(229 days)
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No
The document describes a standard MRI device and its capabilities, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No
The device is described as a "Magnetic Resonance Diagnostic Device" intended to produce images to provide "information that can be useful in determining a diagnosis," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The PoleStar N-30 is a Magnetic Resonance Diagnostic Device." It also mentions that "When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis."
No
The device description explicitly states it utilizes a permanent magnet and is an Intraoperative MRI unit, indicating it is a hardware device that acquires images.
Based on the provided information, the PoleStar N-30 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The PoleStar N-30 is a Magnetic Resonance Diagnostic Device that produces images of sections of the head within the patient's body. It does not analyze biological samples like blood, urine, or tissue outside of the body.
- The intended use describes imaging of anatomical regions. The device's purpose is to create images based on the magnetic resonance properties of protons within the head, not to perform tests on biological specimens.
- The device description focuses on the imaging technology and its use in an operating room. It describes the magnet, pulse sequences, and its physical characteristics for intraoperative use.
Therefore, the PoleStar N-30 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 PoleStar N30 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of sections of the head selected by the physician. The images produced by the PoleStar N30 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*.
Diagnostic uses: T1, T2, T2* and density weighted imaging.
The PoleStar N30 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 N30 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 N30 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N30 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 Imaging (MRI)
Anatomical Site
sections of the head selected by the physician
Indicated Patient Age Range
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Intended User / Care Setting
trained physicians, 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.
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Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol above the word "Medtronic". The symbol depicts three human figures in different poses, arranged in a circular pattern. The text "Medtronic" is written in a bold, sans-serif font.
MAR 1 6 2010
Traditional 510(k) Summary of Safety and Effectiveness
The Following Traditional 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: | Yair Penias -Quality and Regulatory Manager |
|---|---|
| Address: | P.O. Box 548, Yokneam Elit 20692, ISRAEL |
| Phone: | +972-4-909-2306 |
| Fax: | +972-4-959-1011 |
| E-mail: | yair.penias@medtronic.com |
| Contact Person: | Yair Penias -Quality and Regulatory Manager |
| Date: | March 11, 2009 |
807.92(a)(2) - Device Details:
| Trade Name and Common Name: | PoleStar N30 - Magnetic Resonance
Diagnostic Device, Also known as
"PoleStar® N30 Surgical MRI System". |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| 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 |
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Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular emblem above the word "Medtronic". The emblem depicts a stylized human figure in motion, repeated in a circular pattern to suggest continuous movement or progress. The word "Medtronic" is written in a bold, sans-serif font.
807.92(a)(3) - Predicate Devices:
The PoleStar N30 is comparable to:
| Medical
Device Name | Applicant Name | 510(k)
Number | Classification |
|------------------------|------------------------|------------------|-----------------|
| PoleStar N-20 | ODIN Technologies Ltd. | K032541 | Class II device |
Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.
807.92(a)(4) - Device Description:
The PoleStar N30 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 N30 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N30 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.
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Image /page/2/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular emblem above the word "Medtronic". The emblem depicts a figure in motion, with three overlapping silhouettes suggesting movement. The word "Medtronic" is written in a bold, sans-serif font.
807.92(a)(5) - Device Indication For Use:
The general purpose of the device as defined in 21 CFR 892.1000:
The PoleStar N30 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of sections of the head selected by the physician. The images produced by the PoleStar N30 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: sections of the head selected by the physician. .
- . Nuclei excited: H-1
- T1, T2, T2* and density weighted imaging. Diagnostic uses: .
The PoleStar N30 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
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Image /page/3/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol above the word "Medtronic". The symbol depicts a person in three different positions within the circle, suggesting movement or transformation. The word "Medtronic" is written in a bold, sans-serif font.
.
807.92(a){6) – Substantial Equivalence Comparison Table:
| Model | Odin | Medtronic Navigation |
|---|---|---|
| parameter | PoleStar N-20 (K032541) | PoleStar (Model: N30) |
| Clinical application | Extremities and selected | |
| sections of the head | sections of the head | |
| selected by the physician | ||
| Magnet type | Permanent | Permanent |
| Field strength | 0.13T | 0.13T |
| 5 gauss fringe field | ||
| (radial/axial, m) | 2.2 | 2.2 |
| Shimming | Passive, active | Passive, active |
| Gradient subsystem | ||
| Strength mT/m | 22 | 23.5 |
| Rise time to 10mT/m |