(141 days)
The MAGNETOM ESSENZA with syngo MR E11Q is indicated for use as magnetic resonance diagnostic devices (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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The MAGNETOM ESSENZA 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 ESSENZA with software syngo MR E11Q, is the latest software version for the Siemens MR MAGNETOM ESSENZA. It is modified based on the software version syngo MR E11A, which was cleared with K141977 on November 19, 2014. The software functionality and applications are based on syngo MR E11A SW and have been migrated from this previously cleared software. Only minor adaptations were needed to support the system specific hardware and to optimize the sequence/protocols, also to support the DGSU (Digital Gradient Small signal Unit) option for GPA (Gradient Power Amplifier).
Listed below are the hardware updates to the MAGNETOM ESSENZA system with software syngo MR E11Q:
- a modified MARS(Measurement and Reconstruction System), which is the same . as the MaRS of MAGNETOM Amira system with software syngo MR E11N (K152283, cleared on December 24, 2015)
- . an updated MRAWP (MR Syngo Acquisition Workplace), which is the same as the host platform of reference device MAGNETOM Amira with syngo MR E11N (K152283, cleared on December 24, 2015)
- . a successor EOSC (Electrical Optical Signal Converter) of original COB (CAN Open Bridge)
The MAGNETOM ESSENZA with software version syngo MR E11Q will be offered exfactory (new production) as well as in-field upgrades for the currently installed MAGNETOM ESSENZA systems.
A summary of the software feature updates to the MAGNETOM ESSENZA system with software synqo MR E11Q is provided below. All migrated features listed below have been cleared previously with K141977, K151579, and K152283.
The provided document describes the Siemens MAGNETOM ESSENZA with syngo MR E11Q, a magnetic resonance diagnostic device. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel device with performance metrics against a defined acceptance criterion.
Therefore, the document does not contain information related to acceptance criteria, device performance, sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth for training sets.
Instead, the submission details:
- Device Name: MAGNETOM ESSENZA with syngo MR E11Q
- Intended Use/Indications for Use: To produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician, assist in diagnosis. It may also be used for imaging during interventional procedures with MR compatible devices.
- Device Description: The latest software version for the Siemens MR MAGNETOM ESSENZA, modified from syngo MR E11A (cleared with K141977). Adaptations support system-specific hardware, optimize sequence/protocols, and support the DGSU (Digital Gradient Small signal Unit) option for GPA (Gradient Power Amplifier).
- Hardware Updates: Modified MARS (Measurement and Reconstruction System), updated MRAWP (MR Syngo Acquisition Workplace), and a successor EOSC (Electrical Optical Signal Converter).
- Migrated Software Features (previously cleared with K141977, K151579, and K152283): MyoMaps, Quiet Suite, 10-min Exam Dot Engine, Spine Dot Engine, Breast Dot Engine, Large Joint Dot Engine, Neuro fMRI Package, DTI Package, Neuro Perfusion Package, FREEZEit Body MRI Package, LiverLab, BOLD 3D Evaluation, DTI Evaluation.
- Technological Characteristics: Substantially equivalent to predicate MAGNETOM ESSENZA with syngo MR D14 regarding MR image acquisition steps/features, operational environment, programming language, operating system, and performance. Both conform to IEC 62304:2006, IEC, and NEMA standards.
- Nonclinical Tests:
- Description: All software features were verified and validated to perform as intended. Updated hardware (MaRS, MRAWP, EOSC) was tested in system and integration tests. All functionality and performance were tested in system and integration tests.
- Results: Tests demonstrated the device performs as intended and is substantially equivalent to predicate devices.
- Clinical Tests: None were conducted.
- Safety and Effectiveness: Labeling contains instructions, cautions, and warnings. Risk management is ensured via ISO 14971:2007 risk analysis. Adheres to IEC 60601-1 series to minimize electrical and mechanical risk. Conforms to applicable FDA recognized and international IEC, ISO, and NEMA standards.
- Predicate Devices:
- Reference Devices:
- Conclusion: The device is substantially equivalent as there are no changes to the Indications for Use compared to the primary predicate, and the new software features/capabilities are already cleared with the secondary predicate. The different technological characteristics do not raise new questions of safety and effectiveness as all features have been tested and verified/validated.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2016
Siemens Medical Solutions USA, Inc. % Mr. Cordell Fields, Esq. Regulatory Affairs Specialist 65 Valley Stream Parkway MALVERN PA 19355
Re: K161795
Trade/Device Name: MAGNETOM ESSENZA Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: October 20, 2016 Received: October 21, 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-012Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| 510(k) Number (if known)K161795 | |
| Device NameMAGNETOM ESSENZA | |
| Indications for Use (Describe) |
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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM ESSENZA 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 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------- |
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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.65 Valley Stream ParkwayMail Code 65-1AMalvern, PA 19355, USA |
|---|---|
| Registration Number | 2240869 |
| Date Prepared | June 29, 2016 |
| Manufacturer | SIEMENS SHENZHEN MAGNETIC RESONANCELTD.Siemens MRI CenterHi-Tech Industrial park (middle)Gaoxin C. Ave., 2ndShenzhen 518057, P.R. CHINARegistration Number: 3004754211Siemens Healthcare GmbHHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number: 3002808157 |
| Contact Person | Mr. Cordell L. Fields, Esq.Requlatory Affairs SpecialistSiemens HealthcareSiemens Medical Solutions USA, Inc.65 Valley Stream ParkwayMail Code 65-1AMalvern, PA 19355, USAPhone: (610) 448-6469Fax: (610) 448-1787 |
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| Device Name | Software syngo MR E11Q for the MAGNETOMESSENZA |
|---|---|
| Trade Names: | MAGNETOM ESSENZA |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH, Secondary: LNI, MOS |
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SIEMENS
II. Safety and Effectiveness Information Supporting Substantial Equivalence
The subject device, MAGNETOM ESSENZA with syngo MR E11Q, has the same intended use and indications for use as the legally marketed predicate devices.
Indications for Use
The MAGNETOM ESSENZA with syngo MR E11Q is indicated for use as magnetic resonance diagnostic devices (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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The MAGNETOM ESSENZA 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 ESSENZA with software syngo MR E11Q, is the latest software version for the Siemens MR MAGNETOM ESSENZA. It is modified based on the software version syngo MR E11A, which was cleared with K141977 on November 19, 2014. The software functionality and applications are based on syngo MR E11A SW and have been migrated from this previously cleared software. Only minor adaptations were needed to support the system specific hardware and to optimize the sequence/protocols, also to support the DGSU (Digital Gradient Small signal Unit) option for GPA (Gradient Power Amplifier).
Listed below are the hardware updates to the MAGNETOM ESSENZA system with software syngo MR E11Q:
- a modified MARS(Measurement and Reconstruction System), which is the same . as the MaRS of MAGNETOM Amira system with software syngo MR E11N (K152283, cleared on December 24, 2015)
- . an updated MRAWP (MR Syngo Acquisition Workplace), which is the same as the host platform of reference device MAGNETOM Amira with syngo MR E11N (K152283, cleared on December 24, 2015)
- . a successor EOSC (Electrical Optical Signal Converter) of original COB (CAN Open Bridge)
The MAGNETOM ESSENZA with software version syngo MR E11Q will be offered exfactory (new production) as well as in-field upgrades for the currently installed MAGNETOM ESSENZA systems.
A summary of the software feature updates to the MAGNETOM ESSENZA system with software synqo MR E11Q is provided below. All migrated features listed below have been cleared previously with K141977, K151579, and K152283.
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Migrated Software Features:
- MyoMaps
- o Provides quantitative information on tissue composition
- Quiet Suite ●
- o Provides sequences for quiet imaging
- 10-min Exam Dot Engine ●
- o 10 minute exams for the following regions: Head, L-spine, Knee, C-spine, Brain, Shoulder, Spine, T-spine, Hip, Extremities
- Spine Dot Engine ●
- o Delivers optimized cervical, thoracic and lumbar spine imaging
- . Breast Dot Engine
- o Delivers optimized breast imaging
- Large Joint Dot Engine .
- o Delivers optimized large joint imaging
- Neuro fMRI Package ●
- o Package consisting of 3D PACE, MR 3D Inline fMRI, and MR 3D Offline fMRI
- DTI Package ●
- o Allows for acquisition of data sets with multi-directional diffusion weighting to assess anisotropic diffusion properties of brain tissue
- Neuro Perfusion Package
- FREEZEit Body MRI Package ●
- o Facilitates high quality diagnostic MR imaging
- . LiverLab
- o Non-invasive evaluation of liver fat and/or iron.
- BOLD 3D Evaluation .
- o Provides features for clinical fMRI
- DTI Evaluation ●
- o Provides offline post-processing to generate and visualize parametric maps derived from the diffusion tensor to assess diffusion properties of brain tissue
Technological Characteristics
The subject device, MAGNETOM ESSENZA with syngo MR E11Q and the primary predicate device, MAGNETOM ESSENZA with syngo MR D14, are substantially equivalent with regard to acquiring MR images steps/features and with regard to the operational environment, programming language, operating system and performance.
The subject device, MAGNETOM ESSENZA with syngo MR E11Q and MAGNETOM ESSENZA with software syngo MR D14 both conform to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.
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SIEMENS
While there are some different technological characteristics such as some new and modified software applications, and hardware additions these differences have been tested and the conclusions from the non-clinical data suggest that the features (of different technological characteristics with respect to the predicate device) bear an equivalent safety and performance profile as that of the predicate devices.
Nonclinical Tests
The following performance testing was conducted on the subject device:
- All software features were verified and validated to ensure that they will perform . as intended when in the clinical environment.
- Updated hardware MaRS, MRAWP and EOSC were tested in system and integration tests.
All functionality and performance have been tested in system and integration tests.
The results from each set of tests demonstrate that the device performs as intended and is therefore 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.
No animal testing has been performed on this 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.
The MAGNETOM ESSENZA with software syngo MR E11Q 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 following standards are conformed to:
| 19-4 | General | C1:2009/(R)2012 andA2:2010/(R)2012(Consolidated Text) Medical | ES60601-1:2005/(R)2012 and | AAMI ANSI |
|---|---|---|---|---|
| electrical equipment – Part1: General requirements forbasic safety and essentialperformance (IEC 60601-1:2005, MOD) | A1:2012 | |||
| 19-1 | General | Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility -Requirements and tests | 60601-1-2Edition3:2007-03 | IEC |
| 12-207 | Radiology | Medical electricalequipment - Part 2-33:Particular requirements forthe basic safety andessential performance ofmagnetic resonanceequipment for medicaldiagnostic | 60601-2-33Edition 3.02010-03 | IEC |
| 5-40 | General | Medical devices -Application of riskmanagement to medicaldevices | 14971Secondedition 2007-03-01 | ISO |
| 5-89 | General | Medical electricalequipment -- Part 1-6:General requirements forbasic safety and essentialperformance -- CollateralStandard: Usability | 60601-1-6Edition 3.12013-10 | IEC |
| 13-8 | Software | Medical device software -Software life cycleprocesses | 62304 Firstedition 2006-05 | IEC |
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Substantial Equivalence
While the new and modified software and hardware features give the subject device greater capabilities than the primary predicate device, MAGNETOM ESSENZA with software syngo MR D14 (K130262; March 1, 2013), these additional capabilities are currently cleared features of secondary predicate device, MAGNETOM Aera with software syngo MR E11A. (K141977; November 19, 2014). Therefore, we believe the subject device to be substantially equivalent to the predicate devices.
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| Predicate Device Name | Clearance | Product code | Manufacturer |
|---|---|---|---|
| MAGNETOM ESSENZA withsyngo MR D14(Primary Predicate) | K130262cleared onMar. 1, 2013 | LNH | Siemens ShenzhenMagnetic ResonanceLtd. |
| MAGNETOM Aera withsyngo MR E11A(Secondary Predicate) | K141977cleared onNov. 19, 2014 | LNH, LNI, MOS | Siemens HealthcareGmbH |
Reference Device:
| Reference Device Name | Clearance | Productcode | Manufacturer |
|---|---|---|---|
| MAGNETOM Amira withsyngo MR E11N | K152283cleared onDec 24, 2015 | LNH | Siemens ShenzhenMagnetic ResonanceLtd. |
| MAGNETOM Aera withsyngo MR E11B | K151579clearedSeptember 29,2015 | LNH, LNI,MOS | Siemens HealthcareGmbH |
Conclusion as to Substantial Equivalence
There are no changes to the Indications for Use for the subject device, compared to that of the legally marketed predicate device MAGNETOM ESSENZA with software syngo MR D14.
While the updated software provides the user with additional capabilities compared to the primary predicate device, MAGNETOM ESSENZA with software version syngo MR D14, these software features have been cleared with secondary predicate device MAGNETOM Aera with software syngo MR E11A (K141977, cleared on November 19, 2014). The different technological characteristics of the new software do not raise new questions of safety and effectiveness. All features have been tested and verified and validated to be effective.
Therefore, Siemens believes that the subject device, software version syngo MR E11Q for MAGNETOM ESSENZA, is substantially equivalent to the predicate devices mentioned above.
N/A