(63 days)
No
The document describes standard MRI technology and image processing techniques (like MIP). There is no mention of AI, ML, or related terms, nor any description of training or test sets characteristic of AI/ML development.
No.
The device is used for imaging to assist in diagnosis, not for treating diseases or conditions.
Yes
The device is described as collecting, displaying, and analyzing MR images to "provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions." This explicitly states its role in aiding diagnosis.
No
The device description explicitly mentions hardware components like a 0.4T permanent Magnet, a C-shape, and an enhancement of the PC board with a new processor. It also describes testing related to hardware, such as surface heating testing and performance tests for a Body coil. While software is a significant part of the device, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a magnetic resonance imaging (MRI) device. MRI is an in vivo imaging technique, meaning it scans the body directly without requiring samples to be taken.
- Intended Use: The intended use is to "scan any targeted area of the body, to collect, display and analyze MR images." This is consistent with an in vivo imaging device, not an in vitro diagnostic.
The device is used to produce images of the inside of the body, which are then used by physicians for diagnosis. This is fundamentally different from performing tests on biological samples outside the body.
N/A
Intended Use / Indications for Use
The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyze MR images and other real-time imaging procedures.
Imaging portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration).
MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.
Product codes
LNH
Device Description
The new Magnifico EVO 23 employs the same fundamental scientific technology as its predicate device, the first version of Esaote Magnifico, cleared via K212419.
The modifications, do not affect the intended use or alter the fundamental scientific technology of the device.
The software, used on the proposed Magnifico system has been modified, from EVO 21 to include the
• LSDWI sequence for brain examination
- · MR Angiography
· Maximum Intensity Projection (MIP) - and to support:
· Additional multi-channel technology coil for body - · Enhancement of PC board with new processor
Maqnifico keeps all the other technological characteristics of the first cleared, version, as the 0.4T permanent Magnet, based on NdFeB (neodymium), C-shape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint, head
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)
Software verification and validation activities are provided. Bench testing outputs from new features (LSDW, MRA and MIP), image quality test, relevant electromagnetic compatibility tests. Surface heating testing and all relevant performance tests the Body coil were provided. Sample clinical images for the new features were reviewed by a ACR registered radiologist and determined to be of good diagnostic quality. The testing and software documentation demonstrate that the Magnifico MRI system with EVO 23 Software release is substantially equivalent to the predicate device, and conform to applicable medical device safety and performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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.
June 26, 2024
Esaote S.p.A. Alberto Carcagnì Regulatory Affairs Specialist Via Melen 77 Genova. 16152 Italy
Re: K241133
Trade/Device Name: Magnifico Open (100009900); Magnifico MSK (100009910) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: June 6, 2024 Received: June 6, 2024
Dear Alberto Carcagnì:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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,
Daniel M. Krainak, Ph.D Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K241133
Device Name Magnifico Open (100009900): Magnifico MSK ( 100009910)
Indications for Use (Describe)
The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyze MR images and other real-time imaging procedures.
Imaging portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration).
MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) #: K241133
510(k) Summary
Prepared on: 2024-06-26
21 CFR 807.92(a)(1)
Contact Details
| Applicant Name | Esaote S.p.A. | |
|---|---|---|
| Applicant Address | Via Melen 77 Genova 16152 Italy | |
| Applicant Contact Telephone | +39 338 7170634 | |
| Applicant Contact | Mr. Alberto Carcagni | |
| Applicant Contact Email | alberto.carcagni@esaote.com | |
| Device Trade Name | Magnifico Open (100009900); | |
| Magnifico MSK ( 100009910) | ||
| Common Name | Magnetic resonance diagnostic device | |
| Classification Name | System, Nuclear Magnetic Resonance Imaging | |
| Regulation Number | 892.1000 | |
| Product Code(s) | LNH | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K212419 | Magnifico Open, Magnifico MSK | LNH |
| K032232 | Hitachi Airis Elite | LNH |
| K153736 | 3Mensio WORKSTATION | LLZ |
The new Magnifico EVO 23 employs the same fundamental scientific technology as its predicate device, the first version of Esaote Magnifico, cleared via K212419.
The modifications, do not affect the intended use or alter the fundamental scientific technology of the device.
The software, used on the proposed Magnifico system has been modified, from EVO 21 to include the
• LSDWI sequence for brain examination
-
· MR Angiography
· Maximum Intensity Projection (MIP) -
and to support:
· Additional multi-channel technology coil for body -
· Enhancement of PC board with new processor
Maqnifico keeps all the other technological characteristics of the first cleared, version, as the 0.4T permanent Magnet, based on NdFeB (neodymium), C-shape.
4
Intended Use/Indications for Use
The general-purpose magnetic resonance imaging (MR) device is designed to scan any targeted area of the body, to collect, display and analyze MR images and other real-time imaging procedures.
lmaqing portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration).
Indications for Use Comparison
The indications for use of the new version of Esaote Magnifico MRI system are the first version of Magnifico, registered via K212419.
Only the Outcome related to diagnosis, due to the introduction of Magnifico (Magnifico Magnifico MSK), contains, for new Magnifico EVO23, a distinguish of the configurations. This is irrelevant because is referred to the more complete Version of Magnifico
Technological Comparison
The technological characteristics of this device are similar to the primary predicate device. There has been no change to the magnet design or control system. The base elements of the operating system software are identical to the primary predicate device but the software have been improved with new functions like MR Angiography and DW. Both are consolidated standard MRI functions, cleared also with a low field MRI as Hitachi Airis Elite.
The MIP feature is exactly the same that was firstly realized by 3Mension (in Esaote Group) for a S.a.M.D. called Warkstation and, successively, included in a Esacte software tool, called 3D Viewer registered, with G-scan Brio. Both S.a.M.D, Workstation and 3D viewer, have been FDA cleared, respectively via K153736 and K180592.
The additional body coil has the same technical characteristics of the coils cleared with Primary Predicate device Magnifico.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Software verification and validation activities are provided. Bench testing outputs from new features (LSDW, MRA and MIP), image quality test, relevant electromagnetic compatibility tests. Surface heating testing and all relevant performance tests the Body coil were provided. Sample clinical images for the new features were reviewed by a ACR registered radiologist and determined to be of good diagnostic quality. The testing and software documentation demonstrate that the Magnifico MRI system with EVO 23 Software release is substantially equivalent to the predicate device, and conform to applicable medical device safety and performance requirements.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)