ELIXBO PM545

K130658 · Xbo Medical Systems Co., Ltd. · LNH · Jul 19, 2013 · Radiology

Device Facts

• Record ID: K130658
• Device Name: ELIXBO PM545
• Applicant: Xbo Medical Systems Co., Ltd.
• Product Code: LNH · Radiology
• Decision Date: Jul 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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.

Device Story

Elixbo PM545 is a 0.45 Tesla permanent magnet MRI system with an open gantry design. It acquires MR signals from the head, body, or extremities using various receiving coils (head, neck, knee, shoulder, wrist, breast, ankle, body, and general purpose). The system includes a magnet, gradient/shimming system, RF system, spectrometer, temperature controller, patient table, isolation transformer, respiratory gating unit, and chiller. Operated by trained professionals in a clinical setting, the system uses the 'Prospect' software (Windows XP-based) to process signals into cross-sectional images. Physicians interpret these images to assist in clinical diagnosis. Imaging functions include maximum intensity projection, zoom/pan, pixel detection, measurements (distance/angle), statistical analysis, filtering, image summation/subtraction, and movie display. The device provides anatomical and pathological visualization to support diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance verified against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-33 (MRI safety), and NEMA MS 1, 2, 3, and 5 standards for image quality (SNR, geometric distortion, uniformity, slice thickness). Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

0.45 Tesla permanent magnet MRI system; open gantry. Includes gradient/shimming system, RF system, spectrometer, and respiratory gating. Twelve receiving coils provided. Software: Prospect (Windows XP). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS 1/2/3/5, ISO 10993. Max gradient strength 25mT/m; slew rate 78mT/m/ms. Max SAR 0.0851 W/kg. Max dB/dt 19.06 T/s.

Indications for Use

Indicated for use as an MRI diagnostic device to produce cross-sectional images (axial, sagittal, coronal, oblique) of the head, body, or extremities to display anatomical and pathological information for physician interpretation and diagnosis. No specific age or gender contraindications provided.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• mStar MPF4500 (K073457)

Submission Summary (Full Text)

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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

2. 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: [phone] Fax: [phone]

Email: [e-mail]

3. Submission Correspondent Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]

- 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

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").

- 7. 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 Device<br>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<br>diagnostic device that produces axial, sagittal, coronal and<br>oblique cross sectional images, and that displays the anatomical<br>and pathological information of the head, body, or extremities.<br>When interpreted by a trained physician, these images yield<br>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<br>coil, ankle coil, breast coil, general coil | Similar |
| Pulse Sequence | SE, GRE, FSE, FSE+FC, FSE+Sat, LSDWI, TOF2D, TOF3D,<br>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<br>location & value detection, distance measurement, angle<br>measurement, statistical analysis, filtering, image summation &<br>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, IEC<br>60601-2-33:2002 + 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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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

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