(134 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or performance studies related to AI/ML.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images and/or spectra that "may assist in diagnosis," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the images/spectra it produces, when interpreted by a physician, "yield information that may assist in diagnosis."
No
The device description explicitly states it is an "MRI system" and utilizes a "superconducting magnet design," indicating it is a hardware device with associated software, not a software-only device.
Based on the provided information, the MAGNETOM Amira is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- MAGNETOM Amira Function: The MAGNETOM Amira is a Magnetic Resonance (MR) device. It produces images and spectra of the internal structure and function of the head, body, or extremities within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the internal structure and function of the body.
Therefore, the MAGNETOM Amira falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MAGNETOM Amira is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used.
These images and or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
MAGNETOM Amira may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
The MAGNETOM Amira is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
The MAGNETOM Amira may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
Product codes
LNH, LNI, MOS
Device Description
MAGNETOM Amira (1.5T) is an MRI svstem that is substantially equivalent to the previously cleared primary predicate device MAGNETOM Aera (K141977, cleared November 19, 2014) and secondary predicate device MAGNETOM ESSENZA (K130262, cleared Mach 1, 2013).
The MAGNETOM Amira utilizes a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to simplify the MR workflow.
The MAGNETOM Amira systems will be available in a fixed configuration.
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
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 Tests:
- The coils were tested for SNR, image uniformity, and heating.
- All other software features were verified and validated.
Results: The device performs as intended and is thus substantially equivalent to the predicate devices.
Clinical Tests:
No clinical tests were conducted to support the subject device and the substantial equivalence argument; however, clinical images were provided to support the new coils for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2015
Siemens Medical Solutions USA, Inc. % Cordell Fields, Esq. Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355
Re: K152283
Trade/Device Name: MAGNETOM Amira Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: November 23, 2015 Received: November 24, 2015
Dear Mr. Fields:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
к152283
Device Name MAGNETOM Amira
Indications for Use (Describe)
MAGNETOM Amira is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used.
These images and or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
MAGNETOM Amira may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
| Type of Use (Select one or both, as applicable) | 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:
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Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"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."
3
Section 5 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
l. General Information
| Establishment | Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Date Prepared | August 10, 2015 |
| Manufacturer | Siemens Shenzhen Magnetic Resonance Ltd.
Siemens MRI Center, Gaoxin C. Ave., 2nd
Hi-Tech Industrial Park
518057 Shenzhen
China
Registration Number: 3004754211 |
| Contact Person | Mr. Cordell L. Fields, Esq.
Regulatory Affairs Technical Specialist
Siemens Healthcare
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd
Mail Code 65-1A
Malvern, PA 19355, USA
Phone: (610) 219-8518
Fax: (610) 448-1787 |
| Device Name | MAGNETOM Amira with Software syngo MR E11 |
| Trade Names: | MAGNETOM Amira |
| Classification Name:
Classification Panel:
CFR Code:
Classification:
Product Code: | Magnetic Resonance Diagnostic Device (MRDD)
Radiology
21 CFR § 892.1000
Class II
Primary: LNH, Secondary: LNI, MOS |
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II. Safety and Effectiveness Information Supporting Substantial Equivalence
Indications for Use
The MAGNETOM Amira is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
The MAGNETOM Amira may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
Device Description
MAGNETOM Amira (1.5T) is an MRI svstem that is substantially equivalent to the previously cleared primary predicate device MAGNETOM Aera (K141977, cleared November 19, 2014) and secondary predicate device MAGNETOM ESSENZA (K130262, cleared Mach 1, 2013).
The MAGNETOM Amira utilizes a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to simplify the MR workflow.
The MAGNETOM Amira systems will be available in a fixed configuration.
Technological Characteristics
While the MAGNETOM Amira with Software syngo MR E11N, the subject device, has the same basic technological characteristics as the predicate devices, there are some differences which do not affect safety or effectiveness. These differences are summarized below and are also addressed in further detail in this submission (Section 12.4).
The MAGNETOM Amira system has some different technological characteristics in comparison to the predicate devices which include:
- Different bore diameter and length of the magnet
- Different current output and power supply of the gradient system
- Differences in the RF system concerning the maximum number of RF ● channels and the maximum number of receiving coil elements
- Patient table maximum vertical and horizontal range difference
- New coils to be used with the subject device .
- o Head/Neck 10
- o Spine 18
- Body 13 o
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- Peripheral Angio 16 O
- Breast 4 о
- Extremity 12 O
- iTX Extremity 18 O
- Shoulder Small/Large 6 O
- o Wrist 8
- o Foot/Ankle 10
- 10 minute exam application/feature .
The subject and the primary predicate device. MAGNETOM Aera (K141977. cleared November 19, 2014) are substantially equivalent with regard to the following:
- MR image acquisition steps/features
- Operational environment, programming language, operating system . and performance
- Conformance to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.
Nonclinical Tests
The following performance testing was conducted on the subject device:
- The coils were tested for SNR, image uniformity, and heating. .
- All other software features were verified and validated. ●
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared.
Clinical Tests
No clinical tests were conducted to support the subject device and the substantial equivalence argument; however, clinical images were provided to support the new coils for the subject device.
Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development, SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
6
The MAGNETOM Amira with software synqo MR E11N conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.
Substantial Equivalence
The MAGNETOM Amira with software syngo MR E11N is substantially equivalent to the following devices:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date | Product
Code |
|-------------------------------------------------------------|-------------------------|-----------------------|------------------|
| Siemens MAGNETOM Aera (1.5T)
(Primary Predicate) | K141977 | Nov 19th 2014 | LNH, LNI,
MOS |
| Siemens MAGNETOM ESSENZA
(1.5T)
(Secondary Predicate) | K130262 | Mar 1st 2013 | LNH |
Reference Device:
| Reference Device Name | FDA
Clearance
Number | FDA
Clearance
Date | Product
Code |
|-----------------------|----------------------------|--------------------------|------------------|
| MAGNETOM Spectra | K121160 | July 16th 2012 | LNH, LNI,
MOS |
Conclusion as to Substantial Equivalence
MAGNETOM Amira with Software syngo MR E11N has the same intended use and the same basic technical characteristics as the predicate devices: MAGNETOM Aera (K141977, cleared November 19, 2014) and MAGNETOM ESSENZA (K130262, cleared March 1, 2013), with respect to the magnetic resonance features and functionalities.
MAGNETOM Amira with Software syngo MR E11N will be used for acquiring MR images (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra). The predicate devices, MAGNETOM Aera (K141977) and MAGNETOM ESSENZA (K130262), are also capable of acquiring MR images (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra). Though there are differences between the subject device and the predicate devices, which include the new and modified software and hardware features, the conclusions from the nonclinical data suggest that the features (of different technological characteristics with respect to the predicate devices) bear an equivalent safety and performance profile as that of the predicate and reference device.
MAGNETOM Amira with Software syngo MR E11N has similar functionality as the predicate devices, and does not introduce new issues of safety or effectiveness. Therefore, Siemens is of the opinion that MAGNETOM Amira with Software syngo MR E11N does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed devices, MAGNETOM Aera (K141977) and MAGNETOM ESSENZA (K130262).