(72 days)
No
The summary describes an MRI system with various software features for image acquisition and processing, but it does not mention any AI or ML capabilities. The focus is on hardware improvements, existing software platforms, and standard MRI techniques.
No
Explanation: The device is indicated for diagnostic purposes to produce images and spectra that assist in diagnosis, not for treating or curing diseases.
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 information derived from it "may assist in diagnosis."
No
The device description explicitly states it is an "MRI system" and details hardware components like a Gradient Amplifier and a fixed patient table, indicating it is a physical device with integrated software, not software-only.
Based on the provided text, the MAGNETOM Sempra is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the internal structure and/or function of the head, body, or extremities. It assists in diagnosis when interpreted by a trained physician. This describes an in vivo diagnostic imaging system, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description details an MRI system, which is a type of medical imaging equipment used to visualize internal structures of the body.
- Input Imaging Modality: The input modality is Magnetic Resonance, which is an in vivo imaging technique.
- Anatomical Site: The device is used on the "head, body, or extremities," which are parts of the living organism.
IVD devices are used to examine specimens such as blood, urine, or tissue samples in vitro to provide information for diagnosis, monitoring, or screening. The MAGNETOM Sempra operates directly on the patient's body to produce images.
N/A
Intended Use / Indications for Use
The MAGNETOM Sempra is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images 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 Sempra 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 (comma separated list FDA assigned to the subject device)
LNH, LNI, MOS
Device Description
The subject device, MAGNETOM Sempra (1.5T) with syngo MR E11S, is an MRI system that is substantially equivalent to the previously cleared predicate device MAGNETOM Amira with software version syngo MR E11N; K152283).
MAGNETOM Sempra is equipped with Tim4G + Dot technology and Siemens latest software platform syngo MR E11 which includes latest applications like Quiet Suite for quiet brain, spine and musculoskeletal exams, CAIPIRINHA for shorter breathhold times and Advanced WARP which enables correction of in- through-plane distortions for better evaluation of soft tissue around metallic implants.
From the operational side, Brain, Spine and Large Joint Dot engines included in standard configuration of MAGNETOM Sempra deliver consistency in imaging of core body regions. The same software platform E11 would help users to shorten learning curve, plus the consistent result from Dot engines, MAGNETOM Sempra helps the user to get uniform quality. The Eco-Power technology is included and works by automatically switching off the cold head compressor during system standby or power off at night, and intelligently switching on/off of components between patients together with Zero Helium Boil-off technology to help customers to save operating cost.
MAGNETOM Sempra utilizes the similar design of hardware as the predicate device MAGNETOM Amira with syngo E11N (K152283), the main hardware changes are the modified Gradient Amplifier and introducing a new fixed patient table without vertical movement.
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 / Interventional procedures
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.
- Key results: 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:
- Study type: Clinical study to determine the nerve stimulation thresholds.
- Sample size: 34 individuals.
- Key results: The observed parameters were the PNS (Peripheral Nerve Stimulation) THRESHOLD LEVEL which are required in IEC 60601-2-33 (Edition 3.1:2013).
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.
MAGNETOM Amira with software version syngo MR E11N K152283
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.
Software syngo MR E11C for the MAGNETOM System Aera K153343, Software syngo MR D14 for the MAGNETOM ESSENZA (1.5T) K130262
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.
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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 a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 65 Valley Stream Pkwy. MALVERN PA 19355
Re: K163211
Trade/Device Name: MAGNETOM Sempra with syngo MR E11S Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: November 15, 2016 Received: November 16, 2016
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 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.
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/Resourcesfor You/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
2
Indications for Use
510(k) Number (if known) K163211
Device Name MAGNETOM Sempra with syngo MR E11S
Indications for Use (Describe)
The MAGNETOM Sempra is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images 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 Sempra 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 201, Subpart D) | Over-The-Counter Use (21 CFR 201, Subpart C) |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.
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.
I. General Information
| Establishment | Siemens Medical Solutions USA. Inc.
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Registration Number: 2240869 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | November 15, 2016 |
| 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 Specialist
Siemens Healthcare
Siemens Medical Solutions USA, Inc.
Customer Solutions Group
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Phone: (610) 448-6469
Fax: (610) 640-4481 |
| Device Name: | MAGNETOM Sempra with syngo MR E11S |
| Trade name: | MAGNETOM Sempra |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD)
Emission Computed Tomography System |
MAGNETOM Sempra with syngo MR E11S
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Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a cluster of orange dots arranged in a pattern.
| Classification Panel: | Radiology |
|---|---|
| Regulation Number: | 21 CFR § 892.1200 |
| 21 CFR § 892.1000 | |
| Device Class: | II |
| Primary Product Code: | LNH |
| Secondary Product Codes: | LNI, MOS |
II. Safety and Effectiveness Information Supporting Substantial Equivalence
The MAGNETOM Sempra has the same intended use as the legally marketed predicate device, MAGNETOM Amira (K152283).
Intended Use
The MAGNETOM Sempra 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 Sempra 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
The subject device, MAGNETOM Sempra (1.5T) with syngo MR E11S, is an MRI system that is substantially equivalent to the previously cleared predicate device MAGNETOM Amira with software version syngo MR E11N; K152283).
MAGNETOM Sempra is equipped with Tim4G + Dot technology and Siemens latest software platform syngo MR E11 which includes latest applications like Quiet Suite for quiet brain, spine and musculoskeletal exams, CAIPIRINHA for shorter breathhold times and Advanced WARP which enables correction of in- through-plane distortions for better evaluation of soft tissue around metallic implants.
MAGNETOM Sempra with syngo MR E11S
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Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
From the operational side, Brain, Spine and Large Joint Dot engines included in standard configuration of MAGNETOM Sempra deliver consistency in imaging of core body regions. The same software platform E11 would help users to shorten learning curve, plus the consistent result from Dot engines, MAGNETOM Sempra helps the user to get uniform quality. The Eco-Power technology is included and works by automatically switching off the cold head compressor during system standby or power off at night, and intelligently switching on/off of components between patients together with Zero Helium Boil-off technology to help customers to save operating cost.
MAGNETOM Sempra utilizes the similar design of hardware as the predicate device MAGNETOM Amira with syngo E11N (K152283), the main hardware changes are the modified Gradient Amplifier and introducing a new fixed patient table without vertical movement.
Technological Characteristics
The subject device, MAGNETOM Sempra with syngo MR E11S and the predicate device, MAGNETOM Amira with syngo MR E11N, are substantially equivalent with reqard to acquiring MR images steps/features and with regard to the operational environment, programming language, operating system and performance.
The subject device, MAGNETOM Sempra with syngo MR E11S conforms 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
A clinical study of 34 individuals was conducted in accordance with IEC 60601-2-33 (Edition 3.1: 2013) to determine the nerve stimulation thresholds used to limit the gradient system output. The observed parameters were the PNS (Peripheral Nerve Stimulation) THRESHOLD LEVEL which are required in IEC 60601-2-33 (Edition 3.1:2013)
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.
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Image /page/6/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
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.
MAGNETOM Sempra with Software syngo MR E11S, 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. The standards conformed to are the following:
| Recognition
Number | Product Area | Title of Standard | Reference
Number and
date | Standards
Development
Organization |
|-----------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------|
| 19-4 | General II
(ES/EMC) | C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated
Text) Medical electrical equipment
- Part 1: General requirements for
basic safety and essential
performance (IEC 60601-1:2005,
MOD) | ES60601-
1:2005/(R)2012
and A1:2012, | AAMI
ANSI |
| 19-1 | General II
(ES/EMC) | Medical electrical equipment - Part
1-2: General requirements for
basic safety and essential
performance - Collateral standard:
Electromagnetic compatibility -
Requirements and tests | 60601-1-2 Edition
3: 2007-03 | IEC |
| 12-271 | Radiology | Medical electrical equipment - Part
2-33: Particular requirements for
the basic safety and essential
performance of magnetic
resonance equipment for medical
diagnosis | 60601-2-33 Ed.
3.1:2013 | IEC |
| 5-40 | General I | Medical devices - Application of | 14971 Second | ISO |
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Image /page/7/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a pattern.
| | (QS/RM) | risk management to medical
devices | Edition 2007-03-
01 | |
|-------|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------------------|
| 5-89 | General I
(QS/RM) | Medical electrical equipment - Part
1-6: General requirements for
basic safety and essential
performance - Collateral standard:
Usability | 60601-1-6 Edition
3.1 2013-10 | IEC |
| 13-32 | Software/I
nformatics | Medical device software -
Software life cycle processes | 62304: 2006 | AAMI
ANSI
IEC |
Substantial Equivalence
The MAGNETOM Sempra with software syngo MR E11S is substantially equivalent to the following devices:
| Predicate Device | FDA Clearance
Number | FDA
Clearance
Date | Product
Code |
|-------------------------------------------------------|-------------------------|--------------------------|------------------|
| MAGNETOM Amira with software
version syngo MR E11N | K152283 | December
24, 2015 | LNH, LNI,
MOS |
| Reference Devices | FDA Clearance
Number | FDA
Clearance
Date | Product
Code |
|-------------------------------------------------------------|-------------------------|--------------------------|------------------|
| Software syngo MR E11C for the
MAGNETOM System Aera | K153343 | April 15,
2016 | LNH, LNI,
MOS |
| Software syngo MR D14 for the
MAGNETOM ESSENZA
(1.5T) | K130262 | March 1,
2013 | LNH |
Conclusion as to Substantial Equivalence
MAGNETOM Sempra with Software syngo MR E11S has the same intended use as the predicate device MAGNETOM Amira (K152283, cleared on December 24,2015), with respect to the magnetic resonance features and functionalities.
MAGNETOM Sempra with Software syngo MR E11S will be used for acquiring MR images (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra). The predicate device MAGNETOM Amira (K152283), is also capable of acquiring MR images (transverse, sagittal, coronal
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Image /page/8/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a cluster of orange dots arranged in a circular pattern.
and oblique cross sectional images, spectroscopic images and/or spectra). Though there are differences between the subject device and the predicate device, which include the new and modified software and hardware features, MAGNETOM Sempra with software syngo MR E11S has similar functionality as the predicate device, and does not introduce new issues of safety or effectiveness. Therefore, Siemens is of the opinion that MAGNETOM Sempra with Software syngo MR E11S does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device MAGNETOM Amira (K152283).