(67 days)
Not Found
No
The document describes a standard MRI device from the late 1990s, focusing on hardware, pulse sequences, and basic image processing techniques similar to CT. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The testing period (1998-1999) also predates the widespread application of AI/ML in medical imaging.
No
The device is described as a "Magnetic Resonance Diagnostic Device" intended to produce images for diagnostic purposes, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "Magnetic Resonance Diagnostic Device" and that the images it produces "provide information that can be useful in determining a diagnosis."
No
The device description clearly outlines hardware components like a permanent magnet, C-arm gantry, and coils, indicating it is a physical medical device, not software-only.
Based on the provided text, the NORMA 10 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body. The NORMA 10 is a Magnetic Resonance Diagnostic Device that directly images the extremities and head within the human body.
- The intended use clearly states it produces images of anatomical regions. This is characteristic of imaging devices, not IVD devices.
- The device description details the physical components and operation of an MRI system. This is consistent with an imaging modality.
Therefore, the NORMA 10 falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NORMA 10 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the NORMA 10 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 T2*. When interpreted by trained physicians, these images provide information that can be useful in determining a diagnosis.
- Anatomical regions: extremities and selected sections of the . head.
- H-1 Nuclei excited: .
- Diagnostic uses: T1, T2, T2* and density weighted . imaging.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The NORMA 10 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The NORMA 10 is a fixed system.
Magnetic Resonance (MR) is based on the fact that certain anatomic nuclei have electromagnetic properties, which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of Radiofrequency (RF) excitation of wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation. The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times called TI and T2, which can be measured.
These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can he constructed by using image processing techniques similar to those used in CT.
For magnetic fields up to 1.5T, the RF frequencies commonly used range up to 65MHz. The RF fields have pulsed power from several watts to greater than 2 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The time-varying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds.
ODIN Technologies Ltd., has developed an open MRI system based on an innovatively designed permanent magnet of 0.12 Tesla. The system is compact, displaceable, inexpensive and widely open.
The magnetic probe consists of two lateral permanent-magnet poles that can be adjusted laterally and longitudinally, mounted on a C-arm gantry. The anatomic region to be scanned is positioned between the poles. Except for the anatomic region been scanned, the patient is positioned outside of the gantry, thus enhancing patient comfort and reducing the possibility of a claustrophobic reaction.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
extremities and selected sections of the head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
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
Testing of the system was performed at the Odin premises, during the period of October 1998 through February 1999. The scans were performed on normal anatomy including extremities and selected sections of the head.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and magnetic resonance performance tests were performed on the NORMA 10 in accordance with the NEMA standards.
The results obtained from the safety tests including acoustic noise, Specific Absorption Rate (SAR) and Time-Varying Gradient Fields (dB/dt) were found to be below the levels of significant risk as described in the FDA Guidance for the Submission Of Premarket Notification for Magnetic Resonance Diagnostic Device, dated November 14, 1998. The performance results obtained including Signal-to-Noise Ratio (SNR), Geometric Distortion, Image Uniformity, Slice Thickness, Characterization of Special Purpose Coils and spatial resolution meets the performance specifications claimed.
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.
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
JUN 18 1999
:
KQ9/243
ATTACHMENT 1
510(k) Summary of Safety and Effectiveness
1
ODIN Technologies Ltd.
P.O. Box 248, Yokneam Elit 20698, Israel. Tel. 972-4-9591010, Fax. 972-4-9591011
510(k) Summary of Safety and Effectiveness
The Following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).
807.92(a)(1) - Submitter Details:
| Submitter name: | Adi Ickowicz – Regulatory Affairs / Quality Assurance
Director |
|-----------------|-------------------------------------------------------------------|
| Address: | P.O. Box 248, Yokneam Elit 20698, Israel |
| Phone: | +972-4-959-1010 |
| Fax: | +972-4-959-1011 |
| E-mail: | adi@odin.co.il |
| Contact Person: | Adi Ickowicz – Regulatory Affairs / Quality Assurance
Director |
| Date: | March 15, 1999 |
2
807.92(a)(2) - Device Details:
| Trade Name and Common Name: | NORMA 10 - Magnetic Resonance
Diagnostic Device |
|-----------------------------|-----------------------------------------------------------------------------------------------|
| Classification: | 21 CRF 892.1000 Magnetic Resonance
Diagnostic Device. |
| Class: | II
MRDD were reclassified by FDA from
Class III to Class II effective July 28,
1998. |
| Product Code: | LNH - Magnetic Resonance Imaging
System |
807.92(a)(3) - Predicate Devices:
| Medical Device
Name | Applicant
Name | 510(k) Number | Classification |
|------------------------|-------------------|---------------|-----------------|
| Ortho 8000 | Inner Vision | K963186 | Class II device |
| MRP-5000 | Hitachi | K911642 | Class II device |
Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.
3
807.92(a)(4) - Device Description:
Device Functions:
The NORMA 10 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The NORMA 10 is a fixed system.
Scientific Concepts:
Magnetic Resonance (MR) is based on the fact that certain anatomic nuclei have electromagnetic properties, which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of Radiofrequency (RF) excitation of wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation. The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times called TI and T2, which can be measured.
These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under
4
consideration can he constructed by using image processing techniques similar to those used in CT.
For magnetic fields up to 1.5T, the RF frequencies commonly used range up to 65MHz. The RF fields have pulsed power from several watts to greater than 2 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The time-varying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds.
Physical and Performance Characteristics:
ODIN Technologies Ltd., has developed an open MRI system based on an innovatively designed permanent magnet of 0.12 Tesla. The system is compact, displaceable, inexpensive and widely open.
The magnetic probe consists of two lateral permanent-magnet poles that can be adjusted laterally and longitudinally, mounted on a C-arm gantry. The anatomic region to be scanned is positioned between the poles. Except for the anatomic region been scanned, the patient is positioned outside of the gantry, thus enhancing patient comfort and reducing the possibility of a claustrophobic reaction.
807.92(a)(5) — Device Intended Use:
The NORMA 10 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the NORMA 10 reflect the special 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 T2*.
5
When interpreted by trained physicians, these images provide information that can be useful in determining a diagnosis.
- Anatomical regions: extremities and selected sections of the . head.
- H-1 Nuclei excited: .
- Diagnostic uses: T1, T2, T2* and density weighted . imaging.
807.92(a)(6) - Substantial Equivalence Comparison Table:
| Model | Odin | Hitachi | Innervision |
|---|---|---|---|
| parameter | NORMA 10 | MRP-5000 | Ortho 8000 |
| Clinical application | Extremities and | ||
| selected sections of | |||
| the head | Whole body | Extremities | |
| Magnet type | Permanent | Permanent | Permanent |
| Field strength | 0.12T | 0.2T | 0.17T |
| 5 gauss fringe field | |||
| (radial/axial, m) | 1.5 |