TOSHIBA 1.5T EXTRA LARGE KNEE COIL

K103185 · Quality Electrodynamics · MOS · Feb 25, 2011 · Radiology

Device Facts

• Record ID: K103185
• Device Name: TOSHIBA 1.5T EXTRA LARGE KNEE COIL
• Applicant: Quality Electrodynamics
• Product Code: MOS · Radiology
• Decision Date: Feb 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resonance scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.

Device Story

The Toshiba 1.5T Extra Large Knee Coil is a specialty radiofrequency (RF) coil designed for use with Toshiba 1.5T EXCELART Vantage and 1.5T Vantage Titan MR systems. It functions as an accessory to the MR scanner, receiving RF signals from the knee anatomy during imaging procedures. The device is used in clinical imaging environments by trained medical professionals. The coil facilitates the acquisition of diagnostic-quality MR images of the knee, which are then interpreted by a physician to aid in clinical decision-making and diagnosis of knee pathologies. The device provides a larger form factor to accommodate patients requiring a larger knee coil, potentially improving patient comfort and image quality for this population.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety) and IEC 60601-2-33 (SAR requirements) was verified. Signal-to-noise ratio (SNR) performance was validated using internal manufacturer protocols.

Technological Characteristics

Specialty MR receive coil. Materials: Enclosure materials cleared under K072935 and K093667. Sensing principle: RF signal reception for 1.5T MR systems. Standards: IEC 60601-1, IEC 60601-2-33. Form factor: Extra large knee coil. Connectivity: Dedicated interface for Toshiba 1.5T EXCELART Vantage and Vantage Titan systems.

Indications for Use

Indicated for use with Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan MR scanners to produce diagnostic knee images for interpretation 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 QD Knee/Foot Coil (K051763)

Submission Summary (Full Text)

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

# KID3

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

### FEB 25 2011

#### 1. Applicant

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

#### 2. Contact

Christie Zydyk, MBA Chief Regulatory Affairs and Quality Assurance Officer

#### 3. Date prepared:

February 25, 2011

#### 4. Tradename

Toshiba 1.5T Extra Large Knee Coil

#### 5. Common name

Coil, magnetic resonance, specialty

#### 6. Classification

21 CFR 892.1000

#### 7. Equivalent Device

| Trade name | Legally marketed predicate device | Manufacturer |
|---------------------------------------|-----------------------------------|-------------------------------|
| Toshiba 1.5T Extra Large<br>Knee Coil | 1.5T QD Knee Coil | Toshiba Medical Systems Corp. |

#### 8. Device Description

The Toshiba 1.5T Extra Large Knee Coil is designed for use with the with the 1.5T EXCELART Vantage and the 1.5T Vantage Titan MR Systems manufactured by Toshiba Medical Systems Corporation.

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

#### 9. Intended Use

For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resonance scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.

#### 10. Comparison with Predicate Devices

| 510(k) # | Legally marketed predicate device | Manufacturer |
|----------|-----------------------------------|-------------------------------|
| K051763 | 1.5T QD Knee/Foot Coil | Toshiba Medical Systems Corp. |

The Toshiba 1.5T Extra Large Knee Coil and the predicate device have the same intended use as well as similar designs and are constructed of similar materials. Specifically, the enclosure materials used in Toshiba 1.5T Extra Large Knee Coil have been previously cleared under K072935 and K093667.

#### 11. Non-Clinical Tests

The Toshiba 1.5T Extra Large Knee Coil was tested to and found complaint with IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 1988 plus Amendments 1 (1991) and 2 (1995).

The coil SAR complies with the requirements of IEC 60601-2-33, Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis, 2002 plus Amendment 1 (2005).

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

#### 12. Conclusion

It is the opinion of Quality Electrodynamics that the Toshiba 1.5T Extra Large Knee 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.

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

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 stylized eagle with three stripes forming its body and wings. The eagle is facing 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

Quality Electrodynamics % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

FEB 2 5 2011

Re: K103185

Trade/Device Name: Toshiba 1.5T Extra Large Knee Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 12, 2011 Received: January 13, 2011

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 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

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

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,

Mary S. Postel

Mary Pastel. ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known):

Device Name: Toshiba 1.5T Extra Large Knee Coil

Indications for Use:

For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resonance scanner to produce diagnostic images of the knee 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 Device Evaluation (ODE) O ITVD

Mary S. Pastel

Office of Ir

510k

Page 1 of 1