The "MAGNETOM Symphony a Tim System" is 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. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

The "MAGNETOM Symphony a Tim System" may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Device Description

Device Deseripati designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Avanto and Symphony systems.

AI/ML Overview

The provided text is a 510(k) summary for the MAGNETOM Symphony a Tim System. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for a new study, but rather refers to conformance with existing standards.
Sample sizes used for the test set and the data provenance: No new test set is described as a performance study was not conducted.
Number of experts used to establish the ground truth for the test set and their qualifications: No new ground truth establishment is described.
Adjudication method: Not applicable as no new test set was used.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as no such study is mentioned.
If a standalone performance study was done: Not applicable as a standalone study to prove performance was not done, rather substantial equivalence was claimed.
The type of ground truth used: Not applicable as no new ground truth was established for a performance study.
The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. Here's what can be extracted regarding the device's "performance" and the "study" that proves it:

Acceptance Criteria and Reported Device Performance (based on Substantial Equivalence):

The "study" in this context is the comparison against predicate devices and adherence to established standards.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Conformance to FDA recognized NEMA Standards for measurement of performance and safety parameters.	The MAGNETOM Symphony a Tim System will conform to these standards.
Conformance to international IEC standard for safety issues with Magnetic Resonance Imaging Devices.	The MAGNETOM Symphony a Tim System will conform to this standard.
Performance and safety that is "safe and effective" with respect to currently available MAGNETOM Avanto and Symphony systems.	The operation of the MAGNETOM Symphony a Tim System is substantially equivalent to the commercially available MAGNETOM 1.5 T Avanto System and 1.5 T Symphony System. This implies its performance and safety are comparable to these cleared devices.

Summary of the "Study" Proving Acceptance Criteria:

The "study" described in the 510(k) summary is not a traditional clinical trial or performance evaluation of the new device's capabilities against specific quantitative metrics. Instead, it's a demonstration of substantial equivalence to previously cleared devices.

Sample size used for the test set and the data provenance: Not applicable. No new test set of patient data was used for a performance study. The "test" is the comparison of the new device's design, hardware types, and intended use against the predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a new test set.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The submission relies on substantial equivalence.
If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: No, a standalone performance study was not done.
The type of ground truth used: Not applicable. The "ground truth" for this submission is the prior FDA clearance and established safety and effectiveness of the predicate devices (Siemens MAGNETOM 1.5 T Avanto and Siemens MAGNETOM 1.5 T Symphony) and their compliance with NEMA and IEC standards.
The sample size for the training set: Not applicable. This is a medical imaging system, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

In essence, the "proof" that the MAGNETOM Symphony a Tim System meets its (implied) acceptance criteria is its demonstration of not introducing new questions of safety and effectiveness compared to predicate devices and its conformance to recognized industry standards. The FDA's review and subsequent clearance (K050199) affirmed this substantial equivalence.

Summary

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12 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in This summary of 910(R) barry and of Safe Medical Device Act 1990 and 21 CFR § 807.92.

I. General Information

Establishment	Siemens Medical Solutions. Inc.51 Valley Stream ParkwayMalvern. PA 19355
Registration Number	2240869
Manufacturer	Siemens AG. Bereich MedHenkestrasse 127D-91052 Erlangen. Germany
Registration Number	8010024
Contact Person	Ms. Ana LadinoTechnical Specialist, Regulatory Submissions51 Valley Stream ParkwayMalvern. PA 19355Phone: (610)448-1785Fax: (610) 448-1787
Device Name	Trade Name: MAGNETOM Symphony a Tim System
	Classification Name: Magnetic Resonance Diagnostic Device
	CFR Code: 21 CFR § 892.1000
	Classification: Class II

Performance Standards

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

Classification:

CONFIDENTIAL

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III. Safety and Effectiveness Information Supporting Substantial Equivalence.

Intended Use

The MAGNETOM Symphony a Tim System is intended for use as a magnetic resonance The MANDI on 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. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

The MAGNETOM Symphony a Tim System may also be used for imaging during interventional procedures performed with MR compatible devices such as in room display and MR safe biopsy needles.

Device Description

Device Deseripati designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Avanto and Symphony systems.

Substantial Equivalence

The system is substantially equivalent to the following cleared medical devices:

Predicate Device Name	FDA ClearanceNumber	FDA Clearance Date
Siemens MAGNETOM 1.5 T Avanto	K032428	10/16/03
Siemens MAGNETOM 1.5 T Symphony	K971684	08/05/97

General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Symphony a Tim System is substantially equivalent to the commercially available MAGNETOM 1.5 T Avanto System and 1.5 T Symphony System.

The MAGNETOM Symphony a Tim System will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Avanto and Symphony systems.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

FEB 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ana Ladino Technical Specialist, Regulatory Submissions Siemens Medical Solutions, USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K050199 Trade/Device Name: MAGNETOM Symphony a Tim System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 26, 2005 Received: January 28, 2005

Dear Ms. Ladino:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have teviewed your becaren be (a) p.
above and have determined the device is substantially equivalent (for the indications for use stated in above and have decemininarketed predicate devices marketed in interstate commerce prior to the chelosure) to regary mannent date of the Medical Device Amendments, or to devices that have been May 20, 1 770, the Chactinent dato of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmen in accordantes internet approval application (PMA). You may, therefore, market the do not require approval of a promance appear. The Act. The general controls provisions of the Act uceries, subject to the generation, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your de rice is classinia (coo acch additional controls. Existing major regulations affecting your Apploval), it may of bacycer to and Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA de roce but of total announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease be advised mat rest in 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 I cacan statues and regalative, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, moractice requirements as set forth in the quality systems (QS) (21 CFR Part 8017, good x20); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin hanceing of substantial equivalence of your device to a legally premarked notheation: The PDA maing of basisification 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 Part 801), please If you desire specific advice for your cerros of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picase note the regulation entitled, formation on your responsibilities under the Act from the 607.77). Tou may obtain outer general and Consumer Assistance at its toll-free number (800) DVISion of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmadsmam.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3 Indications for Use Statement

Koro199 510(k) Number (if known)

Device Name: MAGNETOM Symphony a Tim System

Indications for Use:

The "MAGNETOM Symphony a Tim System" may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room 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 OR Over-The-Counter Use Division Sinn-Of Division of Reproductive. Ab and Radiological Device 510(k) Number

Siemens 510(k) Premarket Notification MAGNETOM Symphony a Tim System

January 26, 2005

Page 14

CONFIDENTIAL

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.