The intended use of the new 14-Channel Extremity Coil is, in conjunction with THE 1.5T MAGNETOM ESSENZA Magnetic Resonance Scanner, the MR examination of the human knee, foot, ankle, hand and wrist.

Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist. The images produced by the MAGNETOM ESSENZA with the, 14-Channel Extremity Coil reflects the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The intended use of the MAGNETOM ESSENZA is not affected in any way by the use of the new 14-Channel Extremity Coil.

Device Description

The new 14-Channel Extremity Coil is indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, in the MR examination of the human knee, foot, ankle, hand and wrist.

AI/ML Overview

The provided text describes the 510(k) summary for the Siemens 14-Channel Extremity Coil for 1.5T MAGNETOM ESSENZA. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria, particularly for performance metrics that would typically involve a test set, expert adjudication, or MRMC studies.

Here's an breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document lists safety and performance parameters considered, but it does not specify quantitative acceptance criteria or specific reported device performance values against these criteria. Instead, it states that these parameters were considered and that testing showed equivalence with a predicate device.

Category	Parameter	Acceptance Criteria (Not explicitly stated with values)	Reported Device Performance (as stated in document)
Safety	Maximum Static Field	Specified by FDA Guidance document for MR, Diagnostic Devices (Unaffected by modifications)	Unaffected by the modifications described.
	Rate of Change of Magnetic Field	Specified by FDA Guidance document for MR, Diagnostic Devices (Unaffected by modifications)	Unaffected by the modifications described.
	Acoustic Noise Level	Specified by FDA Guidance document for MR, Diagnostic Devices (Unaffected by modifications)	Unaffected by the modifications described.
	RF Power Deposition (SAR)	Not explicitly stated, but implies meeting FDA guidance/predicate levels	SAR tests were performed for the new 14-Channel Extremity Coil, and the results presented show they are equivalent with the predicate devices.
	Biocompatibility	No new materials used, hence no new tests performed to establish this. Implies equivalence to predicate materials.	No new materials were used, therefore no new biocompatibility tests were performed.
Performance	Geometric Distortion	Specified by FDA Guidance document for MR, Diagnostic Devices (Unaffected by modifications)	Unaffected by the modifications described.
	Slice Profile, Thickness and Gap	Specified by FDA Guidance document for MR, Diagnostic Devices (Unaffected by modifications)	Unaffected by the modifications described.
	High Contrast Spatial Resolution	Specified by FDA Guidance document for MR, Diagnostic Devices (Unaffected by modifications)	Unaffected by the modifications described.
	Signal to Noise Ratio (SNR)	Not explicitly stated, but implies equivalence to predicate's SNR.	SNR tests were performed for the new 14-Channel Extremity Coil, and the results presented show they are equivalent with the predicate devices.
	Image Uniformity	Not explicitly stated, but implies equivalence to predicate's image uniformity.	Image uniformity tests were performed for the new 14-Channel Extremity Coil, and the results presented show they are equivalent with the predicate devices.

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

This information is not provided in the document. The document refers to "laboratory testing" but does not detail the nature of the test set (e.g., patient data, phantom studies), sample size, or provenance. This is a device modification for an existing technology (MR coil), and typically for such submissions, the focus is on technical equivalence rather than clinical performance studies with patient data.

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 provided. Given the nature of a magnetic resonance coil submission, it's unlikely that expert-adjudicated ground truth for a test set of clinical images would be a primary requirement unless novel image interpretation features were introduced. The document emphasizes technical equivalence.

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

This information is not provided.

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

An MRMC comparative effectiveness study was not conducted or mentioned. This is not an AI-assisted device; it's a hardware component (an MRI coil). Therefore, the concept of human readers improving with AI assistance is not applicable.

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

This is not an AI algorithm. It is a hardware component. Therefore, a standalone algorithm performance study is not applicable.

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

The document primarily relies on technical performance metrics (e.g., SNR, uniformity, SAR) and comparison to a predicate device. If patient images were used in testing, the ground truth source is not specified, and typically for coil submissions, the "ground truth" would be the objective measurements of image quality and safety parameters.

8. The sample size for the training set

This is not an AI/software device that requires a training set. This information is not applicable and not provided.

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

This is not an AI/software device that requires a training set. This information is not applicable and not provided.

Summary of the Study (as described in the document):

The study primarily focused on demonstrating substantial equivalence to a predicate device (QED TxRx 15Ch Knee Coil 1.5T). The method involved:

Comparison of Intended Use and Device Description: Showing the new coil is used for the same anatomical regions and produces the same types of images as the predicate.
Assessment of Safety Parameters: Verifying that parameters like Maximum Static Field, Rate of Change of Magnetic Field, and Acoustic Noise Level are unaffected, and that RF Power Deposition (SAR) and Biocompatibility are equivalent to the predicate device.
Assessment of Performance Parameters: Verifying that Geometric Distortion, Slice Profile, Thickness and Gap, and High Contrast Spatial Resolution are unaffected, and that Signal to Noise Ratio (SNR) and Image Uniformity are equivalent to the predicate device.
Laboratory Testing: "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." This testing specifically covered SNR, image uniformity, and SAR.

The document states that the results presented in the submission show that they (SNR, image uniformity, SAR) are equivalent with the predicate devices. This "equivalence" is the primary acceptance criterion and the outcome of the study.

Summary

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Attachment B - 510(k) Summary

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 SolutionsUSA, Inc.51 Valley Stream ParkwayMalvern, PA 19355
Registration Number	2240869
Manufacturer	Siemens Mindit Magnetic Resonance Ltd.Siemens MRI CenterGaoxin C. Ave. 2ndHi-Tech Industrial Park,ShenZhen 518057, PR. China
Registration Number	3004754211
Contact	Kim RendonManager, Regulatory/Clinical Affairs51 Valley Stream Parkway, MS G01Malvern, PA 19355Phone: (610) 717-8085Fax: (610) 448-1787E-mail address: kimberly.rendon@siemens.com
Device Name	Trade Name: 14-Channel Extremity Coil for1.5T MAGNETOM ESSENZAClassification Name: Coil, Magnetic Resonance SpecialtyDevice Class: Class II 21 CFR § 892.1000Product Code: MOSClassification 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 new 14-Channel Extremity Coil is indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, in the MR examination of the human knee, foot, ankle, hand and wrist.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The intended use of the MAGNETOM ESSENZA is not affected in any way by the use of the new 14-Channel Extremity Coil.

Device Description

The new 14-Channel Extremity Coil is indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, in the MR examination of the human knee, foot, ankle, hand and wrist.

Substantial Equivalence

Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, the 14-Channel Extremity Coil is substantially equivalent to the QED TxRx 15Ch Knee Coil 1.5T.

Predicate Device Name	FDA ClearanceNumber	FDA ClearanceDate
TxRx 15Ch Knee Coil 1.5T .(QED)	K082636	Sep. 25, 2008

General Safety and Effectiveness Concerns:

The following are the safety and performance parameters:

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Safety

-Maximum Static Field -Rate of Change of Magnetic Field -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 14-Channel Extremity Coil:

Safety -RF Power Deposition -Biocompatibility

Performance -Signal to Noise Ratio -Image Uniformity

No new materials were used for the new 14-Channel Extremity Coil compared to the predicate device. Therefore no new biocompatibility tests were performed. Signal to Noise Ratio (SNR), image uniformity and SAR tests were performed for the new 14-Channel Extremity Coil 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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a representation of human figures.

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

Ms. Judith Campbell Regulatory Technical Specialist Siemens Medical Solution USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355

AUG 2 7 2010

Re: K100141

Trade/Device Name: 14-Channel Extremity Coil for MAGNETOM ESSENZA Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 6, 2010 Received: August 9, 2010

Dear Ms. Campbell:

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,

Donald J. Trump

Donald J. St.Pierre 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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Attachment A - Indications for Use

510(k) Number (if known): K100141

Device Name: 14-Channel Extremity Coil for MAGNETOM ESSENZA

Indications for Use:

The intended use of the new 14-Channel Extremity Coil is, in conjunction with THE 1.5T MAGNETOM ESSENZA Magnetic Resonance Scanner, the MR examination of the human knee, foot, ankle, hand and wrist.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The intended use of the MAGNETOM ESSENZA is not affected in any way by the use of the new 14-Channel Extremity Coil.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (0) O J V D

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K100141

K100141 - MAGNETOM Essenza 14-Channel Extremity Coil

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.