(28 days)
The MAGNETOM ESSENZA with syngo MR D14 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 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.
The MAGNETOM ESSENZA is being upgraded with software syngo MR D14. The MAGNETOM ESSENZA is a 1.5T, whole body scanner designed for economical optimized reasons. Siemens intends to modify the cover, gradient coil, Physiological Measurement Unit (PMU), Measurement and Reconstruction System (MaRS), update the software and add two new coils for the existing MAGNETOM ESSENZA Magnetic Resonance System.
The provided document is a 510(k) summary for the Siemens MAGNETOM ESSENZA 1.5T System with syngo MR D14 software. This document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to regulatory standards for a Magnetic Resonance Diagnostic Device (MRDD).
Crucially, this document does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to the diagnostic accuracy (e.g., sensitivity, specificity) of an AI-powered diagnostic algorithm.
The 510(k) submission for the MAGNETOM ESSENZA with syngo MR D14 is for an imaging hardware system (a 1.5T MRI scanner) with updated software, coils, and mechanical components. It is not for an AI/algorithm-driven diagnostic aid. Therefore, the types of studies and acceptance criteria typically associated with AI-powered diagnostic devices (e.g., MRMC studies, sensitivity/specificity targets, expert adjudication for ground truth) are not applicable to this specific submission and are consequently not present in the provided text.
The document indicates that the device's substantial equivalence is based on:
- Its intended use being the same as the predicate (K071925).
- The fact that it is an upgrade to an existing, cleared MRI system.
- Conformity to applicable FDA-recognized and international IEC, ISO, and NEMA standards for performance and safety.
- Risk management in compliance with ISO 14971:2007.
Therefore, I cannot populate the requested table or answer the specific questions related to AI acceptance criteria and performance studies based on the provided text.
To reiterate, the provided document describes a magnetic resonance diagnostic device (MRI scanner), not an AI-driven diagnostic algorithm. The "performance" discussed in this context relates to the safety and functionality of the imaging system itself, not the diagnostic accuracy of an AI interpreting images.
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SIEMENS
Special 510(k) Submission: MAGNETOM ESSENZA 1.5T System
Section 5 510(k) Summary
MAR 1 2013
130262
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. The 510(k) Summary is provided on the next page and is suitable for publication on the FDA website.
l. General Information
| Establishment | Siemens Medical Solutions USA. Inc.51 Valley Stream ParkwayMail Code G01Malvern, PA 19355, USARegistration Number 2240869 |
|---|---|
| Date Prepared | January 31, 2013 |
| Registration Number | 2240869 |
| Manufacturers | Siemens Shenzhen Magnetic Resonance Ltd.Siemens MRI CenterGaoxin C. Ave., 2ndHi-Tech Industrial Park,Shenzhen 518057, P.R. ChinaRegistration Number 3004754211Siemens AGHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number 3002808157 |
| Contact Person | Ms. Nadia SookdeoRegulatory Affairs Technical SpecialistSiemens HealthcareSiemens Medical Solutions USA, Inc.Customer Solutions Group51 Valley Stream ParkwayMail Code G01Malvern, PA 19355, USAPhone: (610) 448-4918Fax: (610) 448-1787 |
| Device Name | Trade Names: MAGNETOM ESSENZAClassification Name: Magnetic Resonance Diagnostic DeviceCFR Code: 21 CFR § 892.1000Classification: Class II |
Performance Standards
None established under Section 514 the Food, Drug and Cosmetic Act.
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Special 510(k) Submission: MAGNETOM ESSENZA 1.5T System
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
SIEMENS
The intended use for the MAGNETOM ESSENZA with syngo MR D14 is the same as MAGNETOM ESSENZA that is described in K071925 and cleared on August 14, 2007.
The MAGNETOM ESSENZA with syngo MR D14 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 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.
Device Description
The MAGNETOM ESSENZA is being upgraded with software syngo MR D14. The MAGNETOM ESSENZA is a 1.5T, whole body scanner designed for economical optimized reasons. Siemens intends to modify the cover, gradient coil, Physiological Measurement Unit (PMU), Measurement and Reconstruction System (MaRS), update the software and add two new coils for the existing MAGNETOM ESSENZA Magnetic Resonance System.
Substantial Equivalence
Siemens feels that the new system is substantially equivalent to the following predicate devices:
| Predicate Device Name-System | FDAClearanceNumber | FDA ClearanceDate |
|---|---|---|
| Siemens MAGNETOM ESSENZA (1.5T) | K071925 | August 14, 2007 |
| Siemens MAGNETOM Avanto(1.5T)/MAGNEOM Aera(1.5T) with syngo MRD13A | K121434 | November 5, 2012 |
| Predicate Device Name-Coils | FDAClearanceNumber | FDA ClearanceDate |
|---|---|---|
| Specialty coils for MAGNETOM ESSENZA | K083166 | January 13, 2009 |
| 14-Channel Extremity Coil For MAGNETOMESSENZA | K100141 | August 27, 2010 |
| 2/4-ch Sentinelle Breast Coil | K060873 | April 14, 2006 |
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SIEMENS
Special 510(k) Submission: MAGNETOM ESSENZA 1.5T System General Safety and Effectiveness Concerns:
The MAGNETOM ESSENZA with software syngo MR D14 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 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 beginning early in the design cycle and continuing throughout the development of the product.
Siemens Medical Solutions USA, Inc. and Siemens AG adhere to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2013
Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, INc 51 Valley Stream Pkwy MALVERN PA 19355
Re: K130262
Trade/Device Name: MAGNETOM ESSENZA with syngo MRD14 software Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 31, 2013 Received: February 1, 2013
Dear Ms. Sookdeo:
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. Ilisting 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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Page 2-Ms. Sookdeo
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
MichaEL Hasa
for Janine Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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SIEMENS
Section 4 Indications for Use Statement
510(k) Number (if known) K130262
MAGNETOM ESSENZA Device Names:
Indications for Use:
The MAGNETOM ESSENZA with syngo MR D14 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 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.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OVID)
Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K130262 510(k) =
Page 1 of 1
§ 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.