(179 days)
Not Found
No
The document describes standard MRI technology and image processing techniques, with no mention of AI or ML.
No
The device is described as an "imaging device" and its purpose is to "provide information that can be useful in diagnosis determination," which indicates a diagnostic rather than therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the images, "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination." This indicates that the device produces information used for diagnosis.
No
The device description clearly describes a physical Magnetic Resonance (MR) system, including components like a static magnetic field, RF excitation, and magnetic field gradients, which are hardware components. While it mentions image processing, this is part of the overall hardware system's function.
Based on the provided information, 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 APERTO Lucent System is an imaging device that uses Magnetic Resonance (MR) to produce images of the internal structure of the body. It obtains information non-invasively and without the use of ionizing radiation.
- Intended Use: The intended use is to provide physiological and clinical information through imaging, which is then interpreted by a trained physician for diagnosis determination. This is a diagnostic process, but it's based on in vivo imaging, not in vitro testing of samples.
The description clearly states it's an imaging device and describes the principles of MRI, which is a non-invasive imaging technique. There is no mention of analyzing biological samples.
N/A
Intended Use / Indications for Use
The APERTO Lucent System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton
Diagnostic uses:
- T1, T2, proton density weighted imaging
- Diffusion weighted imaging
- MR Angiography
- Image processing
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The APERTO Lucent is a modification of the AIRIS Elite MRI System. The APERTO Lucent has been revised to increase the clinical utility as compared to the AIRIS Elite Magnetic Resonance imaging system. Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In MR imaging, difference in proton density, blood flow, and T1 and T2 relaxation times can all contribute to image contrast. By varying the pulse sequence characteristics, the resulting images can emphasize T1, T2, proton density, or the molecular diffusion of water or other proton containing molecules.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, Body, Spine, Extremities
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)
The APERTO Lucent MRI System was subjected to the following laboratory testing:
- IEC60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM:2012. Medical electrical equipment -. part 1: general requirements for basic safety and essential performance
- IEC 60601-2-33 Edition 3.2 b:2015. medical electrical equipment part 2-33: particular . requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic.
- IEC 62304 Edition 1.1 2015-06, CONSOLIDATED VERSION medical device software software . life cycle processes.
- NEMA MS 1-2008, Determination of Signal-to-noise Ratio (SNR) in Diagnostic Magnetic . Resonance Images
- . NEMA MS 2-2008, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- . NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- . NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices
- NEMA MS 5-2018, Determination of Slice Thickness in Diagnostic Resonance Imaging
- NEMA MS 8-2016, Characterization of the Specific Absorption Rate for Magnetic Resonance . Imaging Systems
- . NEMA MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
- . IEC 60601-1-2 Edition 4.0:2014, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances requirements and tests.
- . IEC 62464-1 Edition 2.0 2018-12 Magnetic resonance equipment for medical imaging Part1: Determination of many essential image quality
Clinical image examples were provided for applicable new features and three new RF coils. A radiologist validated that the clinical images have acceptable image quality for clinical use.
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.
AIRIS Elite V4.9 MRI system (K032232)
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.
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 10, 2024
FUJIFILM Healthcare Corporation Kotei Aoki Manager, Regulatory Affairs 81 Hartwell Avenue, Suite 300 Lexington, Massachusetts 02421
Re: K233629
Trade/Device Name: APERTO Lucent MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: April 2, 2024 Received: April 11, 2024
Dear Kotei Aoki:
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).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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,
D.G.K.
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
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
APERTO Lucent MRI System
Indications for Use (Describe)
The APERTO Lucent System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton
Diagnostic uses:
- · T1, T2, proton density weighted imaging
- · Diffusion weighted imaging
- · MR Angiography
- · Image processing
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)
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Submitter Information
| Submitter: | FUJIFILM Healthcare Corporation |
|---|---|
| 2-1, Shintoyofuta | |
| Kashiwa-Shi, Chiba, 277-0804 Japan | |
| Contact: | |
| Telephone number: | 765-246-2931 |
| E-mail: | kotei.aoki@fujifilm.com |
| Date: | November 10, 2023 |
Subject Device Name
| Trade/Proprietary Name: | APERTO Lucent MRI system |
|---|---|
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code: | LNH |
| Class: | 2 |
| Panel: | Radiology |
Predicate Device Name
| Predicate Device(s): | AIRIS Elite V4.9 MRI system (K032232) |
|---|---|
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code | LNH |
| Class | 2 |
| Panel | Radiology |
Device Intended Use
The APERTO Lucent System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses:
- T1, T2, proton density weighted imaging
- . Diffusion weighted imaging
- MR Angiography ●
- Image processing
4
Device Description
Function
The APERTO Lucent is a modification of the AIRIS Elite MRI System. The APERTO Lucent has been revised to increase the clinical utility as compared to the AIRIS Elite Magnetic Resonance imaging system.
.Scientific Concepts
Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events.
The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
Physical and Performance Characteristics
MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In MR imaging, difference in proton density, blood flow, and T1 and T2 relaxation times can all contribute to image contrast. By varying the pulse sequence characteristics, the resulting images can emphasize T1, T2, proton density, or the molecular diffusion of water or other proton containing molecules.
Performance Evaluation
The APERTO Lucent MRI System is equivalent to the AIRIS Elite V4.9 (K032232) with following exceptions:
- Field strength is changed from 0.3T to 0.4T. ●
- . Gradient field strength is change from 21mT/m to 22mT/m.
- . Patient table
- Software operating system is changed to Windows 10 IoT from UNIX. .
A rationale analysis was then conducted, and the results are contained in Table 1.
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Bench | Performance bench testing was conducted on the applicable new feature. |
| Test data confirmed that new feature perform as intended for diagnostic use. | |
| Performance Testing - | |
| Clinical | Clinical image examples are provided for applicable new feature and that we judged to be sufficient to evaluate clinical |
| usability. In addition, a radiologist validated that the clinical images have acceptable image quality for clinical use. |
Table 1 Performance Analysis
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Device Technological Characteristics
The control and image processing hardware and the base elements of the system software are identical to the predicate device. The APERTO Lucent MRI system software is substantially equivalent to the AIRIS Elite V4.9A (K0323232). See tables below. The technological characteristics in regard to hardware of the APERTO Lucent MRI system and the predicate are listed in Table 2.
| ITEM | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE | |
|---|---|---|---|---|
| AIRIS ELITE(K032232) | APERTO LUCENT | |||
| System | Standards Met | NEMA: MS 1, MS 2, MS 3, MS 4, MS 5, MS 8, | ||
| IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | NEMA: MS 1, MS 2, MS 3, MS 4, MS 5, MS 8, MS 14, | |||
| IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | Yes | |||
| Magnet and | ||||
| Gantry | Type and Field | |||
| Strength | 0.3T Permanent magnet | 0.4T Permanent magnet | Yes | |
| Resonant Frequency | 12.7 MHz | 16.18MHz | Yes | |
| Gradient System | Gradient Strength | 21mT/m | 22mT/m | Yes |
| Slew Rate | 55 T/m/sec | 55 T/m/sec | No | |
| Rise Time | 380µsec to 21mT/m | 400µsec to 22mT/m | Yes | |
| Audible Noise (MCAN) | ||||
| Ambient | - | 47.4 dBA | Yes | |
| Lpeak | - | 104.4 dB | Yes | |
| Leq |