The MAGNETOM Aera and the MAGNETOM Skyra systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectro-scopic 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 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

MAGNETOM Aera (1.5 T) and MAGNETOM Skyra (3 T) are similar to the previously cleared MAGNETOM Espree and MAGNETOM Verio, utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to reduce complexity of the MR workflow.

The MAGNETOM Aera and the MAGNETOM Skyra systems will be available in fixed and mobile configurations.

AI/ML Overview

The Siemens MAGNETOM Aera and MAGNETOM Skyra systems are Magnetic Resonance Diagnostic Devices (MRDD). The study described in the provided documents did not involve a clinical study with human patients to establish acceptance criteria or device performance in the traditional sense (e.g., diagnostic accuracy, sensitivity, specificity).

Instead, the study's purpose was to demonstrate substantial equivalence to previously cleared predicate devices (MAGNETOM Espree and MAGNETOM Verio) by showing that the new systems conform to established safety and performance standards for MRDDs.

Here's a breakdown of the information based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Measurement/Standard	Reported Device Performance
Safety	Maximum Static Field	Conforms to international IEC, ISO, and NEMA standards for safety issues with MRDDs.
	Rate of Change of Magnetic Field	Conforms to international IEC, ISO, and NEMA standards for safety issues with MRDDs.
	RF. Power Deposition	Conforms to international IEC, ISO, and NEMA standards for safety issues with MRDDs.
	Acoustic Noise Levels	Conforms to international IEC, ISO, and NEMA standards for safety issues with MRDDs.
Performance	Specification Volume	Equivalent to predicate devices (MAGNETOM Espree & MAGNETOM Verio).
	Signal to Noise	Equivalent to predicate devices (MAGNETOM Espree & MAGNETOM Verio).
	Image Uniformity	Equivalent to predicate devices (MAGNETOM Espree & MAGNETOM Verio).
	Geometric Distortion	Equivalent to predicate devices (MAGNETOM Espree & MAGNETOM Verio).
	Slice Profile, Thickness and Gap	Equivalent to predicate devices (MAGNETOM Espree & MAGNETOM Verio).
	High Contrast Spatial Resolution	Equivalent to predicate devices (MAGNETOM Espree & MAGNETOM Verio).

Explanation of the "Study" and Acceptance:

The "study" for these devices was a series of technical measurements and comparisons to demonstrate that the MAGNETOM Aera and Skyra meet internationally recognized standards for safety and that their performance is equivalent to that of the predicate devices. This type of testing is common for demonstrating substantial equivalence for medical devices that are refinements or updates to existing technology rather than entirely new diagnostic methods.

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

Sample Size for Test Set: Not applicable in the context of human clinical data. The "test set" consisted of the MAGNETOM Aera and MAGNETOM Skyra devices themselves, subjected to various technical measurements and comparisons against established standards and predicate device performance.
Data Provenance: The data provenance is from technical measurements performed on the devices according to NEMA, IEC, and ISO standards. It is not patient data from a specific country or collected retrospectively/prospectively.

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

This is not applicable as the "ground truth" for this submission was based on established engineering and physics standards (IEC, ISO, NEMA) and the performance characteristics of predicate devices. There was no diagnostic "ground truth" derived from expert interpretation of images in a clinical study. The standards themselves represent a form of "expert consensus" in the engineering and medical device community.

4. Adjudication Method for the Test Set

Not applicable for this type of technical performance and safety validation.

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

No, an MRMC comparative effectiveness study was not done. The submission is for an MRI system, not an AI-powered diagnostic tool, and it focuses on the safety and technical performance of the scanner itself.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an MRI system, which requires a human operator and physician interpretation. It is not an algorithm that operates standalone.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the devices was based on:
- International Safety and Performance Standards: NEMA, IEC, and ISO standards for MRI devices.
- Predicate Device Performance Data: Comparisons were made to the established performance of the legally marketed Siemens MAGNETOM Espree (1.5T) and MAGNETOM Verio (3T) systems.

8. The Sample Size for the Training Set

Not applicable. This submission is for an MRI hardware system, not a machine learning algorithm that requires a training set of data.

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

Not applicable as there was no training set for a machine learning algorithm.

Summary

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K101347

page 1/3

Section: 5 510(k) Summary

Section 5 510(k) Summary

FOCT 2 2010

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. 51 Valley Stream Parkway Mail Code G01 Malvern, PA 19355, USA 2240869 Registration Number Manufacturer Siemens AG Henkestrasse 127 D-91052 Erlangen, Germany Registration Number 8010024 Contact Person Ms. Kim Rendon Manager, Regulatory Affairs/Clinical Affairs Siemens Healthcare Siemens Medical Solutions USA, Inc. Customer Solutions Group 51 Valley Stream Parkway Mail Code G01 Malvern, PA 19355, USA Phone: (610) 448-1773 Fax: (610) 448-1787 MAGNETOM Aera Trade Names: Device Name MAGNETOM Skyra Classification Name: Magnetic Resonance Diagnostic Device 21 CFR § 892.1000 CFR Code: Classification: Class II

Performance Standards

None established under Section 514 the Food, Drug and Cosmetic Act.

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Section: 5 510(k) Summary

II. Safety and Effectiveness Information Supporting Substantial Equivalence

Intended Use

Device Description

The MAGNETOM Aera and the MAGNETOM Skyra systems will be available in fixed and mobile configurations.

Substantial Equivalence

Siemens feels that the new systems are substantially equivalent to the following predicate devices:

Predicate Device Name	FDA ClearanceNumber	FDA ClearanceDate
Siemens MAGNETOM Espree (1.5T)	K041112	July 21, 2004
Siemens MAGNETOM Verio (3T)	K072237	October 10, 2007
syngo® MR B17 Software update	K082427	November 7, 2008

General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Aera (1.5T) and the MAGNETOM Skyra (3T) systems is substantially equivalent to the commercially available MAGNETOM Espree (1.5T) and MAGNETOM Verio (3T) System.

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Section: 5 510(k) Summary

As specified in the FDA guidance document "Guidance for the Submission Of Premarket Notifications for Maqnetic Resonance Devices" (released Nov. 1998) the following measurements of performance and safety data have been performed following NEMA or equivalent IEC and ISO standards:

Safety:

· Maximum Static Field
· Rate of Change of Magnetic Field
· RF. Power Deposition
Acoustic Noise Levels

Performance:

· Specification Volume
· Signal to Noise
· Image Uniformity
· Geometric Distortion
· Slice Profile. Thickness and Gap
High Contrast Spatial Resolution

The MAGNETOM Aera and MAGNETOM Skyra will conform to the measurements of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices.

Furthermore performance measurements have been done on the predicate devices MAGNETOM Espree and MAGNETOM Verio to show that the performance of the MAGNETOM Aera and MAGNETOM Skyra is equivalent with respect to the predicate devices.

This will assure that the performance of these devices can be considered safe and effective with respect to the currently available MAGNETOM Espree and MAGNETOM Verio systems.

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Public Health Service

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

Ms. Kim Rendon Manager, Regulatory/Clinical Affaris Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy, Mail Code G01 MALVERN PA 19355

OCT 1 2010

Re: K101347

Trade/Device Name: Magnetom Aera and Magnetom Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and LNI Dated: August 13, 2010 Received: August 16, 2010

Dear Ms. Rendon:

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/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/cdrh/industry/support/index.html.

Sincerely yours,

Signature

David G. Brown, Ph.D. Acting 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

Section 4 Indications for Use Statement

510(k) Number (if known)

MAGNETOM Aera and MAGNETOM Skyra Device Names:

Indications for Use:

The MAGNETOM systems described above are 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.

The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use X	OR	Over-The-Counter Use ______
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signature
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K.	K101347
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Siemens 510(k) Premarket Notification	May 12, 2010	Section 4-1
MAGNETOM Aera and MAGNETOM Skyra		Page 1 of 1

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.