Who is the manufacturer of MRopen 0.5 T?

Asg Superconductors S.P.A. filed the 510(k) submission for MRopen 0.5 T (K190524).

What is the FDA product code for MRopen 0.5 T?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MRopen 0.5 T?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MRopen 0.5 T?

Paramed S.r.l Mr Open (K151466); Siemens Magnetom C! (K082331); Siemens AVANTO (K032428); Paramed S.r.l MrJ 3300 (K122034).

Who can help prepare an FDA 510(k) submission like MRopen 0.5 T?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MRopen 0.5 T

K190524 · Asg Superconductors S.P.A. · LNH · Jul 1, 2019 · Radiology

Device Facts

Record ID	K190524
Device Name	MRopen 0.5 T
Applicant	Asg Superconductors S.P.A.
Product Code	LNH · Radiology
Decision Date	Jul 1, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

MRopen 0.5 T is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

Device Story

MRopen 0.5 T is a total body MRI system featuring a high-homogeneity, open-sky, U-shaped magnet using high-temperature cryogenless superconductive technology. It acquires proton density, T1, T2, chemical shift, and flow velocity data to generate cross-sectional images. Operated by trained clinicians in a clinical setting, the device allows for weight-bearing or weight-free (supine/seated) imaging. Modifications from the predicate (K151466) include a new DWI technique using HASTE readout, an internally developed user interface, updated spectrometer, compressors, cold heads, and RF amplifier, as well as a new long spine receiving coil and shoulder coil. The device provides diagnostic images to assist physicians in clinical decision-making. The open design aims to reduce patient claustrophobia.

Clinical Evidence

No formal clinical trials were performed. Performance was demonstrated via imaging of healthy adult volunteers (aged 20-60) to verify image quality for the new DWI technique and new receiving coils. Bench testing confirmed conformance to safety standards (IEC 60601-1, 60601-2-33, 60601-1-2, 62366-1, 62304) and NEMA performance standards.

Technological Characteristics

0.5T high-temperature cryogenless superconductive magnet; U-shaped open-sky gantry; MgB2 wire; 200x200x170 cm dimensions; 28,000 kg. Connectivity: internally developed UI. RF amplifier: Analogic AN8102 or RFT RF9200. Gradient system: 20mT/m. Standards: IEC 60601-1, 60601-2-33, 60601-1-2, 62366-1, 62304, NEMA MS-1, MS-2, MS-3, MS-4, MS-5, MS-8, MS-10.

Indications for Use

Indicated for diagnostic total body imaging (excluding cardiac and breast) in patients weighing less than 200 kg. Examinations performed in weight-free (supine/seated) or weight-bearing positions.

Regulatory Classification

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

Paramed S.r.l Mr Open (K151466)
Siemens Magnetom C! (K082331)
Siemens AVANTO (K032428)
Paramed S.r.l MrJ 3300 (K122034)

Related Devices

K151466 — MrOpen · Paramed S.R.L. · Oct 15, 2015
K193116 — MRopen EVO · Asg Superconductors S.P.A. · Dec 20, 2019
K141945 — ECHOSTAR COMFORT 1.5T MRI · Alltech Medical Systems America, Inc. · Feb 3, 2015
K242258 — MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) · Asg Superconductors S.P.A. · Nov 26, 2024
K053009 — GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM · GE Medical Systems · Nov 17, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ASG Superconductors S.p.A. % Luisella De Benedetti Quality and Regulatory Affairs Corso Ferdinando Maria Perrone 73/R Genova, 16152 ITALY Re: K190524 Trade/Device Name: MRopen 0.5 T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: May 14, 2019 Received: May 31, 2019 Dear Luisella De Benedetti: 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/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. 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 July 1, 2019 {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}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The text reads "ASG" on the top line and "SUPERCONDUCTORS" on the bottom line. # 6. Statement of Indications for Use (form 3881) ![](https://i.imgur.com/949999l.png) An21/778 Image /page/2/Picture/4 description: The image shows the number 21/606 written in black ink on a white background. The numbers are written in a cursive style, and there is a horizontal line through the numbers. The numbers are slightly smudged, but they are still legible. {3}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |-----------------------------------------|--| | Food and Drug Administration | | | Indications for Use | | | Form Approved: | OMB No. 0910-0120 | |--------------------------|-------------------| | Expiration Date: | 06/30/2020 | | See PRA Statement below. | | | 510(k) Number (if known) | K190524 | |--------------------------|--------------| | | K190524 | | Device Name | MRopen 0.5 T | Indications for Use (Describe) MRopen 0.5 T is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis. | Type of Use (Select one or both, as applicable) | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> 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 (7/17) Page 1 of 1 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized symbol on the left, consisting of two intersecting arcs in blue, with five colored lines (blue, green, yellow, orange, and red) between them. To the right of the symbol is the text "ASG" in large, bold, blue letters, with the word "SUPERCONDUCTORS" in smaller blue letters underneath. # 7. 510(k) Summary (21 CFR 807.92) Date: (month/day/year) 05/14/2019 807.92(a)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared; ## Submitter Information | Name | ASG Superconductors S.p.A. | |----------------|-------------------------------------------------------------------------------------------------------------------| | Address | Corso Perrone 73R - 16152 Genova, Italy | | Telephone n. | +39 010 6489 358 | | Contact Person | Luisella De Benedetti ASG Superconductors S.p.A. Corso F.M. Perrone 73R 16152 Genova +39 010 6489 358 | | | debenedetti.luisella@as-g.it | 807.92(a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known | Name of the device | MRopen 0.5 T | |------------------------------------|----------------------------------------------------| | Trade name | ASG Superconductors | | Classification name | Total Body Magnetic Resonance Diagnostic Device | | Classification and class of device | 21 CFR 892.1000, class II | | Classification Number | 90LNH | AM 23/778 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is made up of curved lines in different colors, including blue, green, yellow, orange, and red. The text "ASG" is in large, blue letters, and the word "SUPERCONDUCTORS" is in smaller, blue letters below "ASG". 807.92(a)(3) An identification of the legally marketed device to which the submitter claims equivalence. PRIMARY PREDICATE (for all items excluded the below specified) Paramed S.r.1 Mr Open K151466 SECONDARY PREDICATE (FOR DWI-HASTE APPLICATION) K082331 Siemens Magnetom C! SECONDARY PREDICATE (FOR Compressors) AVANTO K032428 Siemens SECONDARY PREDICATE (FOR Spectrometer and shoulder coil) K122034 Paramed S.r.l MrJ 3300 807.92(a)(4) A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties; Like the previously cleared device K151466, the actual MRopen 0.5 T is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV. Modification of K151466 cleared device. - Introduce DWI technique based on HASTE readout sequence 0 - Introduce internally developed User Interface 0 - Introduce changes in hardware such as spectrometer, compressors and cold heads, 0 RFA - 0 Introduce change in hardware inside the magnet (double current same magnetic field, same superconductive MgB2 wire, less coils) - Long Spine receiving coil o - 0 Shoulder coil new model - Changes to patient support shapes and courtesy cushions o MRopen 0.5 T is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is made up of curved lines in blue, green, yellow, orange, and red. The text "ASG SUPERCONDUCTORS" is in blue. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis. The modification reflected in this Traditional 510(k) for the MRopen 0.5 T Tomograph are to introduce updates in hardware and software including the DWI technique previously not released. The modifications have not altered the scientific technology of the unmodified version MrOpen K151466 as detailed in below table. | Claimed Feature | Discussion | |----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Introduce DWI technique based on HASTE readout sequence | This sequence has been introduced to complete the sequence package of the MRopen 0.5 T tomograph, now that the updated hardware and software grant better image quality results. Here the referred predicate is Siemens Magnetom C! K082331 Bibliography is supplied regarding this well-known technique | | Introduce internally developed User Interface | After many years of development it is possible to release this user interface which is completely internally designed and excludes legacy software or software developed prior to IEC62304. | | Introduce changes in hardware such as: | | | spectrometer | This spectrometer already employed for smaller tomograph ASG Superconductors S.p.A. K122034 grants more flexibility to the new software granting DWI technique performance | | Compressors and cold heads | We intend to adopt as an alternative (to Leybold ones) for servicing and for newly designed device the Sumitomo F70H compressor models already in use with Siemens AVANTO K0322428 predicate. CH-210 Cold Head are indicated to be used together with F70H compressors. Both compressors and Cold Heads are declared conformant to IEC 60601-1 by Sumitomo | | RFA | We intend to adopt as an alternative (to Analogic Corp.) for servicing and for newly designed devices the RFT RF9200 9KW model | | Introduce change in hardware inside the magnet (double current same magnetic field) | ASG superconductors decided to double the current inside the magnet while keeping unchanged the magnetic field to reduce the number of superconductive coils inside the vacuum chambers and this results in a cost reduction due to less MgB2 wire. No change in material which is the same MgB2 manufactured within ASG Superconductors S.p.A. Columbus Wire Business Unit No change in supplier manufacturing process Completely owned proprietary magnet construction process | | Long Spine receiving coil | This receiving coil is equivalent to standard Spine coil in K151466 designed to fit a longer column segment. It allows performing exams on adjacent sections of the spine without moving the coil under the patient | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized symbol to the left, consisting of curved lines in blue, green, yellow, orange, and red. To the right of the symbol is the text "ASG" in large, bold, blue letters, with the word "SUPERCONDUCTORS" in smaller blue letters underneath. | Shoulder coil | This new model is derived from MrJ 3300 predicate device K122034 and it will be employed together with the new patient comfort accessories supplied | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Patient comfort accessories | back, but just adjusting patient table position inside the magnet isocenter. | | | Some new cushion shapes and supports have been studied to improve comfort during shoulder and head exams (no new materials and technologies) | 807.92(a)(5) A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in paragraph (a) (3) of this section, the 510 (k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled; MRopen 0.5 T product is a Magnetic Resonance Diagnostic Device MRopen 0.5 T is Total Body MRDD with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T Tomograph produces transverse, sagittal, coronal and oblique crosssectional images that display the internal structure of the anatomies. The examinations may be performed both in weight free (supine) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis. Intended population is for Patients less than 200 Kg The new MRopen 0.5 T Tomograph can perform DWI images based on a Diffusion excitation pattern applied on a specific acquisition sequence, in this case the HASTE AM26/778 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized symbol on the left, resembling a series of curved lines in different colors (blue, green, yellow, orange, and red). To the right of the symbol is the text "ASG" in a bold, blue font, with the word "SUPERCONDUCTORS" written in smaller blue letters underneath. The overall design is clean and modern. readout sequence. DWI is a well known diagnostic technique which does not rise safety and effectiveness issues different form the previously addressed ones when used as labeled. 807.92(a)(6) If the device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device identified in paragraph (a) (3) of this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. If the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to a legally marketed device identified in paragraph (a) (3) of this section ### Technological Characteristics The MRopen 0.5 T MRI system is substantially equivalent to | General item | MRopen 0.5 T | Primary Predicate K151466 MrOpen | Secondary Predicate Siemens Magnetom C! K082331 | | |--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|---------| | Anatomical regions | Total body with the following limitation: no cardiac imaging, no breast imaging. | Total body with the following limitation: no cardiac imaging, no breast imaging. | Total Body | | | Nucleus excited | Proton (hydrogen nucleus) | | | | | Diagnostic uses | Magnetic Resonance Diagnostic Device | | | | | SCOUT Multiplanar | Yes | Yes | | | | Ortogonal (SE ο GFE) | | | | | | Spin echo T1 (SET1) | Yes | Yes | | | | Spin echo T2 (SET2) | Yes | Yes | | | | Short TE spin echo (ERASE) | Yes | Yes | | | | Double echo (DE) | Yes | Yes | | | | Inversion recovery (IR) | | | | | | Short TAU inversion recovery (STIR) | Yes | Yes | | | | General item | MRopen 0.5 T | Primary Predicate K151466 MrOpen | Secondary Predicate Siemens Magnetom C! K082331 | | | Short time inversion recovery gradient field echo (GFE-STIR) | Yes | Yes | | | | Gradient Field Echo (GFE) | Yes | Yes | | | | Gradient Field Echo 3D (3D-GFE) | Yes | Yes | | | | RF spoiled gradient echo 3D (3D-SPGFE) | Yes | Yes | | | | Time reversed 3D gradient Field Echo (3D-EMIT) | Yes | Yes | | | | Rapid Imaging SE T2 (RISE) | Yes | Yes | | | | Rapid Imaging DE (RIDE) | Yes | Yes | | | | Fast Inversion Recovery (FIR) | Yes | Yes | | | | FLAIR - Fluid attenuated Inversion Recovery | Yes | Yes | | | | Spin Echo Presat - FAST RISE9 PRESAT | Yes | Yes | | | | Fast Rise (up to 16 echoes) | Yes | Yes | | | | Fast PD (Fast proton density) | Yes | Yes | | | | 3D Gradient Balanced Steady State (3D- GBASS) | Yes | Yes | | | | Fat-Water separation T1 (FWS T1) | Yes | Yes | | | | ANGIO sequences | Yes | Yes | | | | General item | MRopen 0.5 T | Primary Predicate | Secondary Predicate | | | | | K151466 MrOpen | Siemens Magnetom C! K082331 | | | HASTE sequence | Yes | No | Yes | | | DWI technique | Yes | No | Yes | | | General item | MRopen 0.5 T | Primary | Predicate | K151466 | | | | MrOpen | | | | Magnetic system | • | High homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive, horizontal field | | | | | Maximum Magnetic field 0.5 Tesla | | | | | | Current 146A | Current 84 A | | | | | 28000 kg | | | | | | 200x200x170 cm (HxDxW) | | | | | | 4.0 x 4.6 x 3.6 m (Vertical x Transversal x Longitudinal) | | | | | | <2 ppm FWHM over 30 cm DSV | | | | | Gantry | 56 cm lateral gap | | | | | Gradient System | | 20mT/m | | | | | 0.6 msec (from 0 - 20 mT/m) | | | | | | 33 mT/m/ms | | | | | | 9 kW | | | | | RF amplifier | Analogic AN8102 or RFT RF9200 model as alternative | | Analogic model AN8102 | | AM 27/778 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized "X" made of curved lines in blue, green, yellow, orange, and red. To the right of the "X" is the text "ASG" in large, blue letters, with the word "SUPERCONDUCTORS" in smaller, blue letters underneath. AM 28/778 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is made up of curved lines in the colors blue, green, yellow, orange, and red. The text "ASG" is in a large blue font, and the text "SUPERCONDUCTORS" is in a smaller blue font below the "ASG" text. | General item | MRopen 0.5 T | Secondary Predicate K122034 MrJ | |--------------|--------------|---------------------------------| | | | 3300 | | Spectrometer | | ACS MRIBox | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is made up of curved lines in blue, red, yellow, and green. The text "ASG SUPERCONDUCTORS" is in blue and is to the right of the graphic. | Receiving Coils' list | Code#autom. Recogn. digit | MRopen 0.5 T | Primary Predicate K151466 MrOpen | Secondary Predicate K122034 MrJ 3300 | |--------------------------|------------------------------|--------------|-------------------------------------------|-----------------------------------------------| | C-Spine | 03-2003 #7 | ✓ | ✓ | | | Shoulder | 03-2005 #9 | ✓ | ✓ | | | Hand | 03-2006 #4 | ✓ | ✓ | | | MP-Loop | 03-2010 #8 | ✓ | ✓ | | | Flex S | 03-2011 #12 | ✓ | ✓ | | | Flex L | 03-2012 #13 | ✓ | ✓ | | | MP_Flat | 03-2015 #14 | ✓ | ✓ | | | Body | 03-2019 #2 | ✓ | ✓ | | | Knee | 03-2018#3 | ✓ | ✓ | | | Head | 03-2001#1 | ✓ | ✓ | | | Head/Neck | 03-2020#10 | ✓ | ✓ | | | Spine | 03-2016#8 | ✓ | ✓ | | | Long Spine | 03-2100#11 | ✓ | longer version of 03-2016#8 | | | Shoulder | 03-2101#9 | ✓ | | ✓ | (b) 510(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on an assessment of performance data shall contain the following information: (1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence; The MRopen 0.5 T has been evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, software verification and image quality and has been found to conform to the following medical device safety standards (see also Section 8 Conformance to Consensus Standards and test reports). An 30/278 {12}------------------------------------------------ Image /page/12/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized symbol on the left, consisting of two curved lines that intersect, with five colored lines in between. To the right of the symbol is the text "ASG" in large, blue letters, with the word "SUPERCONDUCTORS" in smaller, blue letters underneath. According to our quality management system a report is issued if a standard changes, if the device changes or both. Not all the tests were newly performed where the above conditions did not apply | Standard | FDA Recog. number | Rationale for repeating tests | 510(k) ref | |---------------------------------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | IEC 60601-1 | 19-4 | Hardware/Software changes Test repeated | See below section 8 | | 60601-2-33 Ed. 3.2 b:2015 | 12-295 | Standard Changed Test repeated | See below section 8 | | 60601-1-2 Edition 4.0 2014-02 | 19-8 | Hardware changes Test repeated | See below section 8 | | 60601-1-6 Edition 3.1 2013-10 | 5-89 | Software/Hardware changes Test repeated | See below section 8 | | 62366-1 Edition 1.0 2015-02 | 5-114 | Software changes Test repeated | See below section 8 | | 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | 13-79 | Software changes Test repeated | See below section 8 | | 62471 First edition 2006-07 | 12-249 | No change - Not repeated | K151466 | | MS-1-2008 (R2014) | 12-188 | No change - Not repeated | K151466 | | MS 2-2008 (R2014) | 12-19 | The standard NEMA MS-2 2008 (R2014) changed introducing the requirement of using a square voxel for the test image. We already fullfilled that requirement and do not need to repeat the test | K151466 | | MS 3-2008 (R2014) | 12-187 | No change - Not repeated | K151466 | | NEMA MS-4 | 12-232 | No change - Not repeated | K151466 | | NEMA MS-5 | 12-231 | No change - Not repeated | K151466 | {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for ASG Superconductors. The logo consists of a stylized graphic to the left of the company name. The graphic is made up of two blue arcs that intersect, with a series of colored lines (blue, green, yellow, orange, and red) filling the space between the arcs. | MS (R2014) | 6-2008 | 12-195 | New Long Spine coil Test repeated | See below section 8 | | |---------------|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--| | MS 8-2016 | | 12-315 | The Standard NEMA MS-8 2016 differ from the version used for previous 510(k) submission. As stated in the Introduction at pag. v, the modification aim to consider the method adjustement required by higher frequency transmitting coil (125 MHz) used in 3T systems. As the proposed equipment works at a much lower frequency (21 MHz) we evaluate to not repeat the connected test | K151466 | | | MS (R2014) | 9-2008 | 12-288 | New Long Spine coil Test repeated | See below section 8 | | | MS 10-2010 | | 12-298 | No change - Not repeated | K151466 | | | NEMA PS 3.1 | | 12-300 | Software Changed | See Appendix H | | (2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence; and #### No clinical tests were performed. We supply images of healthy volunteers who agreed to cooperate to demonstrate performance of the device on humans. A732/278 {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is composed of curved lines in different colors, including blue, green, yellow, and red. To the right of the graphic is the text "ASG" in large, blue letters, with the word "SUPERCONDUCTORS" in smaller, blue letters underneath. Only main changes were tested: | Item tested | Result/remarks | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | New DWI technique base on HASTE readoutsequence | The images on healthy volunteers conform to the expected image quality. Both ADC calculated image and DWI images along the three main directions are displayed | | New Long Spine coil | The use of this new receiving coil has been referred to the previous spine model for equivalent or better quality image, with the workflow improvement of not new coil positioning in case of multiple scan of different streches of spine. Performance test report in Section 18 | | Shoulder coil New model | This design is exactly the same employed in MrJ 3300 secondary predicate device which better fits the new patient comfort accessories during shoulder exam. Performance test report in Section 18 | ### Population (healthy volunteers) The healthy volunteers were adult male and female aged between 20 and 60 available in our firm. (3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a) (3) of this section. The non clinical (bench) and clinical (healthy volunteers) data demonstrate MRopen 0.5T to be as safe, as effective and performs as well than the predicates. Mropen 0.5 T is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards. AM33/778