PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201

K081340 · Shanghai Chenguang Medical Technologies Co, Ltd. · MOS · Jun 18, 2008 · Radiology

Device Facts

• Record ID: K081340
• Device Name: PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
• Applicant: Shanghai Chenguang Medical Technologies Co, Ltd.
• Product Code: MOS · Radiology
• Decision Date: Jun 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 1.5T magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.

Device Story

The Model 0100040201-AP Body Cardiac ArrayCoil1.5T 8ch is a receive-only, 8-channel phased array MRI coil; designed for pediatric cardiac and body imaging. The device consists of a base plate and a bottom part with a cable. It functions as an accessory to 1.5T MRI systems; capturing magnetic resonance signals from the patient. The resulting images are interpreted by trained physicians to assist in clinical diagnosis. The device is intended for use in clinical settings where MRI diagnostic procedures are performed.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

8-channel phased array, receive-only MRI coil; designed for 1.5T magnetic resonance imaging systems. Form factor includes a base plate and bottom section with cable. No specific materials or software algorithms described.

Indications for Use

Indicated for pediatric patients requiring diagnostic imaging of cardiac and body regions using Philips Achieva 1.5T MRI systems.

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

• Echelon MR-RCC-150 Coil (K063513)
• Model PHS-63 Pediatric Head Spine Array Coil

Submission Summary (Full Text)

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KOSI3YO

JUN 1 8 2008

* 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: International Regulatory Consultants

For: Shanghai Chenguang Medical Technologies Co., Ltd

Telephone: [phone] Fax: [phone] E-mail: stzhang(@)shanghaicg.net Company Contact: Songtao Zhang Date Summary Prepared: April 5, 2008

### Device Name

Trade Name: Body Cardiac ArrayCoil1.5T 8ch Common Name: Body Cardiac Coil Classification Name: 892.1000 Magnetic Resonance Diagnostic Devices Classification: Class II

### Predicate Devices (Legally Marketed Devices)

A predicate device for the 0100040201-AP Pediatric Cardiac Body coil 1.5T is the Echelon MR-RCC-150 Coil, manufactured by Hitachi and cleared under K063513 and also the Model PHS-63 Pediatric Head Spine Array Coil, manufactured by MRI Devices.

### Device Description

The Model 0100040201-AP Body Cardiac ArrayCoil1.5T 8ch consists of two parts, bottom part with a cable and a base plate. Bottom part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of body and cardiac of a pediatric body in magnetic resonance imaging systems. Bottom part forms an 8channel phased array, receive-only coil, used for obtaining diagnostic images of the Page 17 of 132

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cardiac -body area of a pediatric patient in magnetic resonance imaging systems. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

# Intended Use

The Pediatric Cardiac Body Coil is a receive-only coil, used for obtaining diagnostic images of pediatric body and cardiac regions in magnetic resonance imaging systems. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Anatomic regions: Cardiac Body areas of a pediatric body.

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Image /page/2/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" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2008

Shanghai Chenguang Medical Technologies % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K081340

Trade/Device Name: Magnetic Resonance Diagnostic Device, Model 010040201, Pediatric Body-Cardic Coil

Regulation Number: 21 CFR 892,1000

Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II

Product Code: MOS

Dated: June 2, 2008

Received: June 3, 2008

#### Dear Mr. Job:

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) prematket 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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy 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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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Magnetic Resonance Diagnostic Device, Model 0100040201 , Pediatric Body-Cardiac Coil

Indications for Use: The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 1.5T 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)

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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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Aogn MWhay

(Division Sidn-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __