CAROTID COIL 5000004901

K092962 · Shanghai Chenguang Medical Technologies Co, Ltd. · MOS · Oct 9, 2009 · Radiology

Device Facts

• Record ID: K092962
• Device Name: CAROTID COIL 5000004901
• Applicant: Shanghai Chenguang Medical Technologies Co, Ltd.
• Product Code: MOS · Radiology
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

The Carotid Coil is an 8-channel phased array, receive-only MRI coil designed for imaging the carotid arteries. It functions as a component within a compatible Philips 3.0T MRI system. The device captures magnetic resonance signals from the carotid region, which are then processed by the host MRI system to generate diagnostic images. These images are reviewed by a trained physician to assist in clinical diagnosis. The device is intended for use in a clinical or hospital setting by trained medical professionals.

Clinical Evidence

Bench testing only. Evidence includes safety tests, performance tests, biocompatibility tests, and IEC 60601-1 compliance testing. No clinical data provided.

Technological Characteristics

8-channel phased array, receive-only MRI coil. Compatible with Philips 3.0T MRI systems. Compliant with IEC 60601-1 standards.

Indications for Use

Indicated for patients requiring diagnostic imaging of the carotid arteries using magnetic resonance imaging systems. For use by trained physicians.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Machnet Carotids Coil Array Assembly (K012491)

Submission Summary (Full Text)

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OCT - 9 2009

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* 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

Telephone: -- 86-21-52961075-837 Fax: -- 86-21-52961075-826 E-mail: [e-mail] Company Contact: Jie Huang Date Summary Prepared: Apr 10, 2009

Device Name: Carotid Coil Applicability: Compatible with PHILIPS 3.0T System 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: Model 5000004901 Carotid Coil Establishment Registration Number: 3006239787 Regulatory Class: II

### Predicate Devices (Legally Marketed Devices)

The predicate device for the Carotid Coil is the Machnet Carotids Coil Array Assembly from Machnet B.V., with the 510k number of K012491.

# Device Description

The Carotid Coil is an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yields information that may assist in diagnosis.

# Intended Use

Diagnostic Uses: 2D, 3D imaging, proton density, T1 and T2 weighted imaging, 2D, 3D time of flight, phase contrast imaging.

Anatomic regions: carotid.

### Comparison with Predicate Device:

The Carotid Coil and the predicate device has the similar intended use, work in the similar principle, is compliant with the similar standards and is of the similar safety and effectiveness.

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K092962

مسلم

# Conclusions

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The submitted Carotid Coil have been proved to be safe and effective by safety tests, performance tests, bio-compatibility tests, practical application tests and JEC60601-1 compliance tests. All the tests results are available in section 10 of this submission.

i

As stated above, the Carotid Coil, comply with the appropriate medical device standards and are as safely and effectively substantially equivalent to the earlier identified predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

# 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

Shanghai Chenguang Medical Technologies Co., Ltd. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747

OCT - 9 2009

Re: K092962

> Trade/Device Name: Magnetic Resonance Diagnostic Device, 5000004901, Carotid Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: MOS Dated: September 18, 2009 Received: September 25, 2009

Dear Mr. Conry:

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.

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

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Janine M. Morris

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

Enclosure

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K092962

#### Indications for Use Section 3

510(k) Number (if known):

্রামের মাধ্যমে বাংলাদেশ করে আন্তর্জাতিক প্রকল্প করে আন্তর্জাতিক প্রকল্প করে আর করে আন্তর্জাতিক প্রকল্প করে আর করে আর করে আর করে আর করে আর করে আর করে আর করে আনা করে আর করে আর

Device Name: Magnetic Resonance Diagnostic Device, 5000004901, Carotid Coil

K092962

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

Prescription Use V (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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