(25 days)
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No
The provided text describes a standard MRI device and its technical specifications. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or the sections explicitly checked for these terms. The focus is on the physical principles of MRI and image acquisition techniques.
No
The device is described as a "Magnetic Resonance Diagnostic Device" intended for producing images to aid in diagnosis, not for treating conditions.
Yes
The text explicitly states, "The PoleStar N-20 is a Magnetic Resonance Diagnostic Device." and "Diagnostic uses: T1, T2, T2* and density weighted imaging." It also mentions that the images "can be useful in determining a diagnosis."
No
The device description clearly indicates it is a physical Magnetic Resonance Diagnostic Device utilizing a permanent magnet and various hardware components for image acquisition.
No, 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. They are used to examine these samples outside of the body.
- PoleStar N-20 Function: The PoleStar N-20 is a Magnetic Resonance Diagnostic Device. It produces images of the extremities and head by using magnetic fields and radio waves to interact with the protons in the body. This is an in vivo diagnostic method, meaning it is performed on the living body.
- Intended Use: The intended use clearly states it produces images of anatomical regions (extremities and head) and that these images are interpreted by physicians to aid in diagnosis. This is consistent with imaging devices, not IVDs.
- Device Description: The description details a permanent magnet, pulse sequences, and its use in an operating room. These are characteristics of an MRI machine, not an IVD.
Therefore, based on the provided information, the PoleStar N-20 is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The general purpose of the device as defined in 21 CFR 892.1000:
The PoleStar N-20 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 PoleStar N-20 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*.
The PoleStar N-20 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.
Product codes
LNH
Device Description
The PoleStar N-20 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 PoleStar N-20 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N-20 can be moved within the room between procedures, from the operating table to its Magnet Storage Cabinet, thus allowing the operating room to be used for any type of surgery.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance
Anatomical Site
extremities and selected sections of the head.
Indicated Patient Age Range
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Intended User / Care Setting
When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.
intraoperatively in a standard operating room.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
SEP 1 2 2003
Image /page/0/Picture/2 description: The image shows the logo for Odin Medical Technologies. The logo features the word "ODIN" in bold, sans-serif font, with the words "Medical Technologies" in a smaller font size underneath. A stylized, incomplete circle or ring is positioned to the right of the word "ODIN", with a small, solid circle placed at the top of the ring, giving the impression of a planet with a ring system. The overall design is clean and modern.
Special 510(k) Summary of Safety and Effectiveness
The Following Special 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:
Address:
Phone:
Fax:
E-mail: | Einav Shlomovitz -- Quality and Regulatory Director
P.O. Box 548, Yokneam Elit 20698, Israel
+972-4-959-1010
+972-4-959-1011
einav@odin.co.il |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Einav Shlomovitz -Quality and Regulatory Director |
| Date: | August 4, 2003 |
807.92(a)(2) - Device Details:
| Trade Name and Common Name: | PoleStar N-20 - 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 |
1
807.92(a)(3) -- Predicate Devices:
The PoleStar N-20 is comparable to Odin's PoleStar N-10
| Medical
Device Name | Applicant Name | 510(k)
Number | Classification |
|------------------------|---------------------------------------------------|------------------|-------------------|
| | PoleStar N-10 Odin Medical Thechnologies Ltd. | K010850 | l Class Il device |
Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.
807.92(a)(4) - Device Description:
The PoleStar N-20 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 PoleStar N-20 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N-20 can be moved within the room between procedures, from the operating table to its Magnet Storage Cabinet, thus allowing the operating room to be used for any type of surgery.
2
807.92(a)(5) - Device Intended Use:
The general purpose of the device as defined in 21 CFR 892.1000:
The PoleStar N-20 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 PoleStar N-20 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*.
- . Anatomical regions:
Diagnostic uses:
extremities and selected sections of the head.
- . Nuclei excited:
.
T1, T2, T2* and density weighted imaqing.
The PoleStar N-20 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.
H-1
3
Image /page/3/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is in bold, sans-serif font, with the "o" slightly larger than the other letters. Below "odin" is the phrase "Medical Technologies" in a smaller, italicized font. A circular design element is to the right of the word "odin".
807.92(a)(6) – Substantial Equivalence Comparison Table:
| Model | Odin | Odin |
|---|---|---|
| parameter | PoleStar N-10 (K010850) | PoleStar N-20 |
| Clinical application | Extremities and selected | |
| sections of the head | Extremities and selected | |
| sections of the head | ||
| Magnet type | Permanent | Permanent |
| Field strength | 0.12T | 0.13T |
| 5 gauss fringe field | ||
| (radial/axial, m) | 1.5 | 2.2 |
| Shimming | Passive, active | Passive, active |
| Gradient subsystem | ||
| Strength mT/m | 25 | 22 |
| Rise time to 10mT/m |