TOSHIBA 1.5T CARDIAC COIL

K120290 · Quality Electrodynamics · MOS · Feb 28, 2012 · Radiology

Device Facts

• Record ID: K120290
• Device Name: TOSHIBA 1.5T CARDIAC COIL
• Applicant: Quality Electrodynamics
• Product Code: MOS · Radiology
• Decision Date: Feb 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Toshiba 1.5T Cardiac coil is intended for use with the Toshiba 1.5T Vantage Titan MRI system to produce diagnostic images of the heart that can be interpreted by a trained physician.

Device Story

The Toshiba 1.5T Cardiac Coil is a specialty magnetic resonance imaging (MRI) coil designed for use with the Toshiba 1.5T Vantage Titan MRI system. It functions as a receiver coil to capture radiofrequency signals from the heart during MRI procedures. The device is operated by trained clinical staff in a radiology or clinical setting. The captured signals are processed by the MRI system to produce diagnostic images of the heart, which are then interpreted by a physician to aid in clinical decision-making and patient diagnosis. The coil is a passive hardware component of the imaging chain.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety/performance) and NEMA MS-3 2008 (image uniformity) was demonstrated. Signal-to-noise ratio (SNR) was verified via internal protocol.

Technological Characteristics

Specialty MRI receiver coil. Materials consistent with previously cleared devices (K093667, K091114, K112313). Compliant with IEC 60601-1 (safety) and NEMA MS-3 2008 (image uniformity). Passive hardware component; no software or active electronic processing within the coil itself.

Indications for Use

Indicated for patients requiring diagnostic cardiac imaging using the Toshiba 1.5T Vantage Titan MRI system. 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

• 1.5T SENSE Cardiovascular Array Coil (K061952)

Submission Summary (Full Text)

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#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. Applicant

Quality Electrodynamics (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143 Phone [phone]

# 2. Contact

Christie Zydyk Chief Quality and Regulatory Affairs Officer

#### 3. Date prepared:

January 30, 2012

#### 4. Tradename

Toshiba 1.5T Cardiac Coil

#### 5. Common name

Coil, magnetic resonance, specialty

#### 6. Classification

21 CFR 892.1000

### 7. Equivalent Device

| Trade name | Legally marketed<br>predicate device | Manufacturer |
|---------------------------|-----------------------------------------|--------------------|
| Toshiba 1.5T Cardiac Coil | 1.5T SENSE<br>Cardiovascular Array Coil | Invivo Corporation |

#### 8. Device Description

The Toshiba 1.5T Cardiac Coil is designed for use with the Toshiba 1.5T MRI system manufactured by Toshiba Medical Systems Corporation.

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FEB 2 8 2012

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#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# 9. Indications for Use

The Toshiba 1.5T Cardiac coil is intended for use with the Toshiba 1.5T Vantage Titan MRI system to produce diagnostic images of the heart that can be interpreted by a trained physician.

## 10. Comparison with Predicate Devices

| 510(k) # | Legally marketed predicate<br>device | Manufacturer |
|----------|-----------------------------------------|--------------------|
| K061952 | 1.5T SENSE Cardiovascular Array<br>Coil | Invivo Corporation |

The Toshiba 1.5T Cardiac coil and the predicate device have the same intended use, and are of a similar design. The Toshiba 1.5T Cardiac coil is constructed of the same materials as the devices in the following previously cleared submissions: K093667, K091114, and K112313.

# 11. Non-Clinical Tests

The Toshiba 1.5T Cardiac coil was tested to and found compliant with IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, second and third editions.

The signal-to-noise ratio (SNR) was measured according to Toshiba Medical Systems Corporation's internal protocol.

Image Uniformity was assessed in accordance with NEMA MS-3 2008, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images

## 12.Conclusion

It is the opinion of Quality Electrodynamics that the Toshiba 1.5T Cardiac coil is substantially equivalent to the above-listed legally marketed predicate devices. Use of the Quality Electrodynamics coil does not result in any new potential hazards.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -. WO66-G609 Silver Spring, MD 20993-0002

Ms. Christie Zydyk Chief Quality and Regulatory Affairs Officer Quality Electrodynamics 700 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143

FEB 2 8 2012

Re: K120290

Trade/Device Name: Toshiba 1.5T Cardiac Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 21, 2012 Received: February 22, 2012

Dear Ms. Zydyk:

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 (QS) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Mdrri Acting 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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K120290 510(k) Number (if known):

Device Name: Toshiba 1.5T Cardiac Coil

Indications for Use:

The Toshiba 1.5T Cardiac coil is intended for use with the Toshiba 1.5T Vantage Titan MRI system to produce diagnostic images of the heart that can be interpreted by a trained physician.

Prescription Use (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 In Vitro Diagnostic Devices (OIVD)

Mary S. Patel

Division Sign-Off Office of in Vitro Diagnostic Device Evaluation and Safety

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