(125 days)
No
The summary does not mention AI, ML, deep learning, or any related terms. The device description focuses on standard MRI components and software.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images that "may assist in diagnosis," not for therapy.
Yes
The "Intended Use / Indications for Use" states that the device is indicated for use as "magnetic resonance diagnostic devices (MRDD)" and that the images produced "may assist in diagnosis."
No
The device description explicitly lists multiple hardware components (Magnet, Patient Table, Gradient Coil, RF Coils, etc.) in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Mona - Orthopedic MRI System Function: This device uses magnetic resonance imaging to create images of the internal structure of the body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it produces images to assist in diagnosis when interpreted by a trained physician. This is a characteristic of imaging devices, not IVDs.
Therefore, based on the provided information, the Mona - Orthopedic MRI System is an imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
LNH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
mStar MPF4500 (K073457)
Reference Device(s)
Not Found
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.
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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: +852 2156 1711 F: +852 2156 0908
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: Diana.hong@mid-link.net
- 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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K092230
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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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
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
3
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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)
Page _ 1_of _ l
的
ision Sign-off
Givision of Reproductive, Abdominal a Radiological Devi
., the.Biological Devices
(k) Number