(21 days)
Not Found
No
The summary describes a modification to the gradient subsystem of an existing MRI device, focusing on increased current limits and slew rate. There is no mention of AI or ML in the intended use, device description, or performance studies. The image processing mentioned is standard for MRI data acquisition and does not imply AI/ML.
No
The device is described as an imaging system (Magnetic Resonance Imaging System) used for producing images and providing diagnostically useful information, not for therapeutic intervention.
Yes
The device is described as producing images that, "when interpreted by a trained physician, can yield diagnostically useful information." This explicitly states its role in diagnosis.
No
The device description explicitly states that it is a modification to an existing MRI scanner's gradient subsystem, which is a hardware component. While software limits are mentioned as a primary difference, the device itself 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 medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Indomitable Magnetic Resonance Imaging System produces images of the internal structure of the head and body based on the distribution of hydrogen nuclei. This is an in vivo imaging technique, meaning it examines the body directly, not specimens taken from the body.
- Intended Use: The intended use is to produce images that, when interpreted by a physician, can yield diagnostically useful information. This aligns with the function of an imaging device, not an IVD.
Therefore, the Indomitable Magnetic Resonance Imaging System is an imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Indomitable Magnetic Resonance Imaging System is indicated for use in producing images of multiple planes in the head and body. These images correspond to the distribution of hydrogen nuclei exhibiting nuclear magnetic resonance (NMR) and depend for their contrast upon NMR parameters [hydrogen nuclei concentration and flow velocity, T1 (spinlattice relaxation time) and T2 (spin-spin relaxation time)]. As a result of the acquisition and processing of the NMR data, these images display the internal structure of the head and body, and when interpreted by a trained physician, can vield diagnostically useful information.
WARNING: This device is limited by U.S. Federal law to investigational use for indications not in the indications statement.
Under the requirements of the law, the non-indicated applications can be used only under an Institutional Review Board approved protocol for a non-significant risk device or an Investigational Device Exemption application approved by the FDA for a significant risk device. The procedures to be followed, under the sponsorship of FONAR Corporation, are determined by the current guidelines established by the FDA, which should provide the IRB with sufficient guidance to determine the level of risk for a MRI device.
WARNING: U.S. Federal law restricts the sale, distribution and use of this device by or on the order of a physician.
Product codes
LNH
Device Description
FONAR Corporation has modified the existing control limits for the Indomitable scanner gradient subsystem to allow the maximum gradient current to increase by 50 percent, with a corresponding increase in the maximum slew rate for the gradient waveforms. All other subsystems remain essentially unchanged from their previously approved (K002490) state.
This modified gradient subsystem follows the same basic design principles as our previously approved gradient systems. It functions on the same basic operating and physical principles as the predicate device, the Indomitable gradient system (K002490). It is constructed with the same manufacturing materials, and is fabricated in the same fashion to the previously approved gradients.
The primary differences of this modification to the gradient subsystem are the software limits for maximum gradient current value and the increased slew rate that accompanies the changed current value. It is, in summary, a significant equivalent of FONAR's currently approved predicate device.
The gradients provide the ability of the system to accurately determine spatial location within the imaging volume. They are also used to help establish control of other imaging factors such as slice thickness and field-of-view. The gradients used on the Indomitable magnet, which are unchanged in this submission have the same overall diameter, and are still comprised of the same three quadrupolar (linear) gradients installed on all Fonar scanners.
One pair is placed in each of the orthogonal imaging planes (X, Y, and Z), developing a typical readout gradient of 1.2 mT/m. Note that while the typical gradient remains at 1.2 mT/m for this submission, the value of maximum gradient change has increased from a value of 12 mT/m to a new maximum of 20.27 mT/m. The gradient linearity remains unchanged at better than 2% over a 28 cm DSV with a stability of + 0.01%.
The gradient current amplifier power required does not affect the actual gradient strength (which is still specified at a typical value of 1.2 mT/m with a typical amplifier power dissipation of 12 kW). The amplifiers for the Indomitable are still designed for accurate control of the current output to the gradient coils with very low distortion. and are rated for a maximum current output of 300 Amps. The gradient amplifiers are unchanged from previous submissions.
The operating characteristics for the hardware of the gradient system described above are controlled by the Indomitable's Sympulse scanner operating software. The software is programmed to operate the scanner system in a safe and efficient manner, and is substantially equivalent to the current operating software in the Indomitable system as approved in K002490. The software has always included "safety limits", which were established through laboratory testing and clinical imaging.
Prior to this submission, the maximum current value allowed by software for the gradient current amplifiers was 200 Amps. This setting effectively limited the maximum gradient amplitude (dB/dt) to 12 mT/m for the system. This rate of change produced a maximum slew rate of 19.73 mT/m/ms and allowed the Indomitable scanner to operate in the NORMAL mode. Testing performed for this submission has shown that an increase of the maximum current from the previous maximum of 200 Amps to the new maximum value of 300 Amps would still allow the scanner to be operated in the NORMAL mode, since no PNS was detected in the test subjects.
Therefore, the maximum gradient current for the gradient amplifiers will now be established by the Sympulse operating software at a value of 300 Amps. This will translate to a maximum dB/dt of 20.27 mT/m with a corresponding maximum slew rate of 33.34 mT/m/ms. The scanner will continue to operate in the NORMAL mode.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
head and body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Non-Clinical Testing:
The following specific parameters have been identified by the FDA as being pertinent to patient safety and thereby have been highlighted for inclusion in 510(k) submissions. The majority of these concerns are specifically tested by comparison to the ISO and NEMA standards, and where utilized are described individually.
- a. Static Field Strength: 0.6T +- 5%
- b. Peak and A-Weighted acoustic noise: 98.3 DBA +- 0.05
- c. Description of operational modes of the system: Normal Mode Only
- d. Maximum SAR for transmit coil: (Unaffected for this submission)
e. Maximum dB/dt (pulsing X, Y and Z gradients): 20.27 mT/m
f. Potential emergency conditions and shutdown: (Unaffected for this submission)
g. Biocompatibility of materials: (Unaffected for this submission)
Clinical Testing:
A voluntary clinical trial was conducted under the testing guidelines described in the ISO standard IEC 60601-2-33, which describes the criteria for experimental studies of human subjects to directly determine limits related to minimizing PNS for any given type of gradient system. All volunteers participated in the study under informed consent. All volunteers completed the test. During the testing process, no volunteer experienced any sensations associated with PNS. This result meets the criteria for continued operation in the normal mode for the Indomitable scanner with the new maximum current limits.
Summary:
The results of the testing, combined with the additional material within this submission has demonstrated that the modified gradient subsystem of the Indomitable magnet is substantially equivalent to the previously approved gradient subsystem of the predicate device (K002490) under the current conditions for intended use, with no adverse effects to patient health or safety reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
7/5/2006
Fonar Corporation 110 Marcus Drive Melville, New York 11747-4292
JUL 2 8 2006
June 30, 2006
Special 510(k) Summary - Device Modification
Submitter Information:
| Company | FONAR Corporation
Registration Number 2432211
110 Marcus Drive, Melville, New York 11747-4292 |
|----------|---------------------------------------------------------------------------------------------------------------------|
| Contact: | Luciano Bonanni Executive Vice President
Phone: (631) 694-2929 Fax: (631) 753-5150
E-mail: lbonanni@fonar.com |
Device Designation:
| Trade Name: | Indomitable Magnetic Resonance Imaging Scanner Accessory |
|---|---|
| Common Name: | Magnetic Resonance Imaging Scanner (MRI Scanner) |
| Classification: | System, Nuclear Magnetic Resonance Imaging (NMR/MRI) |
| Product Code: | LNH |
| Class: | 2 |
| Tier: | 2 |
| C.F.R. Section | 892.1000 |
| Classification Panel: | Radiology |
Reason for Submission: Change in operational limits for gradient subsystem.
FONAR Corporation has modified the existing control limits for the Indomitable scanner gradient subsystem to allow the maximum gradient current to increase by 50 percent, with a corresponding increase in the maximum slew rate for the gradient waveforms. All other subsystems remain essentially unchanged from their previously approved (K002490) state.
Device Modifications
This modified gradient subsystem follows the same basic design principles as our previously approved gradient systems. It functions on the same basic operating and physical principles as the predicate device, the Indomitable gradient system (K002490). It is constructed with the same manufacturing materials, and is fabricated in the same fashion to the previously approved gradients.
The primary differences of this modification to the gradient subsystem are the software limits for maximum gradient current value and the increased slew rate that accompanies the changed current value. It is, in summary, a significant equivalent of FONAR's currently approved predicate device.
1
7/5/2006
Description of Device
Gradient Subsystem
The gradients provide the ability of the system to accurately determine spatial location within the imaging volume. They are also used to help establish control of other imaging factors such as slice thickness and field-of-view. The gradients used on the Indomitable magnet, which are unchanged in this submission have the same overall diameter, and are still comprised of the same three quadrupolar (linear) gradients installed on all Fonar scanners.
One pair is placed in each of the orthogonal imaging planes (X, Y, and Z), developing a typical readout gradient of 1.2 mT/m. Note that while the typical gradient remains at 1.2 mT/m for this submission, the value of maximum gradient change has increased from a value of 12 mT/m to a new maximum of 20.27 mT/m. The gradient linearity remains unchanged at better than 2% over a 28 cm DSV with a stability of + 0.01%.
Gradient Current Amplifiers
The gradient current amplifier power required does not affect the actual gradient strength (which is still specified at a typical value of 1.2 mT/m with a typical amplifier power dissipation of 12 kW). The amplifiers for the Indomitable are still designed for accurate control of the current output to the gradient coils with very low distortion. and are rated for a maximum current output of 300 Amps. The gradient amplifiers are unchanged from previous submissions.
Gradient System Control
The operating characteristics for the hardware of the gradient system described above are controlled by the Indomitable's Sympulse scanner operating software. The software is programmed to operate the scanner system in a safe and efficient manner, and is substantially equivalent to the current operating software in the Indomitable system as approved in K002490. The software has always included "safety limits", which were established through laboratory testing and clinical imaging.
Prior to this submission, the maximum current value allowed by software for the gradient current amplifiers was 200 Amps. This setting effectively limited the maximum gradient amplitude (dB/dt) to 12 mT/m for the system. This rate of change produced a maximum slew rate of 19.73 mT/m/ms and allowed the Indomitable scanner to operate in the NORMAL mode. Testing performed for this submission has shown that an increase of the maximum current from the previous maximum of 200 Amps to the new maximum value of 300 Amps would still allow the scanner to be operated in the NORMAL mode, since no PNS was detected in the test subjects.
Therefore, the maximum gradient current for the gradient amplifiers will now be established by the Sympulse operating software at a value of 300 Amps. This will translate to a maximum dB/dt of 20.27 mT/m with a corresponding maximum slew rate of 33.34 mT/m/ms. The scanner will continue to operate in the NORMAL mode.
2
Magnet and Gradient Subsystem Comparisons
The tables of information presented below compare and summarize the common specifications for the Indomitable magnets and gradient subsystems as configured in the original submission (K002490) and in this revision. These tables show that the specifications compare favorably and therefore are substantially equivalent.
| MAGNET CONFIGURATIONS | FROM 510(K) K002490 | THIS SUBMISSION |
|---|---|---|
| Magnet Specification | Indomitable Electromagnet | Indomitable Electromagnet |
| Type | Iron-core Electromagnet | Iron-core Electromagnet |
| Field Strength | $0.6 T \pm 5%$ | $0.6 T \pm 5%$ |
| Operational Mode | Normal Operating Mode for both dB/dt and SAR | Normal Operating Mode for both dB/dt and SAR |
| Calculated SAR | 0.76 W/kg | 0.76 W/kg |
| Power Consumption | 98 KVA | 98 KVA |
| Magnet Coil Winding Material | Copper Bar with hollow core cooling | Copper Bar with hollow core cooling |
| Cooling | 30 ton closed loop liquid chiller | 30 ton closed loop liquid chiller |
| Stability (magnet drift) | long-term |