The MAGNETOM Aera and the MAGNETOM Skyra systems are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display 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 Aera and the MAGNETOM Skyra systems 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 software and some of the hardware of the previously cleared MAGNETOM Aera and MAGNETOM Skyra have been modified and updated. The updates enable new options, including sequences, applications, coils and coil adapters, for MAGNETOM Aera and MAGNETOM Skyra.

AI/ML Overview

The provided document describes a 510(k) premarket notification for updates to the Siemens MAGNETOM Aera and MAGNETOM Skyra MRI systems. It does not contain a study proving the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics like accuracy, sensitivity, specificity, with a test set, ground truth established by experts, etc.).

This submission is for modifications and updates to existing MRI devices, encompassing new options, sequences, applications, coils, and coil adapters. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices and adherence to safety and effectiveness standards, rather than proving performance against specific quantitative acceptance criteria for a novel AI or diagnostic algorithm.

Therefore, many of the requested details about acceptance criteria, study design for performance validation, sample sizes, expert qualifications, and ground truth establishment are not present in this document.

Here's a breakdown of the information that can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantitative performance metrics for a diagnostic task. The "acceptance criteria" here refer to regulatory compliance and demonstrating substantial equivalence to predicate devices, along with adherence to recognized standards (ISO 14971:2007, IEC 60601-1 series, FDA recognized and international IEC, ISO and NEMA standards).
Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, AUC) are reported in this document. The "performance" discussed is related to the device's ability to produce images and spectra as a magnetic resonance diagnostic device, consistent with its intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable/not provided. This submission is about hardware/software updates to an existing MRI system, not a study evaluating a diagnostic algorithm on a test set of patient data.
Data Provenance: Not applicable/not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable/not provided. Ground truth establishment for a diagnostic algorithm is not described.
Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not provided. There is no test set or diagnostic efficacy study described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This document does not present an MRMC study.
Effect Size of Human Readers with AI vs Without AI: Not applicable, as no AI-assisted diagnostic claims or studies are presented.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No. This document does not describe a standalone performance study of an algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable/not provided. No ground truth is established for diagnostic performance metrics in this document.

8. Sample Size for the Training Set

Sample Size: Not applicable/not provided. This is not a submission for a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable/not provided.

Summary of what the document does describe regarding validation:

The validation approach for the modifications to the MAGNETOM Aera and MAGNETOM Skyra systems primarily relies on:

Substantial Equivalence: Comparing the modified devices to a list of previously cleared predicate devices (K101347, K082427, K072237, K041112, K103275, K100113).
Risk Management: Adherence to ISO 14971:2007 for identifying and mitigating potential hazards.
Compliance with Standards: Conformance to applicable FDA recognized and international IEC, ISO, and NEMA standards (e.g., IEC 60601-1 series) for performance and safety.
Device Labeling: Ensuring the device labeling contains appropriate instructions, cautions, and warnings for safe and effective use.

In essence, this 510(k) submission is for an incremental update to an established medical device, where the focus is on maintaining the established safety and effectiveness profile and demonstrating that the changes do not introduce new questions of safety or effectiveness compared to the predicate devices. It is not a submission for a novel diagnostic algorithm requiring extensive clinical performance studies with acceptance criteria based on metrics like sensitivity or specificity.

Summary

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NOV 2 3 2011

KII1242

Section 5 - 510(k) Summary

This 510(k) summary is being submitted in accordance with 21 CFR § 807.92.

1.1 General Information

Establishment	Siemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USARegistration Number 2240869
Manufacturer	Siemens AGHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number 8010024SIEMENS MINDIT MAGNETIC RESONANCE LTD.Siemens MRI Center, Hi-TechIndustrial park (middle)Gaoxin C. Ave., 2ndShenzhen 518057, P.R. CHINARegistration Number 3004754211
Contact Person	Ms. Michelle L. ByrneRegulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USAPhone: (610) 448-4293Fax: (610) 448-1787E-mail: michelle.l.byrne@siemens.com
Device Name	MAGNETOM Aera and MAGNETOM Skyra withsyngo MR D11Please note: syngo MR D11 is the broad name for thesoftware version; it includes all iterations of the software(i.e. the previously cleared software version

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Classification Name: CFR Code: Classification: Product Code:

Magnetic Resonance Diagnostic Device 21 CFR § 892.1000 Class II LNH

1.2 Safety and Effectiveness Information Supporting Substantial Equivalence

Device Description

Substantial Equivalence

The modified MAGNETOM Aera and MAGNETOM Skyra are substantially equivalent to the following predicate devices:

Predicate Device Name	510(k) Number	FDA ClearanceDate
Siemens MAGNETOM Aera (1.5T)and MAGNETOM Skyra withsyngo® MR D11A	K101347	October 1, 2010
Siemens MAGNETOM Skyra (3T)with syngo® MR D11A	K101347	October 1, 2010
syngo® MR B17 Software update	K082427	November 7, 2008
Siemens MAGNETOM Verio (3T)	K072237	October 10, 2007
Siemens MAGNETOM Espree(1.5T)	K041112	July 21, 2004
Specialty coils for MAGNETOMAera and MAGNETOM Skyra	K103275	January 11, 2011
Sentinelle Vanguard Breast Coils	K100113	April 22, 2010

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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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.

The modified MAGNETOM Aera and MAGNETOM Skyra conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as required by the respective MR FDA Guidance Document.

Intended Use

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

NOV 2 3 2011

Ms Mitchelle L. Byrne Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355

Re: K111242

Trade/Device Name: MEGNETOM Aera and MAGNETOM Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 17, 2011 Received: November 18, 2011

Dear Ms. Byrne:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

510(k) Number (if known) K111242

MAGNETOM Aera and MAGNETOM Skyra Device Names:

Indications for Use

The MAGNETOM systems described above are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities.

The MAGNETOM systems described above 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.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

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 (OIVD)

Arachnol D'O'Hara

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k<111242

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Regulation Number and Section

§ 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.