(192 days)
Not Found
No
The summary describes a standard MRI system and its components, focusing on hardware and basic imaging software. There is no mention of AI, ML, or advanced image processing techniques typically associated with AI/ML applications in medical imaging. The performance studies focus on compliance with standards and substantial equivalence to a predicate device, not on the performance metrics (like sensitivity, specificity, AUC) that would be expected for an AI/ML-driven diagnostic algorithm.
No
The device is described as a "magnetic resonance diagnostic device (MRDD)" and its images "may assist in diagnosis," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices "are indicated for use as magnetic resonance diagnostic devices (MRDD)".
No
The device description explicitly lists multiple hardware components (Magnet, Patient Table, Gradient Coil, RF Coils, Client PC, Imaging Cabinet) in addition to the system software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images of the internal structure and/or function of the head, body, or extremities. These images are then interpreted by a trained physician to assist in diagnosis.
- Device Description: The description details the physical components of an MRI system, which is an imaging modality.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device directly images the body itself.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
MRI SYSTEMS, including ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000), are 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 yield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
MRI SYSTEMS, including ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000), are 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 yield information that may assist in diagnosis.
MRI SYSTEMS include a series of open permanent magnet MRI system with magnetic field strength of 0.3T, 0.4T and 0.5T respectively. The model number for each of the corresponding system is ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000) respectively. They are composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil. RF Transmission Coil. RF Receiver Coil. Client PC, and Imaging Cabinet. The system software, APEX, based on Windows XP® Professional is an interactive program with user friendly interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Not Found
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)
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, Medical Electrical Equipment - Part 1-2: General Requirements for Safety Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004: Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
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; 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 5-2003. Determination of Slice Thickness in Diagnostic Resonance Imaging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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.
0
1 7 2012
Section III 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: 113281
-
- Date of Submission: September 5, 2011
- iv Sponsor
Shenzhen Anke High-tech Co., Ltd. 26 Yanshan Road, Shekou. . Shenzhen, Guangdong 518067, P.R. China Contact Person: Haibo Yin Position: Regulatory Officer Tel: +86-755-26868889 Fax: +86-755-26695307 Email: yinhaibo@anketech.com
- Submission Correspondent 3. Ms. Diana Hong & Mr. Lee Fu 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
Proposed Device Name: MRI SYSTEMS Proposed Device Model: ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000), ASM-050P (OPENMARK 5000)
Classification: Il Product Code: LNH Regulation Number: 21 CFR 892.1000 Review Panel: Radiology Intended Use Statement:
MRI SYSTEMS, including ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000), are indicated for use as magnetic resonance diagnostic devices
111-1
1
(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 yield information that may assist in diagnosis.
-
- Predicate Device Identification
510(k) Number: K091580 Product Name: Pica Whole Body MRI System Manufacturer: Time Medical Limited
- Predicate Device Identification
Device Description 6.
MRI SYSTEMS, including ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000), are 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 yield information that may assist in diagnosis.
MRI SYSTEMS include a series of open permanent magnet MRI system with magnetic field strength of 0.3T, 0.4T and 0.5T respectively. The model number for each of the corresponding system is ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000) respectively. They are composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil. RF Transmission Coil. RF Receiver Coil. Client PC, and Imaging Cabinet. The system software, APEX, based on Windows XP® Professional is an interactive program with user friendly interface.
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, Medical Electrical Equipment - Part 1-2: General Requirements for Safety Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004: Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
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; 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 III-2
2
. III-3
Magnetic Resonance Images.
NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images. NEMA MS 5-2003. Determination of Slice Thickness in Diagnostic Resonance Imaging.
- Substantially Equivalent Conclusion 8.
The proposed device, MRI SYSTEMS, is determined to be Substantially Equivalent (SE) to the predicate device, Pica Whole Body MRI System (K091580), in respect of safety and effectiveness.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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
Shenzhen Anke High-tech Co., Ltd. % Mr. Marc M. Mouser Engineering Leader/ FDA Office Coordinator UL Health Sciences Underwriters Laboratories Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542
Re: K113281
Trade/Device Name: MRI Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 26, 2012 Received: May 2, 2012
MAY 1 7 2012
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Section II Indications for Use
510(k) Number: Device Name: MRI SYSTEMS
Indications for Use:
MRI SYSTEMS, including ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000), are 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 yield information that may assist in diagnosis.
OPRESCRIPTION USE (Part 21 CFR 801 Subpart D)
OOVER-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 In Vitro Diagnostic Devices (OIVD)
Page I of 1
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K