(58 days)
Not Found
No
The summary describes a standard MRI system and its components. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The software is described as a "Windows-based software" with a "user friendly interface," which does not imply AI/ML capabilities.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images that "may assist medical diagnosis," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "magnetic resonance diagnostic device (MRDD)" and that the images it produces "may assist medical diagnosis."
No
The device description explicitly lists multiple hardware components (Magnet, Patient Table, Coils, Client PC, Imaging Cabinet) in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Description and Intended Use: The description clearly states that the EMMA 1.5T MR System is a magnetic resonance diagnostic device (MRDD) that produces images of the internal structure and/or function of the head, body, or extremities. This is an in vivo imaging technique, meaning it is performed within the living body.
- Input Imaging Modality: The input modality is Magnetic Resonance Imaging (MRI), which is an imaging technique, not a test performed on a biological sample.
The device is a medical imaging system used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EMMA 1.5T MR System is a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The EMMA 1.5T MRI System is a 1.5T superconducting magnet MRI system which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, Client PC, and Imaging Cabinet. The system software, Prodiva, a Windows-based software, is an interactive program with user friendly interface. The device is conformed to IEC and DICOM standards.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
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)
Nonclinical Testing Summary:
- Biocompatibility testing: The biocompatibility evaluation for the filing device was conducted in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA.
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted in accordance with AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012 "Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance", IEC 60601-2-33:2010+A1:2013 "Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic for safety" and IEC 60601-1-2:2014 Edition 4 "Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests" for EMC as recognized by FDA.
- Surface Heating of RF Receive Coils: Surface heating was tested with both coil-plugged and coil-unplugged configurations according to AAMI/ANSI ES60601-1. The measured temperature of the surface of the coil never exceeds the maximum limit of 41°C in either configuration.
- Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Acoustic testing: Acoustic testing were conducted in accordance with NEMA MS 4-2010 "Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices"
- Performance testing - Bench: The filing device complies with the following NEMA MS standard as does the predicate device:
- NEMA MS-1-2008 (R2014) - Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- NEMA MS 2-2008 (R2014) - Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- NEMA MS 3-2008 (R2014) - Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- NEMA MS 5-2010 - Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
- NEMA MS 6-2008 (R2014) - Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- NEMA MS 8-2016 - Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
The performance testing results demonstrate the safety and performance as expected. Therefore, the filing device is substantially equivalent to the legally marketed predicate device.
Clinical Testing Summary: Sample clinical images are provided to verify the claim of filing device's capability in generating images for diagnostic purposes. Sample clinical image sets from filing device and predicate device on same pulse sequences are provided to demonstrate the substantial equivalence of filing device to legally marketed predicate device.
Conclusions Drawn from Non-Clinical Information and Clinical Images: The non-clinical information (safety and performance tests), combined with clinical images (both from filing device and predicate device), demonstrate that the filing device is as safe, as effective, and performs as well as the predicate device.
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.
Time Medical Limited % Mr. Nick Tse Compliance Manager G/F, Bio-Informatics Center No., 2 Science Park West Avenue Shatin, N.T., Hong Kong CHINA
February 22, 2019
Re: K183621
Trade/Device Name: EMMA 1.5T MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: December 12, 2018 Received: December 26, 2018
Dear Mr. Tse:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
2.2 INDICATIONS FOR USE
FDA Indications for Use Form (FDA Form 3881) is shown below and at Annex K.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| K183621 | |
| Device Name | |
EMMA 1.5T MRI System
Indications for Use (Describe)
The EMMA 1.5T MR System is a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| 2 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW . | ||||
| The burden time for this collection of information is estimated to average 79 hours per response, including the | ||||
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | ||||
| and review the collection of information. Send comments regarding this burden estimate or any other aspect | ||||
| of this information collection, including suggestions for reducing this burden, to: | ||||
| Department of Health and Human Services | ||||
| Food and Drug Administration | ||||
| Office of Chief Information Officer | ||||
| Paperwork Reduction Act (PRA) Staff | ||||
| PRAStaff@fda.hhs.gov | ||||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | ||||
| information unless it displays a currently valid OMB number." |
FORM FDA 3881 (7/17)
Page 1 of 1
POC Fultidaing Services (301) 443-4345 EF
3
2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date of Submission: | February, 9, 2018 |
|---|---|
| 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: Nick Tse - Compliance Manager | |
| Telephone number: +852 21561711 Fax.: +852 2156 0908 | |
| Correspondent: | 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: Nick Tse - Compliance Manager | |
| Telephone number: +852 21561711 Fax.: +852 2156 0908 | |
| Filing Device: | EMMA 1.5T MRI System |
| Classification Name: | System. Nuclear Magnetic Resonance Imaging |
| Regulatory Description: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Class | Class II / LNH / 21 CFR 892. 1000 |
| Intended Use: | The EMMA 1.5T MRI System is indicated for use as a magnetic resonance |
| diagnostic device (MRDD) which produces transverse, sagittal, coronal and | |
| oblique cross-sectional images, and those display the internal structure | |
| and/or function of the head, body, or extremities. Depending on the region of | |
| interest, contrast agents may be used. These images when interpreted by | |
| trained physician yield information that may assist medical diagnosis. | |
| Device Description: | The EMMA 1.5T MRI System is a 1.5T superconducting magnet MRI |
| system which produces transverse, sagittal, coronal and oblique | |
| cross-sectional images, and those display the internal structure and/or | |
| function of the head, body, or extremities. It is composed of Magnet, Magnet | |
| Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, | |
| Client PC, and Imaging Cabinet. The system software, Prodiva, a | |
| Windows-based software, is an interactive program with user friendly | |
| interface. The device is conformed to IEC and DICOM standards. |
General Comparison to Predicate Device:
| Comparison Element | Filing Device: | Predicate Device: |
|---|---|---|
| 510(k) Number | N/A | K161567 |
| Model | 15000-01 | SIGNA Voyager 1.5T |
| Device Name | EMMA 1.5T MRI System | SIGNA Voyager |
| Applicant | Time Medical Limited | GE Healthcare |
| Applicant Address | Unit G01-G03, 05 & 08, G/F, | |
| Bio-Informatics Centre, Hong Kong | ||
| Science Park, Shatin, N.T | 3200 N. Grandview Blvd. | |
| Waukesha, WI 53188, USA | ||
| Classification Name | System, Nuclear Magnetic | |
| Resonance Imaging | Magnetic Resonance Diagnostic | |
| Device | ||
| Product Code | LNH | LNH, MOS |
| Regulation Number | 21 CFR 892.1000 | |
| Panel | Radiology | |
| Class | Class II | |
| Indications for Use | The EMMA 1.5T MRI System is | |
| indicated for use as a magnetic | ||
| resonance diagnostic device | ||
| (MRDD) which produces | ||
| transverse, sagittal, coronal and | ||
| oblique cross-sectional images, | ||
| and those display the internal | ||
| structure and/or function of the | The SIGNA Voyager is a whole body | |
| magnetic resonance scanner | ||
| designed to support high resolution, | ||
| high signal-to-noise ratio, and short | ||
| scan time imaging. The SIGNA | ||
| Voyager is indicated for use as a | ||
| diagnostic imaging device to produce | ||
| axial, sagittal, coronal, and oblique |
4
The filing device has the same US FDA classification including classification name, product code, regulation number, panel, and class with the predicate device.
The filing device has the same major indications for use as the predicate device produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
The minor differences in indications for use do not constitute any safety and effectiveness issue, as indicated in performance data provided.
| General | Filing Device | Predicate Device |
|---|---|---|
| Design | Cylindrical | Cylindrical |
| Materials | FRP, ABS | |
| Power Source | Isolated power supply | |
| Performance Data | Comply with: |
- NEMA MS standards
- IEC standards: IEC 60601-1,
IEC60601-1-2,
IEC60601-2-33 | |
| Magnet | Filing Device | Predicate Device |
| Type | Superconducting | |
| Field Strength | 1.5T | |
| Weight | 3,200 kg | 3,900 kg |
| Overall Dimensions | 1497 x 1880 x 2421 mm
(L x W x H) | 1730 x 2070 x 2360 mm
(L x W x H) |
| Cryogen Type | Liquid Helium | |
| Spatial Homogeneity | 1.45 ppm at 40 cm DSV | 0.40 ppm at 40 cm DSV |
| Fringe Field | 5 gauss line