1.5T ATLAS SPEEDER HEAD-NECK COIL

K083160 · Quality Electrodynamics · MOS · Nov 7, 2008 · Radiology

Device Facts

• Record ID: K083160
• Device Name: 1.5T ATLAS SPEEDER HEAD-NECK COIL
• Applicant: Quality Electrodynamics
• Product Code: MOS · Radiology
• Decision Date: Nov 7, 2008
• 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 Excelart Vantage Atlas or Vantage Titan MR scanner to produce diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest that can be interpreted by a trained physician.

Device Story

1.5T Atlas SPEEDER Head-Neck coil is a phased array, multi-channel, receive-only MR coil. Device consists of rigid posterior head base, flexible posterior chest assembly, and removable rigid assemblies tailored to specific anatomy. Foam pads included for patient positioning and comfort. Used in clinical settings with Toshiba Excelart Vantage Atlas or Vantage Titan MR scanners. Operates as a passive signal receiver for MR imaging; output is raw signal data processed by the host MR scanner into diagnostic images. Physician interprets images to aid in clinical diagnosis of head, neck, and upper chest pathologies. Benefits include high-quality diagnostic imaging of specified anatomical regions.

Clinical Evidence

No clinical data. Substantial equivalence based on design, material, and functional comparison to the predicate device.

Technological Characteristics

Phased array, multi-channel, receive-only MR coil. Components include rigid posterior head base, flexible posterior chest assembly, and removable rigid assemblies. Materials are standard for MR coil construction. Compatible with Toshiba Excelart Vantage Atlas/Titan 1.5T scanners.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest. For use with Toshiba Excelart Vantage Atlas or Vantage Titan MR scanners.

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 Head Speeder Coil (K041487)

Submission Summary (Full Text)

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

K083/60

## 1. Applicant

Quality Electrodynamics (QED) 777 Beta Drive Mayfield Village, OH 44143 Phone [phone]

NOV - 7 2008

#### 2. Contact

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

### 3. Date prepared:

Revised - October 24, 2008

#### 4. Tradename

1.5T Atlas SPEEDER Head-Neck Coil

#### Common name 5.

Coil, magnetic resonance, specialty

#### Classification 6.

21 CFR 892.1000

## 7. Equivalent Device

1.5T QD Head Speeder Coil manufactured by USA Instruments Inc. (K041487).

## 8. Device Description

The Atlas SPEEDER Head-Neck coil is a phased array, multi-channel, receive-only coil. The coil consists of a rigid posterior head base and a flexible posterior chest assembly that are used in combination with various removable rigid assemblies selected based on the anatomy of interest. Foam pads also aid in positioning and enhance patient comfort.

### 9. Intended Use

For use with a Toshiba Excelart Vantage Atlas or Vantage Titan MR scanner to produce diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head. neck and upper chest that can be interpreted by a trained physician.

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

### 10. Comparison with Predicate Devices

| 510(k) # | PERSONAL MARKET AND ALL ALL ALL ALL ALL ALL ALL ALL ALL ALL ALL ALL PROPERT PRESENT STORE FOR STORE FOR STORE FOR A PRODUCT OF PRESENT FOR CONSULT OF PRESENT AND A PROPERTY C<br>Device | Manufacturer |
|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| K041487 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>And Annual Angeland Andrews Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children<br>1.5T QD Head Speeder Coil | USA Instruments Inc. |

The 1.5T Atlas SPEEDER Head-Neck coil and the predicate device are designed for use in conjunction with magnetic resonance scanners to produce diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest that can be interpreted by a trained physician. The 1.5T Atlas SPEEDER Head-Neck coil and the predicate device have similar designs and are constructed of similar materials. The main differences are the number of channels and the number of removable assemblies to accommodate different imaging options.

### 11.Conclusion

It is the opinion of Quality Electrodynamics that the 1.5T Atlas SPEEDER Head-Neck coil is substantially equivalent to the above-listed legally marketed predicate device. Use of the Quality Electrodynamics coil does not result in any new potential hazards

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Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

# NOV - 7 2008

Re: K083160

Trade/Device Name: 1.5T Atlas SPEEDER Head-Neck Coil Regulation Number: 21 CFR 892.1000 · Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 24, 2008 Received: October 27, 2008

### 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 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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#### Page 2

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 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.xxx<br>21 CFR 884.xxx | (Gastroenterology/Renal/Urology)<br>(Obstetrics/Gynecology) | 240-276-0115<br>240-276-0115 |
|----------------------------------|-------------------------------------------------------------|------------------------------|
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.

Sincerely yours,

hoque Mr. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

1.5T Atlas SPEEDER Head-Neck Coil

Indications for Use:

For use with a Toshiba Excelart Vantage Atlas or Vantage Titan MR scanner to produce diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest.hat can be interpreted by a trained physician.

Prescription Use (Part 21 CFR 801 Subpart D)

510(k) Number

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of ODRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices