MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01

K092230 · Time Medical Limited · LNH · Nov 25, 2009 · Radiology

Device Facts

• Record ID: K092230
• Device Name: MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01
• Applicant: Time Medical Limited
• Product Code: LNH · Radiology
• Decision Date: Nov 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Mona - Orthopedic MRI System is 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 of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Device Story

Mona - Orthopedic MRI System is a 0.2T permanent magnet MRI system; components include magnet, magnet enclosure, patient table, gradient coil, RF transmission/receiver coils, imaging cabinet, and client PC. System operates via PRODIVA software on Windows XP Professional. Device produces transverse, sagittal, coronal, and oblique cross-sectional images of head, body, or extremities. Used in clinical settings by trained professionals; images interpreted by physicians to assist in diagnosis. Benefits include non-invasive visualization of internal structures to support clinical decision-making.

Clinical Evidence

Performance testing included both clinical and laboratory testing to validate and verify that the device met all design specifications. No specific clinical trial metrics (e.g., sensitivity, specificity) were provided in the summary.

Technological Characteristics

0.2T permanent magnet MRI system. Components: magnet, magnet enclosure, patient table, gradient coil, RF transmission/receiver coils, client PC. Software: PRODIVA (Windows XP Professional). Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, NEMA MS 1-2001, NEMA MS 2-2003, NEMA MS 3-2003, NEMA MS 5-2003, NEMA MS 6-1991, NEMA MS 7-1993, and NEMA MS 8-1993.

Indications for Use

Indicated for patients requiring magnetic resonance imaging of the head, body, or extremities for diagnostic purposes. Contrast agents may be used depending on the region of interest. Intended for use by trained physicians.

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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K092230
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ime Medical System

Abbreviated 510(k) Report for MONA MRI system

Ref No.: A2009-002-060 510(k) Summary

# Exhibit #9 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:____

May 11, 2009 Date of Submission:

Sponsor:

#### Time Medical Limited

G/F Bio-Informatics Centre, No. 2 Science Park West Avenue, Hong Kong Science Park, Shatin, New Territories, Hong Kong, China Contact Person: Johnson Chong, VP Product Development T: [phone] F: [phone]

Correspondent:

Ms. Diana Hong / Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, No. 19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Email: [e-mail]

- Proposed Device

| Trade Name | Mona - Orthopedic MRI System |
|----------------------|--------------------------------------------|
| Model: | TMS-2000ORTH-01 |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code: | LNH |
| Regulation Number: | 892.1000 |
| Device Class: | II |

mStar MPF4500 (K073457) Predicate Device:

Intended Use:

Mona - Orthopedic MRI System is 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 of the

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me Medical System Abbreviated 510(k) Report for MONA MRI system

> Ref No.: A2009-002-060 510(k) Summary

head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description: Mona - Orthopedic MRI System is a 0.2T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP® Professional is aninteractive program with user friendly interface.

Testing Conclusion: Performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device, Mona - Orthopedic MR1 System met all design specifications and was substantially equivalent to the predicate device. The proposed device complies with the following standards: IEC 60601-1:1988+A1:1991+A2:1995 / IEC 60601-1-1:2000 / IEC 60601-1-2:2001+A1:2004-NEM:MS=1-2001 / NEMA MS 2-2003 / NEMA MS 3-2003 / NEMA MS 5-2003 / NEMA MS 6-1991 / NEMA MS7:1993 / NEMA MS8:1993(R2000).

SE Conclusion: Mona - Orthopedic MRI System, is claimed to be Substantially Equivalent (SE) to the predicate device, mStar MPF4500 (K073457)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

、

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

NUV 2 5 2009

Time Medical Limited c/o Mr. Marc Mouser Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607-9526

Re: K092230

> Trade/Device Name: Mona - Orthopedic MRI System Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 11, 2009 Received: November 13, 2009

Dear Mr. Mouser:

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.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

<http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm>.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Time Medical System Abbreviated 510(k) Report for MONA MRI system

> Ref No.: A2009-002-060 Section II Indication for Use

# Exhibit #8 Indication for Use

510(k) Number: K092230 Device Name: Mona - Orthopedic MRI System

### Indications for Use:

Mona - Orthopedic MRI System is 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 of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K092230

(k) Number