CORDLESS COIL

K050476 · Siemens Medical Solution, Inc. USA · MOS · Mar 25, 2005 · Radiology

Device Facts

• Record ID: K050476
• Device Name: CORDLESS COIL
• Applicant: Siemens Medical Solution, Inc. USA
• Product Code: MOS · Radiology
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Cordless coil is a receive type surface coil. When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a when about in alle interese to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), and spin-spin echo time (T2) of the corresponding nucleus. When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.

Device Story

Cordless coil is a receive-type surface coil set consisting of two coils; one coupling loop connected via cable and one receive coil inductively coupled to the other. Used within MAGNETOM Concerto and C! MR systems to acquire magnetic resonance signals from internal brain and body surface structures. Device transforms proton spin density, T1, and T2 relaxation data into transverse, sagittal, coronal, and oblique images and spectra. Operated by trained clinical staff in a radiology environment. Output is interpreted by a physician to assist in clinical diagnosis. Benefits include non-invasive visualization of internal anatomy.

Clinical Evidence

No clinical data. Bench testing only. Performance and safety parameters verified against FDA-recognized NEMA standards and IEC 60601-2-33:2002.

Technological Characteristics

Receive-type surface coil set; inductive coupling mechanism; dimensions/form factor specific to MAGNETOM Concerto and C! systems; conforms to IEC 60601-2-33:2002 for MR safety; no active software algorithm; passive hardware component.

Indications for Use

Indicated for use with MAGNETOM Concerto and C! MR systems to produce transverse, sagittal, coronal, and oblique images of internal brain and body surface structures for diagnostic purposes 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

• Coils used with Siemens Medical Solutions MAGNETOM Concerto (K003192)
• Coils used with Siemens Medical Solutions MAGNETOM C! (K043030)

Submission Summary (Full Text)

{0}------------------------------------------------

# Section 1: 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in This Sunmilling of 51 (tr). Sales) and 21 CFR § 807.92.

| I. General Information<br>Device Name | Trade Name: Cordless coil<br>Classification Name: Magnetic Resonance Diagnostic Device<br>CFR Section: CFR § 892.1000<br>Classification: Class II<br>Product Code: LNH |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Rapid Biomedical GmbH<br>Technologiepark Wuerzburg-Rimpar<br>Kettelerstrasse 3-11<br>D-97222 Rimpar, Bayern<br>Germany |
| Initial Importer/Distributor | Siemens Medical Solutions, Inc.<br>51 Valley Stream Parkway<br>Malvern, PA 19355 |
| Registration Number | 2240869 |
| Contact Person | Ms. Ana Ladino<br>Technical Specialist, Regulatory Affairs<br>Siemens Medical Solutions<br>51 Valley Stream Parkway E-50<br>Malvern, PA 19355<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Performance Standards | None established under Section 514 the Food, Drug, and Cosmetic Act. |

{1}------------------------------------------------

## II. Safety and Effectiveness Supporting Substantial Equivalence

#### Intended Use

The Cordless coil is a receive type surface coil.

When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a when about in alle interese to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface.

The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), and spin-spin echo time (T2) of the corresponding nucleus.

When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.

#### Device Description

Device Deserplish
The Cordless Coil. It is a set consisting of two coils. The coupling loop is connected with a cable and one receive coil is inductively coupled to the other.

### Substantial Equivalence

Rabid and Siemens believe that, within the meaning of the Safe Medical Devices Act of 1990, the cordless coil for MAGNETOM Concerto and MAGNETOM C! is substantially equivalent to :

| Coil Name | Premarket Notification | Clearance Date |
|----------------------------------------------------------------|------------------------|----------------|
| Coils used with Siemens Medical Solutions<br>MAGNETOM Concerto | K003192 | 12/21/2000 |
| Coils used with Siemens Medical Solutions<br>MAGNETOM C! | K043030 | 12/09/2004 |

The Cordless Coil for MAGNETOM Concerto and C! described in this Premarket Notification has the same intended use and similar technical characteristics as the devices listed above. In summary, Rapid Biomedical and Siemens are of the opinion that the Cordless coil does not introduce any new safety risks and is substantially equivalent to, and performs as well as, the predicate devices.

## General Safety and Effectiveness Concerns

The cordless coil for MAGNETOM Concerto and MAGNETOM C! will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standard for safety issues with Magnetic Resonance Imaging Devices, IEC 60601-2-33: 2002. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Concerto and C! systems.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ana Ladino Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 MALVERN PA 19355

MAR 2 5 2005

Re: K050476 Trade/Device Name: Cordless Coil for MAGNETOM Concerto and MAGNETOM C! MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II Product Code: MOS Dated: February 18, 2005 Received: February 24, 2005

Dear Ms. Ladino:

We have reviewed vour 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 (Premarket Approval), 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.

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.

{3}------------------------------------------------

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 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.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" (21 CFR 807.97). 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 yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### Indications for Use

KUS 04 76 510(k) Number (if known) __

Cordless Coil for MAGNETOM Concerto and MAGNETOM Device Name: C! MR Systems.

#### Indications for Use:

The Cordless coil is a receive type surface coil.

When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a When wood in the nirrore to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface.

The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin distinguision. Inc relaxation time (T1), and the spin-spin echo time (T2) of the corresponding nucleus.

When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device

Evaluation

Prescription Use_ V

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Nancy bradon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050476

Traditional 510(k) Premarket Notification Cordless Coil for MAGNETOM Concerto and C! CONFIDENTIAL