The speciality coils are indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the body. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

The Speciality Coils are intended to be used in conjunction with the MAGNETOM ESSENZA, a Magnetic Resonance Diagnostic Device. These coils will be used to present images which reflect the spatial distribution and the other physical parameters derived from the images may also be produced. The Speciality Coils will include: 8-Channel Wrist Coil, 4-Channel Special-Purpose Coil, 8-Channel Foot-Ankle Coil, and the Focus Shoulder Array Coil, Small for the existing 1.5T MAGNETOM ESSENZA Magnetic Resonance System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the modification of existing coils and the introduction of new specialty coils for an MRI system. The key acceptance criteria revolve around safety and performance parameters, particularly Signal-to-Noise Ratio (SNR) and Image Uniformity, compared to predicate devices.

Acceptance Criteria	Reported Device Performance
Safety Parameters:
Maximum Static Field	Unaffected by modifications (implied to meet existing standards)
Rate of Change of Magnetic Field	Unaffected by modifications (implied to meet existing standards)
RF Power Deposition	Unaffected by modifications (implied to meet existing standards)
Acoustic Noise Level	Unaffected by modifications (implied to meet existing standards)
Biocompatibility	No new materials were used for the new specialty coils compared to their predicate device, therefore no new biocompatibility tests were performed. (Implied to meet existing biocompatibility standards of predicate devices)
Performance Parameters:
Geometric Distortion	Unaffected by modifications (implied to meet existing standards)
Slice Profile, Thickness and Gap	Unaffected by modifications (implied to meet existing standards)
High Contrast Spatial Resolution	Unaffected by modifications (implied to meet existing standards)
Signal to Noise Ratio (SNR)	"Signal to Noise Ratio (SNR) and image uniformity tests were performed for the new speciality coils and the results presented in this submission show that they are equivalent with the predicate devices." (Specific quantitative values for performance or acceptance thresholds are not provided in the summary, but equivalence to predicate devices is claimed.)
Image Uniformity	"Signal to Noise Ratio (SNR) and image uniformity tests were performed for the new speciality coils and the results presented in this submission show that they are equivalent with the predicate devices." (Specific quantitative values for performance or acceptance thresholds are not provided in the summary, but equivalence to predicate devices is claimed.)

Study Details

The provided document describes a bench testing approach to demonstrate substantial equivalence, rather than a clinical study involving human subjects or artificial intelligence performance evaluation.

Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the specialty coils themselves, which were tested in a laboratory setting. No patient data or images are referenced as a "test set" in the context of an AI/human performance study. The testing was conducted in a laboratory, so the data provenance would be "in-house laboratory testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for image quality metrics like SNR and uniformity is established through physical measurements and phantom studies, not typically through human expert consensus, especially for hardware (coils) evaluation.
Adjudication method for the test set: Not applicable. The assessment was based on objective physical measurements of the coils' performance.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This submission is for MRI hardware (specialty coils), not an AI algorithm or diagnostic software that would typically undergo such a study. The focus is on the physical performance and safety of the coils themselves.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study was not done. This submission is for hardware.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance parameters (SNR, Image Uniformity) would be based on objective physical measurements using phantoms and established MR safety and performance measurement protocols. This is a technical validation of hardware, not a diagnostic accuracy study.
The sample size for the training set: Not applicable. The device is a set of MRI coils, not an AI algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this hardware submission.

Summary

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K083166

Section 5: 510(k) Summary

5 510(k) Summary

JAN 1 3 2009

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
Siemens Medical Solutions USA, Inc. Establishment 51 Valley Stream Parkway Malvern. PA 19355

Registration Number 2240869

Manufacturer

Siemens Mindit Magnetic Resonance Ltd.

Siemens MRI Center, Gaoxin C. Ave. 2nd Hi-Tech Industrial Park, ShenZhen 518057, PR. China

Registration Number 3004754211

Contact

Elizabeth Lazaro Technical Specialist. Regulatory Submissions 51 Vallev Stream Parkway Malvern. PA 19355 Phone: (610)448-3393 Fax: (610) 448-1787 e-mail:Elizabeth.lazaro@siemens.com

Device Name

Speciality Coils for MAGNETOM ESSENZA Trade Name: Coil, Magnetic Resonance Speciality Classification Name: Class II 21 CFR § 892.1000 Device Class: MOS Product Code: Classification Panel: Radiology

Performance Standards

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

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II. Safety and Effectiveness Information Supporting Substantial Equivalence.

Intended Use

The Speciality Coils are indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, a magnetic resonance diagnostic devices (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the body. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

The Speciality Coils will include: 8-Channel Wrist Coil, 4-Channel Special-Purpose Coil, 8-Channel Foot-Ankle Coil, and the Focus Shoulder Array Coil, Small for the existing 1.5T MAGNETOM ESSENZA Magnetic Resonance System.

Substantial Equivalence

Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, the MAGNETOM ESSENZA with Speciality Coils are substantially equivalent to the following cleared medical devices:

Predicate Device Name	FDA ClearanceNumber	FDA ClearanceDate
Siemens MAGNETOM Avanto 1.5 T(8-Channel Wrist Coil, 8-Channel Foot-Ankle Coil)	K032428	Oct 16, 2003
Siemens MAGNETOM ESSENZA 1.5 T(Focus Shoulder Array Coil)	K071925	Aug 14, 2007
MACHNET CAROTIDS COIL ARRAYASSEMBLY	K012491	Oct 24, 2001

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General Safety and Effectiveness Concerns:

The following safety and performance parameters:

[Safety]

-Maximum Static Field

-Rate of Change of Magnetic Field

-RF Power Deposition

-Acoustic Noise Level

[Performance] -Geometric Distortion -Slice Profile, Thickness and Gap -High Contrast Spatial Resolution

Specified by the FDA Guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.

The following parameters were considered for the new Speciality Coils:

[Safety] -Biocompatibility

[Performance] -Signal to Noise Ratio -Image Uniformity

No new materials were used for the new speciality coils compared to their predicate device. Therefore no new biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests were performed for the new speciality coils and the results presented in this submission show that they are equivalent with the predicate devices.

Conclusion as to Substantial Equivalence

Laboratory testing was performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to effectiveness.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three thick, curved lines and a wavy line at the bottom.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AN 1 3 2009

Ms. Elizabeth Lazaro Regulatory Technical Specialist Siemens Medical Solutions USA. Inc. 51 Valley Stream Parkway MALVERN PA 19533

Re: K083166

Trade/Device Name: Speciality Coils for MAGNETOM ESSENZA Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 23, 2008 Received: September 27, 2008

Dear Ms. Lazaro:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Tanine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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4 Indications for Use Statement

510(k) Number (if known)

Speciality Coils for MAGNETOM ESSENZA Device Name:

Indications for Use:

These images when interpreted by a trained physician yield information that may assist in diagnosis.

(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
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(Division/Sign-Off)

Division of Reproductive, Abdominal and

Radiological Devices
Page

Siemens 510(k) Premarket Notifiqat(ke Number

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.