← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K974438 # MEDRAD ATD-T INTERFACE DEVICE (K974438) _Medrad, Inc. · MOS · Apr 30, 1998 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K974438 ## Device Facts - **Applicant:** Medrad, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Apr 30, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## 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 Story Interface device for MRI systems; enables use of Medrad disposable endorectal coils with GEMS Signa 1.5T MRI scanner and Torso Array Coil. Hardware consists of two electronic units: input port housing with PCB attached to Torso Array posterior cable; external unit between Torso Array output and system Phased Array port. Functions: tuning, impedance matching to 63.87 MHz Larmour frequency; decoupling endorectal coils during RF excitation; signal combining from Torso Array posterior elements. Used in clinical imaging environments; operated by MRI technicians/radiologists. Durable design; 3,000-procedure lifespan. Ensures compatibility between endorectal coils and MRI scanner; maintains signal-to-noise ratio (SNR) performance; facilitates diagnostic imaging of prostate, cervix, and colon. ## Clinical Evidence Bench testing only. Evaluated using NEMA Standard No. 6 for special purpose coils. SNR performance compared against predicate GE 1.5T ATD-III using loaded phantoms and identical scan parameters. Results verified equivalent or increased SNR. No clinical data provided; laboratory testing confirmed no adverse effect on image performance of endorectal coils, GE Torso Array, or GE MRI system. ## Technological Characteristics Electronic interface device; includes PCB and external signal-combining unit. Operates at 1.5 Tesla (63.87 MHz). Features internally selectable circuitry for compatibility with different GEMS/Gore Torso Array versions (IEC-601 First Fault detection compliant). Durable construction; 5-year/3,000-procedure service life. Passive electronic components for tuning, impedance matching, and decoupling. ## Regulatory 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). ## Special Controls *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. ## Predicate Devices - GE 1.5T ATD-III ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} MEDRAD® APR 30 1998 QA-97-1232 510(k) SUMMARY **MEDRAD 1.5T ATD-T** K974438 | OFFICIAL CONTACT: | Mary Ann Greenawalt, J.D. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051 | | --- | --- | | CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Accessory [21 CFR 892.1000] | | COMMON/USUAL NAME: | MRI System Interface Device | | PROPRIETARY NAME: | Medrad 1.5T ATD-T | | PREDICATE DEVICES: | GE 1.5T ATD-III | **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. QA-97-1232 {1} MEDRAD QA-97-1232 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. ## 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. ## 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. 0 {2} MEDRAD 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. E {3} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 30 1998 Jim Ferguson, Jr. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051 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 (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. 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/dsma/dsmamain.html". Sincerely yours, ![img-0.jpeg](img-0.jpeg) Enclosure {4} MEDRAD® # INDICATIONS FOR 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. *Medrad, Inc.* One Medrad Drive Indianola, PA 15051-0780 (412) 767-2400 *David H. Sagem* (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number **8974438** Prescription Use ☑ (Per 21 CFR 801.109) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K974438](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K974438) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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