SPECIALTY COILS FOR THE MAGNETOM ESSENZA

K083166 · Siemens Medical Solutions USA, Inc. · MOS · Jan 13, 2009 · Radiology

Device Facts

• Record ID: K083166
• Device Name: SPECIALTY COILS FOR THE MAGNETOM ESSENZA
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jan 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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 Story

Speciality Coils (8-Channel Wrist, 4-Channel Special-Purpose, 8-Channel Foot-Ankle, Focus Shoulder Array) designed for 1.5T MAGNETOM ESSENZA MRI system; function as signal acquisition hardware to capture magnetic resonance signals; images processed by MRI system to display internal anatomy/function; used in clinical radiology settings by trained technicians/physicians; output interpreted by physicians to assist in clinical diagnosis; provides high-resolution imaging of specific anatomical regions.

Clinical Evidence

Bench testing only. Performance evaluated via Signal to Noise Ratio (SNR) and image uniformity testing. Results demonstrate equivalence to predicate devices.

Technological Characteristics

RF receiver coils for 1.5T MRI. Includes 8-Channel Wrist, 4-Channel Special-Purpose, 8-Channel Foot-Ankle, and Focus Shoulder Array. Materials consistent with predicate devices; no new biocompatibility testing required. Connectivity via proprietary interface to MAGNETOM ESSENZA system.

Indications for Use

Indicated for use with 1.5T MAGNETOM ESSENZA MRI systems to produce cross-sectional images of internal body structures/functions for diagnostic assistance by trained physicians. No specific patient population, age, or gender restrictions stated.

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

• Siemens MAGNETOM Avanto 1.5 T (8-Channel Wrist Coil, 8-Channel Foot-Ankle Coil) (K032428)
• Siemens MAGNETOM ESSENZA 1.5 T (Focus Shoulder Array Coil) (K071925)
• MACHNET CAROTIDS COIL ARRAY ASSEMBLY (K012491)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] e-mail:[e-mail]

#### 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 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.

#### 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 Clearance<br>Number | FDA Clearance<br>Date |
|----------------------------------------------------------------------------------------|-------------------------|-----------------------|
| Siemens MAGNETOM Avanto 1.5 T<br>(8-Channel Wrist Coil, 8-Channel Foot-<br>Ankle Coil) | K032428 | Oct 16, 2003 |
| Siemens MAGNETOM ESSENZA 1.5 T<br>(Focus Shoulder Array Coil) | K071925 | Aug 14, 2007 |
| MACHNET CAROTIDS COIL ARRAY<br>ASSEMBLY | 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 [phone] or [phone] 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:

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.

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Concurrence of CDRH, Office of Device Evaluation

| Prescription Use | <div style="display:inline-block;">/</div> | 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