface and support functions" for MRI imaging and does not directly treat or diagnose a medical condition.

Diagnostic

The device, ATD-T, is described as an interface and support system for endorectal coils used with an MRI scanner. Its primary function is to facilitate the operation of the coils with the MRI system, ensuring proper tuning and impedance matching. It does not directly produce or interpret diagnostic information; rather, it enables the diagnostic imaging process performed by the MRI system. Its performance evaluation focuses on Signal to Noise Ratio (SNR) and does not affect image performance, indicating it's a component that enables diagnostic imaging, not a diagnostic device itself.

SaMD (Software as a Medical Device)

The device description explicitly states that the ATD-T consists of "two electronic devices, a printed circuit board installed in an Input Port housing... and an external unit placed between the Torso Array Coil output cable and the system Phased Array Coil Port." This indicates the device is hardware-based, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide interface and support functions for using endorectal coils with an MRI scanner for imaging purposes. This is a diagnostic imaging procedure, not a test performed on biological samples in vitro.
Device Description: The device is described as electronic hardware that interfaces with an MRI system and coils. It deals with signal processing and hardware compatibility, not with analyzing biological specimens.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information about a patient's health status based on in vitro testing.

The device is clearly an accessory for an MRI system, which is a medical imaging device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

90 MOS

Device Description

The electronic components required to provide effective decoupling disposable endorectal coils resonant response from the MRI RF excitation field during the transmit portion of the MR imaging pulse sequence are included in the ATD-T Input Port Unit.

The ATD-T External Unit combines the signal from the two posterior coil elements of the Torso Array coil to drive a single Phased Array Coil Port, making one Port available for the output of the endorectal coil. It includes internally selectable circuitry to enable it to be used with either the current version of the GEMS/Gore Torso Array Coil [using PA Ports 3, 4, 5, and 6], or the future version designed to meet IEC-601 First Fault detection conditions [using PA Ports 2, 4, 5, and 7].

The ATD-T is designed as a durable item with an expected life of at least three thousand procedures, equivalent to at least five years of service. The specific application of this version of the ATD-T involves MR imaging at 1.5 Tesla, using a Medrad disposable endorectal coil, and a GEMS Signa 1.5 Tesla MRI System including the GEMS Phased Array feature and the Torso Array Coil.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance Imaging (MRI)

Anatomical Site

male prostate gland and associated anatomy, or other target region of interest, including the cervix and colon.

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)

Signal to Noise Ratio (SNR)
The Medrad 1.5T ATD-T was evaluated using National Electric Manufacturer's Association (NEMA) Standard No. 6, Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images.
Both the Medrad 15T ATD-T and the predicate GE ATD-III were evaluated with a loaded phantom to determine the SNR for both coils. The coils were evaluated using the same scan parameters to produce identical images. The results were compared to verify the equivalent or increased SNR of the proposed coil.

Image Uniformity Testing: Not Applicable. No uniformity claims are made for this device.

Clinical Testing:
Medrad has demonstrated with Laboratory testing that the proposed Medrad 1.5T ATD-T does not affect the image performance of the Medrad Endorectal Coils, the GE Torso Array, or the GE MRI System. No claims for enhanced images are made herein.

SAR: Not applicable.

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.

GE 1.5T ATD-III

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

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.

Summary

Image /page/0/Picture/0 description: The image shows the word "MEDRAD" in all capital letters. The letters are bold and black, and they have a slightly rounded, sans-serif font. A small registered trademark symbol is present to the right of the letter "D".

A-97-1232

APR 3 0 1998

510(k) SUMMARY

MEDRAD 1.5T ATD-T

OFFICIAL CONTACT:

Mary Ann Greenawalt, J.D. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051

Medrad, Inc.

One Medrad Drive Indianola, PA 15051-0780 (412) 767-2400

CLASSIFICATION NAME:

Magnetic Resonance Diagnostic Accessory [21 CFR 892.1000] MRI System Interface Device

PROPRIETARY NAME:

COMMON/USUAL NAME:

GE 1.5T ATD-III

Medrad 1.5T ATD-T

DEVICE DESCRIPTION:

PREDICATE DEVICES:

Image /page/0/Picture/16 description: The image shows a logo with the letter 'Q' in a stylized font. Below the 'Q', the words 'Quality' and 'by Life' are stacked on top of each other in a smaller font size. The logo appears to be a symbol or mark associated with quality assurance or a brand identity.

Image /page/1/Picture/0 description: The image shows the word "MERAD" in a stylized, blocky font. The letters are all capitalized and connected, giving the word a solid, unified appearance. A small circled "R" symbol is present to the right of the letter "D", indicating a registered trademark.

QA-97-1232

INTENDED USE:

PERFORMANCE TEST DATA:

Signal to Noise Ratio (SNR)

The Medrad 1.5T ATD-T was evaluated using National Electric Manufacturer's Association (NEMA) Standard No. 6, Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images.

Both the Medrad 15T ATD-T and the predicate GE ATD-III were evaluated with a loaded phantom to determine the SNR for both coils. The coils were evaluated using the same scan parameters to produce identical images. The results were compared to verify the equivalent or increased SNR of the proposed coil.

Image Uniformity Testing: Not Applicable. No uniformity claims are made for this device.

Image /page/1/Picture/11 description: The image shows a logo with a stylized letter 'Q' at the top, which appears to be textured or filled with a pattern. Below the 'Q', there are two lines of text that read 'Quality' and 'for Life'. The text is in a simple, sans-serif font and is smaller than the 'Q' symbol above it. The overall design is simple and conveys a sense of quality and longevity.

Image /page/2/Picture/0 description: The image shows the word "medrad" in a stylized, bold, sans-serif font. The letters are all capitalized and connected, giving the word a modern and technical appearance. A registered trademark symbol is located to the right of the word.

QA-97-1232

Clinical Testing:

Medrad has demonstrated with Laboratory testing that the proposed Medrad 1.5T ATD-T does not affect the image performance of the Medrad Endorectal Coils, the GE Torso Array, or the GE MRI System. No claims for enhanced images are made herein.

SAR: Not applicable.

CONCLUSION:

Extensive safety, verification, durability, and clinical testing was conducted with the Medrad 1.5T ATD-T to substantiate the claims of the proposed device and to verify that the proposed device is substantially equivalent to the predicate device.

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1998

Sr. Regulatory Affairs Associate

Jim Ferguson, Jr

One Medrad Drive

Indianola, PA 15051

Medrad, Inc.

Re:

K974438 Medrad ATD-T Interface Device Dated: March 23, 1998 Received: March 24, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Ms. Greenwalt:

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 requirements, as set forth in the Quality System Regulation (OS) 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. In addition, 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 the Electronic Product 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 questions on the promotion 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/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

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

Enclosure

INDICATIONS FOR USE

Daniel G. Styer

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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

(412) 767-2400 .