The MAGNETOM systems Aera and Skyra with the updated software syngo MR DI3A 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, vield information that may assist in diagnosis.

The MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A 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 version syngo MR D13A is updated for two Siemens MR systems:

o MAGNETOM Aera (1.5T)
o MAGNETOM Skyra (3T)

Systems that are already in clinical use and at customer sites can be updated with this software update; both MAGNETOM systems can be manufactured with this software update.

This software update includes modified software sequences for MAGNETOM Aera and MAGNETOM Skyra.

MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D13A were previously cleared under K121434 (November 5, 2012).

Summary of Features New with the Software Update compared to the commercially available Software Version syngo MR D13A:

Software

Modified sequences: .
- Quiet sequences o
- VIBE sequence improvements o

AI/ML Overview

The provided text describes a 510(k) submission for a software update to already cleared MRI systems (MAGNETOM Aera and MAGNETOM Skyra). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive de novo clinical trials with specific acceptance criteria in the same way a new device might.

Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense, as would be expected for a new AI/CAD device with a specific performance metric, is largely absent or interpreted differently in this context. The "acceptance criteria" here are primarily about demonstrating that the updated software performs as intended and does not raise new issues of safety or effectiveness compared to the predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

As this is a software update for an existing MRI system, the "acceptance criteria" are not reported as specific numerical performance targets (e.g., sensitivity, specificity for a diagnostic task). Instead, the acceptance is based on maintaining the safety and effectiveness of the cleared predicate device while introducing new features.

Acceptance Criteria (Implied)	Reported Device Performance
Performs as intended.	"The results from each set of tests demonstrate that the device performs as intended..." (Page 3)
No new issues of safety or effectiveness.	"…[the modified sequences] do not introduce any new issues of safety or effectiveness." (Page 4)"Risk Management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards..." (Page 3)"MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A conform to the applicable FDA recognized and international IEC. ISO and NEMA standards with regards to performance and safety..." (Page 3)
Maintains existing Indications for Use.	"There are no changes to the Indications for Use for the subject device, compared to that of the predicate MAGNETOM scanners with software syngo MR D13A." (Page 3)
New features (Quiet sequences, VIBE sequence improvements) function as described and offer benefits without compromising safety/effectiveness.	"…the updated software provides the user with additional capabilities… it has the same technological characteristics as that of the predicate devices. The modifications… make the systems and software more user- and patient-friendly - providing imaging techniques with lower noise towards the patient; improving the user's workflow; providing additional information and options to the user." (Page 4) Specific performance metrics for "lower noise" or "improved workflow" are not quantified in this summary.
Compliance with relevant standards.	"MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A conform 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." (Page 3)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated as this was not a clinical trial in the traditional sense for diagnostic accuracy. The document mentions "clinical images are provided to support the modified software features" (Page 3), but the number of images or patients (sample size) for this support is not specified.
Data Provenance: Not specified. Given it's a software update for globally available Siemens MRI systems, the images could be from various regions.
Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The study did not involve establishing ground truth for diagnostic accuracy in a clinical test set. The images were provided to support the functionality of new features, likely evaluated internally by engineering and clinical applications specialists, but not by independent experts in a ground-truth adjudication process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable and not provided. There was no formal adjudication process by independent experts for a diagnostic test set in this 510(k) submission.

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 MRMC comparative effectiveness study was done. This device is an MRI system software update, not an AI/CAD diagnostic aid.

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

This is not an AI algorithm. The performance evaluation would have been on the entire MRI system with the updated software, which always involves a human operator and physician interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. As this was not a diagnostic accuracy study for a specific condition, the concept of "ground truth" for a disease state is not central to this submission. The "ground truth" (or verification/validation) for the software features would relate to whether the sequences produce images as designed (e.g., lower noise as intended for "Quiet sequences," VIBE sequence improvements are visually present and functional as per engineering specifications).

8. The sample size for the training set

Not applicable. This is a software update for an MRI system, not a machine learning or AI-based device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there was no training set for an AI algorithm.

Summary

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NOV 0 1 2013

Traditional 510(k) Submission

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

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 3002808157
	SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.Siemens MRI CenterHi-Tech Industrial park (middle)Gaoxin C. Ave., 2ndShenzhen 518057, P.R. CHINARegistration Number 3004754211
Contact Person	Ms. Nadia SookdeoRegulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USAPhone: (610) 448-4918E-mail: Nadia. Sookdeo@siemens.com
Device Name	Software update syngo MR D13A-AP-AA to thecommercially available software version syngo MR D13Afor MAGNETOM Aera and MAGNETOM Skyra
CFR Code	21 CFR § 892.1000
Classification	Class II
Product Codes	LNH, LNI, MOS
Classification Name	Magnetic Resonance Diagnostic Device,MR Spectroscopy, MR Coils

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SIEMENS

K132831
page 2 of 4

Traditional 510(k) Submission

Information Supporting Substantial Equivalence

DEVICE DESCRIPTION

The software version syngo MR D13A is updated for two Siemens MR systems:

o MAGNETOM Aera (1.5T)
o MAGNETOM Skyra (3T)

Systems that are already in clinical use and at customer sites can be updated with this software update; both MAGNETOM systems can be manufactured with this software update.

This software update includes modified software sequences for MAGNETOM Aera and MAGNETOM Skyra.

MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D13A were previously cleared under K121434 (November 5, 2012).

Summary of Features New with the Software Update compared to the commercially available Software Version syngo MR D13A:

Software

Modified sequences: .
- Quiet sequences o
- VIBE sequence improvements o

INTENDED USE

The MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A 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.

NONCLINICAL TESTS

Software Update syngo MR D13A for MAGNETOM Aera/Skyra

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K132831
page 3 of 4

SIEMENS

Performance testing such as acoustic noise testing was conducted on the subject device. Additionally, all 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

There were not any clinical tests conducted to support the subject device and the substantial equivalence argument, however clinical images are provided to support the modified software features of the subject device.

SUBSTANTIAL EQUIVALENCE

Software update to the commercially available software version syngo MR D13A for MAGNETOM Aera and MAGNETOM Skyra is substantially equivalent to the following predicate devices:

Predicate Device Name	FDAClearanceNumber	FDA ClearanceDate	MainProductCode
MAGNETOM Aera, Skyra,Avanto, and Verio with syngo®MR D13A	K121434	November 5, 2012	LNH

Predicate device for Software Update to the commercially available software version Table 1 syngo MR D13A for MAGNETOM Aera and MAGNETOM Skyra

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 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.

MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A conform 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.

SUBSTANTIAL EQUIVALENCE CONCLUSION

There are no changes to the Indications for Use for the subject device, compared to that of the predicate MAGNETOM scanners with software syngo MR D13A.

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SIEMENS

Traditional 510(k) Submission

While the updated software provides the user with additional capabilities compared to the two subject MAGNETOM systems with the previous software version syngo MR D13A, it has the same technological characteristics as that of the predicate devices. The modifications of the updated software version make the systems and software more user- and patient-friendly - providing imaging techniques with lower noise towards the patient: improving the user's workflow: providing additional information and options to the user.

The differences between the subject device and the predicate devices, which include the aforementioned modified sequences, give the systems greater capabilities than the predicate devices, but have the same technological characteristics as the predicate devices, are similar to the functionalities of the predicate devices, and do not introduce any new issues of safety or effectiveness.

Therefore. Siemens believes that the subject device, the updated software version syngo MR D13A for MAGNETOM systems Aera and Skyra is substantially equivalent to the predicate devices listed above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 1. 2013

Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist 51 Valley Stream Parkway, MC D02 MALVERN PA 19355

Re: K132831

Trade/Device Name: Syngo MR D13A-AP-AA software update Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 25, 2013 Received: September 26, 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. Iisting 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

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

for

Janine M. 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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Indications for Use

510(k) Number (if known): K132831

Device Name: Syngo MR D13A-AP-AA software update for MAGNETOM Aera and MAGNETOM Skyra

Indications for Use:

Prescription Use × (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 Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign-Off Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

210(k) K 13283 1

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.