Promaxo MRI System

{0}------------------------------------------------ March 3, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Promaxo, Inc. % Eva Hellman RA/QA Manager 70 Washington St. Suite 407 OAKLAND CA 94607 Re: K202518 Trade/Device Name: Promaxo MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: January 21, 2021 Received: January 22, 2021 Dear Eva Hellman: 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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202518 Device Name Promaxo MRI System #### Indications for Use (Describe) The Promaxo Magnetic Resonance Imaging (MRI) System is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR guidance in alignment with the current standard of care. Promaxo MR images are not intended to be used for diagnostic purposes, and a 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System. Type of Use (Select one or both, as applicable) | <span style="font-size: 1em;">☑</span> 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the Promaxo logo at the top, with the text "510(k) Summary" below it. The logo features the word "promaxo" in a combination of gray and blue, with a blue checkmark extending from the "x" in the word. Below the text "510(k) Summary" is the identifier "K202518". ## 510(k) Summary | Submitter: | Promaxo, Inc.<br>70 Washington St., Suite 407, Oakland, CA 94607<br>510-770-6819 | |----------------------------|----------------------------------------------------------------------------------| | Contact Person: | Eva Hellman<br>RA/QA Manager<br>(510) 770-6961<br>ehellman@promaxo.com | | Date: | 8/31/2020 | | Trade or Proprietary Name: | Promaxo MRI System | | Common or Usual Name: | System, Nuclear Magnetic Resonance Imaging | | Classification Name: | Magnetic Resonance Diagnostic Device | | Product Code: | LNH, MOS | | Regulation Number: | 892.1000 | | Classification: | Class II | Predicate Device: | Trade Name | Common Name | Class | Product Code | Manufacturer | K-number | |--------------------------------------------------------------------------------------------|-------------|-------|--------------|----------------------------------------|----------| | ASM-030PIII<br>(OPENMARK 111),<br>ASM-040P<br>(OPENMARK 4000), ASM-050P<br>(OPENMARK 5000) | MRI Systems | II | LNH | Shenzhen Anke<br>High-Tech Co.<br>Ltd. | K113281 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Promaxo logo, with the word "promaxo" in gray and blue. A blue checkmark is incorporated into the logo. Below the logo, the text "510(k) Summary" is written in a larger font size. #### Indications for Use The Promaxo Magnetic Resonance Imaging (MRI) System is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR guidance in alignment with the current standard of care. Promaxo MR images are not intended to be used for diagnostic purposes, and a 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System. ### Description of the Device and Summary of the Technological Characteristics Promaxo's MRI system is an open configuration MRI system composed of an array of permanent magnets arranged to provide a constant in-plane magnetic field strength and a built-in z-gradient within its field of view. The system utilizes electromagnetic gradient coils, RF coils, and other components such as the spectrometer and signal amplifiers to capture, reconstruct and display magnetic resonance images of objects within its field of view. Promaxo MRI System's technological features are substantially equivalent to its predicate device. Both of them: - । Are comprised of a magnet, magnet enclosure, electromagnetic gradient coils, RF transmission coil, and RF receiver coil - Have the main magnet comprised of an array of permanent magnets - -Measure spatial distribution of protons exhibiting magnetic resonance - -Are capable of imaging T1, T2, and Diffusion-Weighted Imaging - -Are cryogen free - Provide an interactive user interface to operate the device - Promaxo's MRI system differs in technology in the following ways: - -The z-gradient is built into the main magnetic field and, as a result, the system does not require an electromagnetic z-gradient coil - -The device includes a template holder to be used for procedures under MR guidance - -The device includes an MR guidance user interface workflow such as template calibration and registration with imported MR images A detailed comparison of the Promaxo MRI System and predicate device is described below: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for "promaxo". The word "promaxo" is written in a sans-serif font, with the "pro" in gray and the "maxo" in blue. A blue checkmark extends from the bottom of the "x" and curves upward, resembling an arrow pointing upwards and to the right. 510(k) Summary | Product | Promaxo MRI System | 510(k) Summary<br>OPENMARK III, OPENMARK 4000<br>and OPENMARK 5000 | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Information | | | | Manufacturer | Promaxo | Shenzhen Anke High-tech Co., Ltd | | 510(k) Number | K202518 | K113281 | | Product Code | LNH, MOS | LNH | | Regulation No. | 892.1000 | 892.1000 | | Intended Use | The Promaxo Magnetic Resonance<br>Imaging (MRI) System is an office-<br>based MRI system for producing<br>images that display the prostate<br>and adjoining tissues. When used<br>by a trained urologist or<br>interventional/urologic<br>radiologist, the system is intended<br>to be used for targeting prostatic<br>lesions under MR guidance in<br>alignment with the current<br>standard of care. Promaxo MR<br>images are not intended to be<br>used for diagnostic purposes, and<br>a 3T MR image acquired without<br>an endorectal coil is a required<br>input for guidance using the<br>Promaxo MRI System. | MRI SYSTEMS, including ASM-<br>030PI1 (OPENMARK 1II), ASM-040P<br>(OPENMARK 4000) and ASM-050P<br>(OPENMARK 5000). Are indicated<br>for use as magnetic resonance<br>diagnostic devices (MRDD) that<br>produce transverse, sagittal,<br>coronal and oblique cross-sectional<br>images, and that display the<br>internal structure and/or function<br>of the head, body, or extremities.<br>These images when interpreted by<br>a trained physician yield<br>information that may assist in<br>diagnosis. | | Magnet | | | | Type of Magnet | Permanent Magnet | Permanent Magnet | | Magnetic field<br>strength in FOV | 0.058T-0.074T | 0.3T, 0.4T, 0.5T | | Patient accessible<br>bore-space | Open configuration | Open configuration | | Type of installation | Fixed | Fixed | | Shimming | Passive | Passive | | Gradient System | | | | Cooling System | Cryogen free | Cryogen free | | Gradient System<br>Description | Two-axis electromagnetic coils for<br>x- and y-gradients, built-in<br>permanent z-gradient | Three-axis electromagnetic coils | | dB/dt (time rate of<br>change of<br>magnetic field) | Always within normal operating<br>mode, under normal use<br>conditions | Always less than 20T/s, under<br>normal using condition | | Product | Promaxo MRI System | 510(k) Summary<br>OPENMARK III, OPENMARK 4000<br>and OPENMARK 5000 | | Radiofrequency System | | | | RF Transmission<br>Coil | Peak Power: 4 kW<br>Center Frequency: 2.77 MHz<br>Transmission Bandwidth: 2.47 to 3.07 MHz<br>Configuration: Integrated | Peak Power: 6 kW<br>Center Frequency: 21.29 MHz<br>Transmission Bandwidth: Unknown<br>Configuration: Integrated | | RF Receive Coils | Patient wearable receive coil<br>(plug-in type) | Patient wearable receive coil<br>(various configurations, plug-in type) | | SAR (Specific<br>Absorption Rate)<br>Management | No active SAR management<br>required | No active SAR management<br>required | | Operation | | | | Mains Power<br>Requirements | Power Supply: 208V, 3 phase<br>Power Frequency: 60 Hz<br>Input Power: 15 kVA | Power Supply: 380V 3N~<br>Power Frequency: 50 Hz<br>Input Power: 15 kVA | | Control System | Spectrometer | Spectrometer | | Image Acquisition and Processing | | | | Image Resolution | Varies | Varies | | Slice Thickness | Selectable by technician | Selectable by technician | | Pulse Sequences | T1, T2, DWI | T1, T2, DWI, DCE | | Imaging Protocols | T1, T2, DWI of prostate and<br>adjoining tissues<br>Patient wearable receive coil | T1, T2, DWI of head, body and<br>extremities<br>Patient wearable receive coil<br>Exogeneous contrast media may be<br>applied. | | Image Processing | None | None | | DICOM Compliance | Yes | Yes | | Graphical User<br>Interface | Touchscreen keyboard/mouse | Display, keyboard/mouse | | Other | | | | Software<br>Applications | User operates the system using a<br>main user interface application | User operates the system using a<br>main user interface application | | Networking | Network interface for archival and<br>retrieval | Network interface for archival and<br>retrieval | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Promaxo. The word "promaxo" is written in a sans-serif font, with "pro" in gray and "maxo" in blue. A blue checkmark extends from the bottom of the "x" and curves upward, ending in an arrow pointing to the upper right. # 510(k) Summary {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the "promaxo" logo with the word "promaxo" in gray and blue. The "o" in "promaxo" has a blue checkmark and arrow pointing upwards. Below the logo, the text "510(k) Summary" is written in a larger font. ### Summary of Non-Clinical Testing Promaxo MRI System has been evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, hardware and software verification and validation, and image quality and has been found to conform to the following medical device standards: - । IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - । IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC 60601-2-33:2010, AMD1:2013, AMD2:2015, Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis - -NEMA MS 2-2008 (R2014), Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images. - -NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices - -NEMA MS 5-2018, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging. - -NEMA MS 6-2008 (R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging - -NEMA MS 8-2016, Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems - -NEMA MS 9-2008 (R2014), Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images - -NEMA MS 10-2010, Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging Systems - -NEMA MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems - -ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process Navigation accuracy testing on phantoms was performed to support the indications for use and substantial equivalence. The test included users performing template localization and needle localization activities using the Promaxo MRI System. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "promaxo" in a stylized font, with the first four letters in gray and the last three in blue. A blue checkmark is incorporated into the "o" at the end of the word. Below the word "promaxo" is the text "510(k) Summary" in a simple, sans-serif font. The text is centered and appears to be the title or heading of a document or presentation. ## Summary of Clinical Testing Sample clinical images and testing on sample clinical images were provided to support substantial equivalence. Users performed registration accuracy and motion studies using the Promaxo MRI System on clinical images of human subjects. An end-to-end clinical feasibility study was conducted. ### Conclusion The testing demonstrates that the Promaxo MRI System is as safe and effective as the predicate for the intended use of surgical localization of previously diagnosed prostate lesions on a diagnostic 3T MRI. The subject device is substantially equivalent to the legally marketed predicate device and conforms to applicable medical device safety and performance standards.