(28 days)
No
The summary describes a hardware and software upgrade to an existing MRI system, primarily focusing on a new user interface and updated computer/spectrometer hardware. There is no mention of AI, ML, or related concepts like image processing algorithms that would typically indicate the presence of such technology. The performance studies are standard nonclinical tests (ACR tests) for MRI systems, not studies evaluating AI/ML performance.
No
The device is described as a "diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images display the internal structure of the body regions." Its purpose is to "yield information that can be useful in the determination of a diagnosis," not to treat or cure a disease or condition.
Yes
The device is described as an "MRI diagnostic Device" and its images "can yield information that can be useful in the determination of a diagnosis."
No
The device description explicitly states that the "Upgrade Kit MR GUI PRO is a kit containing HW and SW". This indicates the presence of both hardware and software components, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an MRI diagnostic device that produces images of the internal structure of the body. It works by detecting the spatial distribution of protons exhibiting magnetic resonance.
- No Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient. The device directly interacts with the patient's body to generate images.
Therefore, this device falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MRI diagnostic Device is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images display the internal structure of the body regions for which it is indicated (shoulder, elbow, hand, wrist, foot, ankle, knee, hip, calf, thigh, arm, forearm, Temporo Mandibular Joint, C-spine, L-Spine with limitation to joint pathologies, no tumors, no angiography).
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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
No change will be applied to already marketed devices for what regards: how the device functions, the scientific concepts that form the basis for the device, the significant physical and performance characteristics of the device, such as device design, material used, and physical properties. The only modification to K033507, K100164, K122034 cleared device.
- Introduce internally developed User Interface 0
- Upgrade computer/spectrometer hardware to the state of the art to run user interface 0
The same change when applied to new manufactured units which correspond to K122034+this proposed change will be identified with a new commercial name which is Mr.J 3300 Plus
The produced images will still 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.
The modification reflected in this Special 510(k) for the K033507, K100164, K122034 Tomographs introduce updates in computer/spectrometer hardware and software. The modifications have not altered the scientific technology of the unmodified version K033507, K100164, K122034 as detailed in below table. The same change when applied to new manufactured units which correspond to K122034+this proposed change will be identified with a new commercial name which is MrJ 3300 Plus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
shoulder, elbow, hand, wrist, foot, ankle, knee, hip, calf, thigh, arm, forearm, Temporo Mandibular Joint, C-spine, L-Spine with limitation to joint pathologies, no tumors, no angiography.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests submitted, referenced, or relied on: All the proposed modified hardware already cleared within K190524 file no safety tests were repeated, we grant conformance towards IEC 62304 standard regarding Software lifecycle, DICOM conformance and ACR performance. We supply images from ACR tests performed in firm to check proper functioning of the Software.
| Standard | FDA Recog. number | Rationale for repeating/not repeating tests | 510(k) ref |
|---|---|---|---|
| IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | 13-79 | Software changes Test repeated in K190524 | K190524 |
| NEMA PS 3.1 | 12-300 | Software Changed | K190524 |
The supplied images folders are:
0_scout
1_FSE T2
2_FSE T1
3_FSE PD
4_FIR PD
5_FIR T2
6_GE T1
7_GE T2
8_Stir GE
9_Stir SE
12_FWS
13_FWS
16_FWS
17_FWS
20_Spin Echo
21_FSE PD T2
22_FSE PD T2
23_FIR T2
24_FIR PD
25_3D GBASS
27_3D GFE T1
29_3D GFE
Clinical tests submitted, referenced, or relied on: No clinical tests were performed.
The non clinical (ACR Test) data demonstrate Upgrade Kit MR GUI PRO to be as safe, as effective and performs as well than the predicates. Upgrade Kit MR GUI PRO is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards. When applied in firm to newly manufactured cleared K122034 items this will take the new name of MrJ 3300 Plus.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
October 24, 2019
ASG Superconductors S.p.A. % Luisella De Benedetti Quality and Regulatory Affairs Corso Ferdinando Maria Perrone 73/R 16152 Genova ITALY
Re: K192690
Trade/Device Name: Upgrade Kit MR GUI PRO, MrJ 3300 Plus Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: September 18, 2019 Received: September 26, 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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,
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
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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)
K192690
Device Name Upgrade Kit MR GUI PRO MrJ 3300 Plus
Indications for Use (Describe)
The MRI diagnostic Device is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images display the internal structure of the body regions for which it is indicated (shoulder, elbow, hand, wrist, foot, ankle, knee, hip, calf, thigh, arm, forearm, Temporo Mandibular Joint, C-spine, L-Spine with limitation to joint pathologies, no tumors, no angiography).
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.
| 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 (7/17)
Page 1 of 1
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Image /page/3/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 the colors blue, green, yellow, orange, and red. The text "ASG" is in a large, bold, blue font, and the text "SUPERCONDUCTORS" is in a smaller, blue font below the "ASG" text.
9. 510(k) Summary (21 CFR 807.92)
Date: (month/day/year) 09/18/2019
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 Ferdinando Maria Perrone 73/R - 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 Upgrade Kit MR GUI PRO (which is a kit containing HW and SW to upgrade previously cleared installed models to the state of the art) MrJ 3300 Plus (which is commercial name of the same Upgrade Kit when integrated in factory on newly manufactured K122034+this change) Trade name Upgrade Kit MR GUI PRO (which is a kit containing HW and SW to upgrade previously cleared installed models to the state of the art, upgrade kit for K033507, K100164, K122034) MrJ 3300 Plus (which is commercial name of the same Upgrade Kit when integrated in factory on newly manufactured K122034+this change Classification name Magnetic Resonance Diagnostic Device Classification and 21 CFR 892.1000, class II class of device Classification Number 90LNH
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Image /page/4/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized graphic to the left of the company name. The graphic is made up of curved lines in the colors blue, green, yellow, orange, and red. The company name is written in blue, with "ASG" in a larger font than "Superconductors."
807.92(a)(3) an identification of the legally marketed device to which the submitter claims equivalence.
The proposed change will be applied to the below already marketed devices
| Device name | Applicant | 510(k) Number | Decision date | New owner | Device listing updated to new owner |
|---|---|---|---|---|---|
| Mrj 3300 | PARAMED | K122034 | 12/06/2012 | ASG | D339501 |
| Mr Inspire | |||||
| With | |||||
| Extended | |||||
| Kit | SRL | K100164 | 04/05/2010 | Superconductors | |
| S.p.A. | D339504 | ||||
| Mrj | K033507 | 01/02/2004 | D339507 |
All the Hardware and User Interface Software proposed for this Upgrade Kit or for this new commercial name of the device were cleared within
| Device name | Applicant | 510(k) Number | Decision date | New device listing |
|---|---|---|---|---|
| MRopen 0.5 T | ASG | |||
| superconductors | ||||
| S.p.A. | K190524 | July 1st 2019 | D353105 |
MrJ 3300 Plus which is commercial name of the same Upgrade Kit when applied in factory on newly manufactured K122034+this change devices
| Device name | Applicant | 510(k)
Number | Decision
date | New device
listing |
|---------------|-------------------------------|------------------|------------------|-----------------------|
| MrJ 3300 Plus | ASG superconductors
S.p.A. | To be def | To be def | To be def |
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Image /page/5/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized "X" shape made of curved lines in different colors, followed by the letters "ASG" in a bold, blue font. Below "ASG" is the word "SUPERCONDUCTORS" in a smaller, blue font.
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;
No change will be applied to already marketed devices for what regards: how the device functions, the scientific concepts that form the basis for the device, the significant physical and performance characteristics of the device, such as device design, material used, and physical properties. The only modification to K033507, K100164, K122034 cleared device.
- Introduce internally developed User Interface 0
- Upgrade computer/spectrometer hardware to the state of the art to run user interface 0
The same change when applied to new manufactured units which correspond to K122034+this proposed change will be identified with a new commercial name which is Mr.J 3300 Plus
The produced images will still 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.
The modification reflected in this Special 510(k) for the K033507, K100164, K122034 Tomographs introduce updates in computer/spectrometer hardware and software. The modifications have not altered the scientific technology of the unmodified version K033507, K100164, K122034 as detailed in below table. The same change when applied to new manufactured units which correspond to K122034+this proposed change will be identified with a new commercial name which is MrJ 3300 Plus.
Image /page/5/Picture/9 description: The image contains the numbers 36 and 340, separated by a forward slash. The numbers are written in a cursive style with a blue ink. The numbers are positioned horizontally in the image.
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Image /page/6/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized graphic to the left of the company name. The graphic consists of a curved line and several curved lines that are shaded. The text "ASG SUPERCONDUCTORS" is to the right of the graphic.
In particular here below find the IFU statements from each of the addressed predicates and modified devices
Device Name Upgrade Kit MR GUI PRO MrJ 3300 Plus
Indications for Use (Describe)
The MRI diagnostic Device is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images display the internal structure of the body regions for which it is indicated (shoulder, elbow, hand, wrist, foot, ankle, knee, hip, calf, thigh, arm, forearm, Temporo Mandibular Joint, C-spine, L-Spine with limitation to joint pathologies, no tumors, no angiography).
The images produced reflect the spatial distribution of protons (hydrogen nucle) 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.
510(k) Number (if known): K033507
Device Name: MRJ
Indications For Use:
The intended use of Paramed's MRJ product is for diagnostic MRI imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, TMJ and cervical spine with limitation to joint pathologies - no tumors, no angiography. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend on the MR parameters (spin-lattice relaxation time - T1, spin-spin relaxation time - T2, nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
Image /page/6/Picture/10 description: The image shows a black quarter-circle shape. The curved edge of the quarter-circle is at the top of the image, and the two straight edges form a right angle at the bottom right. The shape is solid black and fills a significant portion of the image.
7
Image /page/7/Picture/0 description: The image shows the logo for ASG Superconductors. The logo consists of a stylized symbol to the left, resembling curved lines, followed by the letters "ASG" in a bold, sans-serif font. Below "ASG" is the word "SUPERCONDUCTORS" in a smaller, sans-serif font. The overall design is clean and professional.
510(k) Number (if known): K100164
Device Name: Mr Inspire (code 01-2000-01) with Extended kit (code 01-1872-01)
Indications for Use:
The intended use of Paramed's Mr. Inspire with Extended is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), with limitation to joint pathologies (no turnors, no angiography) If equipped with the Extended kit (code 01-1872-01) the MrJ inspire device can also produce images of the C-Spine and L-Spine joints. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged.
The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spir-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
510(k) Number (if known): K122034
MrJ 3300 code 06-2000-00 Device Name:
Indications for Use:
The MrJ 3300 is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography).
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 (T), 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.
ADDED 366
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Image /page/8/Picture/0 description: The image shows the logo for ASG Superconductors. The logo consists of a stylized symbol on the left, resembling a series of curved lines, followed by the letters "ASG" in a bold, sans-serif font. Below the letters, the word "SUPERCONDUCTORS" is printed in a smaller, sans-serif font.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2020 Indications for Use See PRA Statement below. 510(k) Number (if known) K190526 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 firee (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 (T)), 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.
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Image /page/9/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized "X" made of curved lines in different colors, followed by the letters "ASG" in blue. Below "ASG" is the word "SUPERCONDUCTORS" in smaller blue letters. The logo is clean and modern, with a focus on the company's name and area of expertise.
| Claimed
| Feature | Discussion |
|---|---|
| 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. | |
| Spectrometer | According to the model to which the Upgrade Kit MR GUI PRO is applied |
| the spectrometer could be upgraded to the model cleared within K190524 | |
| (part number 01-1800-04) | |
| Image: Spectrometer | |
| PC client | According to the model to which the Upgrade Kit MR GUI PRO is applied |
| the server PC will be upgraded to Windows 10 model cleared within | |
| K190524 part number 01-4808 – CE marked- CULUS listed - E105106 - | |
| Dell code D084602 | |
| Image: PC client | |
| Monitor | A possible accessory is a newer wider and more performing monitor which |
| is the same cleared within K190524 (part number 01-0623 cULus Listed | |
| (E332883), FCC, CE, TUV) Samsung 2243SN model | |
| Image: Monitors | |
| User manual | Addendum to describe the new user interface adopted |
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Image /page/10/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 several curved lines in different colors, including blue, green, yellow, and red. The text "ASG" is in a large, bold, blue font, and the word "SUPERCONDUCTORS" is in a smaller, blue font below the "ASG" text.
Drawings, specifications, purchasing datasheet or electric schemes are contained in factory's Device Master Record.
None of the proposed changes impact safety and effectiveness, unless the expected improvement due to updated hardware which means improved performance and cybersecurity.
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;
K033507, K100164, K122034 were, are and will remain Magnetic Resonance Diagnostic Devices
K033507, K100164, K122034 produced, produce and will produce transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the anatomies.
The same change when applied to new manufactured units which correspond to K122034+this proposed change will be identified with a new commercial name which is MrJ 3300 Plus
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
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Image /page/11/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, bold, blue font, and the word "SUPERCONDUCTORS" is in a smaller, blue font below the "ASG".
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
| General item | The proposed change affects this parameter? (Y/N) |
|---|---|
| Anatomical regions | N |
| Excited Nucleus | N |
| Diagnostic uses | N |
| General item | The proposed change affects this parameter? (Y/N) |
| Acquisition sequences | N |
| Magnetic system | N |
| Orientation | N |
| Shape | N |
| Gap | N |
| Weight | N |
| Dimensions | N |
| Homogeneity | N |
| Gradient strength (maximum possible) | N |
| Gradient strength (clinically employed) | N |
| Rise Time | N |
| Slew rate | N |
| RF amplifier | N |
| Receiving coils | N |
| User Interface | Y up to State of the art internally designed cleared within K190524 removes Legacy softwares |
| Spectrometer | Y up to State of the art cleared within K190524 |
| Monitor | Y wider medical monitor same markings as previous (cleared within K190524 unchanged with respect to predicate K151466) |
| PC | Y up to State of the art same as cleared within K190524 |
| Operating system | Y Windows 10 up to State of the art same as cleared within K190524 |
In the following table for each item it is declared if the proposed upgrade impacts or not
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Image /page/12/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 a series of curved lines in different colors, including blue, green, yellow, and red. The text "ASG" is in large, blue letters, and the word "SUPERCONDUCTORS" is in smaller, blue letters below "ASG".
510 (k) summaries for those premarket submissions in which a (b) 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;
Being all the proposed modified hardware already cleared within K190524 file no safety tests were repeated, we grant conformance towards IEC 62304 standard regarding Software lifecycle, DICOM conformance and ACR performance see below detailed discussion table.
| Standard | FDA
Recog.
number | Rationale for repeating/not
repeating tests | 510(k) ref |
|-------------------------------------------------------------|-------------------------|------------------------------------------------|------------|
| IEC 62304 Edition
1.1 2015-06
CONSOLIDATED
VERSION | 13-79 | Software changes Test repeated in
K190524 | K190524 |
| NEMA PS 3.1 | 12-300 | Software Changed | K190524 |
We supply images from ACR tests performed in firm to check proper functioning of the Software. Refer to Miscellaneous eCopy folder
The supplied images folders are:
| 0_scout | 12/06/2019 15:37 |
|---|---|
| 1_FSE T2 | 12/06/2019 15:37 |
| 2_FSE T1 | 12/06/2019 15:37 |
| 3_FSE PD | 12/06/2019 15:37 |
| 4_FIR PD | 12/06/2019 15:37 |
| 5_FIR T2 | 12/06/2019 15:37 |
| 6_GE T1 | 12/06/2019 15:37 |
| 7_GE T2 | 12/06/2019 15:37 |
| 8_Stir GE | 12/06/2019 15:37 |
| 9_Stir SE | 12/06/2019 15:37 |
| 12_FWS | 12/06/2019 15:37 |
| 13_FWS | 12/06/2019 15:37 |
| 16_FWS | 12/06/2019 15:37 |
| 17_FWS | 12/06/2019 15:37 |
| 20_Spin Echo | 12/06/2019 15:37 |
| 21_FSE PD T2 | 12/06/2019 15:37 |
| 22_FSE PD T2 | 12/06/2019 15:37 |
| 23_FIR T2 | 12/06/2019 15:37 |
| 24_FIR PD | 12/06/2019 15:37 |
| 25_3D GBASS | 12/06/2019 15:37 |
| 27_3D GFE T1 | 12/06/2019 15:37 |
| 29_3D GFE | 12/06/2019 15:37 |
13
Image /page/13/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 a series of curved lines in different colors, including blue, green, yellow, and red. The text "ASG" is in a bold, blue font, and the word "SUPERCONDUCTORS" is in a smaller font below "ASG".
(2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination substantial equivalence. This discussion shall include, of 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.
(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 (ACR Test) data demonstrate Upgrade Kit MR GUI PRO to be as safe, as effective and performs as well than the predicates. Upgrade Kit MR GUI PRO is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards. When applied in firm to newly manufactured cleared K122034 items this will take the new name of MrJ 3300 Plus.