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.

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").

AI/ML Overview

The provided document describes the safety and effectiveness information for the Elixbo PM545 Magnetic Resonance Imaging System, submitted as a 510(k) premarket notification. This submission indicates that the device's performance was evaluated through non-clinical bench tests and a comparison to a predicate device, rather than a clinical study with specific acceptance criteria for diagnostic performance metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Elixbo PM545 are primarily based on compliance with international standards for medical electrical equipment and a determination of substantial equivalence (SE) to a legally marketed predicate device (mStar MPF4500, K073457). The "device performance" in this context refers to its ability to meet these technical standards and operate comparably to the predicate device.

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance (Elixbo PM545)
Safety and Electrical	IEC 60601-1: General Requirements for Safety	Conforms to IEC 60601-1:1988 + A1:1991 + A2:1995
	IEC 60601-2-33: Basic Safety and Essential Performance of MR Equipment	Conforms to IEC 60601-2-33:2002 + A1:2005 + A2:2007
Electromagnetic Compatibility (EMC)	IEC 60601-1-2: Electromagnetic Compatibility	Conforms to IEC 60601-1-2: 2007
Image Quality Parameters (NEMA Standards)	NEMA MS 1-2008: Signal-to-Noise Ratio (SNR)	Demonstrated compliance
	NEMA MS 2-2008: Two-Dimensional Geometric Distortion	Demonstrated compliance
	NEMA MS 3-2008: Image Uniformity	Demonstrated compliance
	NEMA MS 5-2010: Slice Thickness	Demonstrated compliance
Biocompatibility	ISO 10993-5: In Vitro Cytotoxicity	Conforms to ISO 10993 series standards
	ISO 10993-10: Irritation & Delayed-Type Hypersensitivity	Conforms to ISO 10993 series standards
	ISO 10993-10: Irritation & Skin Sensitization (2010)	Conforms to ISO 10993 series standards
Functional Equivalence	Intended Use	Same as predicate (magnetic resonance diagnostic device producing axial, sagittal, coronal, oblique images for head, body, or extremities for diagnosis)
	Installation Type	Fixed (Same as predicate)
	Magnet Type	Permanent (Same as predicate)
	RF Amplifier Max Power	6 kW (Same as predicate)
	Pulse Sequences	SE, GRE, FSE, FSE+FC, FSE+Sat, LSDWI, TOF2D, TOF3D, FLAIR, STIR, SPGR2D, SSFSE2D, SSFSE3D (Same as predicate)
	Maximum Gradient Strength	25mT/m (Same as predicate)
	Slew Rate	78mT/m/ms (Same as predicate)
	Static Field Strength	0.45T (Same as predicate)
	Peak and A-Weighted Acoustic Noise	Peak: <99dB, A-Weighted: 81.5dB (Same as predicate)
	Operation Mode	Normal (Same as predicate)
	Safety Parameter Display	SAR (Same as predicate)
	Max SAR for transmit Coil	0.0851 W/kg (Same as predicate)
	Potential Emergency Condition	Yes (Same as predicate)
	Level of Concern of Software	Minor (Image Enhance) / Moderate (Scan Control) (Same as predicate)
Identified Differences from Predicate	Coil	Similar (Head, neck, knee, body, wrist, shoulder, ankle, breast, general coil) - differences reviewed and concluded not to affect safety/effectiveness.
	Gating/Triggering	Respiration (Similar) - differences reviewed and concluded not to affect safety/effectiveness.
	Max dB/dt	19.06 T/s (Similar) - differences reviewed and concluded not to affect safety/effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical bench tests and a comparison to a predicate device. It does not mention a traditional clinical test set involving human subjects or patient data to evaluate diagnostic performance metrics like sensitivity, specificity, or accuracy. The "test results" refer to engineering and performance tests to demonstrate compliance with standards and equivalence to the predicate. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided because such a study was not presented.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

No information is provided regarding experts or ground truth establishment for a diagnostic performance study, as the submission relies on bench testing and comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable, as no external adjudication method for a clinical test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or described in this submission. The device approval relies on substantial equivalence to an existing device, which typically does not require a comparative effectiveness study showing improvement with AI assistance.

6. Standalone Performance Study:

No standalone (algorithm only without human-in-the-loop performance) study for diagnostic performance was conducted or described. The device is a Magnetic Resonance Imaging System, where the human physician is always "in the loop" for interpretation. The "performance" described relates to technical specifications meeting safety and imaging standards.

7. Type of Ground Truth Used:

No "ground truth" (expert consensus, pathology, outcomes data) as typically understood for diagnostic device performance evaluation was used in this 510(k) submission. The "truth" for the evaluation was based on compliance with established technical standards (IEC, NEMA, ISO) and demonstrating that the device's technical specifications and intended use were substantially equivalent to the predicate device.

8. Sample Size for the Training Set:

Not applicable. The document describes a traditional MRI device and its regulatory submission, not an AI/ML-based device that would typically involve a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set or ground truth for such a set in this submission.

Summary

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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:

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Elixbo PM545 - Exhibit #14 510 (k) Summary Additional Information I

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").

1. 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:

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

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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 DeviceK073457
Product Code	LNH	Same
Regulation No.	21 CFR 892.1000	Same
Class	II	Same
Intended Use	Elixbo PM545 is indicated for use as magnetic resonancediagnostic device that produces axial, sagittal, coronal andoblique cross sectional images, and that displays the anatomicaland pathological information of the head, body, or extremities.When interpreted by a trained physician, these images yieldinformation 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, shouldercoil, 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, pixellocation & value detection, distance measurement, anglemeasurement, statistical analysis, filtering, image summation &subtraction and movie display	Same

Table III-I SE Comparison

E14-3

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Additional Information 1 Elixbo PM545 - Exhibit #14 510 (k) Summary

Static Filed Strength	0.45T	Same
Peak and A Weighted acoustic	Peak: <99dB	Same
Noise	A-weighted: 81.5dB	Same
Operation Mode	Normal	Same
Safety Parameter Display	SAR	Same
Max SAR for transmit Coil	0.0851 W/kg	Same
Max dB/dt	19.06 T/s	Similar
Potential Emergency	Yes	Same
Condition		Same
Electrical Safety	Conforms to IEC 60601-1:1988 + A1:1991 + A2:1995, IEC60601-2-33:2002 + A1:2005 + A2:2007	Same
EMC	Conforms to IEC 60601-1-2: 2007	Same
Biocompatibility	Conforms to the requirements of ISO 10993 series standards	Same
Label and Labeling	Conforms to FDA Regulatory Requirements	Same
Level of Concern of the	Minor Level of Concern (Image Enhance)/	Same
Software	Moderate Lever of Concem (Scan Control)	Same

Difference in Coil, Gating/ Triggering and Max dB/dt between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.

The proposed device, Magnetic Resonance Imaging System Elixbo PM545, is determined to be Substantially Equivalent (SE) to the predicate devices, mStar MPF4500 (K073457), in respect of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized eagle emblem, which is the symbol of the U.S. Department of Health and Human Services. The seal is black and white and appears to be a scanned image.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 19, 2013

XBO Medical Systems Co., Ltd. % Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K130658

Trade/Device Name: Magnetic Resonance Imaging System Elixbo PM545 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 17, 2013 Received: June 05, 2013

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Devine

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please " contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address,

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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Indications for Use

510(k) Number (if known): K130658

Device Name:

Magnetic Resonance Imaging System Elixbo PM545

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130658

Page 1 of 1

Regulation Number and Section

§ 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.