(72 days)
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.
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.
The provided document is a 510(k) premarket notification for a Medical Resonance Diagnostic Device (MRDD), the MAGNETOM Sempra with syngo MR E11S. This submission focuses on establishing substantial equivalence to a predicate device, MAGNETOM Amira (K152283), rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics.
The document does not provide acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates compliance with recognized medical device standards and a clinical study related to nerve stimulation. The claims for substantial equivalence are based on similar intended use and functionality, along with verification and validation of software and hardware.
Here's an analysis based on the information provided, highlighting what is present and what is absent regarding your requested points:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria with corresponding performance metrics (e.g., SNR, image uniformity values, specific diagnostic accuracy) is provided in this document relevant to clinical image quality or diagnostic performance. Instead, the document focuses on compliance with standards and safety aspects.
| Acceptance Criteria (related to device functionality/safety) | Reported Device Performance |
|---|---|
| Conformance to IEC 62304:2006 (Software Medical Devices) | "The subject device... conforms to the standard for software medical devices (IEC 62304:2006)" |
| Conformance to IEC 60601-2-33 (Nerve Stimulation) | "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)" |
| SNR, image uniformity, heating for coils | "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..." |
| Risk management in compliance with ISO 14971:2007 | "Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards" |
| Conformance to other applicable standards | ES60601-1:2005/(R)2012 and A1:2012, 60601-1-2 Edition 3: 2007-03, 60601-1-6 Edition 3.1 2013-10 |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For the clinical study related to nerve stimulation, a sample size of 34 individuals was used.
- Data Provenance: The document does not specify the country of origin for the 34 individuals in the nerve stimulation study, nor does it explicitly state if this study was retrospective or prospective, though such safety studies are typically prospective.
- For the non-clinical tests (SNR, image uniformity, heating), no "test set" in the sense of patient data is mentioned; these are likely tests performed on hardware components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: The nerve stimulation study is a physiological measurement, not one requiring expert interpretation to establish a diagnostic ground truth. The document does not describe any test set that would require expert-established ground truth for performance evaluation (e.g., radiologists evaluating image quality for diagnostic purposes against a gold standard). The device is an MRI system, not an AI algorithm making diagnostic predictions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: This question is typically relevant for studies involving human readers or expert consensus for labeling data. The nerve stimulation study does not involve this type of adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This document describes a traditional MRI device. There is no mention of AI assistance or an MRMC study comparing human readers with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is an MRI system, not an algorithm being deployed in a standalone capacity for diagnosis. Its output (images and spectra) is intended for interpretation by a trained physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the nerve stimulation study: The "ground truth" was the observed Peripheral Nerve Stimulation (PNS) THRESHOLD LEVEL in the 34 individuals, measured according to IEC 60601-2-33 standards. This is a direct physiological measurement, not a diagnostic ground truth established by experts or pathology.
- For hardware tests (SNR, image uniformity, heating): The "ground truth" would be the physical measurements obtained from the system.
8. The sample size for the training set
- Not Applicable: This is a premarket notification for an MRI system, not an AI algorithm that requires a "training set" in the machine learning sense. The software component, syngo MR E11S, is verified and validated, but this process doesn't involve a 'training set' as it would for a deep learning model.
9. How the ground truth for the training set was established
- Not Applicable: As there is no "training set" in the context of an AI algorithm, this question does not apply.
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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.
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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
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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 BoulevardMail Code 65-1AMalvern, PA 19355, USARegistration Number: 2240869 |
|---|---|
| Date Prepared | November 15, 2016 |
| Manufacturer | Siemens Shenzhen Magnetic Resonance Ltd.Siemens MRI Center, Gaoxin C. Ave., 2ndHi-Tech Industrial Park518057 ShenzhenChinaRegistration Number: 3004754211 |
| Contact Person | Mr. Cordell L. Fields, Esq.Regulatory Affairs SpecialistSiemens HealthcareSiemens Medical Solutions USA, Inc.Customer Solutions Group40 Liberty BoulevardMail Code 65-1AMalvern, PA 19355, USAPhone: (610) 448-6469Fax: (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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| Classification Panel: | Radiology |
|---|---|
| Regulation Number: | 21 CFR § 892.120021 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:
| RecognitionNumber | Product Area | Title of Standard | ReferenceNumber anddate | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-4 | General II(ES/EMC) | C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText) Medical electrical equipment- Part 1: General requirements forbasic safety and essentialperformance (IEC 60601-1:2005,MOD) | ES60601-1:2005/(R)2012and A1:2012, | AAMIANSI |
| 19-1 | General II(ES/EMC) | Medical electrical equipment - Part1-2: General requirements forbasic safety and essentialperformance - Collateral standard:Electromagnetic compatibility -Requirements and tests | 60601-1-2 Edition3: 2007-03 | IEC |
| 12-271 | Radiology | Medical electrical equipment - Part2-33: Particular requirements forthe basic safety and essentialperformance of magneticresonance equipment for medicaldiagnosis | 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 medicaldevices | Edition 2007-03-01 | ||
|---|---|---|---|---|
| 5-89 | General I(QS/RM) | Medical electrical equipment - Part1-6: General requirements forbasic safety and essentialperformance - Collateral standard:Usability | 60601-1-6 Edition3.1 2013-10 | IEC |
| 13-32 | Software/Informatics | Medical device software -Software life cycle processes | 62304: 2006 | AAMIANSIIEC |
Substantial Equivalence
The MAGNETOM Sempra with software syngo MR E11S is substantially equivalent to the following devices:
| Predicate Device | FDA ClearanceNumber | FDAClearanceDate | ProductCode |
|---|---|---|---|
| MAGNETOM Amira with softwareversion syngo MR E11N | K152283 | December24, 2015 | LNH, LNI,MOS |
| Reference Devices | FDA ClearanceNumber | FDAClearanceDate | ProductCode |
|---|---|---|---|
| Software syngo MR E11C for theMAGNETOM System Aera | K153343 | April 15,2016 | LNH, LNI,MOS |
| Software syngo MR D14 for theMAGNETOM 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).
§ 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.