(129 days)
Not Found
No
The document describes a standard MRI system and its components, software features (image processing), and performance testing against established standards. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The image processing features listed are standard functionalities for medical imaging devices and do not inherently indicate AI/ML.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images that "yield information that can be useful in determining a diagnosis." It does not mention any therapeutic capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Elixbo PM545 is indicated for use as magnetic resonance diagnostic device." The "Device Description" also refers to it as "magnetic resonance diagnostic devices (MRDD)."
No
The device description explicitly lists numerous hardware components including a magnet, gradient & shimming system, RF system, spectrometer, temperature controller, patient table system, isolation transformer, respiratory gating unit, chiller, control system, and twelve receiving coils. While it includes software, it is an integral part of a larger hardware system.
Based on the provided information, the Elixbo PM545 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Elixbo PM545 Function: The Elixbo PM545 is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structure and function of the human body in vivo (within the living body) using magnetic fields and radio waves.
- Intended Use: The intended use clearly states it's a "magnetic resonance diagnostic device that produces axial, sagittal, coronal and oblique cross sectional images... of the head, body, or extremities." This describes an imaging modality, not the analysis of biological specimens.
Therefore, the Elixbo PM545 falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Elixbo PM545 is indicated for use as magnetic resonance diagnostic device that produces axial, sagittal, coronal and oblique cross sectional images, and that displays the anatomical and pathological information of the head, body, or extremities. When interpreted by a trained physician, these images yield information that can be useful in determining a diagnosis.
Product codes
LNH
Device Description
The proposed device, Elixbo PM545, is a Magnetic Resonance Imaging System that utilizes a 0.45 Tesla permanent magnet in an open gantry design.
It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. These images when interpreted by a trained physician vield information that may assist in diagnosis.
The MRI system is composed of magnet, gradient & shimming system, RF system, spectrometer, temperature controller, patient table system, isolation transformer, respiratory gating unit, chiller and control system. The system software, Prospect, based on Windows® XP professional operating system is an interactive program with user friendly interface.
The proposed device includes twelve receiving coils which are Head Coil, Neck Coil, Knee Coil, Shoulder Coil, Wrist Coil, Breast Coil, Ankle Coil, Body Coil (14"), Body Coil (17"), Body Coil (20"), General Purpose Coil (6"), and General Purpose Coil (9").
Mentions image processing
Imaging Process Functions: Maximum intensity projection, image zoom & pan, pixel location & value detection, distance measurement, angle measurement, statistical analysis, filtering, image summation & subtraction and movie display
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
IEC 60601-1-2: 2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility -Requirements and Tests.
IEC 60601-2-33, Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic, 2002; E14-2
Amendment 1, 2005, Amendment 2, 2007.
NEMA MS 1-2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging.
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 5-2010, Determination of Slice Thickness in Diagnostic Resonance Imaging.
ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10: 2002/Amd. 1:2006(E), Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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
Additional Information I Elixbo PM545 - Exhibit #14 510 (k) Summary
JUL 1 9 2013
Exhibit #14 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number:
】 . Date of Submission: August 06, 2012
- Sponsor
XBO Medical Systems Co., LTD RE Application Industrial Park, Rare Earth Hi-Tech Zone, Baotou, Inner Mongolia, 014030, China
Contact Person: Jinhong Guo Position: Deputy Director, Product Department Tel: +86 316 2596056 Fax: +86 316 2595801
Email: guojinhong@xboms.com
- Submission Correspondent Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Proposed Device Identification 4.
Proposed Device Name: Magnetic Resonance Imaging System Proposed Device Model: Elixbo PM545
Classification: II Product Code: LNH Regulation Number: 21 CFR 892.1000 Review Panel: Radiology
Intended Use Statement:
1
Elixbo PM545 - Exhibit #14 510 (k) Summary Additional Information I
Elixbo PM545 is indicated for use as magnetic resonance diagnostic device that produces axial, sagittal, coronal and oblique cross sectional images, and that displays the anatomical and pathological information of the head, body, or extremities. When interpreted by a trained physician, these images yield information that can be useful in determining a diagnosis.
ડાં Predicate Device Identification
510(k) Number: K073457 Product Name: mStar MPF4500 Manufacturer: XinAo MDT Technology, Co., Ltd
Device Description ર.
The proposed device, Elixbo PM545, is a Magnetic Resonance Imaging System that utilizes a 0.45 Tesla permanent magnet in an open gantry design.
It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. These images when interpreted by a trained physician vield information that may assist in diagnosis.
The MRI system is composed of magnet, gradient & shimming system, RF system, spectrometer, temperature controller, patient table system, isolation transformer, respiratory gating unit, chiller and control system. The system software, Prospect, based on Windows® XP professional operating system is an interactive program with user friendly interface.
The proposed device includes twelve receiving coils which are Head Coil, Neck Coil, Knee Coil, Shoulder Coil, Wrist Coil, Breast Coil, Ankle Coil, Body Coil (14"), Body Coil (17"), Body Coil (20"), General Purpose Coil (6"), and General Purpose Coil (9").
-
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
IEC 60601-1-2: 2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility -Requirements and Tests.
IEC 60601-2-33, Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic, 2002; E14-2
2
Additional Information I Elixbo PM545 - Exhibit #14 510 (k) Summary
Amendment 1, 2005, Amendment 2, 2007.
NEMA MS 1-2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging.
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 5-2010, Determination of Slice Thickness in Diagnostic Resonance Imaging.
ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10: 2002/Amd. 1:2006(E), Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- Substantially Equivalent Comparison and Conclusion 8.
| ITEM | Proposed Device | Predicate Device
K073457 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Product Code | LNH | Same |
| Regulation No. | 21 CFR 892.1000 | Same |
| Class | II | Same |
| Intended Use | Elixbo PM545 is indicated for use as magnetic resonance
diagnostic device that produces axial, sagittal, coronal and
oblique cross sectional images, and that displays the anatomical
and pathological information of the head, body, or extremities.
When interpreted by a trained physician, these images yield
information that can be useful in determining a diagnosis. | Same |
| Installation Type | Fixed | Same |
| Magnet Type | Permanent | Same |
| RF Amplifier Max Power | 6 kW | Same |
| Coil | Head coil, neck coil, knee coil, body coil, wrist coil, shoulder
coil, ankle coil, breast coil, general coil | Similar |
| Pulse Sequence | SE, GRE, FSE, FSE+FC, FSE+Sat, LSDWI, TOF2D, TOF3D,
FLAIR, STIR, SPGR2D, SSFSE2D, SSFSE3D | Same |
| Maximum Gradient Strength | 25mT/m | Same |
| Slew Rate | 78mT/m/ms | Same |
| Gating/ Triggering | Respiration | Similar |
| Imaging Process Functions | Maximum intensity projection, image zoom & pan, pixel
location & value detection, distance measurement, angle
measurement, statistical analysis, filtering, image summation &
subtraction and movie display | Same |
Table III-I SE Comparison
E14-3
3
Additional Information 1 Elixbo PM545 - Exhibit #14 510 (k) Summary
| Static Filed Strength | 0.45T | Same |
|---|---|---|
| Peak and A Weighted acoustic | Peak: 510(k) K130658 |
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