MAYO CLINIC BC-10 3.0T

K040122 · Mayo Clinic · MOS · Apr 14, 2004 · Radiology

Device Facts

• Record ID: K040122
• Device Name: MAYO CLINIC BC-10 3.0T
• Applicant: Mayo Clinic
• Product Code: MOS · Radiology
• Decision Date: Apr 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Mayo Clinic BC-10 3.0T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body, which can be imaged.

Device Story

The Mayo Clinic BC-10 is a transmit/receive, high-pass, quadrature birdcage MR coil; designed for imaging small extremities (hand, wrist, forearm, elbow) with a 10cm diameter field of view. Used in clinical settings with commercially available 3.0T MRI systems; operated by MRI technicians or radiologists. The coil receives radiofrequency signals from the patient's anatomy during MRI scanning; these signals are processed by the host MRI system to generate diagnostic images. The device provides high signal-to-noise ratio (SNR) imaging for small extremity anatomy; assists clinicians in identifying pathologies like nerve compression or ligament injuries; facilitates accurate diagnosis and treatment planning.

Clinical Evidence

Bench testing only. The device's safety and reliability were verified against predetermined acceptance criteria. Performance data was previously documented in the abbreviated 510(k) submission K031119, confirming substantial equivalence to existing extremity coils.

Technological Characteristics

High-pass, quadrature, transmit/receive (T/R) birdcage coil. 10cm diameter form factor optimized for small extremity anatomy. No external tuning required. Compatible with 3.0T MRI systems. Passive hardware component; no software or energy source integral to the coil itself.

Indications for Use

Indicated for patients requiring MRI imaging of the hand, wrist, forearm, and elbow to diagnose conditions including carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring.

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

• MRI Devices 1.5T phased array wrist coil
• GE Signa 1.5T birdcage, high-pass, quadrature T/R head coil

Reference Devices

• Mayo Clinic BC-10 (K031119)

Submission Summary (Full Text)

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K040122

# Attachment 3: 510(k) Summary of Safety and Effectiveness

This special 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

| Submitter: | Mayo Medical Ventures<br>200 First St. SW<br>Rochester, MN 55905 |
|-----------------|------------------------------------------------------------------|
| Contact Person: | Jade Sadosty<br>Program Manager |
| Telephone: | [phone] |
| Fax: | [phone] |
| Date Prepared: | November 17, 2003 |

#### Device Name:

Mayo Clinic BC-10 3.0T MR coil

## Device Description:

The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.

#### Indications for Use:

The Mayo Clinic BC-10 3.0T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body, which can be imaged.

#### Predicate Device:

The predicate devices for this coil include both the MRI Devices 1.5T phased array wrist coil and the GE Signa 1.5T birdcage, high-pass, quadrature T/R head coil.

| Feature | Mayo Clinic BC-10 | MRI Devices Signa 1.5T |
|--------------------|------------------------------------------------------------------------------------|--------------------------------|
| Coil Type | High-pass, quadrature, T/R | Phased array, receive only |
| Region of Interest | Small extremities < 10cm | Hand and wrist |
| Compatibility | All Signa 1.5T MR systems | Signa 1.5T with PA option only |
| Tuning | No external tuning necessary.<br>Coil is optimized for small<br>extremity anatomy. | No external tuning necessary. |

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| Patient Positioning | Overhead or at patient's side | Overhead or at patient's side |
|-----------------------|--------------------------------------------------------|------------------------------------------------------|
| Imaging Configuration | High SNR for small extremity<br>imaging with 10cm FOV. | High SNR for hand and wrist<br>imaging with 6cm FOV. |

## Summary of Studies:

Testing was performed to demonstrate the Mayo Clinic BC-10 performed in accordance with predetermined acceptance criteria and that the safety and reliability of the coil meets/exceeds standards. Details of this testing are included in the abbreviated 510(k) submission for the referenced device (K031119)

## Conclusions:

The results of the testing and evaluations referenced above show that the Mayo Clinic BC-10 is substantially equivalent to already approved extremity coils. It is a proven design with well documented clinical, safety, and reliability data from years of use at the Mayo Clinic in Rochester, MN.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2004

Ms. Jade Sadosty Program Manager Mayo Medical Ventures 200 First St. SW ROCHESTER MN 55902

Re: K040122

Trade/Device Name: Mayo Clinic BC-10 3.0T MR coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: January 15, 2004 Reccived: January 30, 2004

Dear Ms. Sadosty:

We have reviewed your Scction 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 cither class II (Special Controls) or class III (PMA). it may be subject to 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a dctermination 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 practicc 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ras lotter will and your your e FDA finding of substantial equivalence of your device to a legally prematicated predicated. " 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 It you dock be proceed in the following numbers, based on the regulation number at the top of the letter.

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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#### Attachment 1: Indications For Use

Page 1 of 1

510(k) Number (if known):

K040122

Device Name:

Indications For Use:

The Mayo Clinic BC-10 3.0T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific arca of the body which can be imaged.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Ingram
(Division Sign-Off)

ision of Reproductive, Abdominal, ... Radiological Devices

:10(k) Number

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|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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