The carotid coil is a receive-only coil, used for high resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T General Electric, Siemens and Philips Magnetic Resonance Imaging (MRI) systems. Nucleus Excited: Proton 1H Anatomic regions: Carotid. The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Description

Carotid Coil is a phased array, receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. Semi-flexible design makes the coil reliable and comforts the patient. The enclosure, which may contact the patient, is made up of biocompatible material.

AI/ML Overview

The provided document is a 510(k) Summary for a Magnetic Resonance Diagnostic Device, Carotid Coil. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its clinical performance against specific acceptance criteria for diagnostic accuracy.

Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not applicable or not provided in this type of submission document, as it is a submission for a medical device (coil) used for imaging, not a diagnostic algorithm.

Here's a breakdown of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not outline specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) of a device that interprets images. The "performance tests" mentioned refer to technical parameters of the coil itself.

Acceptance Criteria (Technical)	Reported Device Performance (Technical)
Bio-compatibility tests	Complies with ISO 10993-5 and ISO 10993-10
IEC60601-1 compliance tests	Complies with UL 60601-1
Safety and Effectiveness	Proved safe and effective by performance tests, biocompatibility tests, and IEC60601-1 compliance tests; substantially equivalent to predicate device.

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

Not Applicable / Not Provided. This document describes a physical medical device (an MRI coil), not a diagnostic algorithm that processes data. Therefore, there is no "test set" in the context of diagnostic performance evaluation. The "performance tests" refer to the engineering and technical performance of the coil.

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)

Not Applicable / Not Provided. See point 2.

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

Not Applicable / Not Provided. See point 2.

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. This is not a study of an AI or diagnostic algorithm, but a physical MRI coil. An MRMC study would not be relevant here.

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

Not Applicable. This is a physical MRI coil, not an algorithm.

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

Not Applicable / Not Provided. The "ground truth" concept as applied to diagnostic algorithms is not relevant for this submission about an MRI coil. The "ground truth" for the coil's performance would be its technical specifications verified by engineering tests.

8. The sample size for the training set

Not Applicable / Not Provided. This is a physical MRI coil, not a machine learning algorithm.

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

Not Applicable / Not Provided. See point 8.

Additional Information provided in the 510(k) Summary:

Device Type: Magnetic Resonance Imaging Coil (receive-only, phased array, 8 elements).
Intended Use: High resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T GE, Siemens, and Philips MRI systems. Nucleus Excited: Proton 1H.
Indications for Use: Obtaining diagnostic images of the carotid for interpretation by a trained physician to assist in diagnosis.
Predicate Device: Carotid Coil, manufactured by Shanghai Chenguang Medical Technologies Co., Ltd. (510k number K092962).
Demonstration of Performance: Substantial equivalence was demonstrated through:
- Performance tests (technical specifications of the coil).
- Bio-compatibility tests (compliance with ISO 10993-5 and ISO 10993-10).
- IEC60601-1 compliance tests (compliance with UL 60601-1).
Conclusion: The device is considered safe and effective and substantially equivalent to the predicate device based on similarities in design features, overall indications for use, and technological characteristics.

Summary

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K1120.0.2

NOV 1 8 2011

This document can be copied and submitted to interested parties as required by 21 CFR 807.92.

510(k) Summary of Safety and Effectiveness

Submitter: Shanghai Chenguang Medical Technologies Co., Ltd Building 8, Lane 1199, Jidi Road, Shanghai, P.R.C. 201107

Company Contact: Name: Meijuan Chen Telephone: +86-21-52961075-833 Fax: +86-21-52961075-826 E-mail: chenmeijuan@shanghaicg.net Date Summary Prepared: May 26, 2011

Reason for 510(K): New Device Classification Name: Magnetic Resonance Diagnostic Device Classification Panel: Radiology Classification Number: 892.1000 Product Code: MOS Common Name: Magnetic Resonance Imaging Coil Proprietary Name: Carotid Coil Establishment Registration Number: 3006239787 Regulatory Class: II

Predicate Devices (Legally Marketed Devices)

Carotid Coil, manufactured by Shanghai Chenguang Medical Technologies Co., Ltd.

510k number is K092962.

Device Description

Coil type	Part number	Compatible system	Field strength
Carotid Coil	5000011501 or0200130101	GE	3T
	5000011401 or0300190101	Siemens	3T
	5000021901 or0100450201	Philips	1.5T
	5000002201 or0200120201	GE	1.5T
	5000022001 or	Siemens	1.5T

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of Children Concession Concession Concession Corporation of Children Company of	STATE AND THE FOR FREE FOR COLLECTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION0300190201	ートーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー
Canada Canada Caracterial Concession	AND THE LEAST	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The enclosure of all the carotid coils above is the same. The enclosure, which may contact the patient, is made up of biocompatible material.

Intended Use

Anatomic regions: Carotid.

Indications for Use:

The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Comparison with Predicate Device:

Carotid Coil is similar to the Shanghai Chenguang Medical Technologies Co., Ltd. made predicate device in all aspects as follow:

Intended use- The carotid coil is a receive-only coil, used for high resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T General Electric, Siemens and Philips Magnetic Resonance Imaging (MRI) systems. Anatomic regions: Carotid.

Indication for use- The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Technical Characteristics-The MR system is an imaging device. The fundamental scientific technology of a radio frequency (RF) coil is that the coil receives radio frequency signals from the tissue of interest. It is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.

The fundamental scientific technology of the subject device is the same as the predicate device.

Suitable standards - UL 60601-1, ISO 10993-5 and ISO 10993-10.

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Conclusions

The submitted Carotid Coil has been proved to be safe and effective by performance tests, bio-compatibility tests and IEC60601-1 compliance tests.

As stated above, Carotid Coil complies with the appropriate medical device standards and is substantially equivalent to the predicate device in safety and effectiveness based on similarities in design features, overall indications for use, and technological characteristics.

It is the opinion of Shanghai Chenguang Medical Technologies Co. LTD. that the Carotid Coils are substantially equivalent to Shanghai Chenguang Medical Technologies Co. LTD. made Carotid Coil (K092962). Testing and usage of the Carotid Coils do not result in any new potential hazards.

End of Section -

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the left side of the emblem.

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

Mr. Meijuan Chen Regulatory Engineer Shanghai Chenguang Medical Technologies Co., LTD Building 8, Lane 1199, Jidi Road 201107 SHANGHAI CHINA

NOV 1 8 2011

Re: K112002

Trade/Device Name: Magnetic Resonance Diagnostic Device, Carotid Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 14, 2011 Received: November 14, 2011

Dear Mr. Chen:

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 (OS) 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,

Mary Pastel

Mary S. Pastel, Sc.D. 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 3 Indications for Use

510(k) Number (if known): _ K 11 200 2

Device Name: Magnetic Resonance Diagnostic Device, Carotid Coil

Indications for Use: The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

End of Section -

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K1262

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.