SHOULDER SPEEDER COIL

K093667 · Quality Electrodynamics · MOS · Jan 28, 2010 · Radiology

Device Facts

• Record ID: K093667
• Device Name: SHOULDER SPEEDER COIL
• Applicant: Quality Electrodynamics
• Product Code: MOS · Radiology
• Decision Date: Jan 28, 2010
• 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 shoulder that can be interpreted by a trained physician.

Device Story

SPEEDER Shoulder Coil is a specialty magnetic resonance (MR) receive-only coil. It interfaces with Toshiba 1.5T EXCELART Vantage and 1.5T Vantage Titan MR systems. The device captures radiofrequency signals from the shoulder anatomy during MR scanning. These signals are processed by the host MR system to generate diagnostic images. Used in clinical radiology settings by trained medical professionals (radiologists/technicians). The coil facilitates high-resolution imaging of shoulder structures, aiding physicians in diagnosing musculoskeletal conditions. It functions as a passive hardware component within the broader MR imaging workflow.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Specialty MR receive-only coil. Designed for 1.5T field strength. Compatible with Toshiba 1.5T EXCELART Vantage and 1.5T Vantage Titan systems. Phased array design. Materials and construction are similar to legally marketed predicate coils.

Indications for Use

Indicated for patients requiring diagnostic shoulder imaging using Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan MR scanners. No specific 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

• 420 GE-64 Phased Array Shoulder Coil (K945778)
• 1.5T Atlas SPEEDER Head-Neck Coil (K083160)

Submission Summary (Full Text)

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# K093667

#### 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

JAN 2 8 2010

Christie Zydyk, MBA VP & GM, Regulatory Affairs, Quality Assurance, & Corporate Communications

3. Date prepared: 12 January 2010

4. Tradename

Shoulder SPEEDER Coil

#### 5. Common name

Coil, magnetic resonance, specialty

#### 6. Classification

21 CFR 892.1000

#### 7. Equivalent Device

| Trade name | Legally marketed predicate device | Manufacturer |
|--------------------------|--------------------------------------|--------------------------------------------|
| SPEEDER<br>Shoulder coil | 420 GE-64 Phased Array Shoulder Coil | Medical Advances Inc. (MAI, now<br>INVIVO) |
| | 1.5T Atlas SPEEDER Head-Neck Coil | Quality Electrodynamics |

#### 8. Device Description

The SPEEDER Shoulder coil is designed for use with the 1.5T EXCELART Vantage and the 1.5T Vantage Titan MR Systems manufactured by Toshiba Medical Systems Corporation.

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age 2/2

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

#### 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 shoulder that can be interpreted by a trained physician.

#### 10. Comparison with Predicate Devices

| 510(k) # | Legally marketed predicate device | Manufacturer |
|----------|--------------------------------------|------------------------------------|
| K945778 | 420 GE-64 Phased Array Shoulder Coil | Medical Advances Inc. (now INVIVO) |
| K083160 | 1.5T Atlas SPEEDER Head-Neck Coil | Quality Electrodynamics |

The SPEEDER Shoulder coil and the predicate devices have intended uses as well as similar designs and are constructed of similar materials.

#### 11. Conclusion

It is the opinion of Quality Electrodynamics that the SPEEDER Shoulder 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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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three tail feathers, representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The seal is simple and monochromatic.

## 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 53313

JAN 2 8 2010

Re: K093667

Trade/Device Name: SPEEDER Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 13, 2009 Received: January 14, 2009

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 iddinons for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmontes, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or o 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, l'isting 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 21c, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish finther 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 af 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 vours.

Donald J. Trump

Donald J. St. Pierre 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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## Indications for Use

510(k) Number (if known): _ K093667

Device Name: SPEEDER Shoulder coil

Indications for Use:

For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resoluce scanner to produce diagnostic images of the shoulder 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)

Dmes. Joff

(Division Sign Off) Division of Radiological Devices .

510(k) Number

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