(125 days)
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.
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.
The provided text describes an Abbreviated 510(k) Report for the MONA MRI system.
Here's an analysis of the acceptance criteria and the study as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria with numerical targets (e.g., specific signal-to-noise ratios, image resolution metrics, or diagnostic accuracy thresholds). Instead, it states a general performance goal for the device:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Meet all design specifications | "conducted to validate and verify that the proposed device, Mona - Orthopedic MRI System met all design specifications" |
| Substantially equivalent to predicate device (mStar MPF4500) | "was substantially equivalent to the predicate device." |
| Compliance with relevant standards (IEC 60601-1, NEMA MS series) | "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)." |
2. Sample size used for the test set and the data provenance:
The document mentions "performance testing including clinical and laboratory testing" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the clinical data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for any clinical test set. The intended use states "These images when interpreted by a trained physician yield information that may assist in diagnosis," implying interpretation by medical professionals, but specifics are missing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study nor any effect size of human readers with vs. without AI assistance. The device in question is an MRI system, not an AI-powered diagnostic tool, so such a study would not typically be part of its clearance process in 2009.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is an MRI system, which is a diagnostic imaging device. Its function is to produce images for human interpretation. Therefore, a "standalone algorithm only" performance study in the context of AI would not be relevant or performed for this type of medical device in 2009. The document only refers to the system meeting design specifications and being substantially equivalent to a predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not specify the type of ground truth used for any clinical testing. It only generally states that testing was done to ensure the device met specifications and was substantially equivalent. For an MRI system, general ground truth would relate to image quality (e.g., resolution, contrast, artifact levels) and the ability to visualize anatomical structures, typically established by physicists, engineers, and clinical radiologists.
8. The sample size for the training set:
The document does not provide any information about a training set size. This is consistent with the device being an MRI system rather than an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Since no training set for an AI/ML algorithm is mentioned, the method for establishing its ground truth is not applicable and not provided.
Summary of available information:
The provided 510(k) summary focuses on demonstrating that the Mona - Orthopedic MRI System is "substantially equivalent" to a predicate device (mStar MPF4500) and complies with relevant international and national standards. It broadly states that "performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device... met all design specifications." However, it lacks specific details regarding the methodology, sample sizes, ground truth establishment, or expert involvement for any clinical or performance studies. This level of detail is typical for 510(k) summaries for devices cleared prior to the more recent emphasis on detailed AI/ML performance evaluations and statistical rigor in some device categories.
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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
1
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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
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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 (800) 638-2041 or (301) 796-7100 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)
Page _ 1_of _ l
的
ision Sign-off
Givision of Reproductive, Abdominal a Radiological Devi
., the.Biological Devices
(k) Number
§ 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.