← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K243428 # e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector (K243428) _Dxtx Medical, Inc. · MOS · Jul 17, 2025 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K243428 ## Device Facts - **Applicant:** Dxtx Medical, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Jul 17, 2025 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use Probe: The DxTx e²Coil probes are recommended for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue in the male human anatomies and are specifically designed for use with the appropriate e²Coil Interface Device and Intermediate Cable Assembly. The one-time use, disposable e²Coil probe has been designed to be inserted into the human rectum. The e²Coil probe may be inserted by a trained healthcare professional, depending on state or country law, who has training in e²Coil probe insertion. Interface Device: The Siemens 3.0T Endo Interface II with Tim 4G SlideConnect (e²Coil™) provides interface and support functions to allow the use of 3.0T disposable e²Coil probes with Siemens 3.0T MRI Systems with a Tim 4G connector. Only trained healthcare professionals are intended to operate this device. ## Device Story Endorectal MRI coil system; improves diagnostic MR image quality of prostate and surrounding pelvic tissues. Consists of disposable rectal probe and interface device for Siemens 3.0T MRI systems with Tim 4G connector. Probe inserted rectally by trained healthcare professional; interface device connects probe to MRI scanner. System uses two loops and four channels to capture MR signals; provides higher SNR compared to scanner body coil alone. Used in clinical imaging environments; output viewed by radiologists/physicians to assist in prostate diagnosis. Includes integrated fuse for electrical protection. Patient contact duration < 60 minutes. ## Clinical Evidence Bench testing only. Performance data includes biocompatibility (ISO 10993-1), electrical safety/EMC (IEC 60601-1), mechanical strength (IEC 60601-1), MR safety (IEC 60601-2-33), SNR testing (NEMA MS 1), and signal uniformity (NEMA MS 3/IEC 62464-1). SNR was consistently higher than scanner body coil alone. ## Technological Characteristics Materials: Latex, PVC, Polymer. Sensing: Two-loop, four-channel endorectal coil. Connectivity: Tim 4G SlideConnect interface for Siemens 3.0T MRI. Safety: MR Conditional (≤ 3.0T), integrated electrical fuse. Standards: IEC 60601-1, IEC 60601-2-33, ISO 10993-1, NEMA MS 1, NEMA MS 3, IEC 62464-1. ## 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 - 3.0T Prostate Imaging System ([K051349](/device/K051349.md)) ## 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} FDA U.S. FOOD & DRUG ADMINISTRATION July 17, 2025 DxTx Medical, Inc. Paul Lawson Director of Quality and Regulatory, R&D Manager 639 Alpha Dr Pittsburgh, Pennsylvania 15238 Re: K243428 Trade/Device Name: e²Coil™ Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: June 11, 2025 Received: June 12, 2025 Dear Paul Lawson: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K243428 - Paul Lawson Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K243428 - Paul Lawson Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Ningzhi Li - Digitally signed S by Ningzhi Li -S for Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K243428 Device Name e²Coil™ Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector Indications for Use (Describe) Probe: The DxTx e²Coil probes are recommended for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue in the male human anatomies and are specifically designed for use with the appropriate e²Coil Interface Device and Intermediate Cable Assembly. The one-time use, disposable e²Coil probe has been designed to be inserted into the human rectum. The e²Coil probe may be inserted by a trained healthcare professional, depending on state or country law, who has training in e²Coil probe insertion. Interface Device: The Siemens 3.0T Endo Interface II with Tim 4G SlideConnect (e²Coil™) provides interface and support functions to allow the use of 3.0T disposable e²Coil probes with Siemens 3.0T MRI Systems with a Tim 4G connector. Only trained healthcare professionals are intended to operate this device. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/23) P2C Publishing Services (301) 443-6740 {4} 510(k) Summary K243428 e²Coil™ Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector I. Sponsor Information DxTx Medical, Inc. 639 Alpha Drive Pittsburgh, PA 15238 Contact Person: Paul Lawson Phone: 412-435-3867 Email: paul.lawson@dxtxmedical.com https://dxtxmedical.com/ Date of 510(k) Preparation: July 14, 2025 II. Subject Device: Trade name: e²Coil™ Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector Common Name: Prostate Endo Coil Classification Name: Coil, Magnetic Resonance, Specialty Regulation number: 21 CFR 892.1000 Product Code: MOS Regulatory class: II Review Panel: Radiology III. Predicate Device 510(k): K051349 Trade name: 3.0T Prostate Imaging System Common Name: Prostate Endo Coil Classification Name: Coil, Magnetic Resonance, Specialty Regulation number: 21 CFR 892.1000 Product Code: MOS Regulatory class: II Review Panel: Radiology {5} \mathrm{e}^2\mathrm{Coil}^{\mathrm{TM}} Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector 510(k) Summary ## IV. Device Description The e²Coil™ Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is a combination of the following two devices for improving the diagnostic MR image of the prostate and its surrounding pelvic tissues: - Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect (e²Coil) - Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e²Coil) – Siemens - Coil contains two loops and four channels The intended contact duration of the device is less than 60 minutes. No components of this device contain medicinal substances, tissues or blood products. The patient contacting device component materials are Latex, PVC, and Polymer. ## V. Intended Use / Indications for Use Probe: The DxTx e²Coil probes are recommended for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue in the male human anatomies and are specifically designed for use with the appropriate e²Coil Interface Device and Intermediate Cable Assembly. The one-time use, disposable e²Coil probe has been designed to be inserted into the human rectum. The e²Coil probe may be inserted by a trained healthcare professional, depending on state or country law, who has training in e²Coil probe insertion. Interface Device: The Siemens 3.0T Endo Interface II with Tim 4G SlideConnect (e²Coil™) provides interface and support functions to allow the use of 3.0T disposable e²Coil probes with Siemens 3.0T MRI Systems with a Tim 4G connector. Only trained healthcare professionals are intended to operate this device. ## VI. Summary of Technological Characteristics Compared to Predicate Device The intended use and principles of operation of the e²Coil™ Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector and the DxTx Medical (formerly MEDRAD/Bayer) 3.0T Prostate Imaging System predicate device are substantially equivalent. Both devices meet the regulatory definition for Coil, Magnetic Resonance, Specialty outlined in 21 CFR 892.1000. Only trained healthcare professionals are intended to operate this device. The technological differences between the e²Coil™ and its predicate eCoil raise no new issues of safety or image quality effectiveness. {6} \mathrm{e}^{2}\mathrm{Coil}^{\mathrm{TM}} Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector 510(k) Summary | Feature | Predicate Device | DxTx Medical Device System | | --- | --- | --- | | | Trade Name: 3.0T Prostate Imaging System Model Numbers: 08624855 (Interface Device), BPX 30 (Disposable Probe) 510(k) Holder: DxTx Medical, Inc. (transferred from Bayer Healthcare in 2019) 510(k) Number: K051349 | Trade Name: e²Coil™ Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector Device Model Numbers - Trade Names in System: 4000518 - Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect (e²Coil) BPX 30 NG-S - Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e²Coil) – Siemens | | Indications for Use | The 3.0T Siemens Prostate Imaging System (“the device”) is part of the Prostate Imaging Offerings from DxTx and is intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human prostate gland and surrounding pelvic tissue. The disposable eCoil Endorectal Coil (eCoil) is intended for one time use and is specifically designed to be used with an appropriate interface device. The 3.0T Siemens Prostate Imaging System is intended for use with Siemens 3.0T Tim Trio scanner platforms only. Only trained healthcare professionals are intended to operate this device. The 3.0T Siemens Prostate Imaging System is comprised of the Siemens Interface Device and the 3.0T eCoil (eCoil). | Probe: The DxTx e²Coil probes are recommended for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue in the male human anatomies and are specifically designed for use with the appropriate e²Coil Interface Device and Intermediate Cable Assembly. The one-time use, disposable e²Coil probe has been designed to be inserted into the human rectum. The e²Coil probe may be inserted by a trained healthcare professional, depending on state or country law, who has training in e²Coil probe insertion. Interface Device: The Siemens 3.0T Endo Interface II with Tim 4G SlideConnect (e²Coil™) provides interface and support functions to allow the use of 3.0T disposable e²Coil probes with Siemens 3.0T MRI Systems with a Tim 4G connector. Only trained healthcare professionals are intended to operate this device. | | Size | Interface Device with cable: 28 ¼” long BPX 30 disposable coil: 25” long | Interface Device with cable + Intermediate Cable 38 ¼” Disposable coil: 14 ½” | | Technology Characteristics | Soft Tip Thin Wall Balloon Semi-flexible shaft Depth stopper Flexible syringe connector tubing One coil (loop) in disposable coil One channel | Soft Tip Thin Wall Balloon (same part as BPX 30) Semi-flexible shaft (same part as BPX 30) Depth stopper (same part as BPX 30) Flexible syringe connector tubing (same part as BPX 30) Two coils (loops) in disposable coil Four channels | | Accessories | 50-60 ml Syringe | 50-60 ml Syringe Intermediate Cable | | Safety | No product related hazards were reported in the FDA MAUDE database in the most recent Post Market | Equivalent low-risk safety design | {7} \mathrm{e}^2\mathrm{Coil}^{\mathrm{TM}} Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector 510(k) Summary | Feature | Predicate Device | DxTx Medical Device System | | --- | --- | --- | | | Surveillance Report 01-Oct-2019 to 30-Sep-2023 Coil Biocompatibility MR ≤ 3.0T Conditional | Coil is the same mechanically as BPX 30 so has the same biocompatibility MR ≤ 3.0T Conditional The disposable coil includes a fuse as an additional level of electrical protection, which the predicate system does not. | | Effectiveness | Performance Tests: Scanner Validation on Siemens 3.0T Skyra MR scanner Coil Leakage, Tensile strength, Burst strength, Depth stopper resistance | Performance Tests: Scanner Validation on Siemens 3.0T Skyra MR scanner Coil is the same mechanically as BPX 30 so has the same mechanical performance | | Material | Thin Wall Double Balloon: Natural Latex | Thin Wall Balloon: Same balloon | | Energy Source | MR scanner | MR scanner | # VII. Performance Data The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility testing The biocompatibility evaluation for the Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate $(\mathrm{e}^{2}\mathrm{Coil})$ was conducted in accordance with FDA Guidance 635 "Immunotoxicity Testing Guidance" May 6, 1999 and International Standard ISO 10993-1:2018 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by the FDA. The battery of testing includes the following tests: Cytotoxicity Irritation - Sensitization. # Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the $\mathrm{e}^2\mathrm{Coil}^{\mathrm{TM}}$ Imaging System for the Siemens MAGNETOM 3.0T MRI, consisting of the Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect and the Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate. The system complies with the IEC 60601-1 standard for EMC. # Mechanical testing Mechanical strength for portable equipment testing, consisting of the following listed tests, was conducted on the $\mathrm{e}^2\mathrm{Coil}^{\mathrm{TM}}$ Imaging System for the Siemens MAGNETOM 3.0T MRI, consisting of the Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect and the Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate: - Push - Impact - Drop - Moulding Stress Relief {8} \mathrm{e}^2\mathrm{Coil}^{\mathrm{TM}} Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector 510(k) Summary The system complies with the IEC 60601-1 standard for mechanical strength. ## MR Safety testing MR safety testing was conducted on the $\mathrm{e}^2\mathrm{Coil}^{\mathrm{TM}}$ Imaging System for the Siemens MAGNETOM 3.0T MRI, consisting of the Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect and the Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate. The system is MR Conditional compliant to the 3.0T environment per IEC 60601-2-33. ## SNR testing Signal to Noise Ratio (SNR) testing was conducted on the $\mathrm{e}^2\mathrm{Coil}^{\mathrm{TM}}$ Imaging System for the Siemens MAGNETOM 3.0T MRI, consisting of the Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect and the Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate. The SNR using the $\mathrm{e}^2\mathrm{Coil}^{\mathrm{TM}}$ Imaging System was consistently higher than the SNR of the scanner body coil alone on the Siemens 3.0T Skyra scanner per NEMA MS 1 2.3.2.4 Method 4. ## Uniformity testing Signal uniformity testing was conducted on the $\mathrm{e}^2\mathrm{Coil}^{\mathrm{TM}}$ Imaging System for the Siemens MAGNETOM 3.0T MRI, consisting of the Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect and the Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate. The signal showed good uniformity per NEMA MS 3 and IEC 62464-1 in the axial, coronal, and sagittal axes. ## VIII. Conclusion The DxTx $\mathrm{e}^2\mathrm{Coil}$ is designed to have safety and effectiveness substantially equivalent to the predicate device. In particular, the subject device has the same or similar indications, technological characteristics, and principles of operation as the predicate device. The minor differences between the two devices do not raise any new issues of safety and effectiveness when the device is used as labeled. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K243428](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K243428) **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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