SPEEDER 1.5T WRIST ARRAY COIL

K072935 · Quality Electrodynamics · MOS · Oct 31, 2007 · Radiology

Device Facts

• Record ID: K072935
• Device Name: SPEEDER 1.5T WRIST ARRAY COIL
• Applicant: Quality Electrodynamics
• Product Code: MOS · Radiology
• Decision Date: Oct 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

For use with a 1.5T Toshiba Vantage magnetic resonance scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician.

Device Story

1.5T Wrist Array Coil is a six-channel phased-array receive-only MRI coil. Device features a rigid, fire-rated, impact-resistant clamshell enclosure designed to match hand and wrist anatomy; includes an adapter plate for patient positioning. Used in clinical MRI settings; operated by MRI technicians or radiologists. Device receives RF signals from patient anatomy during MRI scanning; signals are processed by the host 1.5T Toshiba Vantage scanner to generate diagnostic images. Output is viewed by physicians to assist in clinical diagnosis of wrist and hand conditions. Benefits include improved image quality and patient positioning for specialized musculoskeletal imaging.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Six-channel phased-array receive-only MRI coil. Rigid, fire-rated, impact-resistant mechanical housing with clamshell design. Designed for 1.5T Toshiba Vantage MRI scanners. No active electronic components mentioned beyond receive-only array circuitry.

Indications for Use

Indicated for patients requiring diagnostic MRI imaging of the wrist and hand using a 1.5T Toshiba Vantage scanner. Intended 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

• HRW-63-8 Wrist Array Coil (K050622)
• Alpha 5000 Wrist Coil (K031143)
• Alpha 7000 Wrist Coil (K972205)

Submission Summary (Full Text)

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

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

00: 3 : 2037

#### 2. Contact:

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

## 3. Date prepared:

September 14, 2007

4. Tradename: SPEEDER 1.5T Wrist Coil

## 5. Common name:

Coil, magnetic resonance, specialty

## 6. Classification:

21 CFR 892.1000

#### 7. Equivalent Device

HRW-63-8 Wrist Array Coil by MRI Devices, K050622

#### 8. Device Description

The 1.5T Wrist Array Coil is a six channel phased array receive only coil. The coil has a rigid enclosure which is fire-rated and has impact and tensile strength. The mechanical housing is designed to follow the natural contours of the hand and wrist anatomy. The clamshell design allows the coil to open for patient positioning and alignment without electrical connections between the halves. The mechanical package also includes an adapter plate which can be used to help position patients.

#### 9. Intended Use

For use with a 1.5T Toshiba Vantage magnetic resonance scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician.

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

## 10. Comparison with Predicate Devices

| 510(k) # | Device | Manufacturer |
|----------|---------------------------|-----------------|
| K050622 | HRW-63-8 Wrist Array Coil | MRI Devices |
| K031143 | Alpha 5000 Wrist Coil | USA Instruments |
| K972205 | Alpha 7000 Wrist Coil | USA Instruments |

The 1.5T Wrist Array Coil and predicate devices are designed for use in conjunction with magnetic resonance scanners to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician. The 1.5T Wrist Array Coil and the predicate devices have similar designs and are constructed of similar materials. The main differences are the system interface and the number of channels.

#### 11. Conclusion

it is the opinion of Quality Electrodynamics that the 1.5T Wrist Array Coil wrist 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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 3 1 2007

Quality ElectroDynamics % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 24th Street NW BUFFALO MN 55313

Re: K072935

Trade/Device Name: 1.5T Wrist Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 16, 2007 Received: October 17, 2007

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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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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/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

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# Indications for Use

510(k) Number (if known): k072935

Device Name: 1.5T Wrist Array Coil

Indications for Use:

For use with a 1.5T Toshiba Vantage magnetic resonance scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician

Prescription Use
X
(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)

forgie M. Whan

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices الرئيس الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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